Tag Archives: vaccines

Another New COVID Strain Is in the US; Will Present Vaccines Work with these New Strains, Pandemic Strategies Including New Migrants and What Happened to Merck’s Vaccine?

This has been an interesting few week and almost led me to close my office and retire. We had a patient come in the office and complete the questionnaire and “by-pass” our screening procedures, lying to us about his exposure to the COVID-19 virus. He just visited his brother the two days before the days office visit and lied to us, saying that he had no recent exposure, etc. However, a week later he called our office to allow notification that his COVID test was positive.

The thing that angered me and my staff more was that the patient waited a number of days to notify, besides lying to us about his exposure. This led us to close the office, cancel all patients until we could have a complete cleaning of the office and all get COVID tested.

Luckily, we all tested negative and all my staff and I had at least had our first vaccine doses. If we had tested positive, we would have to notify all the patients that were seen in the office between his visit and the day that we closed the office.

What an irresponsible set of actions and my fear is that this goes on in many situations because many of our patients, etc. are selfish and irresponsible and don’t care about anyone else except themselves…and they think the virus is all a lie, util one of their family members or close friends dies. How totally stupid and disgusting!! 

John Johnson wrote that the virus continues to mutate quickly. Anyone tracking the news is familiar with the new UK strain that is moving around the globe and threatens to become the dominant strain in the US soon. Now, health authorities in California have identified yet another strain that has popped up in about a dozen counties, reports the Los Angeles Times. Coverage on that and more:

  • California strain: The variant has been linked to large outbreaks in Santa Clara County and smaller outbreaks elsewhere. It’s still too early to say whether the new strain is more contagious or more lethal than the first forms of COVID that emerged, but studies on that are being prioritized. Bottom line: “This virus continues to mutate and adapt, and we cannot let down our guard,” says Dr. Sara Cody, Santa Clara County health officer.
  • A lament: In a New York Times op-ed, Ezra Klein runs through the coming COVID changes under the Biden administration. They include plans to get vaccinations organized on a mass scale, along with expanded testing and contract tracing. It’s all pretty basic stuff, he writes, which has him astonished that the Trump administration hasn’t done these things yet. “That it is possible for Joe Biden and his team to release a plan this straightforward is the most damning indictment of the Trump administration’s coronavirus response imaginable.”
  • Hopeful trend: US deaths are about to pass 400,000, but one medical expert spies a positive trend in the new data as well. “Over the last four days for the first time in months, we’ve seen a steady decline … a thousand per day fewer hospitalizations in the United States,” Dr. Jonathan Reiner of George Washington University tells CNN. “We’ve seen the same trend in new cases.” The next two months will likely be brutal, he adds, “but there is a ray of sunshine” as vaccinations continue.
  • Hopeful, II: In “The Morning” newsletter at the Times, David Leonhardt is tired of the “they’re only 95% effective” drumbeat, and he’s not alone. “It’s driving me a little bit crazy,” Dr. Ashish Jha of the Brown School of Public Health tells Leonhardt. Dr. Aaron Richterman of the University of Pennsylvania adds, “We’re underselling the vaccine.” As Leonhardt explains and doctors emphasize, the vaccine will save your life, even if you’re in that other 5%. To wit, of 32,000 people who got the Pfizer and Moderna vaccines in trials, only one person suffered a severe COVID case.

Migrant caravan demands Biden administration ‘honors its commitments’

Now, a real challenge for the new Biden administration. Adam Shaw noted that a migrant caravan moving from Honduras toward the U.S. border is calling on the incoming Biden administration to honor what it says are “commitments” to the migrants moving north, amid fears of a surge at the border when President-elect Joe Biden enters office.

More than 1,000 Honduran migrants moved into Guatemala on Friday without registering, The Associated Press reported. That is part of a larger caravan that left a Honduran city earlier in the day.

The outlet reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.

“We recognize the importance of the incoming Government of the United States having shown a strong commitment to migrants and asylum seekers, which presents an opportunity for the governments of Mexico and Central America to develop policies and a migration management that respect and promote the human rights of the population in mobility,” the statement said. ” We will advocate that the Biden government honors its commitments.” 

Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts migrants at risk. 

Biden has also promised a pathway to citizenship for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.

“A new United States Government is an opportunity to work with the Mexican Government to develop a cooperation plan with Central America to address the causes of migration, together with civil society organizations, as well as an opportunity to increase regional cooperation regarding the persons in need of protection, and to dismantle illegal and inhuman programs such as Remain in Mexico, the United States’ Asylum Cooperation Agreements with El Salvador, Guatemala and Honduras, as well as the Title 42 expulsions by the United States authorities,” it said, referring to the Centers for Disease Control (CDC) order that allows the U.S. to quickly remove migrants on public health grounds.

Biden officials, however, have been keen to send the message to migrants that it will not mean open borders overnight.

“Processing capacity at the border is not like a light that you can just switch on and off,” incoming Biden domestic policy adviser Susan Rice told Spanish wire service EFE. “Migrants and asylum seekers absolutely should not believe those in the region peddling the idea that the border will suddenly be fully open to process everyone on Day 1. It will not.” 

“Our priority is to reopen asylum processing at the border consistent with the capacity to do so safely and to protect public health, especially in the context of COVID-19,” she said. “This effort will begin immediately but it will take months to develop the capacity that we will need to reopen fully.”

It is unclear how far the migrants will get, and Guatemalan and Mexican governments have indicated they intend to turn them back. But the caravan comes amid fears that the new outlook on immigration and asylum from the Biden administration will fuel a surge at the border.

Acting Customs and Border Protection (CBP) Commissioner Mark Morgan said on “America’s News HQ” on Saturday that the caravan could include more than 5,000 migrants and blamed the tone from the incoming administration.

“We’re looking at two groups that are well over five thousand. And one of those groups have already gotten through the Guatemala border. And they’re on their way to El Rancho, which is about the located centrally in Guatemala,” he said. “It’s coming. It’s already started, just as we promised and anticipated it would with this rhetoric from the new administration on the border.”

President Trump warned this week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before” and that there were already signs of increased flows.

“They’re coming because they think that it’s a gravy train at the end,” he said. “It’s going to be a gravy train. Change the name from the caravans, which I think we came up with, to the gravy train because that’s what they’re looking for — looking for the gravy.”

Biden transition official tells migrant caravans: ‘Now is not the time’ to come to US

Yael Halon reported further on the migration noting that a migrant caravan moving from Honduras toward the U.S. border called on the incoming Biden administration to honor their “commitments” to the migrants moving north, citing the incoming administration’s vow to ease Trump’s restrictions on asylum.

But on Sunday, an unnamed Biden transition official said that migrants hoping to claim asylum in the U.S. during the first few weeks of the new administration “need to understand they’re not going to be able to come into the United States immediately,” NBC News reports. 

More than 1,000 Honduran migrants moved into Guatemala on Friday without registering as part of a larger caravan that left a Honduran city earlier in the day.

The Associated Press reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.

The Biden transition official, however, warned migrants against coming to the U.S. during the early days of the new administration, telling NBC that while “there’s help on the way,” now “is not the time to make the journey.” 

“The situation at the border isn’t going to be transformed overnight,” the official told the outlet.

“We have to provide a message that health and hope is on the way, but coming right now does not make sense for their own safety…while we put into place processes that they may be able to access in the future,” the official said.

President-elect Joe Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their political asylum hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts them at risk. 

Biden has also promised a pathway to legal permanent residency for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.

President Trump warned last week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before,” claiming that there were already signs of increased flows.

AMA President: Biden Team Must Create National Pandemic Strategy

Ken Terry stated that now that the campaign is over, that the incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, said Susan R. Bailey, MD, president of the American Medical Association (AMA), in a speech delivered today at the National Press Club in Washington, DC.

Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.

“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Bailey emphasized.

She called on the Biden administration, which takes over next week, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”

In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”

Biden Vaccine Distribution Policy

In a question-and-answer period following her speech, however, Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Tuesday, the Trump administration announced that it plans to do the same thing.

“We’re a little bit concerned about the announcement that [the Department of Health & Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Bailey said. “We don’t have adequate data to tell us that one dose is sufficient — we don’t think it is — and how long you can wait for the second dose without losing the benefits of the first dose.”

