On 23 August, the U.S. Food and Drug AdministrationU.S. Food and Drug Administration approved the first COVID-19 vaccine, made by Pfizer-BioNTech, for anyone 16 years and older. The vaccine requires two doses and is 91% effective in protecting people from COVID- 19 disease, including from severe illness, according to company studies. The vaccine received the emergency utilization authorization in December that allowed the company to administer and distribute the shot due to the public health issue of pandemic.
I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to protect lives and secure herd immunity, said Pfizer Chairman and CEO Albert Bourla in a statement.
With Pfizer permission, little will change in the way of vaccine is made, according to Pfizer. The two companies are discussing with the FDA how the labels on the approved vials will be revised to reflect the full licensure, but manufacturing process will not change appreciably.
What is the Quality Control Standard for each lot of vaccine? In a similar fashion to any approved vaccine, the FDA must now conduct its own analysis of each manufactured quantity and give the green light to release those lots on to the market. Under the EUA, the companies sent samples from each lot they made to FDA at least 48 hours before distributing, along with their own analysis of the doses' safety and quality, but did not have to wait for the FDA to release them.
What could also change are vaccine mandates from both public and private agencies including governments, schools, and businesses Having an approved vaccine may provide stronger support for such entities to require vaccination for employees, students and customers. While others already have such mandates in place, the FDA approval may lead more organizations to adopt similar requirements. This full licensure can also help to whip those who have been reluctant to get vaccinated with a shot that was not approved. 'While millions of people have already received COVID 19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated, acting FDA Commissioner Dr. Janet Woodcock said in a statement Pfizer and BioNTech made their request for approval in May, and the agency had eight months to review the 340,000 page package that included data from 44,000 people who participated in clinical trials. The data showed that the two doses of vaccine are effective 91% in protecting people from COVID - 19 disease up to six months after the second dose. The FDA requires at least six months follow-up data to qualify for approval.
In the months since vaccine has been administered in the world, FDA has added warnings about rare side effects that can occur among vaccinated people, including the risk of inflammation of the heart muscle and tissues around the heart.
With an approved vaccine, Pfizer-BioNTech can also start selling and distributing its shot through its own channels. However, Pfizer said it has an agreement with the U.S. government to provide doses and vaccines through April 2022 at no cost to Americans, and expects the U.S. government to remain the sole distributor of its vaccine through that time. The vaccine will therefore continue to be distributed on the same sites where it has been distributed until now — at federal or state mass vaccination centers, pharmacies, hospitals, doctor's offices and other health care facilities.
Those sites would also be responsible for giving infectious, increased vaccine dose to people which the FDA is currently considering as a way of bolstering protection against the additional Delta variant. The agency is expected to decide in coming weeks whether a booster is needed; the FDA has already authorized a booster shot for people with compromised immune systems.