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 The debate will likely be heated following the Biden
Administration's announcement last month - before the experts could
weigh in - that the U.S. plans to start booster doses Sept. 20 if
regulators approve them.
The White House move usurped the normal process in which the FDA and
the U.S. Centers for Disease Control and Prevention make these sort
of science-based decisions, according to interviews with six current
and former FDA scientists and CDC advisory panel members.
On Wednesday, the FDA set the meeting date to consider a third
booster shot of the Pfizer Inc/BioNTech SE vaccine and may discuss
others. Moderna Inc submitted data to the FDA for consideration of
its booster and Johnson & Johnson last week said it was in
discussions with the agency about one.
"The recommendation shouldn't precede the data, which is what
happened here. And that's why people are so upset," said a source
close to the FDA advisory panel who was not authorized to speak on
the record.
These experts took the FDA's decision to hold an advisory panel
meeting on boosters as a promising sign that their opinions will be
heeded, but said a favorable outcome is not guaranteed.
Dr. Jesse Goodman, an infectious disease expert at Georgetown
University in Washington and a former chief scientist at the FDA,
said the agency will need to go through all the relevant data before
Sept. 17 to be ready for the panel meeting.
"We need to see that there is a meaningful boost in antibody levels
and there are no red flags," he said.
That will be challenging given that scientists still do not agree on
the level of antibodies in the blood that predict vaccine
protection, said Norman Baylor, chief executive of Biologics
Consulting and former director of FDA’s Office of Vaccines Research
and Review.
Much of the drug company argument in favor of boosters hinges on
data that show antibodies wane over time and that another shot
increases them.
"One of the things that committee members have to struggle with is
... what does this mean?" Baylor said. "You see an increase, but is
that increase sufficient? And for how long?"
'SHOW THE DATA'
A fierce debate is expected around whether most Americans should get
another shot rather than just those at high risk of severe illness,
such as the elderly and those with compromised immune systems.
[to top of second column] |
 A Reuters/Ipsos poll
https://www.reuters.com/business/
healthcare-pharmaceuticals/most-vaccinated-americans-want-covid-19-booster-shots-reutersipsos-poll-2021-09-01
this week found that most vaccinated Americans
want the additional dose.
"You've got to show the data - show me that you're solving an
important public health problem," said Dr. Greg Poland, a former FDA
vaccine advisory panel member and head of Mayo Clinic's Vaccine
Research Group.
The issue, according to Poland and others, is that the current crop
of vaccines were designed to prevent hospitalization and death,
which the CDC says they continue to do.
The Biden Administration has taken a cue from Israel, where early
data shows that a booster campaign appears to be lowering
transmission of the virulent Delta variant, which has begun to cause
mostly asymptomatic and mild infections in fully vaccinated people.
Boosters would increase antibody levels, which fight infections. But
immune memory from other components of the immune system is what
offers protection from severe disease and hospitalization, and that
can last for years.
"No matter how many booster doses you give, you cannot convert a
disease-blocking vaccine into an infection-blocking vaccine," Poland
said.
Whatever the United States decides will likely influence decisions
about boosters in other parts of the world, said Dr. Amesh Adalja,
in infectious disease expert at the Johns Hopkins Center for Health
Security.
"I think you'll probably see a trend in high-income countries to
boost if the FDA grants them," he said.
(Reporting by Julie Steenhuysen; Additional reporting by Ahmed
Aboulenein in Washington; Editing by Caroline Humer and Bill Berkrot)
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