#USA, August 27, 2021 – The US Food and Drug Administration has done what was expected… the Pfizer BioNtech COVID-19 vaccine is now approved by the regulator as a market ready defence against the contagion which has killed 4.43 million people and sickened 212 million across the globe.
No more Pfizer/BioNtech, it is now called Comirnaty and the FDA believes the US is another step closer to controlling the pandemic in the States.
“Comirnaty has been scrutinised through a BLA or a Biologics License Application to make sure the vaccine is safe and effective.
The mRNA or messenger RNA formula which is introduced to the body in two doses of Comirnaty does not alter ones genetic make-up,” said the FDA.
The FDA also defends the unprecedented speed for this approval; “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
The approval is expected to bolster confidence and many believe it will also bolster vaccine mandates.
Clinical trials for the Pfizer BioNtech vaccine concluded in November 2020, Emergency use started in the UK in December 2020 now it gets FDA market approval within nine-months and after 202 million doses have been administered globally.
Vaccine mandates are not only on the way with the approval by the FDA, but have already resulted in the US Defense Department announcing that all service members are required to get the Covid 19 vaccine.
Comirnity is the market name for the Pfizer branded coronavirus vaccine and media reports inform it would have previously taken a presidential waiver to institute the mandate. A waiver is no longer required with the FDAs full approval of the vaccine for anyone 16 and over which came on Monday.
The US Defense Department mandate impacts at least 1.4 million active troops, say reports.