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The Food and Drug Administration has released an analysis from Pfizer on the need for a booster of the Pfizer-BioNTech COVID-19 vaccine.
Pfizer’s analysis indicates that data from Israel and the United States in the context of the delta variant “suggests that vaccine protection against COVID-19 infection declines approximately 6 to 8 months after the second dose.”
The company says the available data supports its request for FDA approval of a third dose of the COVID vaccine to be administered approximately six months after the second dose in people 16 years of age and older.
The agency released the backgrounder and data ahead of a public advisory committee meeting on Friday. The committee is the same that voted in favor of emergency authorization of the Pfizer-BioNTech vaccine last December.
In an unusual wrinkle, the FDA analysis, which would shed light on the agency’s position, was not released simultaneously. Usually, the agency publishes its own information document at the same time as that of the company.
The agency is making this information available ahead of a public advisory committee meeting scheduled for Friday. The committee is the same that voted in favor of emergency authorization of the Pfizer-BioNTech vaccine last December.
In support of a recall, some public health officials cited research that shows decreased protection against infection with the SARS-CoV-2 virus several months after vaccination. Others countered that vaccines are still very effective in preventing serious illness, hospitalizations and death, even against the delta variant.
Some doctors have said the need for a third COVID vaccine injection is more evident in groups at particular risk, such as people with weakened immune systems or the elderly. In August, the FDA cleared a third dose of Pfizer-BioNTech and Moderna vaccines for people with compromised immune systems.
Due to disagreements within the medical and public health communities, the deliberations of the FDA advisory committee may be more controversial this time around. While the agency is not required to follow the advice of the committee, it generally does.
The administration has set a target on September 20 to begin rolling out boosters for people who were fully vaccinated months ago to further strengthen protection against the SARS-CoV-2 virus. Pfizer-BioNTech COVID vaccine data is the first to be submitted to the FDA for review.
The administration’s announcement of a target date for the availability of boosters before the FDA, Centers for Disease Control and Prevention and their experts make their own assessment was controversial.
Details on the eligibility and timing of a recall would depend on the FDA’s decision on Pfizer’s request.
The World Health Organization has criticized plans by developed countries to widely offer boosters when poorer countries still don’t have enough vaccines to start vaccinating their populations.
“We have been calling for equity in vaccines from the start, not after richer countries have been taken over,” WHO Director-General Tedros Adhanom Ghebreyesus said on September 7.
He called for a moratorium on recalls until the end of the year, except for very high-risk groups of people, to help each country immunize 40% or more of its population. His call for a moratorium has gone unheeded.