She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline healthcare workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”

Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.

Bolstering Public Health

In her speech, Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the US has a public health crisis:

  • Restore trust in science and science-based decision making. Make sure that scientific institutions like the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
  • Ensure that the health system provides all Americans with affordable access to comprehensive healthcare. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
  • Work to remove healthcare inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA policy statement that recognized racism as a public health threat.
  • Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
  • Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised Biden for his promise that the US will rejoin the World Health Organization.

At several points in her presentation, Bailey rejected political interference with science and healthcare. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.

Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”

Asked when she thought that life might get back to normal again in the US, Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”

Merck Ends Development of Two Potential COVID-19 Vaccines

Tom Murphy, AP Health Writer, pointed out that the drug maker, Merck, said Monday that it will focus instead on studying two possible treatments for the virus that also have yet to be approved by regulators. The company said its potential vaccines were well tolerated by patients, but they generated an inferior immune system response compared with other vaccines.

Merck was developing one of the potential vaccines with France’s Pasteur Institute based on an existing measles vaccine. The French institute said it will keep working on two other vaccine projects using different methods.

Merck entered the race to fight COVID-19 later than other top drug makers.

It said last fall that it had started early-stage research in volunteers on potential vaccines that require only one dose. Vaccines developed by Pfizer and Moderna were already in late-stage research at that point.

The Food and Drug Administration allowed emergency use of both the Pfizer and Moderna vaccines late last year. Each requires two shots.

Five potential vaccines have reached late-stage testing in the United States, the final phase before a drug maker seeks approval from regulators. Results from a single-dose candidate developed by Johnson & Johnson are expected soon.

Since vaccinations began in December, nearly 22 million doses have been delivered to people nationwide, according to the Centers for Disease Control and Prevention. Nearly 6% of the population has received at least one dose.

A total of 3.2 million people, or 1% of the population, have received both doses required for those vaccines.

More than 419,000 people in the United States and 2 million globally have died due to the coronavirus, according to Johns Hopkins University.

The government is paying Merck & Co. about $356 million to fast-track production of one of its potential treatments under Operation Warp Speed, a push to develop COVID-19 vaccines and treatments. The money will allow the Kenilworth, New Jersey, company to deliver up to 100,000 doses by June 30, if the FDA clears the treatment for emergency use.

The treatment, known as MK-7110, has the potential to minimize the damaging effects of an overactive immune response to COVID-19. This immune response can complicate the life-saving efforts of doctors and nurses.

Merck said early results from a late-stage study of that drug showed a more than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate or severe COVID-19. The company expects full results from that study in the first quarter.

Merck’s other potential treatment is an oral antiviral drug.

Merck said it will focus COVID-19 research and manufacturing efforts on two investigational medicines: MK-7110 and MK-4482, which it now calls molnupiravir. Molnupiravir, which is being developed in collaboration with Ridgeback Bio, is an oral antiviral being studied in both hospital and outpatient settings. If these oral antiviral drugs are effective this will be a real advancement in the treatment of COVID-19. Merck said a phase 2/3 trial of the drug is set to finish in May, but initial efficacy results are due in the first quarter and will be made public if clinically meaningful. 

Merck said results from a phase 3 study of MK-7110, an immune modulator being studied as a treatment for patients hospitalized with severe COVID-19, are expected in the first quarter. In December, the company announced a deal to supply MK-7110 to the U.S. government for up to about $356 million. (Reporting by Deena Beasley Editing by Shri Navaratnam)

Moderna Study: Vaccine Effective vs COVID Variants

With the weekly announcement of new mutant strains of the COVID virus we are all wondering whether the vaccine that are being administered will be effective against the new strains. Carolyn Crist noted that as mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.

Moderna, whose two-dose vaccine has been authorized for use in the U.S. since Dec. 18, said Monday that it is now investigating whether a third dose of the vaccine will work to prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.

“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stephane Bancel said in a statement.

Moderna on Monday also said its COVID-19 vaccine could protect against the U.K. strain but that it is less effective against the strain identified in South Africa.

Pfizer and BioNTech, whose vaccine were also authorized in December, announced last week that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the coronavirus variant first identified in the United Kingdom.

“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.

“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”

There were at least 195 confirmed cases of patients infected with the U.K. variant in the U.S. as of Friday, according to the CDC. No cases from the South African variant have been confirmed in the U.S. To try and prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.

The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.

That means about 1 in 13 people in the U.S. have contracted the virus, or about 7.6% of the population.

“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.

After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year. Following a major surge throughout January, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.

Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Sunday, about 111,000 patients were hospitalized, which is the lowest since mid-December.

The U.S. has also reported nearly 420,000 deaths. As recently as last week, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily deaths.

The University of Washington’s Institute for Health Metrics and Evaluation released a new projection last week that said new cases would decline steadily in coming weeks. New COVID-19 cases have fallen about 21% in the last 2 weeks, according to an analysis by The New York Times.

“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.

At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.

“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Rivers told the newspaper.

So, next, when we get vaccinated do we need to wear masks and continue social distancing?

We will explore that set of questions next.

U.S. Hits Highest 1-Day Toll from Coronavirus With 3,054 Deaths, Hospitalizations and Answers to the Questions About the Vaccines

I have rewritten this post about 15 times but finally decided with the approval of the Pfizer vaccine for emergency use that I needed to answer a number of questions. So, here we go.

Vanessa Romo reported on the Covid Tracking Project and found that the coronavirus pandemic has pushed the U.S. past another dire milestone Wednesday, the highest daily death toll to date, even while the mortality rate has decreased as health experts learn more about the disease.

The Covid Tracking Project, which tracks state-level coronavirus data, reported 3,054 COVID-19 related deaths — a significant jump from the previous single-day record of 2,769 on May 7.

The spread of the disease has shattered another record with 106,688 COVID-19 patients in U.S. hospitals. And overall, states reported 1.8 million tests and 210,000 cases. According to the group, the spike represents more than a 10% increase in cases over the last 7 days.

Additionally, California nearly topped its single-day case record at 30,851. It is the second highest case count since December 6, the organization reported.

The staggering spike in fatalities and infections has overwhelmed hospitals and intensive care units across the nation, an increase attributed by many experts to people relaxing their precautions at Thanksgiving.

New Data Reveal Which Hospitals Are Dangerously Full. Is Yours?

Audrey Carlsen reported that Health care workers at United Memorial Medical Center in Houston face another full-throttle workday last week.

The federal government on Monday released detailed hospital-level data showing the toll COVID-19 is taking on health care facilities, including how many inpatient and ICU beds are available on a weekly basis.

Using an analysis from the University of Minnesota’s COVID-19 Hospitalization Tracking Project, NPR has created a tool that allows you to see how your local hospital and your county overall are faring. 

It focuses on one important metric — how many beds are filled with COVID-19 patients — and shows this for each hospital and on average for each county.

The ratio of COVID-19 hospitalizations to total beds gives a picture of how much strain a hospital is under. Though there’s not a clear threshold, it’s concerning when that rate rises above 10%, hospital capacity experts told NPR.

Anything above 20% represents “extreme stress” for the hospital, according to a framework developed by the Institute for Health Metrics and Evaluation at the University of Washington.

If that figure gets to near 50% or above, the stress on staff is immense. “It means the hospital is overloaded. It means other services in that hospital are being delayed. The hospital becomes a nightmare,” IHME’s Ali Mokdad told NPR.

At Hospitals, A Race to Save ‘Hundreds of Thousands’ Of Lives with New Vaccine

Sarah McCammon noted that lately, Jon Horton has been dreaming about freezers.

“I was opening the freezer and I was taking something out of the freezer and putting it in something else,” Horton said. “And it was just like — whew!”

And not just an ordinary freezer. Horton is pharmacy operations director at Sentara — a health care network based in Norfolk, Va.

Sentara officials are working out every detail of the logistics involved in rolling out the coronavirus vaccine from Pfizer, which has to be kept at nearly minus 100 degrees Fahrenheit or risk losing effectiveness.

“At a certain point, you’re just trying to figure out what needs to be done next,” Horton said during an interview with NPR at Sentara Norfolk General Hospital. “So, you’re focusing on this process, and as you open up that door, you learn a little more.”

