Expect a bumpy ride this week when FDA advisers consider Covid-19 booster shots

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Nine months later, these advisers meet to discuss booster shots and the situation is very different.

It won’t be a slam dunk.

When this advisory committee meets on Friday, it will be presented with dueling data, some of which suggests the need for reinforcers, but other data suggesting none.

Advisors will also discuss the very essence of Covid-19 boosters: whether they would work and what they were even supposed to achieve.

“This will be much more messy than in December,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University. Schaffner has been closely following FDA deliberations as he acts as a member of an advisory committee to U.S. Centers for Disease Control and Prevention that will review booster shots if the FDA lights up the Pfizer app.

CDC says the effectiveness of the Covid-19 vaccine against serious diseases has not dropped much

To complicate matters, the reinforcement controversy has become political and even a bit bitter.

Last month, President Joe Biden announced his administration’s intention to launch a reinforcement program, even citing a specific schedule: the week of September 20th. CDC did its reviews.

Two FDA vaccine experts announced plans to leave the agency amid speculation that the president’s announcement was a reason.
On Monday, these FDA officials, two of the agency’s top vaccine experts, co-authored an article stating that the data does not appear to support the need for booster shots for the public at this time. It was an unexpected move, as FDA staff often kept quiet about drug and vaccine applications.

Schaffner, an infectious disease expert at Vanderbilt University, sought the right word to explain the full set of circumstances surrounding Friday’s meeting.

“It’s … well, unconventional,” he said.

Do reinforcements even be needed?

An August panel of experts, formally called the FDA Advisory Committee on Vaccines and Related Biological Products, will meet Friday. Most are academic medical researchers and advise the FDA if it approves new drugs and vaccines. Usually, the agency takes your advice.

One of your first questions will probably be: Do we even need drivers? Maybe two Pfizer vaccines are enough?

Three separate articles published last week in the CDC’s weekly morbidity and mortality report suggest we don’t need boosters.

Two FDA leaders among scientists say Covid-19 vaccines currently do not
All three studies basically concluded that until well into the summer, both doses did a good job of preventing people from ending up in the hospital with Covid-19. One study looked at data from 13 states and counties, another looked at data from nine states, and a third looked at data from five Veterans Affairs medical centers.
Along the same lines, a study in Qatar found that protection against hospitalization and death persists for at least six months after the second dose.
On the other hand, an Israeli study found that over time, the power of vaccines to prevent people from getting very sick with Covid-19 decreased. Analyzing diseases in the second half of July, this study found that those who had received the second dose of Pfizer vaccine in March had 70% more protection against serious illness than those who received the second vaccine in January.

On Friday, expect a lot of discussion about the strengths and weaknesses of each of these studies.

“There are several data sources we are using to make this decision and they are different from each other,” said Dr. Eric Rubin, a member of the advisory committee and expert on infectious diseases at Harvard. “Some are better than others and everyone asks different questions, so there are a lot of comparisons of apples and oranges on this topic.”

What is Pfizer expected to say?

At Friday’s meeting, Pfizer is expected to present three types of data.

The first will show that antibodies against Covid-19 decreased over time after people received their second dose and that a third dose about six months later increased antibodies.

This will not necessarily impress advisors. Dr. Paul Offit, one of the committee members, argues that antibodies often decrease in the months after vaccination and that other parts of the immune system with better “memory” are released to protect against the virus.

The September 20 reinforcement release of the Biden administration may be reduced to the Pfizer Covid-19 vaccine at first

The second set of data will be the Israeli study which suggests that over time, two vaccine vaccines ceased to be so effective in keeping people out of the hospital.

The third set of data will examine whether giving a third shot helps keep people out of the hospital.

Two countries – Hungary and Israel – have launched a major reinforcement program. Israel has data showing that people over the age of 60 who received reinforcement were more than 10 times less likely to suffer from serious illnesses with Covid-19.

Israel felt so strong with a strengthening program that it didn’t even expect the FDA and CDC to weigh in on whether it’s a good idea.

“I think a different level of urgency was felt in the two countries,” said Dr. Ran Balicer, chair of Israel’s Covid-19 national expert advisory group. “We could have followed [the FDA] but in the situation in which we found ourselves, it was obvious that urgent action was needed. Decisions had to be made. ”

Two Israeli scientists are expected to present data at the consultative meeting on Friday.

Frictions with the Biden administration

All of this scientific back-and-forth will happen in a context of friction between committee members and the Biden administration.

FDA advisers told CNN they don’t like Biden announcing a reinforcement program even though the FDA and CDC have not considered a potential reinforcement program.

“They completely subverted the process. They marginalized the FDA and marginalized the CDC,” Offit said. “You just can’t do it like they did.”

Schaffner added that the Biden administration’s action came as a surprise to doctors and scientists.

He compared it to when President Donald Trump last year pronounced certain approaches, such as the drug hydroxychloroquine, as treatments for Covid-19, although no studies had been done.

What Trump did “deeply upset people,” Schaffner said, and “nothing like the current administration was expected to happen.”

Rubin, the Harvard infectious disease expert and FDA vaccine advisor, said he and his colleagues would not care what Biden said.

“I think it’s very important to point out that none of us work directly for the president and that what the president says doesn’t really affect our vote,” the commission said. “I’m so sorry.”

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