Pfizer’s Covid-19 vaccine became the United States’ first fully approved vaccine. The twp dose vaccine used for the prevention of Covid-19 among individuals above the age of 16 years or more will be now marketed as Comirnaty.
The emergency use authorization (EUA) on the other hand remains for beneficiaries in the age groups 12 to 15 years and for third or booster doses of the vaccine in immunocompromised individuals. The US Food and Drug Administration (FDA) will take. A call on giving the vaccine a complete nod after new data on its efficacy in the younger population is available.
As Pfizer receives FDA’s highest standards for safety and vaccine effectiveness, the US government is hopeful more and more unvaccinated people will now come forward and take the shots.
What EUA means
FDA grants Emergency Use Authorization to a drug only after it has sufficient data that establishes that its potential benefits outweigh its potential risks on use. A EUA application can be considered when there is sufficient data to prove the efficacy of a drug after three phases of clinical trials.
EUA granted to Pfizer-BioNTech vaccine was earlier based on efficacy and safety data from randomized, controlled clinal trials conducted on thousands of individuals after which it was made available for administration December 11, 2020, onwards on people above or is 16 years of age. Ts use was expanded further to individuals aged between 15 and 12 from May this year as cases of Delta variant were witnessed.
How FDA’s full approval will help in vaccination drive
The FDA studied effectiveness data from over 20, 000 samples and 20, 000 cases where a placebo was applied on subjects who were 16 years or older. Evaluations were made based on 22,000 people who randomized received vaccines and the same number who got placebo shots.
Based on these results from the trial, BioNTech vaccines were found 91 percent effective in preventing Covid-19. The participants were followed up for four months after the second dose to check if vaccination yielded any side effects and other safety outcomes. But EUA gives the manufacturers only two months for the follow-up process to make the vaccines available to the general public at the earliest.
Pfizer followed 12, 000 recipients, for at least six months after administering them vaccine doses. FDA confirms that the vaccine has been proved effective in preventing Covid-19 and its serious outcomes like death or hospitalization.