As federal regulators prepare to meet Thursday to consider whether they’ll approve Pfizer’s brand-new coronavirus vaccine, employees like Horton are preparing to receive the vaccine at hospitals around the United States.

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The Sentara health system has four of the ultracold freezers that the vaccine requires, including one obtained through collaboration with a local medical school.

“We usually just deal with freezing temperatures, you know, a typical freezer,” said Tim Jennings, Sentara’s chief pharmacy officer. “That’s why we had to actually go out and acquire a special freezer for this.”

For sites that don’t, there’s dry ice. Jennings opens a big blue bin full of it, which resembles white “cheese doodles,” he notes.

There’s little room for error here: The vaccines must be monitored to make sure the temperature is stable each step of the way. And they’re in short supply right now; the first shipment from Pfizer is expected to include only about 72,000 doses for all of Virginia, a state of more than 8 million people.

Michelle Hood, chief operating officer at the American Hospital Association, said health care administrators across the country are gearing up for a major logistical undertaking.

“We’ve never done anything like this as a country or in the world, as significant as this exercise is,” Hood said. “And everything is new.”

The first vaccines will go mostly to front-line health care workers at the highest risk of exposure.

That’s where Mary Morin, a vice president in charge of employee vaccination at Sentara, comes in. She has a lot to think about as well.

“I did wake up last night and I’m going, ‘Oh, my God,’ ” Morin said.

Morin, whose background is as a registered nurse, has to turn Centers for Disease Control and Prevention guidelines about who should be first in line for the coronavirus vaccine into a real-life plan for her hospital workers.

“A front door to the hospital is the emergency department. You may have a security guard there. They’re patient facing. They’re forward facing,” she said. “So, it’s the staff — it isn’t just the nurses and the physicians.”

Unlike the flu shot, Sentara officials say, the coronavirus vaccine will be optional for staff. Large studies indicate the Pfizer vaccine is about 95% effective with few side effects. But it’s brand-new, and convincing people to take it may be a challenge.

The challenge ahead for hospital staff members like Jennings is making sure the vaccine is properly stored and administered to those who are willing and able to take the first doses. If the vaccine receives federal approval, officials say it could start being given to health care workers within days.

“We realize if we do this right, we could save thousands of lives,” Jennings said, “if not hundreds of thousands.”

The Covid-19 Vaccine: When Will It Be Available for You?

I was included in the set of clinical trials for the COVID-19 vaccine. But I was just notified that I was being “kicked out” due to the fact that the Committee wanted to make sure that I was vaccinated and not having the possibility of being given the placebo as per the trials due to the fact as a physician I am seeing cancer patients daily.

Vaccines, especially as one is already approved by the FDA and the other should be approved for emergency use this coming week.

I thought that I would review a number of questions that many have regarding the new vaccines.

First U.S. rollouts of doses could start in December, with health-care workers, older Americans likely to take priority

Peter Loftus and Betsy McKay reported that Pfizer Inc.  and its partner, BioNTech SE, have asked the U.S. Food and Drug Administration to authorize use of their coronavirus vaccine, and an FDA decision could come as soon as this weekend. Moderna Inc.  has made a similar request for its shot, and other vaccines could follow. The first rollouts could begin within days.

Here is what we know and don’t know about how, and when, the vaccine will get to you.

How will the Covid-19 vaccines be approved, and who decides who will get them?

The FDA will determine whether to authorize Covid-19 vaccines for use. An FDA advisory committee of outside experts voted Thursday in favor of Pfizer’s request for authorization of its vaccine. The FDA is expected to decide imminently.

The FDA has scheduled a Dec. 17 advisory committee meeting to consider Moderna’s request for authorization. A separate advisory committee to the U.S. Centers for Disease Control and Prevention has voted to recommend that health workers and residents of nursing homes and other long-term care facilities be first in line for the limited number of doses. The same committee will hold additional votes on which groups should be next in line. But governors can make the final call within their states.

How will the vaccines be distributed?

The federal government has a contract with McKesson Corp. to be a centralized distributor of Covid-19 vaccines, with the exception of Pfizer’s. Pfizer has set up its own distribution network. Federal health officials say initial doses would be shipped within 24 hours of any FDA authorization, and immunizations could begin within about 48 hours. The federal government also has partnerships with national pharmacy chains CVS and Walgreens to vaccinate residents and staff at long-term care facilities.

Some experts say it could take more than 48 hours for dosing to begin, as hospital workers and others get used to procedures for opening specialized, temperature-controlled boxes of vaccine vials and learn the risks and benefits of the shots.

“Many providers are going to need a few days to get it up and running, if not a week,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members run state, territorial and local vaccination programs.

What logistics are in place to deliver the vaccines?

McKesson, the centralized distributor for vaccines other than Pfizer’s, also will receive and package kits of medical supplies needed to administer the Covid-19 vaccine, such as needles and syringes and alcohol prep pads. It will send the kits and vials of the vaccine out to pharmacies, doctors’ offices and other facilities, at a minimum of 100 doses per order, based on order information supplied by the CDC.

Pfizer plans to use its own distribution centers and ship its vaccine in specially designed reusable containers that can keep thousands of doses at the ultracold temperatures required for it.

How many doses will be available at first?

The initial expected supply of Pfizer’s vaccine after authorization is about 6.4 million doses, according to Gen. Gustave Perna, chief operating officer of the U.S. government’s Operation Warp Speed initiative.

Of this, about 2.9 million doses will be shipped within 24 hours. A federal official said Wednesday that an additional 2.9 million doses would be held back and shipped about three weeks later for those initial vaccine recipients to get the second of the two-dose regimen. Another 500,000 doses from the initial supply would be held in reserve in case any problems arise, the official said. If Moderna’s vaccine is authorized, officials estimate the initial allocation will be about 12.5 million, which may also be sent in separate shipments to accommodate the second injection.

Including that initial supply, federal officials have estimated there would be enough doses to vaccinate 20 million Americans in December.

How many doses will be available next year?

Federal officials have estimated there could be enough to vaccinate about 30 million people in the U.S. in January and then about 50 million in February, with more in the months following. Globally, Pfizer expects to produce up to 1.3 billion doses in 2021 and Moderna expects up to 1 billion.

Who will get the first doses?

The first doses will likely go to health-care workers and residents of nursing homes and other long-term care facilities, which together number about 24 million. After that, the CDC vaccine advisory committee is considering recommending that essential workers such as teachers, police and food workers get vaccinated, followed by adults with underlying conditions that put the at high risk, and seniors age 65 and older.

The committee hasn’t completed its recommendation beyond the first phase, and decisions on which groups get vaccinated when could depend in part on the particular vaccine and what its data show about effectiveness among different age groups or health conditions.

Is there any debate about who should get vaccinated first?

Yes. Some health officials and experts believe health-care workers should be vaccinated first, while others are advocating for the most vulnerable—older Americans—to be first in line. And some state governors have singled out occupations such as teachers that should be at or near the top of the list. There is a similar debate about whether non-health-care essential workers such as teachers and police should be ahead of adults with high-risk medical conditions and people age 65 and over who aren’t in congregate settings.

When can the general public expect to have access?

Secretary of Health and Human Services Alex Azar said he expects there to be enough vaccine doses starting in the second quarter of 2021 so that anyone who wants a vaccine can get it. Other federal health officials have said in the spring or summer. The timeline could change if manufacturing doesn’t go as planned.

How will vaccine doses be allocated to U.S. states?

For the initial supplies, the federal government plans to allocate doses to states proportionally based on the size of their adult populations. It is unclear how long the federal government would stick with population-based proportions and how it would allocate supplies later.

How do states decide to distribute doses?

State, territorial and some local immunization programs, working with the CDC, have drawn up plans to distribute doses within their jurisdictions and to conduct vaccination campaigns. These plans include identifying facilities where vaccination campaigns can be conducted, enrolling them and ensuring the necessary equipment is in place to conduct them. States also have estimated their populations of high-priority groups like health-care workers.

Does the vaccine work the same way in all population groups?

