CHICAGO, September 3 (Reuters) – U.S. Food and Drug Administration advisers are expected to discuss two key issues when they meet on September 17 to consider a COVID-19 vaccine booster campaign this fall: protection against initial shots decreasing, and boosters will help?
The debate will likely be heated after the Biden administration announced last month – before experts could intervene – that the United States plans to begin booster doses on September 20 if regulators approve them.
The White House decision usurped the normal process in which the FDA and the US Centers for Disease Control and Prevention make these kinds of science-based decisions, according to interviews with six current and former FDA scientists and members of the CDC Advisory Board.
The FDA set a date for the meeting on Wednesday to consider a third booster of the Pfizer Inc (PFE.N) / BioNTech SE vaccine and may discuss more. Moderna Inc (MRNA.O) has submitted data to the FDA for review of its booster and Johnson & Johnson (JNJ.N) said last week that it was in discussions with the agency about one. Read more
“The recommendation shouldn’t precede the data, that’s what happened here. And that’s why people are so unhappy,” said a source close to the unauthorized FDA advisory committee. to express themselves officially.
These experts took the FDA’s decision to hold a Booster Advisory Group meeting as a promising sign that their views will be taken into account, but said a favorable outcome is not guaranteed.
Dr Jesse Goodman, an infectious disease expert at Georgetown University in Washington and former chief scientist for the FDA, said the agency will need to review all relevant data by September 17 to be ready for the panel meeting .
“We have to see that there is a significant increase in antibody levels and that there are no red flags,” he said.
This will be a challenge given that scientists still disagree on the level of antibodies in the blood that predict vaccine protection, said Norman Baylor, chief executive of Biologics Consulting and former director of the Office of Research and of the FDA vaccine review.
Much of the drug companies’ argument for boosters is based on data that shows antibodies decrease over time and another injection increases them.
“One of the things that committee members have to struggle with is … what does that mean?” Baylor said. “You see an increase, but is that increase enough? And for how long ? “
A fierce debate is expected over whether most Americans should receive another injection rather than just those at high risk for serious illness, such as the elderly and those with weakened immune systems.
A Reuters / Ipsos poll this week found that most Americans vaccinated want the extra dose.
“You have to show the data – show me you solve an important public health problem,” said Dr. Greg Poland, former member of the FDA’s Vaccine Advisory Board and head of the Vaccine Research Group. Mayo Clinic.
The problem, according to Poland and others, is that the current crop of vaccines has been designed to prevent hospitalizations and deaths, which the CDC says they continue to do.
The Biden administration took inspiration from Israel, where early data shows that a recall campaign appears to reduce transmission of the virulent variant Delta, which has started causing mostly asymptomatic and mild infections in fully vaccinated people.
The boosters are said to increase the levels of antibodies, which fight infections. But the immune memory of other components of the immune system is what provides protection against serious illness and hospitalization, and this can go on for years.
“No matter how many booster doses you administer, you cannot convert a vaccine that blocks the disease to a vaccine that blocks the infection,” Poland said.
Whatever the United States decides, it will likely influence decisions about boosters in other parts of the world, said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security.
“I think you’ll probably see a trend in high-income countries to increase 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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