FDA approves Pfizer COVID-19 vaccine
September 1, 2021
The Food and Drug Administration (FDA) approved the first COVID-19 vaccine, marking a key achievement for public health amid a global pandemic.
The Pfizer-BioNtech vaccine, now marketed as Comirnaty, will continue to be used for emergency use authorization for people 16 and older and administered as a third dose in certain immunocompromised individuals.
“As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality [of the FDA],” The agency said in the approval statement.
The agency reports a 91% effectiveness in preventing the COVID-19 disease.
Out of more than 170 million people in the United States that are fully vaccinated against COVID-19, more than 92 million have received the Pfizer vaccine.
FDA Acting Commissioner, Janet Woodcock, says she hopes that the full approval of the vaccine will push more unvaccinated people to get vaccinated.
Additionally, the new approval could lead to vaccine mandates being implemented as the FDA has now publicly diminished any proposed threat.
“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA will help them to move forward,” US Surgeon General Vivek Murthy said.
Initially, due to the severity of the COVID-19 pandemic, the FDA, opted to approve Pfizer, along with the Moderna and Johnson and Johnson one-shot vaccine, for emergency use. The emergency authorization process takes far less time than full approval.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, reports that it has been 97 days since Pfizer completed the rolling submission of its approval license, which means the FDA completed the approval process “in about 40 percent” of the time it would take for an approval submission.
To grant full approval, the FDA looked at real world data from the hundreds of million people globally that have received the Pfizer vaccine as well as inspecting the facilities where the vaccine is manufactured.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after receiving their second dose. By the end of the trials over 12,000 recipients were followed for at least six months.
Common side effects were reported- pain at injection site, fatigue, muscle or joint pain, chills, and fever – however there is a measurable effectiveness in preventing serious hospitalization and death.
There are already measured effects from the approval. Several large companies – such as United Airlines, Disney, Walmart, Microsoft, Google and Facebook- have already announced plans to require vaccination.
Secretary of Defense, Lloyd Austin, announced the Pentagon plans to make vaccination mandatory for all active duty members of the US military by September.
Staff and students may also see changes in mandates from their school districts. In July, an Ohio law was signed regulating that no state or public institution of education can require an individual to receive a vaccine that FDA has not approved.
However, childhood vaccines that have been approved by the FDA are required in school districts across all 50 states. After the approval, a COVID-19 vaccine could be added to that list.
Moderna and Johnson and Johnson are also working on approval trials and expanding their administration to younger children.
The FDA approval of this vaccine could mark a major change in COVID-19 protocols and case numbers.