Pfizer and Moderna haven’t yet provided full breakdowns of vaccine efficacy by age and race or ethnicity, but the companies have said efficacy was consistent across these groups.

Does everyone get the same dose regardless of age or other demographic?

Yes.

Coronavirus Daily Briefing and Health Weekly

How many people need to get vaccinated to stop the pandemic in the U.S.?

Moncef Slaoui, chief adviser to Operation Warp Speed, has said if 70% of the population were immunized, that level would achieve herd immunity, based on the approximately 95% effectiveness of both the Pfizer and Moderna vaccines.

A vaccine would need to be at least 80% effective, with about 75% of a population receiving it, to extinguish an epidemic without any other public-health measures, according to a study published in October in the American Journal of Preventive Medicine.

Reaching those levels of immunization would require educating millions of Americans about the safety and effectiveness of vaccines and confronting a strong antivaccine movement, said Peter Hotez, a vaccine scientist at the Baylor College of Medicine and an author of the paper. Those are steps the government hasn’t taken yet, he said. “To use a vaccine to eliminate this virus—it is a really high bar,” he said.

One open question is how effective the vaccines are at preventing people from transmitting the virus to others, Dr. Hotez said. Both vaccines were tested primarily for their effectiveness at preventing people from becoming ill. They are expected to be evaluated for effectiveness at preventing infection regardless of symptoms, but those data haven’t been released yet.

What is herd immunity?

Epidemiologists estimate that between 60% and 70% of a population needs to develop an immune response to the virus to reach “herd immunity,” a state in which enough people have either been infected or vaccinated to stop transmission of the virus. Some epidemiologists say herd immunity to Covid-19 might be achieved at a lower threshold of 50%.

When the vaccines are widely available, how will I get the shot?

Federal officials say they want to make getting a Covid-19 vaccine as easy as going to a pharmacy to get a flu shot. The government has formed partnerships with about 60% of U.S. pharmacies to administer Covid-19 vaccines to the broader population after high-priority groups are vaccinated. Manufacturers would ship doses to distributors to get them to hospitals, pharmacies, nursing homes and other administration sites, as determined by state and federal plans. Pfizer’s vaccine requires ultracold shipping and storage, while Moderna’s can be shipped at higher—though still freezing—temperatures. After thawing, doses can be kept in refrigerators for certain periods.

How many doses will I need?

Vaccines from Pfizer, Moderna and AstraZeneca PLC are given in two doses, three or four weeks apart. Federal and state officials are planning to issue reminders to people to come back for their second doses. A Johnson & Johnson vaccine is being tested as a single dose, but the company hasn’t yet reported how well that works.

How much does it cost? Will insurance cover it?

Both the Trump administration and President-elect Joe Biden have said the vaccine would be free of charge to all Americans, with administration fees billed to private or government insurance plans or to a special government relief fund for the uninsured.

Does it have to be a needle?

The vaccines closest to authorization are given as injections. Merck & Co. is exploring an oral formulation of a Covid-19 vaccine, but it isn’t expected to be available in the near term.

Should I get a vaccine if I’ve already been infected?

You can still benefit from the vaccine, the CDC says. Scientists don’t yet know how long someone is protected from getting sick again once they have had Covid-19. There is some evidence that natural immunity doesn’t last long.

How long does immunity last after vaccination?

The median follow-up period in the large clinical trials was only about two months after vaccination, so it isn’t yet known how long protection will last beyond that.

Will my child be able to get vaccinated? Has it been tested in children?

Children likely won’t get vaccinated until later because they are much less likely to have severe Covid-19 than adults. Pfizer has requested U.S. authorization of use of the vaccine in people 16 and older. Pfizer and Moderna have started to test the vaccine in children as young as 12, and other companies also plan to test their Covid-19 vaccines in children.

Can I stop wearing a mask after getting a COVID-19 vaccine?

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the US could reach herd immunity by May, based on the effectiveness of the Pfizer and Moderna vaccines if enough people are vaccinated

Can I stop wearing a mask after getting a COVID-19 vaccine?

No. For a couple reasons, masks and social distancing will still be recommended for some time after people are vaccinated.

To start, the first coronavirus vaccines require two shots; Pfizer’s second dose comes three weeks after the first and Moderna’s comes after four weeks. And the effect of vaccinations generally isn’t immediate.

People are expected to get some level of protection within a couple of weeks after the first shot. But full protection may not happen until a couple weeks after the second shot.

It’s also not yet known whether the Pfizer and Moderna vaccines protect people from infection entirely, or just from symptoms. That means vaccinated people might still be able to get infected and pass the virus on, although it would likely be at a much lower rate, said Deborah Fuller, a vaccine expert at the University of Washington.

And even once vaccine supplies start ramping up, getting hundreds of millions of shots into people’s arms is expected to take months.

Fuller also noted vaccine testing is just starting in children, who won’t be able to get shots until study data indicates they’re safe and effective for them as well.

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the country could reach herd immunity as early as May, based on the effectiveness of the Pfizer and Moderna vaccines. That’s assuming there are no problems meeting manufacturers’ supply estimates, and enough people step forward to be vaccinated.

FDA panel endorses Pfizer coronavirus vaccine for emergency use.

Thomas Barrabi reported that the U.S. Food and Drug Administration advisory panel voted Thursday to endorse the Pfizer-BioNTech coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country. And Friday it was official that the Pfizer vaccine is approved for emergency use.

Vaccine shipments would begin within hours of the FDA’s decision, which could come by as early as Friday, with the first vaccinations to follow soon afterward. Pfizer’s vaccine will be available in limited quantities, with initial doses earmarked for frontline health care workers and high-risk patients.

In November, Pfizer announced that its coronavirus vaccine was 95 percent effective and has not displayed any major side effects.

The advisory panel, comprised of outside experts, based its decision on data from clinical trials. Members were asked to vote on “whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older” based on the totality of available evidence.

Some committee members raised concerns about the wording of the question and whether trials have provided enough information regarding the vaccine’s effects on people aged 16 and 17 years old. The committee opted to vote on the question as it was originally worded.

Of the committee’s 23 members, 17 voted to recommend the vaccine and four voted against the recommendation. One member abstained in its endorse

Pfizer is one of several companies in the final stages of development. The FDA is expected to decide whether to approve a vaccine developed by Moderna for mass use later this month. Johnson & Johnson and AstraZeneca also have vaccines in the works.

More than 290,000 Americans have died from COVID-19 since the pandemic began. More than 15.4 million cases have been reported.

Convincing people to get COVID vaccine is vital — here’s how to do it

Dr. Austin Baldwin and Jasmin from Fox News makes us aware that the decision by the Food and Drug Administration Friday night to issue an emergency use authorization for Pfizer’s COVID-19 vaccine is a critical breakthrough in the battle against the disease that has infected more than 15.7 million Americans and killed nearly 300,000.

The FDA ruling that the Pfizer vaccine is safe and effective is just a first step in a massive rollout of the vaccine. Now the enormous task of distributing the vaccine around the nation begins.

But a crucial obstacle to widespread vaccinations will be public hesitancy to take the vaccine, driven by doubts, fears, and misinformation spreading throughout the nation and the world.

The same challenge will face other vaccines now awaiting approval in the U.S. and vaccines distributed globally. Gaining public acceptance for the Pfizer vaccine and other vaccines is vital, because we won’t end the worst global health crisis in a century until the majority of the world’s 7.7 billion people are vaccinated against COVID-19. The disease has infected more than 70 million people around the world and killed nearly 1.6 million.

Behavioral science will be as important to vaccine acceptance as basic science was to vaccine development. If government and health care leaders take the right approach to educating the public about the vaccines, we can create a pathway for the public to assess options and choose to get vaccinated. Given the accelerated development of the Pfizer vaccine and other vaccines not yet approved, convincing people that the vaccines are safe and effective is critical.

The World Health Organization identified vaccine hesitancy as a top global health threat in 2019 — just months before the COVID-19 outbreak. An Axios-Ipsos survey found that only half of Americans say they are likely to get a COVID-19 vaccine as soon as it is available. These numbers are even lower among African Americans, at just more than a quarter. Why?

Historically, minority communities have been suspicious of new health technologies and biomedical research due to past unethical experimentation on African Americans and Native Americans.

