Why Pfizer’s FDA Approval Matters And What It Means For Vaccine Mandates

A Palestinian medic administers a dosage of the Pfizer-BioNTech COVID vaccine throughout a shot project at a medical center in Gaza City on Aug. 23.

Majdi Fathi/NurPhoto through Getty Images

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A Palestinian medic administers a dosage of the Pfizer-BioNTech COVID vaccine throughout a shot project at a medical center in Gaza City on Aug. 23.

Majdi Fathi/NurPhoto through Getty Images

Should kids under age 12 still not get vaccinated? The FDA still does not recommend that kids under age 12 get the Pfizer vaccine. Woodcock stated it “would be an excellent concern” for children under 12 to get the vaccine, as the FDA does not have the data on what the proper dose would be or information on the security of the vaccine for younger kids. “They are not just little adults. We have found out that time and time once again,” she said. Peter Marks, the director of the FDAs Center for Biologics Evaluation and Research, said that trials relating to immunizing kids under 12 are still continuous which the FDA is awaiting information to be submitted. The American Academy of Pediatrics likewise cautioned medical professionals not to give vaccines to kids under 12 until authorized by the FDA.

A healthcare worker fills a syringe with the Pfizer-BioNTech COVID-19 vaccine at the American Museum of Natural History in New York.

Amongst the steps the FDA required for complete approval that werent needed for emergency situation usage were information on how people fared six months after being fully vaccinated. The FDA also inspected manufacturing centers in the intervening months. The last approval also implies the Pfizer vaccine gets a brand name: Comirnaty (its pronounced koe-mir- na-tee, according to the FDA).

The Food and Drug Administration has given its complete approval of the Pfizer-BioNTech COVID-19 vaccine, calling it a “key accomplishment for public health.” The two-dose vaccine is now fully approved for people ages 16 and older. For those who are ages 12 to 15 and for those who are immunocompromised and need a booster shot, the vaccine is still readily available under an FDA emergency use authorization.The approval, states the FDA, means “the general public can be very positive that this vaccine fulfills the high standards for security, efficiency, and making quality the FDA requires of an approved item.” How does a drug get last FDA approval? Back in December 2020, the FDA allowed the Pfizer vaccine to be used under an emergency situation use permission. Pfizer and BioNTech got full approval in May. Now that it has gone through a complete evaluation by a U.S. regulator, this final stamp of approval indicates the Pfizer vaccine can now be marketed with other approved drugs and vaccines. The procedure of last approval, described by the FDA, requires an analysis of the drugs advantages that also examines its dangers and takes a look at scientific trials from the drugmaker. When the FDA authorized the vaccines emergency use, much of this was already done.

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A health care worker fills a syringe with the Pfizer-BioNTech COVID-19 vaccine at the American Museum of Natural History in New York.

Mary Altaffer/AP

She said a few lawsuit have started to browse the legal aspects of what it would suggest for states and private employers to need a person to accept an unapproved product– but up until now, it seems that courts are not excited to use FDA approval as a restriction on vaccine requireds. What does this mean for school and company vaccine requireds? Its most likely well see more vaccine requirements put in place now that there is one vaccine with full FDA approval.

Misty Cunningham chews out a passing vehicle driver outside Winchester Medical Center on August 10, 2021 in Winchester, VA. Healthcare workers went on strike over a COVID-19 vaccine required by their employer Valley Health.

The Defense Department, for example, has already revealed that all service members will be required to get the vaccine now that the FDA has authorized the Pfizer vaccine. Without the approval, it would have taken a presidential waiver to enable the secretary of defense to require service members to be immunized. Even prior to the FDAs full approval of the Pfizer vaccine, federal departments consisting of the departments of Health and Human Services and Veterans Affairs had mandated that their staff members who deal with clients get the vaccine.

Is there a legal difference, when it concerns requireds, in between emergency situation usage and complete approval? There isnt a lot of clearness on this. Law teacher Lindsay Wiley from American University in Washington, D.C., told NPR its an open concern right now whether having the full approval makes a distinction in terms of legal authority to issue a vaccination requirement.

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Misty Cunningham chews out a passing vehicle driver outside Winchester Medical Center on August 10, 2021 in Winchester, VA. Healthcare workers went on strike over a COVID-19 vaccine mandate by their employer Valley Health.

The Washington Post/The Washington Post by means of Getty Im

“While millions of people have already safely gotten COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine might now instill extra self-confidence to get immunized,” Woodcock of the FDA stated.

Outside of government entities, its possible that more universities will need vaccines for adults over age 18, something that lots of states have long needed for meningitis, for instance. New York City, the countrys biggest public school district, announced its own vaccine required for instructors and personnel on Monday morning. New Jersey also announced a required for teachers and state employees on Monday.

Woodcock stated it “would be a great concern” for children under 12 to get the vaccine, as the FDA does not have the data on what the appropriate dosage would be or data on the safety of the vaccine for younger kids. Its most likely well see more vaccine requirements put in place now that there is one vaccine with complete FDA approval.

The Defense Department, for example, has currently revealed that all service members will be required to get the vaccine now that the FDA has actually approved the Pfizer vaccine. Even before the FDAs complete approval of the Pfizer vaccine, federal departments consisting of the departments of Health and Human Services and Veterans Affairs had actually mandated that their employees who work with clients get the vaccine.

How will the FDA approval effect those who are vaccine hesitant? Health officials are hoping the complete approval will offer some peace of mind for those who have felt reluctant about getting vaccinated. “While millions of individuals have already securely gotten COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine might now impart extra confidence to get immunized,” Woodcock of the FDA said.

The White Houses primary medical consultant, Dr. Anthony Fauci, told NPRs All Things Considered that he estimates the FDAs “official stamp of approval” will convince as lots of as 20% of the 90 million vaccine-eligible individuals in the U.S. who are still unvaccinated to sign up. “I think that those individuals will now advance and get vaccinated,” he stated. A Kaiser Family Foundation study from June revealed that approximately 30% of unvaccinated adults who felt reluctant about the vaccine stated a complete approval would suggest they would be more most likely to get immunized. The same study showed that two-thirds of adults either already believe the vaccines available in the U.S. are completely authorized by the FDA or are unsure if they have approval.

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