The U.S. Food and Drug Administration (FDA) has approved Pfizer’s COVID-19 vaccine. In a press release dated August 23, the FDA stated that the Pfizer-BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty, will continue to remain under Emergency Use Authorization (EUA) for citizens between 12 and 15 years of age, and in third dose administration for immunocompromised individuals. Acting FDA Commissioner Janet Woodcock called the approval a “milestone” in the battle against the pandemic.
“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 the FDA requires of an approved product… While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” Woodcock said.
The Pfizer vaccine has been available under EUA since December 11, 2020, for individuals aged 16 and older. From May 10, 2021, the vaccine has been made available for those in the age groups, 12 to 15.
Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said that the agency’s medical and scientific experts have conducted “an incredibly thorough and thoughtful evaluation” of the Pfizer vaccine, including analyzing Comirnaty’s safety and a “detailed assessment” of the vaccine’s manufacturing process. Marks stated that the public and the medical community can be “confident” of the vaccine even though it was approved expeditiously. “It was fully in keeping with our existing high standards for vaccines in the U.S.,” Marks said.
In a statement to The Epoch Times, Pfizer CEO Albert Bourla stated that the FDA approval affirms the “efficacy and safety profile” of the company’s product. He expressed hope that the approval will “increase confidence” in the vaccine since inoculation “remains the best tool” to protect people and attain herd immunity.
President Joe Biden said that “the time to get vaccinated” has come. “Let me say this loud and clear: If you are one of the millions of Americans who have said that you will get the shot when it [has] full FDA approval — that has now happened,” Biden said in a tweet.
Clinical trial, risks
According to the FDA, an analysis of the clinical trial of around 44,000 people showed that the Pfizer vaccine was “91% effective in preventing COVID-19 disease.” 58 percent of the trial participants were monitored for four or more months after they had taken the second dose. Of these, a third of them reported adverse events.
The most commonly found side effects include swelling, pain, and redness at the injection site, fever, headache, fatigue, chills, and muscle and joint pain. 108 individuals who received the vaccine and 151 who received a single dose or placebo reported serious adverse events, including Bell’s palsy that causes facial paralysis.
In addition, the FDA also found that there were “increased risks” of pericarditis and myocarditis following vaccination, especially during the seven-day period after taking the second shot. Pericarditis is inflammation of the sac-like structure called pericardium that surrounds the heart, while Myocarditis is inflammation of the heart muscle, myocardium.
The risk was observed to be higher among males below the age of 40 when compared to females and older males. The highest risk is among males between the ages of 12 and 17. Though most individuals experienced “resolution of symptoms,” some individuals required “intensive care.” The Comirnaty Prescribing Information contains warnings regarding these risks.
According to the Vaccine Adverse Event Reporting System (VAERS) that is run by the U.S. Centers for Disease Control and Prevention (CDC) and the FDA, roughly 3,079 people have died after receiving a Pfizer shot. Moreover, around 15,268 people were hospitalized and 3,900 individuals have ended up with permanent disabilities.
The FDA decision to approve the Pfizer vaccine is being criticized by several experts. Last year, the agency had said that it would use an advisory committee of independent experts to ensure that “deliberations about authorization or licensure are transparent for the public.”
However, the FDA did not set up such an advisory committee before approving Pfizer. In a statement to The BMJ, Pfizer said that such a meeting was not necessary ahead of expected approval.
According to Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, the FDA’s decision to not set up an advisory committee removed an important mechanism for scrutinizing data. Such public meetings are necessary to build up trust and confidence, “especially when the vaccines came to market at lightning speed under emergency use authorization,” Kim said to the media outlet.
The Pfizer vaccine’s approval has been the fastest in the FDA’s history. Just four months after the company filed for licensing on May 7, the agency has approved the product. The fact that it has been less than two years since the beginning of the pandemic and the FDA has already approved a vaccine can be a cause for concern for many since a vaccine usually takes anywhere from five to 10 years to get approved.
“It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know,” Diana Zuckerman, president of the National Center for Health Research, said to The BMJ.
The FDA’s Pfizer approval comes as CDC director Rochelle Walensky warned in an August 18 press briefing that vaccines were becoming less effective against the Delta variant. She also cited international reports that individuals who were vaccinated early on might be at “increased risk” of severe disease.
“Given this body of evidence, we are concerned that the current strong protection against severe infection, hospitalization, and death could decrease in the months ahead, especially among those who are at higher risk or who were vaccinated earlier during the phases of our vaccination rollout,” Walensy said.