Given that African Americans are hardest hit by COVID-19, public health officials must respond to these concerns. Beliefs in vaccine conspiracies and rumors that the government is cutting corners in testing and development must also be addressed if we are to achieve herd immunity, the threshold of 70 percent of the population needed in order for person-to-person transmission to be largely eliminated.

As plans are developed to roll out the Pfizer vaccine and later other COVID-19 vaccines throughout the nation, public health officials and other health care leaders should consider three steps.

Transparency to build trust

Leaders at all levels of government and the health care community must be upfront that science is always evolving and that knowledge about the vaccines will continue to accumulate.

Communications should stress that the Pfizer vaccine and the Moderna vaccine (not yet approved) are 90 to 95% percent effective. It’s also important to emphasize that while the development, testing, and approval processes for vaccines have been accelerated, no steps were skipped.

When people are asked if they’re willing to get a vaccine that is “more than 90% effective” or one that has been “proven safe and effective,” willingness to be vaccinated increases to 65 to 70%.

Transparency also means being upfront about potential side effects of vaccines. These include possible arm soreness (as with most vaccines) and possible fatigue a day or two after vaccination. If people expect knowledge to evolve and believe public health leaders will be upfront, reports of new side effects are less likely to undermine confidence and trust.

 Active engagement with vaccine information

Communications about the vaccines should pose questions such as: “How will my family and I benefit from the vaccine?” or “If I don’t get a vaccine and then later get COVID-19, to what extent would I regret that decision?”

Such questions lead people to more actively engage with the information rather than simply being told that the vaccine is safe.

We took this approach when we developed an app and website to address parental hesitancy about the HPV vaccine among diverse populations. We are now working to adapt this approach to provide information on COVID-19 vaccines.

Interactive technology makes it more likely that people will become engaged in the decision to be vaccinated and be motivated to follow through to get the required second dose. 

Meeting different informational needs and styles of decision-making among people 

Some people will want detailed information to weigh the scientific evidence before being vaccinated against COVID-19. Others will want information mediated through a trusted source, like health care providers, faith-based leaders and public figures.

To accommodate different needs and maintain transparency, educational materials should provide information in a stepped manner. Basic information from trusted sources is presented first. This is followed by more detailed information using different media such as print, video and formats such as personal stories and graphics to explain numbers and risk.

Websites and apps that enable people to navigate to their level of desired information provide another level of empowerment. We found our app’s stepped approach led previously hesitant parents to be 2.5 times more likely to decide in favor of the HPV vaccine.

Our major investments in vaccine development and testing will fall short of achieving their potential impact unless the public takes the COVID-19 vaccines. We must work proactively to communicate better than ever before.

So, as I have said before about the flu vaccine, if it is offered to you, get the COVID-19 vaccine and be part of the solution to ending this Pandemic.

And wear the Damn MASKS, as Governor Hogan keeps telling us!

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

It is truly amazing how out of touch the GOP and, I believe President Trump is, on health care, especially “after” or during this COVID pandemic. Consider the amount of monies spent on caring for the millions of patients diagnosed with COVID-19. One must remember that due to the EMTALA Act, which ensures public access to emergency services regardless of ability to pay. Think of all the COVID testing and ICU care that has been provided for all that needed it. This experience, etc. should convince, even the clueless that we need a type of universal health care policy.

They, the GOP and the President, promised us all that they would create, provide a wonderful healthcare for all, better than Obamacare. But have they? No!

And now is the time to produce a well-designed alternative, or consider Obamacare as a well thought out program, except for the lack of financial sustainability. And guess what happened after I had a phone call with a member of the Trump administration. He asked me what I thought Trump’s chances of winning re-election. I responded that I thought he had about a 20% chance of getting re-elected. He pressed me as what I thought that would increase his chances. My response was to finally reveal their, the GOP/Trump’s

, plan and I suggested that they should adopt the Affordable Care Act but outline a plan to sustainably finance the healthcare plan.

My suggestion- embrace the Affordable Care Act as a good starting point and use a federal sales tax to finance it instead of putting the onus on the young healthy workers.

 At a hearing on the coronavirus response, Senator Dick Durbin asked the Trump administration’s top health officials about the president’s comments touting a plan to replace the Affordable Care Act, also known as Obamacare. They said they did not know about such a plan.

And a Republican victory in Supreme Court battle could mean millions lose health insurance in the middle of a pandemic.

John T. Bennett noted that Ruth Bader Ginsburg, Barack Obama, Donald Trump and Mitch McConnell could soon be forever linked if the late Supreme Court justice’s death leads to the termination of the 44th president’s signature domestic policy achievement: the Affordable Care Act

All sides in the coming battle royal over how to proceed with filling the high court seat she left behind are posturing and pressuring, floating strategic possibilities and offering creative versions of history and precedent. Most Republicans in the Senate want to hold a simple-majority floor vote on a nominee Mr. Trump says he will announce as soon as this week before the end of the calendar year. Democrats say they are hypocrites because the blocked a Barack Obama high court pick during his final year.

It appears Democrats have only extreme options as viable tactics from preventing confirmation hearings and a floor vote before this unprecedented year is up. Speaker Nancy Pelosi on Sunday refused to rule bringing articles of impeachment against the president or even William Barr, his attorney general whom the Democrats say has improperly used his office to help Mr. Trump’s friends and use federal law enforcement unjustly against US citizens.

Unless Ms Pelosi pulls that politically dangerous lever, the maneuvering of the next few weeks most likely will end after Congress returns after the 3 November election with a high court with a 6-3 conservative bend. Analysts already are warning that conservatives appear months away from being able to partially criminalize abortion and also take down the 2011 Affordable Care Act, also known as Obama care.

Democrats have sounded off since Ms. Ginsburg’s death to warn that millions of Americans could soon lose their health insurance, especially those with pre-existing conditions. Last year, 8.5m people signed up for coverage using the Affordable Care Act, according to the Congressional Budget Office.

“Healthcare in this country hangs in the balance,” Joe Biden, who is the Democratic nominee for president and was vice president when Mr. Obama signed the health plan now linked to his name into law, said on Sunday.

Mr. Biden accused Republicans of playing a “game” by rushing the process to replace Ms. Ginsburg on the court because they are “trying to strip healthcare away from tens of millions of families.”

Doing so, he warned, would “strip away their peace of mind” because insurance providers would no longer be required to give some Americans policies. Should a 6-3 court decide to uphold a lower court’s ruling that the 2011 health law be taken down, those companies would “drop coverage completely for folks with pre-existing conditions,” Mr. Biden warned in remarks from Philadelphia.

“If Donald Trump has his way, the complications from Covid-19 … would become the next deniable pre-existing condition for millions of Americans.” That means they would lose their health insurance and be forced to either pay for care out of their pocket or use credit lines. Both could force millions into medical bankruptcy or otherwise create dire financial hardships.

Mr. Trump about a month ago promised to release a new healthcare plan that, if ever passed by both chambers of Congress and signed into law, would replace Obamacare.

So far, however, he has yet to unveil that alleged plan.

Trump Press Secretary Kayleigh McEnany told reporters last week that the White House’s Domestic Policy Council is leading the work on the plan. But when pressed for more details, she chose to pick a fight with a CNN reporter.

“I’m not going to give you a readout of what our healthcare plan looks like and who’s working on it,” Ms. McEnany said. “If you want to know, if you want to know, come work here at the White House.”

When pressed, Ms. McEnany said “stakeholders here in the White House” are working on a plan the president has promised for several years. “And, as I told you, our Domestic Policy Council and others in the White House are working on a healthcare plan,” she insisted, describing it as “the president’s vision for the next five years.”

The president frequently mentions healthcare during his rowdy campaign rallies, but only in general terms. He promises a sweeping plan that will bring costs down across the board and also protect those with pre-existing conditions. But he mostly brings it up to hammer Mr. Obama and Mr. Biden for pushing a flawed law that he has been forced to tinker with to make it function better for consumers.

