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peter doshi :: Article Creator New Research Reports On Financial Entanglements Between FDA Chiefs And The Drug Industry An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating. Regulations prohibit FDA employees from holding financial interests in any FDA "significantly regulated organization" and the FDA says it takes conflicts of interest seriously, but Peter Doshi, senior editor at The BMJ, finds that financial interests with the drug industry are common among its leaders. Doshi reports that nine of the FDA's past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company. That includes Margaret Hamburg, who led FDA between 2009 and 2015, but whose story is less well known. Like her colleagues, Margaret Hamburg h

8 Things to Know About COVID-19 Booster Shots - AARP

En español | Millions of Americans who had the Pfizer-BioNTech vaccine are now eligible for a booster shot, which is meant to wake up the immune system so it stays sharp if confronted with COVID-19. 

And experts predict boosters for Moderna and Johnson & Johnson vaccine recipients are right around the corner. Here's what you need to know as the shots roll out:.

1. Boosters are available, but not everyone qualifies right now 

Nearly 183 million Americans are fully vaccinated, according to the Centers for Disease Control and Prevention (CDC), but only a portion of this population can get a booster shot at this time. That's because Pfizer is the only vaccine maker authorized by the U.S. Food and Drug Administration (FDA) for boosters, so the additional doses are currently limited to the roughly 100 million Americans who were fully vaccinated with Pfizer's product. 

What's more, the CDC is recommending that only some Pfizer vaccine recipients get the booster, including adults 65 and older, people living in long-term care facilities and people 50 to 64 with underlying medical conditions. The booster should be administered at least six months after completion of the primary vaccine series, so anyone vaccinated during the spring and summer still needs to wait to meet this mark. 

People ages 18 to 49 with chronic health issues and people over 18 whose work puts them at high risk for COVID-19 can also get a Pfizer booster, depending on their individual risk of getting COVID and the benefit another shot could provide, the CDC says. Young and otherwise healthy adults whose jobs don't put them at risk are encouraged to hold off on a booster shot for now. 

2. Wait for Moderna and J&J boosters could be longer 

People who initially received the Moderna and Johnson & Johnson vaccines will have to wait for their brand's boosters to be cleared, which could still be a few weeks away. Moderna has requested FDA authorization for boosters and Johnson & Johnson is expected to do so soon. 

Before a booster dose becomes available to the public, its safety and efficacy must be carefully vetted by the FDA and a panel of outside experts. Then, the CDC and its advisory committee review the data and determine who should receive the boosters and when. An official recommendation from the CDC's chief signals that it's OK for the shots to go in arms. 


3. Booster shots could rev up waning protection in some  

While the coronavirus vaccines can help to thwart infection (vaccinated people are eight times less likely to get COVID-19 than unvaccinated individuals, according to the CDC), their primary function is to prevent serious illness, explains Anna Durbin, M.D., a vaccine and infectious disease expert at Johns Hopkins Bloomberg School of Public Health. And the COVID-19 vaccines are still highly effective at doing just that — they're keeping people out of the hospital and preventing them from succumbing to the disease. Very few fully vaccinated Americans have been hospitalized or have died from COVID-19 — about 0.009 percent, according to the most recent data.

That said, multiple studies show that some populations are starting to see protection against disease dwindle, including older adults, who account for the majority of the severe breakthrough infections. And top public health experts have said that the current protection could continue to diminish in the months ahead, "especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout."  

It's not unusual to see this waning response. "Even highly effective vaccines become less effective over time," U.S. Surgeon General Vivek Murthy, M.D., explained in a White House COVID-19 task force briefing. And other vaccines require booster shots to wake up the immune system, like the tetanus, diphtheria and pertussis (Tdap) vaccine.

Israel started administering booster shots to its 60-plus population this summer and has seen a significant reduction in the risk of infection and severe disease, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, explained in a recent briefing.

Many experts, including the majority of the FDA's advisory panel, argue the data isn't strong enough to support booster shots for younger populations who are showing a slower decline in immune protection — at least right now. "And we shouldn't be giving a valuable resource just because we can," Durbin says about booster doses for everybody. "It really needs to be indicated, I think, by the epidemiology of the disease and of the illness," she notes, adding that the science could change.

