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US experts convene to decide whether to OK Pfizer vaccine | Vaccine Tracker – Kansas City, Missouri

Kansas City, Missouri 2020-12-10 10:44:59 –

Washington (AP) — US Government Advisory Board Convened Thursday to Support Pfizer’s Massive Use of COVID-19 Vaccine to Help Conquer Outbreaks That Killed Nearly 300,000 Americans Was decided.

The Food and Drug Administration’s meeting of external advisors represents the penultimate hurdle before the expected launch of the largest vaccination campaign in US history. Shots can start within a few days, depending on how quickly the FDA approves panel recommendations.

The FDA panel acts like a scientific court. During the scheduled all-day session, it is expected that the data will be discussed and degraded publicly and live-streamed on whether the vaccine is safe and effective enough to be cleared for emergency use. I did.

“Americans demand and deserve a rigorous, comprehensive and independent review of their data,” said FDA Dr. Doran Fink, an institutional scientist who works at night, weekends, and Thanksgiving to accomplish that. Said.

With unprecedented interest in the normally ambiguous panel, the FDA broadcast the conference via Youtube and thousands of people logged on to follow the discussion.

The FDA does not have to follow the committee’s advice, but it is widely expected to. When that happens, the United States will begin shipping millions of shots.

The conference was held when the coronavirus continued to proliferate around the world, killing more than 1.5 million people, including more than 289,000 in the United States.

Hanging at the meeting is a warning from British authorities that people with a history of severe allergic reactions should not be vaccinated. Government officials are investigating two reports of reactions that occurred when the country began mass vaccination on Tuesday.

Nevertheless, after FDA scientists published an overwhelmingly positive initial review of the vaccine earlier this week, positive recommendations and prompt US approval seemed almost certain.

The FDA has found that Pfizer’s large-scale ongoing study shows that shots developed at BioNTech in Germany have more than 90% of people of all ages, races, and underlying health conditions, including diabetes and obesity. He said he showed that it was effective. No major safety issues were found and common vaccine-related side effects such as fever, malaise, and pain at the injection site were acceptable.

“The data presented in the briefing report is in line with what we’ve heard before and is really exciting,” said Dr. William Moss, director of the International Vaccine Access Center at Johns Hopkins University. .. “What I see does not delay emergency licenses.”

The conference was also an opportunity for regulators to build public confidence in the groundbreaking development process that produced the Pfizer-BioNTech vaccine and other series of upcoming shots within a year.

The FDA also faced weeks of criticism from President Donald Trump for not rushing out the vaccine before the election day.

In an interview, FDA Commissioner Steven Hahn said, “I had a lot of questions about why it took so long or was it’strict enough’?” “With our transparency, we want people to see that we are very strict about this.”

Hahn said the authorities had already completed the process of approving the vaccine by filling out all legal documents in advance, regardless of the final decision.

Thursday agenda:

Rare side effects

The FDA did not find any major safety issues in a review of Pfizer’s 44,000 studies, including the absence of the type of allergic reaction reported in the United Kingdom. However, such studies cannot detect rare problems that can affect only a small part of the general population.

FDA reviewers noted four cases of Bell’s palsy among vaccinated people. They concluded that these cases were probably unrelated to the vaccine because they occurred at the expected rate without medical intervention. However, given that other vaccines can cause problems, authorities said they needed to track cases of neuropathy.

“I think we have to do what we don’t know about potential, rare, long-term adverse events in advance, without scaring people,” Moss said.

Questions about effectiveness

The FDA has found that the vaccine is highly effective across various demographic groups. However, it is unclear how well the vaccine works for people with HIV and other immune system disorders.

Although this study excluded pregnant women, experts break down the data on tips in case they are vaccinated before they realize they are pregnant.

Research on children up to 12 years is underway.

Impact of emergency permits

Pfizer’s research will need to continue for months to answer some of these questions.

When the FDA Panel met in October, experts warned that study participants who received the placebo would not be allowed to switch and obtain the real vaccine immediately after receiving the FDA’s emergency OK. Doing so may prevent you from getting answers to long-term questions, such as the duration of protection.

Pfizer and BioNTech have stated that they would like to allow such participants to be vaccinated on request or after a follow-up of at least 6 months. The FDA has yet to say whether it will accept that approach.

“The FDA is determined to complete these trials,” said Norman Baylor, a former director of the FDA’s vaccine office.

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AP writer David Koenig contributed to the story from Dallas.

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

Copyright 2020 AP communication. all rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.



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