Broad brush

His top spokeswoman echoed those broad strokes during a briefing on Wednesday. “In aggregate, it’s going to be a very comprehensive strategy, one where we’re saving healthcare while Democrats are trying to take healthcare away,” she told reporters. “We’re making healthcare better and cheaper, guaranteeing protections for people with preexisting conditions, stopping surprise medical billing, increasing transparency, defending the right to keep your doctor and your plan, fighting lobbyists and special interests, and making healthier and making, finding cures to diseases.”

If there is a substantive plan that would protect millions with pre-existing conditions and others affected by Covid-19, it would have made a fine backbone of Mr. Trump’s August Republican National Committee address in which he accepted his party’s presidential nomination for a second time. But healthcare was not the major focus, even though it ranks in the top two issues – along with the economy – in just about every poll that asks voters to rank their priorities in deciding between Mr. Trump and Mr. Biden.

If there is a coming White House healthcare plan that would protect those with pre-existing conditions and prevent millions from losing coverage as the coronavirus pandemic is ongoing, the president is not using his campaign rallies at regional airport hangars to describe or promote it.

“We will strongly protect Medicare and Social Security and we will always protect patients with pre-existing conditions,” said at a campaign stop Saturday evening in Fayetteville, North Carolina, before pivoting to a completely unrelated topic: “America will land the first woman on the moon, and the United States will be the first nation to land an astronaut on Mars.”

The push to install a conservative to replace the liberal Ms. Ginsburg and the lack of any expectation Mr. Trump has a tangible plan has given Democrats a new election-year talking point less than two months before all votes must be cast.

“Whoever President Trump nominates will strike down the Affordable Care Act,” Hawaii Democratic Senator Mazie Hirono told MSNBC on Sunday. “It will throw millions of people off of healthcare, won’t protect people with pre-existing conditions. It will be disastrous. That’s why they want to rush this.”

 About 1 In 5 Households in U.S. Cities Miss Needed Medical Care During Pandemic

Patti Neighmond noted that when 28-year-old Katie Kinsey moved from Washington, D.C., to Los Angeles in early March, she didn’t expect the pandemic would affect her directly, at least not right away. But that’s exactly what happened.

She was still settling in and didn’t have a primary care doctor when she got sick with symptoms of what she feared was COVID-19.

“I had a sore throat and a debilitating cough,” she says, “and when I say debilitating, I mean I couldn’t talk without coughing.” She couldn’t lie down at night without coughing. She just wasn’t getting enough air into her lungs, she says.

Kinsey, who works as a federal consultant in nuclear defense technology, found herself coughing through phone meetings. And then things got worse. Her energy took a dive, and she felt achy all over, “so I was taking naps during the day.” She never got a fever but worried about the coronavirus and accelerated her effort to find a doctor.

No luck.

She called nearly a dozen doctors listed on her insurance card, but all were booked. “Some said they were flooded with patients and couldn’t take new patients. Others gave no explanation, and just said they were sorry and could put me on a waiting list.” All the waiting lists were two to three months’ long.

Eventually Kinsey went to an urgent care clinic, got an X-ray and a diagnosis of severe bronchitis — not COVID-19. Antibiotics helped her get better. But she says she might have avoided “months of illness and lost days of work” had she been able to see a doctor sooner. She was sick for three months.

Kinsey’s experience is just one way the pandemic has delayed medical care for Americans in the last several months. A poll of households in the four largest U.S. cities by NPR, the Robert Wood Johnson Foundation and Harvard’s T.H. Chan School of Public Health finds roughly one in every five have had at least one member who was unable to get medical care or who has had to delay care for a serious medical problem during the pandemic (ranging from 19% of households in New York City to 27% in Houston).

We had people come in with heart attacks after having chest pain for three or four days, or stroke patients who had significant loss of function for several days, if not a week.

There were multiple reasons given. Many people reported, like Kinsey, that they could not find a doctor to see them as hospitals around the U.S. delayed or canceled certain medical procedures to focus resources on treating COVID-19.

Other patients avoided critically important medical care because of fears they would catch the coronavirus while in a hospital or medical office.

“One thing we didn’t expect from COVID was that we were going to drop 60% of our volume,” says Ryan Stanton, an emergency physician in Lexington, Ky., and member of the board of directors of the American College of Emergency Physicians.

“We had people come in with heart attacks after having chest pain for three or four days,” Stanton says, “or stroke patients who had significant loss of function for several days, if not a week. And I’d ask them why they hadn’t come in, and they would say almost universally they were afraid of COVID.”

Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”

He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”

The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).

Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.

“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “

By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”

He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.

“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”

Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.

In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.

“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.

“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.

“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”

In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.

“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.

Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”

And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.

For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.

Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”

Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.

As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.

“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.

Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.

His muscles got so tight that his feet would uncontrollably curl.

“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”

Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.

‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines

Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”

Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.

The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.

“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”

The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.

However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”

Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.

Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.

Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects

Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.

The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.

Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.

Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects

Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.

What’s the worst that could happen if we give an untested vaccine to millions of people?

We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.

If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.

“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”

One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.

If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.

What happened with the last vaccine rush?

On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”

How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.

By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.

What else can go wrong when vaccines are rushed

“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.

One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.

We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.

All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.

“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.

An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.

Other issues with inadequately tested vaccines

Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)

If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”

“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.

So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.

And finally, don’t forget to get your Flu vaccine, now!

Dr. Atlas and Others on coronavirus lockdowns: ‘The policy … is killing people’ and Not from the Corona virus!

As a physician I only stopped seeing my patients for two weeks during the pandemic. Why? I considered my patients cancer care a necessary demand. My cancer patients needed surgical procedures and the hospital didn’t consider those procedures urgent. So, I offered to do their surgical procedures in my office surgical suite under local anesthesia. If I didn’t the tumors would continue to grow and possibly metastasize or spread reducing their chances for cure. This brings up the important consideration that this pandemic is allowing our regular medical and surgical patient to result in delayed diagnoses and treatment. Victor Garcia reported that the Coronavirus lockdowns may be “killing” just as many people as the virus because as I mentioned, many people with serious conditions unrelated to the virus have been skipping treatment, Hoover Institution senior fellow Dr. Scott Atlas said Saturday on “Fox Report.”

“I think one thing that’s not somehow receiving attention is the CDC just came out with their fatality rates,” Atlas said. “And lo and behold, they verify what people have been saying for over a month now, including my Stanford epidemiology colleagues and everyone else in the world who’s done this analysis — and that is that the infection fatality rate is less than one-tenth of the original estimate.”

Even White House coronavirus task force member Dr. Anthony Fauci is acknowledging the harm caused by the lockdown, Atlas said. “The policy itself is killing people. I mean, I think everyone’s heard about 650,000 people on cancer, chemo, half of whom didn’t come in. Two thirds of cancer screenings didn’t come in. 40 percent of stroke patients urgently needing care didn’t come in,” Atlas said. “And now we have over half the people, children in the United States not getting vaccinations. This is really what [Fauci] said was irreparable harm.”

More on Dr. Fauci later in this post.

“And I and my colleagues from other institutions have calculated the cost of the lockdown in terms of lives lost,” Atlas said. “Every month is about equal to the entire cost of lives lost during the COVID infection itself. This is a tragic, misguided public policy to extend this lockdown, whether or not it was justifiable in the beginning.”

Many states are currently reopening their economies slowly, while a few have pledged to extend the lockdowns through the summer.

The doctor also argued against keeping children out of schools, saying there’s no reason they can’t go back. “There’s no science whatsoever to keep K-through-12 schools closed, nor to have masks or social distancing on children, nor to keep summer programs closed,” Atlas said. “What we know now is that the risk of death and the risk of even a serious illness is nearly zero in people under 18.”

Lockdown measures have kept nearly 80 million children from receiving preventive vaccines

Caitlin McFall of Fox News reported that the coronavirus pandemic has resulted in stay-at-home orders that are putting young children at risk of contracting measles, polio and diphtheria, according to a report released Friday by the World Health Organization (WHO).

Routine childhood immunizations in at least 68 countries have been put on hold due to the unprecedented spread of COVID-19 worldwide, making children under the age of one more vulnerable.

More than half of 129 counties, where immunization data was readily available, reported moderate, severe or total suspensions of vaccinations during March and April.

