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FDA set to give Pfizer's COVID-19 vaccine full approval next week, report says

( CNet )


The US Food and Drug Administration could give full approval to Pfizer's coronavirus vaccine as early as Monday, according to a report from The New York Times. Regulators were reportedly working to finish paperwork and negotiations with the company on Friday.


The two-dose Pfizer vaccine is currently being given in the US under an emergency use authorization, which was granted in December. Pfizer and its partner BioNTech sought full approval from the FDA in May. Full approval would allow Pfizer to market its vaccine directly to consumers, and could make it easier for government agencies and schools to require vaccinations.


More than 203 million doses of the Pfizer vaccine have been administered in the US, according to data from the Centers for Disease Control and Prevention. Last week, the FDA and CDC signed off on a third shot of the Pfizer and Moderna vaccines for some immunocompromised people. And on Wednesday, health officials with the Biden administration said fully vaccinated adults who received the Pfizer or Moderna shots will be eligible for a booster shot starting next month.


FDA approval of the Pfizer vaccine could slip past Monday, according to the Times, but is expected to come well ahead of the agency's unofficial Labor Day deadline.


The FDA declined to comment.


Moderna is also seeking FDA approval of its COVID-19 vaccine, though a decision reportedly may take several more weeks.



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