Pfizer’s COVID-19 vaccine just received full FDA approval. Here’s what it means
Pfizer’s Covid-19 vaccine became the first to receive full FDA Approval on Monday, a milestone that may help lift public confidence in the shots as the world battles Delta – the most contagious coronavirus mutant yet.
The vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety.
In early August, a Wall Street Journal report stated that India was in talks to buy 50 million doses of Pfizer and German partner BioNTech COVID-19 vaccine, citing people familiar with the matter.
What does full approval mean?
It means Pfizer’s shot for people 16 and older has now undergone the same rigorous testing and regulatory review as dozens of other long-established vaccines.
Covid vaccines in the US have so far been rolled out under the Food and Drug Administration’s emergency use authorization, which allows the agency to speed the availability of medical products during public health emergencies.
Under the process, the FDA waived some of its regular data requirements and procedures to fast track the vaccines, making them available months earlier than regulation.
Pfizer’s vaccine, along with those from Moderna and Johnson & Johnson, still underwent rigorous testing to establish safety and effectiveness against the virus. But the FDA initially required the companies to submit about only two months of safety monitoring data on study participants, the period when side effects are most likely to occur.
For full approval, the FDA required six months of follow-up data. FDA inspectors also visited the plants where the vaccines are made and reviewed each step of the production process for extra assurance that the shots are made under safe, sterile conditions.