“Immunization is one of the most powerful and fundamental disease prevention tools in the history of public health,” said WHO Director-General Tedros Adhanom Ghebreyesus. “Disruption to immunization programs from the COVID-19 pandemic threatens to unwind decades of progress against vaccine-preventable diseases like measles.”

The WHO has reported the reasons for reduced immunization rates vary. Some parents are afraid to leave the house due to travel restrictions relating to the coronavirus, whereas a lack of information regarding the importance of immunization remains a problem in some places.

Health workers are also less available because of COVID-19 restrictions.

The Sabin Vaccine Institute, the United Nations Children’s Fund (UNICEF) and GAVI, The Vaccine Alliance also contributed to the report.

Experts are worried that worldwide immunization rates, which have progressed since the 1970s, are now being threatened.

“More children in more countries are now protected against more vaccine-preventable diseases than at any point in history,” said Gavi CEO Dr. Seth Berkley. “Due to COVID-19 this immense progress is now under threat.”

UNICEF has also reported a delay in vaccine deliveries because of coronavirus restrictions and is now “appealing to governments, the private sector, the airline industry, and others, to free up freight space at an affordable cost for these life-saving vaccines.”

Experts say that children need to receive their vaccines by the age of 2. And in the case of polio, 90 percent of the population need to be immunized in order to wipe out the disease. Polio is already making a comeback in some parts of the world, with more than a dozen African countries reporting polio outbreaks this year.

“We cannot let our fight against one disease come at the expense of long-term progress in our fight against other diseases,” said UNICEF’s Executive Director Henrietta Fore. “We have effective vaccines against measles, polio and cholera,” she said. “While circumstances may require us to temporarily pause some immunization efforts, these immunizations must restart as soon as possible or we risk exchanging one deadly outbreak for another.”

Six Social Health System Teams to Encourage People to Seek Healthcare

Alexandra Wilson Pecci noted that the campaign, which aims to encourage people to get healthcare when they need it, comes as providers across the country have seen a dramatic drop in visits and revenue during the COVID-19 pandemic.

Six of Los Angeles County’s largest nonprofit health systems with hospitals, clinics, and care facilities are teaming for BetterTogether.Health, a campaign that aims to encourage people to get healthcare when they need it, despite the current pandemic.

The campaign, from Cedars-SinaiDignity HealthProvidenceUCLA HealthKeck Medicine of USC, and Kaiser Permanente, comes as hospitals and healthcare provider offices across the country have seen a dramatic drop in visits and revenue.

“We know many patients who in the past dialed 911 for life-threatening emergencies are now not accessing these vital services quickly,” Julie Sprengel, President, Southwest Division of Dignity Health Hospitals, CommonSpirit Health, said in a statement. “We are instead seeing patients that delayed, postponed or cancelled care coming to emergency departments with serious conditions that should have been treated far earlier.”

Indeed, outpatient hospital visits experienced a record one-week 64% decline during the week of April 5-11, compared to pre-COVID-19 volumes, according to research from TransUnion Healthcare. In addition, hospital visit volumes further declined 33%-62% between the weeks of March 1-7 and April 12-18.

Those stats were echoed in a Medical Group Management Association (MGMA) survey last month showing that physician practices reported a 60% average decrease in patient volume and a 55% average decrease in revenue since the beginning of the public health emergency. 

In addition, nearly two-thirds of hospital executives expect full year revenues will decline by at least 15% due to the coronavirus disease 2019 (COVID-19) outbreak, according to a Guidehouse analysis of a survey conducted by the Healthcare Financial Management Association (HFMA).

The campaign’s website and PSAs communicate messages like “Life may be on pause. Your health isn’t.,” “Thanks L.A. for doing your part.,” and “Get care when you need it.”

In addition to lost revenue, healthcare providers are warning of a “silent sub-epidemic” of those who are avoiding getting medical care when they need it, which could result in serious, negative health consequences that could be avoided.

“There is concern that patients with serious conditions are putting off critical treatments,” Tom Jackiewicz, CEO of Keck Medicine of USC, said in a statement. “We know that seeking immediate care for heart attacks and strokes can be life-saving and may minimize long-term effects. Our hospitals and health care providers are ready and open to serve your needs.”

The BetterTogether.Health public service effort combines those health systems’ resources to create a joint message that will include multi-language television and radio spots, and billboards, messages in newspapers, magazines, digital, and social media; online information, and links to healthcare resources.

It’s reminding people to seek care for things ranging from heart attack symptoms to keeping up with children’s immunization schedules.

“Receiving timely treatment by skilled medical professionals is essential to helping us achieve for our patients and communities the best possible outcomes,” Tom Priselac, President and CEO of Cedars-Sinai Health System. “Please do not delay getting your health care. We encourage you to call a trusted health care provider like your doctor’s office, hospital or urgent care center.”

Doctors raise alarm about health effects of continued coronavirus shutdown: ‘Mass casualty incident’

Furthermore, Tyler Olson reported something that most of us physicians realized as this pandemic continued that and that more than 600 doctors signed onto a letter sent to President Trump Tuesday pushing him to end the “national shutdown” aimed at slowing the spread of the coronavirus, calling the widespread state orders keeping businesses closed and kids home from school a “mass casualty incident” with “exponentially growing health consequences.”

The letter what I stated in the beginning of this post, which outlines a variety of consequences that the doctors have observed resulting from the coronavirus shutdowns, including patients missing routine checkups that could detect things like heart problems or cancer, increases in substance and alcohol abuse, and increases in financial instability that could lead to “poverty and financial uncertainty,” which “is closely linked to poor health.”

“We are alarmed at what appears to be the lack of consideration for the future health of our patients,” the doctors say in their letter. “The downstream health effects … are being massively under-estimated and under-reported. This is an order of magnitude error.”

The letter continues: “The millions of casualties of a continued shutdown will be hiding in plain sight, but they will be called alcoholism, homelessness, suicide, heart attack, stroke, or kidney failure. In youths it will be called financial instability, unemployment, despair, drug addiction, unplanned pregnancies, poverty, and abuse.

“Because the harm is diffuse, there are those who hold that it does not exist. We, the undersigned, know otherwise.”

The letter comes as the battle over when and how to lift coronavirus restrictions continues to rage on cable television, in the courts, in protests and among government officials. Those for lifting the restrictions have warned about the economic consequences of keeping the shutdowns in effect. Those advocating a more cautious approach say that having more people out and about will necessarily end with more people becoming infected, causing what National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci warned in a Senate hearing last week would be preventable “suffering and death.”

But these doctors point to others that are suffering, not from the economy or the virus, but simply from not being able to leave home. The doctors’ letter lists a handful of patients by their initials and details their experiences.

“Patient E.S. is a mother with two children whose office job was reduced to part-time and whose husband was furloughed,” the letter reads. “The father is drinking more, the mother is depressed and not managing her diabetes well, and the children are barely doing any schoolwork.”

“Patient A.F. has chronic but previously stable health conditions,” it continues. “Her elective hip replacement was delayed, which caused her to become nearly sedentary, resulting in a pulmonary embolism in April.”

 Dr. Mark McDonald, a psychiatrist, noted in a conversation with Fox News that a 31-year-old patient of his with a history of depression who was attending school to get a master’s degree in psychology died about two weeks ago of a fentanyl overdose. He blames the government-imposed shutdown.

“She had to stay in her apartment, essentially in-house arrest as most people here in [Los Angeles] were for weeks and weeks, she could not see her therapist — she could speak to the therapist over the phone but she couldn’t see her in person. She could not attend any of her group meetings, which were helping to maintain her abstinence from opiates … and she relapsed into depression.

“She was just too withdrawn to ask for help,” McDonald continued before noting that due to regulations only six people could be at her funeral. “She was simply trying to escape from her pain… I do blame these actions by the government for her death.”

Fox News asked McDonald, as well as three other doctors who were involved with the letter, if they thought the indirect effects of the shutdowns outweighed the likely direct consequences of lifting them — the preventable “suffering and death” Fauci referred to in last week’s Senate hearing. All four said that they believe they do.

“The very initial argument … which sounded reasonable three months ago, is that in order to limit the overwhelmed patient flux into hospitals that would prevent adequate care, we needed to spread out the infections and thus the deaths in specific locales that could become hotspots, particularly New York City… It was a valid argument at the beginning based on the models that were given,” McDonald said. “What we’ve seen now over the last three months is that no city — none, zero — outside of New York has even been significantly stressed.”