4. Don't expect any new or unusual side effects

The Pfizer data reviewed by FDA shows that booster shots do not appear to have different safety risks than the first two vaccine doses, Mark McClellan, M.D., a former FDA commissioner and director of the Duke-Margolis Center for Health Policy at Duke University, told AARP in a statement. And evidence on boosters from Israel and elsewhere "seems to show benefits in people who are older or are at higher risk of serious complications because of health conditions, without unusual side effects," McClellan adds.

Pfizer's booster trial reported symptoms similar to what some people experienced after their first and second doses: temporary pain at the injection site, fever, chills, headache, fatigue, vomiting, diarrhea, and joint and muscle pain. And data presented on Sept. 22 by a vaccine safety group within the CDC's advisory committee found that a third dose of the mRNA vaccines brought on fewer side effects than the second shot.   

5. Hold off on mixing and matching vaccines

A lot of people are asking, "Does it matter if I mix and match the brands?" This is a bit of a gray area, since data is lacking on the safety and efficacy of mixing.

The CDC's recommendations for the mRNA shots, which require two initial doses, is that "both doses of the series should be completed with the same product." And immunocompromised people who are already eligible for a third mRNA shot are being advised to stick to the same brand the third time around, unless it's unavailable. So it's not a stretch to think the advice will stand when it comes to boosters — at least initially.

A National Institutes of Health (NIH) study is underway to determine how safe and effective it is for fully vaccinated adults to receive booster shots of different COVID-19 vaccines; initial trial results are expected soon. And other research already published suggests mixing vaccines may provide a high level of protection in some, so guidelines could change in the near future.

6. Booster doses should be widely available   

Wondering how you can get your booster shot? The same way you got the first shot: Health clinics, pharmacies and other official vaccination sites will continue to administer the COVID-19 vaccines, as well as the boosters. You may need an appointment, so it's good to check ahead of time.

Health officials have confirmed that the government has adequate supplies, so no shortages are expected. And just like the initial series, the booster shots will be free in the U.S. — no ID or insurance card is required. It is, however, a good idea to bring your paper vaccination record so the date of your booster shot can be added.

"The bottom line is that we are prepared for boosters and we will hit the ground running," said Jeffrey Zients, White House coronavirus response coordinator. 

7. It's unclear whether boosters will be needed annually

Experts aren't sure if the COVID-19 vaccine will be needed on a regular basis, like the flu shot. One thing that could make that scenario more likely, Durbin says, is "if we are unable to control this pandemic — if we continue to see surges that are requiring hospitalization and really taxing health care systems."


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However, if we can control the spread of COVID-19 and bring down the levels of severe disease we're seeing, "we may not need booster shots every year," Durbin adds. "But a lot of that is going to depend on the epidemiology of the pandemic."

8. There could be a new standard for 'fully vaccinated'

Now that boosters are available, our definition of "fully vaccinated" could change. Currently, people are considered fully vaccinated if they have had two doses of the Pfizer or Moderna vaccines or a single dose of the J&J vaccine.   

"I anticipate, over time, that may be updated," CDC Director Rochelle Walensky, M.D., recently said in a COVID-19 news briefing. "But we will leave that to our [CDC Advisory Committee on Immunization Practices] to give us some recommendations."

So stay tuned.

​Who Qualifies for Pfizer's Booster Shot?

The CDC recommends the following people get a COVID-19 booster at least six months after getting shots one and two in the Pfizer-BioNTech series:

  • People 65 years and older and residents in long-term care settings. 
  • People ages 50–64 years with underlying medical conditions.
  • People ages 18–49 years with underlying medical conditions, based on their individual benefits and risks.
  • People ages 18–64 years who are at increased risk for COVID-19 exposure and transmission because of their occupation (i.e., health care workers, teachers, grocery store employees), based on individual benefits and risks.

Rachel Nania writes about health care and health policy for AARP. Previously she was a reporter and editor for WTOP Radio in Washington, D.C. A recipient of a Gracie Award and a regional Edward R. Murrow Award, she also participated in a dementia fellowship with the National Press Foundation.

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