While noting the risks of the vaccine, the Food and Drug Administration opened the door Monday to what is expected to be a flood of vaccine mandates by giving full approval to Pfizer-BioNTech’s COVID-19 vaccine.
Prior to Monday’s decision by the FDA, the vaccine was administered under what is known as an emergency use authorization, which was granted in December given the extreme nature of the COVID-19 pandemic.
The FDA’s decision applies only to the Pfizer vaccine. Vaccines produced by Moderna and Johnson & Johnson have yet to receive full FDA approval, but Moderna is expected to be considered for full approval next month.
Approval will lead to “the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that,” Dr. Anthony Fauci said earlier this month, according to CNBC. “The time has come. … We’ve got to go the extra step to get people vaccinated.”
Private businesses, governments and colleges have indicated to employees, students and others that once the vaccine has FDA approval, vaccine mandates will follow.
Treat a vaccine mandate at work like a contract negotiation, because they are trying to renegotiate your contract. Maybe ask for a 10K incentive, a raise to accompany your new qualification, and a liability clause that the company becomes liable for any and all negative effects?
— Jay Tysick (@carletonjtysick) August 22, 2021
Vaccine mandates violate ADA, can constitute the tort of battery, can violate religious freedom laws when religious exemptions unhonored, and violate Constitutional rights when a state actor orders them, unless they can show more than they can prove to mandate #COVID19 vaccine.
— Robert Barnes (@barnes_law) August 23, 2021
Breaking: NYC Mayor to announce vaccine mandate for all school staff, without testing alternative. All education dept staff must provide proof of first dose by 9/27. In doing so, NYC joins strictest vaccine mandates for school staff in country.
— Jessica Gould (@ByJessicaGould) August 23, 2021
In granting its approval, the FDA said the Pfizer vaccine will now be marketed as Comirnaty and has full approval for use in Americans 16 and older. The vaccine is under an EUA for children ages 12 to 15, the FDA said in a statement.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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.”
The FDA reported the vaccine was 91 percent effective in preventing COVID-19.
The Pfizer and Moderna vaccines have both been linked to an increase in myocarditis, an inflammation of the heart, with Moderna’s being twice as likely to trigger the rare condition.
The FDA addressed that concern in its statement, saying “the data demonstrate increased risks, particularly within the seven days following the second dose” of the Pfizer-BioNTech vaccine.
“The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age.”
The FDA noted “some individuals required intensive care support” and long-term information about the risks is not yet available.
The FDA said Pfizer is required to study the longer-term risks of the drug for producing myocarditis. The company is also conducting additional post-marketing safety studies to evaluate the impact on mothers and babies of taking the drug during pregnancy.
The drug’s approval was “remarkably fast,” according to Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania, who said a thorough review was the best way to convince those hesitant about the vaccine to be vaccinated.
“You can’t have it both ways. You can’t have people saying they won’t get vaccinated until there’s full approval and then say the FDA has to hurry up” to approve it, she said, according to The Washington Post.
Some said approval will have little impact when it comes to convincing those who do not want the shot to get it.
“It will provide an additional nudge but not make a huge difference,” said Jesse Goodman, a former FDA chief scientist who is a professor of medicine and infectious diseases at Georgetown University.
As of now, no vaccine exists for anyone under the age of 12.
Pfizer is still conducting trials on a vaccine for children ages 5 to 11, and has indicated results will be out by the end of September, according to CNN. Data for children ages 2 to 5 will follow.
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