McDonald is referring to the misconception that business closures and stay-at-home orders aimed at “flattening the curve” are meant to reduce the total number of people who will fall ill because of the coronavirus. Rather, these curve-flattening measures are meant largely to reduce the number of people who are sick at any given time, thus avoiding a surge in cases that overwhelms the health care system and causes otherwise preventable deaths because not all patients are able to access lifesaving critical care.

McDonald said that “hospitals are not only not overwhelmed, they’re actually being shut down.” He noted that at one hospital in the Los Angeles area where Dr. Simone Gold, the head organizer of the letter, works “the technicians in the ER have been cut by 50 percent.”

Gold also said the effects of the shutdown are more serious for the vast majority of people than the potential virus spread if it is quickly lifted.

“When you look at the data of the deaths and the critically ill, they are patients who were very sick to begin with,” she said, “There’s always exceptions. … But when you look at the pure numbers, it’s overwhelmingly patients who are in nursing homes and patients with serious underlying conditions. Meaning, that that’s where our resources should be spent. I think it’s terribly unethical… part of the reason why we let [the virus] fly through the nursing homes is because we’re diverting resources across society at large. We have limited resources we should put them where it’s killed people.”

People of all ages, of course, have been shown to be able to catch the coronavirus. And there have been reported health complications in children that could potentially be linked to the disease. Fauci also warned about assuming that children are largely protected from the effects of the virus.

“We don’t know everything about this virus … especially when it comes to children,” Fauci said in a Senate hearing last week. “We ought to be careful and not cavalier.”

Newport Beach, Calif., concierge doctor Dr. Jeffrey Barke, who led the letter effort with Gold, also put an emphasis on the disparity in who the virus effects.

“There are thousands of us out there that don’t agree with the perspective of Dr. Fauci and [White House coronavirus response coordinator] Dr. Deborah Birx that believe, yes, this virus is deadly, it’s dangerous, and it’s contagious, but only to a select group of Americans,” he said. “The path forward is to allow the young and healthy, the so-called herd, to be exposed and to develop a degree of antibodies that both now is protective to them and also prevents the virus from spreading to the most vulnerable.”

Dr. Scott Barbour, an orthopedic surgeon in Atlanta, reflected the comments the other doctors made about how the medical system has been able to handle the coronavirus without being overwhelmed, but also noted that the reported mortality rates from the coronavirus might be off.

“The vast majority of the people that contract this disease are asymptomatic or so minimally symptomatic that they’re not even aware that they’re sick. And so the denominator in our calculation of mortality rate is far greater than we think,” he said. “The risk of dying from COVID is relatively small when we consider these facts.”

Gold, an emergency medicine specialist based in Los Angeles, led the letter on behalf of a new organization called A Doctor a Day.

A Doctor a Day has not yet formally launched but sent the letter, with hundreds of signatures from physicians nationwide, to the White House on Tuesday. Gold and the group’s co-founder, Barke, said they began the organization to advocate for patients against the government-imposed coronavirus shutdowns by elevating the voices of doctors who felt that the negative externalities of the shutdowns outweigh the potential downside of letting people resume their normal business.

To gather signatures for the letter, Gold and Barke partnered with the Association of American Physicians and Surgeons (AAPS), a doctors’ group that advocates for less government interference in the relationship between doctors and patients, and notably has taken part in legal challenges against the Affordable Care Act and advocated to allow doctors to use hydroxychloroquine on themselves and their patients.

Gold, in a conversation with Fox News, lamented that the debate around hydroxychloroquine has become politicized, noting that it is taken as a preventative measure for other diseases and that the potentially harmful effects of the drug mainly affect people with heart issues.

The drug is approved to treat malaria, lupus and rheumatoid arthritis, but the Food and Drug Administration has said that “hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.”

The FDA has also warned health professionals that the drug should not be used to treat COVID-19 outside of hospital or research settings.

Gold said she has direct knowledge of physicians who are taking hydroxychloroquine and said that although “we will see” about its efficacy as it is studied more, there have been some indicators that it could be effective at preventing or mitigating COVID-19 and she could therefore understand why doctors might take the drug themselves or prescribe it to their patients.

There is also other research that appears to indicate hydroxychloroquine is not an effective treatment for the coronavirus, which has largely informed the consensus that the risks of the drug outweigh the potential benefits.

Gold, who is a member of the national leadership council for the Save Our Country Coalition — an assortment of conservative groups that aim “to bring about a quick, safe and responsible reopening of US society” — also said she was concerned that her message about the harms of shutdowns is becoming politicized. She said that she agreed with the general principles of the coalition and decided to sign on when asked, but hasn’t done much work with it and is considering asking to have her name removed because people are largely associating her message on reopening the country with a conservative political point of view.

“I haven’t done anything other than that,” she said. “It’s causing a big misunderstanding about what I’m doing so I actually think I’m just going to take my name off because it’s not really supposed to be political.”

Gold also said she is not associated with the Trump reelection campaign in any way, referring to her inclusion in an Associated Press story about the Trump campaign’s efforts to recruit doctors to support the president’s message on lifting coronavirus restrictions. The AP story details a call organized CNP Action, also part of the Save Our Country Coalition, which involved a senior Trump campaign staffer and was aimed at recruiting “extremely pro-Trump” doctors to make television appearances calling for the reopening of the economy as quickly as possible.

Fauci says extended stay-home orders could cause ‘irreparable damage’

Just recently Dr. Fauci changed his view on stay-home orders. Dom Calicchio reported that stay-home orders that extend too long could cause the U.S. “irreparable damage,” Dr. Anthony Fauci finally warned Friday.

Strict crackdowns on large gatherings and other orders, such as for home quarantines, were needed when the coronavirus first hit the nation, but those rules can now begin to be lifted in many parts of the country, Fauci said during an interview on CNBC.

“I don’t want people to think that any of us feel that staying locked down for a prolonged period of time is the way to go,” the member of the White House coronavirus task force said.

“But now is the time, depending upon where you are and what your situation is, to begin to seriously look at reopening the economy, reopening the country to try to get back to some degree of normal.” He warned, however, against reckless reopenings and called for the use of “very significant precautions” as restrictions are lifted.

Fauci told CNBC that staying closed for too long could cause “irreparable damage.” He said the US had to institute severe measures because #Covid19 cases were exploding “But now is the time, depending upon where you are and what your situation is” to open.

“In general, I think most of the country is doing it in a prudent way,” he said. “There are obviously some situations where people might be jumping over that. I just say, ‘Please, proceed with caution if you’re going to do that.’”

Fauci’s comments came one day after two top Republicans – Sen. Rand Paul of Kentucky and Rep. Andy Biggs of Arizona – wrote in an op-ed that Fauci’s initial safety recommendations had “emasculated” the nation’s health care system and “ruined” its economy.

“Fauci and company have relied on models that were later found to be deficient. He even has suggested that he can’t rely, on any of the models, especially if the underlying assumptions are wrong,” the pair wrote in USA Today. “Yet, Fauci persists in advocating policies that have emasculated the medical care system and ruined the economy.”

They also pointed to Fauci’s testimony last week before a Senate committee that opening too soon would “result in needless suffering and death.”

“What about the countless stories of needless suffering and death produced by Fauci’s one-size-fits-all approach to public health?” Paul and Biggs asked.

They called for policies based on trusting the risk assessment of the American people rather than a federal government mandate.

Earlier Friday, Fauci said it was “conceivable” that the U.S. could begin to distribute a coronavirus vaccine by December. “Back in January of this year when we started the phase 1 trial, I said it would likely be between a year and 18 months before we would have a vaccine,” Fauci said during an interview on NPR. “I think that schedule is still intact.

“I think it is conceivable,” he continued, “if we don’t run into things that are, as they say, unanticipated setbacks, that we could have a vaccine that we could be beginning to deploy at the end of this calendar year, December 2020, or into January, 2021.”

My question is what does the future of medicine look like going forward from this pandemic and how do we plan for a better healthcare system and assist in the recovery of our economy?

More on that in future posts.