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Pfizer-BioNTech vaccine becomes the first vaccine to receive full FDA validation

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The vaccine by Pfizer-BioNTech is the first vaccine that has been lincensed for COVID-19. The mRNA vaccine has shown to prevent 95 percent of COVID-19 during the clinical trials and can be administered in people aged 16 and older. It has also been given emergency use authorisation for use in adolescents in December last year. The two dose vaccine can be given with a gap of three weeks.

What impact will this approval have?

This achievement could bring a wave of vaccine mandates in the U.S. as full FDA approval signals towards high standards for safety and effectiveness of the vaccine. People who haven’t received the vaccine yet and were still questioning the manufacturing and safety can now go for it with more belief and confidence taking into consideration the high evidentiary bar the FDA has set for authorisation. This will lead to a boost in inoculation rates.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated,” FDA Commissioner Janet Woodcock said in a statement.

Up until now, more than 204 million doses of the vaccine have been given. The vaccine will be marketed as Comirnaty. Pfizer and BioNTech SE have also partenered with a Brazilian Pharmaceutical company, Eurofarms to produce at least 100 million doses annually for distribution. In order to enhance the global supply chain network so that maximum people can have access to the vaccine, this step has been taken. 

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