What does full approval of Pfizer’s COVID-19
vaccine mean?
By Matthew Perrone
The Associated Press
AP Illustration by Peter Hamlin
August 24, 2021
What does full approval of Pfizer’s COVID-19 vaccine mean?
It means Pfizer’s shot for people age 16 and older has now
undergone the same rigorous testing and regulatory review as
dozens of other long-established vaccines.
COVID-19 vaccines in the U.S. were initially rolled out under
the Food and Drug Administration’s (FDA) 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 normal data
requirements and procedures to make the COVID-19 vaccines
available months earlier than would have been possible under
normal circumstances.
Pfizer’s vaccine — along with those from Moderna and Johnson
& Johnson — still underwent testing in tens of thousands of
people to establish safety and effectiveness against COVID-19.
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.
Because vaccines are typically given to otherwise healthy
individuals, they are generally subject to more regulatory
scrutiny than other medical products, including prescription
drugs. Full approval means the Pfizer vaccine now carries the
FDA’s strongest endorsement of safety and effectiveness.
Public health experts hope the change will convince more
unvaccinated people to get the shot and spur more employers to
require vaccinations.
Moderna has also applied for full approval, and Johnson &
Johnson has said it hopes to apply later in the year.
Pfizer’s shot still is available for 12- to 15-year-olds
under emergency use authorization. The full approval also
doesn’t apply to boosters. The agency will decide separately
whether an extra shot is necessary for healthy people.
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