Declining Vaccine Efficacy—Particularly Among Older Individuals—Prompting Pfizer’s Emergency Booster Request, Former FDA Chief Says - Forbes

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Topline

In a televised interview Sunday, Dr. Scott Gottlieb, a former chief of the Food and Drug Administration, stressed the urgency of approving new vaccine boosters in the United States and said data from Israel shows declining efficacy among people vaccinated late last year—prompting vaccine-maker Pfizer to request an emergency use authorization for its Covid-19 booster.

Key Facts

Speaking to CBS News' Face the Nation, Gottlieb said the declining efficacy in Israel seems to be clustered among people who are older and who were vaccinated in December and pointed out many nursing-home residents and physicians in the U.S. were also vaccinated around that time.

Gottlieb also said the declining efficacy has likely been compounded by the rapidly spreading delta variant, which has higher viral loads than originally seen with the virus.

Discussing Pfizer's Thursday announcement regarding a booster emergency authorization, Gottlieb, who sits on the company's board, said the process needs to start immediately in order to have the boosters available in the fall and said the nation has likely "missed the window" to provide the follow-up doses before a summer wave of variant-spurred infections.

"We're a little bit behind here in the United States," he said, noting that countries like the United Kingdom and Israel have already decided to provide boosters to people above the age of 70 and those who are immunocompromised.

Gottlieb also suggested President Joe Biden's administration may not want to start recommending boosters yet because doing so could discourage those who are vaccine-hesitant from going out and seeking vaccination, notably in light of the administration's failed goal of vaccinating 70% of Americans by July 4.

Gottlieb's comments came hours after Israel's health ministry on Sunday published limited data showing vaccine protection starts to fade after six months of inoculation and a "growing correlation" between the recently infected and those who were vaccinated early, but experts working with the ministry said it's still too early to draw conclusions from the data.

On CNN's State of the Union, Dr. Anthony Fauci, who serves as Biden's second chief medical advisor, said current data shows people don't need a booster shot, reiterating guidance from the FDA and Centers for Disease Control and Prevention, but noted there are ongoing studies to determine if and when Americans may need the extra shot.

Crucial Quote

"What could be happening is that as people's antibodies start to decline because they're further out from their vaccine, the delta variant is able to overwhelm their residual antibodies—the antibodies that they have left—and it takes a little bit of time for their memory B cells, the other components of the immune system, to kick in and start producing more antibodies," Gottlieb said Sunday. "That's why they're more prone to infection."

What To Watch For

On Monday, Pfizer will hold a briefing with U.S. health officials regarding their request for the booster authorization, but Gottlieb says the approval process will take months before the FDA and CDC ultimately decide on a general recommendation.

Key Background

The FDA, which is in charge of approving vaccines, released a statement with the CDC on Thursday after Pfizer and BioNTech announced their move to seek emergency authorization for the booster shots. “Americans who have been fully vaccinated do not need a booster shot at this time,” they said. According to the statement, both agencies and the National Institutes of Health are researching “whether or when a booster might be necessary.”