The US Food and Drug Administration (FDA) has granted emergency use authorization to Pfizer-BioNTech's mRNA COVID-19 vaccine making it the first vaccine to receive approval in the country with the highest number of COVID-19 cases and deaths.
After receiving authorization in the UK, the Pfizer vaccine will now be distributed in the US. Emergency use authorization is granted before a drug/vaccine has completed clinical trials due to the nature of medical emergency. In the pandemic, Pfizer's Phae 3 trials interim results have shown a 95% efficacy against SARS-CoV-2.
"Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization," said FDA Commissioner Stephen Hahn in a statement. He even identified these efforts by all the vaccine manufacturers to produce a vaccine against a novel vaccine in short durations as a true testament to scientific innovation and public-private collaboration worldwide.
The vaccine can be administered to people older than 16 years of age. The current data is insufficient to decide whether children can receive the vaccine, FDA officials stated.
Pfizer- BioNTech have employed an mRNA which contains the spike protein from SARS-CoV-2 that will elicit an immune response in the people it has been administered too. Another American vaccine produced by Moderna seeking EUA from the FDA uses the same technology. Both the vaccines have shown over 90% efficacy against the virus.
Requiring storage at -70ºC, the vaccine has to be given in two dosages three weeks apart. The vaccine manufacturers have provided data for 37,586 of the participants. While the FDA reported over four participants suffering from temporary facial paralysis (Bell's Palsy) after taking the vaccine, the FDA believes that the vaccine is still safe to be used. A link between the vaccine and these cases has so far not been established.
With over 95% effectiveness assured by the FDA, the vaccine will begin distribution in the US soon. The company has also applied to the Indian drug regulator for disseminating its doses but is yet to present in front of the Subject Expert Committee.
Updated On: 2020-12-25T19:10:29+05:30