The Slatest

FDA Reportedly Aims to Grant Full Approval to Pfizer COVID-19 Vaccine Monday

An Israeli health worker displays a vial of the Pfizer-BioNtech COVID-19 vaccine, at the Maccabi Health Service in Jerusalem on August 20, 2021.
An Israeli health worker displays a vial of the Pfizer-BioNtech COVID-19 vaccine, at the Maccabi Health Service in Jerusalem on August 20, 2021. AHMAD GHARABLI/Getty Images

The Food and Drug Administration is seeking to grant full approval to Pfizer’s COVID-19 vaccine on Monday, according to the New York Times. Other media outlets, including Politico, first reported the full approval was expected next week. But the Times hears word that the goal was to get the approval through on Friday but regulators were still getting through “a substantial amount of paperwork and negotiation with the company.” That’s why the paper’s sources say the process could very well be extended beyond Monday as some aspects of the review may not be finished in time. But even if it is delayed beyond Monday, it still looks like approval would come earlier than an unofficial deadline that the agency had set for around Labor Day.

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The move would make Pfizer’s jab the first COVID-19 vaccine to go from emergency use authorization to full FDA approval. Experts have been expressing optimism that once a vaccine obtains full approval it will motivate more people in the United States to get vaccinated. Many who have been reticent to get the shot, say they are uncomfortable to get a vaccine that has only been authorized for emergency use. Dr. Anthony Fauci has publicly said that once a vaccine receives full approval more companies and schools are likely to mandate vaccination.

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If the vaccine is approved as anticipated it would be the end of a relatively quick process. Pfizer and BioNTech had started the process to receive full approval of their two-dose vaccine in May. The FDA usually has a target of six months to approve high-priority drugs. Full approval would also bring several key commercial benefits to the vaccine manufacturers because they would be allowed to advertise their vaccines directly to consumers. After the approval, Pfizer is planning to ask for approval of a booster shot. The White House has already said vaccinated Americans should prepare to start receiving booster shots eight months after the second dose, starting in mid-September.

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