The FDA Authorized a Booster Shot of the Pfizer-BioNTech COVID-19 Vaccine—But Not For Everyone

The decision follows advice from the agency’s advisory committee

The FDA Authorized a Booster Shot of the Pfizer-BioNTech COVID-19 Vaccine—But Not For Everyone
authorized booster doses for certain people already vaccinated against COVID-19 but at high risk of infection, including those over age 65 and those who are more likely to get exposed to the disease, such as health care, frontline, emergency and transportation workers, among others. The booster authorization only applies to Pfizer-BioNTech’s COVID-19 vaccine.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Dr. Janet Woodcock, acting FDA commissioner in a statement announcing the FDA’s decision. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
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The agency’s decision follows the advice of its advisory committee, which met on Sept. 17 to review data on Pfizer-BioNTech’s booster, and voted unanimously to authorize an additional dose for certain populations. The FDA’s decision now goes to the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices to provide details on how long people who have already been vaccinated must wait before getting a booster, and whether the booster should only be given to people who were originally vaccinated with the Pfizer-BioNTech shot, which is likely.

The data that Pfizer-BioNTech presented to the FDA showed the booster dose was both safe and efficacious in increasing waning immune responses to the vaccine. In the companies’ studies involving several hundred people who received the recommended two doses of the vaccine, antibody levels against the COVID-19 virus started to fall after several months. But boosting with third dose of the vaccine about six months after the second shot brought antibody counts back up, in some cases to levels even higher than those generated after the second dose. The FDA also reviewed data from Israeli health agencies, which showed early evidence that booster doses reduced infection rates among people over 60 years by 10-fold compared to those who received only the two original doses, and that the additional dose brought antibody levels up to where they were just after the second dose.

There are less robust data on people in younger age groups, since anyone in that category who has been vaccinated received their shots more recently than the elderly, who the FDA prioritized to receive the Pfizer-BioNTech vaccine first, after the agency authorized the two-dose shot in Dec. 2020. That’s why the advisory committee voted against recommending a booster for all vaccinated people, as Pfizer-BioNTech originally requested, and limited its recommendation to high-risk populations.

Studies looking at people who were originally vaccinated with Moderna or Johnson&Johnson-Janssen’s shot and received a different booster dose are expected soon, but were not available for health officials at FDA or CDC to review yet.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, chairman and chief executive officer of Pfizer, in a statement. “Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19.”

Source : Time More   

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Dr. Lorna Breen’s Family: Doctors Shouldn’t Be ‘Punished’ for Seeking Support

'We’re asking these professionals to take care of us, but when they need help for their mental health, they’re punished for it.'

Dr. Lorna Breen’s Family: Doctors Shouldn’t Be ‘Punished’ for Seeking Support

When Dr. Lorna Breen, an emergency-room physician at NewYork-Presbyterian Hospital, died by suicide in April 2020, her family and colleagues were cratered. She had been on the front lines of the huge, early COVID-19 surge before contracting the virus herself, and she confided in family that the anxiety, exhaustion and uncertainty were overwhelming—for her patients, but also for herself. After recovering, she returned to work, facing back-to-back shifts in multiple locations, but within a few days, she was gone.

In the midst of their grief, the family set up the Dr. Lorna Breen Heroes Foundation to provide mental-health support to health care professionals, and began working with legislators on laws and grants that could bolster the effort. Her brother-in-law Corey Feist talks about why help is urgently needed to address mental-health struggles for those working in health care.
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You’ve worked in health care yourself for over 20 years and for the past 15 years as the CEO of a physician group at the University of Virginia. Given your expertise in the industry, what was your awareness level about this issue before April 2020?

For the last four years, I’d been hearing an increasing drumbeat from our physicians about burnout. They talked about the changing environment of health care expectations, and they were saying, “Practicing medicine is no longer what we signed up for. It’s moving away from the patient care we wanted. That’s burning us out.” We’ve been addressing that, but there’s much more complexity about stigma that I didn’t realize.

What are the factors increasing stigma around mental-health care?

Until Lorna’s death, when we began to look at this issue, I had no idea about the cultural issues embedded in health care around not being able to take a break or seek care. Stigma is enforced on a structural level. For example, in many states, you have to disclose whether you’ve sought mental-health services as part of your licensing, and many doctors are hesitant to get help because they believe it could put their career at risk, and they’re right. It’s hypocritical. We’re asking these professionals to take care of us, but when they need help for their mental health, they’re punished for it. I’m not trying to be dramatic—that’s where we are.

There’s been greater attention this past year to burnout in the profession. Do you think that’s helping at all?

I think it’s important to clarify that burnout is not a mental-health condition; it’s a workplace condition. So, the solutions for that are to improve operations and decrease administrative burdens. Contrast that with a mental-health diagnosis like PTSD, which is the issue my sister-in-law had following her battle on the COVID front lines. That’s the challenge facing an entire workforce now. That means it’s helpful to reduce burnout, but that’s far from enough.

How has COVID, and the death of Dr. Breen and other doctors, played a role in current perceptions?

There have been so many powerful stories and images, like nurses holding up iPads so family members can say goodbye. That’s leading to more awareness of what they’re going through. And we hear from doctors and nurses in our work that talking about Lorna’s suicide has made a difference for them. So, this isn’t just about how people are recognizing the needs of health care professionals. It’s also about how they’re recognizing it for themselves.

How is the work of the foundation, as well as legislation that’s working its way through Congress, offering some hope?

We already have $120 million of programs in place for current health care professionals and future health care workers that will provide training about recognition of mental-health issues and how to prevent and treat them. No one’s ever done this before—this is first-of-its-kind stuff—and we’re hoping to scale solutions across the country.

We don’t need more banners about health care heroes, and we don’t need more free meditation apps for them. We need real solutions that work for people like Lorna. She was the canary in the coal mine for us, and for many people. We don’t need to make our canaries stronger. We need to redesign the coal mine.

Source : Time More   

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