The Covid-19 vaccine known as Pfizer-BioNTech is the first vaccine approved by the U.S. Food and Drug Administration (FDA).
The vaccine will now be marketed with a new brand name, Comirnaty ( koe-mir’-na-tee) for the prevention of Covid-19 disease in people aged 12 years and older. The vaccine had initially been given emergency use authorization (EUA) in individuals 16 years of age and older since Dec. 11,2020. The authorization was expanded on May 10,2021 to include those aged 12 through to 15 years as well and it continues to be under the EUA after approval ” for the administration of a third dose in certain immunocompromised individuals” according to the FDA.
Results from the clinical trial proved the vaccine 91% effective in preventing the Covid disease. FDA Acting Commissioner, Dr Janet Woodcook said during a briefing on Monday, August 23, ” …as the first FDA approved Covid-19 vaccine, the public can be confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product.”
Out of more than 170 million people in the U.S. who are fully vaccinated, more than 92 million have received the Pfizer-BioNTech vaccine. Agency Official said they hope the approval will push unvaccinated persons to get vaccinated.
Moreover, President Biden said in a televised address to the populace that, ” The moment you’ve been waiting for is here, its time for you to go get your vaccination. Get it today.” This he said directly to the “millions” of Americans who were waiting for full and final FDA approval before they get vaccinated.
He further urged private sector companies and non-profits to require employees get vaccinated or “face strict requirements.” Following the announcement of the approval, the U.S. Military said they officially require all 1.3m active duty U.S. troops to get vaccinated.
It stands that this is the fastest vaccine approval in the FDA’s more than 100 year history. The approval came less than four months after Pfizer-BioNTech filed for licensing in early May,2021.