Pfizer/BioNTech request full FDA approval of COVID-19 booster vaccine

Pfizer CEO focused on producing ‘as many doses as possible’ following full FDA approval

Albert Bourla, chairman and CEO of Pfizer, said on ‘America’s Newsroom’ that current demand for his coronavirus vaccine is ‘significantly’ higher than the supply and that the company is ‘working to resolve’ the issue.

Pfizer/BioNTech have initiated an application for full FDA approval of its COVID-19 vaccine booster shot for individuals aged 16 and up, the companies announced Wednesday, noting plans to complete the application later this week.

The request for the so-called supplemental biologics license application draws on Phase 3 clinical trial data among 306 participants aged 18 to 55 who received a third dose between 4.8-8 months following the initial two-dose series, with some 2.6 months of follow-up. The companies said levels of neutralizing antibodies were 3.3 times higher following the third dose, versus the second dose.

Side effects within a week after the booster were mild-to-moderate, the companies said, with most frequent side effects including “injection site pain, fatigue, headache, muscle and joint pain, and chills,” similar to the second dose of the primary series.

Pfizer/BioNTech plan to submit the findings to peer-reviewed journal and will share the data with regulatory agencies worldwide in the weeks ahead. 

While most Americans may become eligible for a third dose of mRNA vaccine next month, pending FDA review, a small fraction of the U.S. population ages 12 and older with weakened immune systems (i.e. immunocompromised patients) became eligible for a third dose of Pfizer or Moderna COVID-19 vaccine earlier this month.

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