FDA approves Pfizer-BioNTech Covid-19 vaccine for emergency use

Last updated on December 14th, 2020 at 06:00 am

 FDA approves Pfizer-BioNTech Covid-19 vaccine: The US Food and Drug Administration has issued EUA (emergency use authorization) to Pfizer-BioNTech Covid-19 vaccine, making it the first approved Covid-19 vaccine to be used in USA for emergency purposes. The vaccine will soon start shipping across the country, in a matter of days. 

Emergency use authorization or EUA means that the particular medical product/ drug/ vaccine has been issued special authorization by the FDA for emergency cases. But this approval is still a step away from complete approval for public use rollout. For complete approval Pfizer-BioNTech would be required to file separately to get full license by the FDA.  

The Pfizer vaccine is found to have 95% efficacy and will be given in two jabs at interval of 21 days to let body develop full immunity against the virus. 

FDA Commissioner Dr. Stephen Hahn said, “The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.” 

He added, “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

The US Centers for Disease Control (CDC) and Prevention Immunization advisory committee are still required to vote for vaccine recommendation before vaccinations can commence in US. Also, this vote recommendation is to be accepted by the CDC. For this purpose, Advisory Committee on Immunization Practices is scheduled for a meeting on Saturday morning.

Pfizer-BioNTech’s Covid-19 vaccine is called BNT162b2. It is an mRNA vaccine. Out of the two jabs required, the first will prime or trigger the body for immune response. The second dose after 21 days will act like a booster dose.  

Experts say that at least 20 million American people can be vaccinated with the Pfizer Covid-19 vaccine in coming few weeks. But until a large population is vaccinated and immunized to trigger a “herd immunity”, it is advised to continue practicing social distancing and wearing masks to curb the spread of Coronavirus infection.