FDA Grants Full Approval of Pfizer COVID Vaccine

MONDAY, Aug. 23, 2021 (HealthDay News) -- The U.S. Food and Drug Administration on Monday granted full approval for Pfizer's coronavirus vaccine.

"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 in an agency news release. "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."

U.S. health officials hope the decision will trigger more vaccine mandates and boost vaccination rates among Americans who remain hesitant about immunization, The New York Times reported.

"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," Woodcock said. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

The approval is likely crucial for greater vaccine uptake.

For example, as students prepare to return to college campuses across the country, some, like Indiana University, already require vaccines for students. But others, like the University of Memphis, will likely only pursue a vaccine mandate when coronavirus vaccines gain full federal approval, the Times reported.

Speaking to CNN on Sunday, U.S. Surgeon General Dr. Vivek Murthy said he thought full FDA approval would definitely have a significant impact on millions of Americans who remain vaccine-hesitant.

"This may tip them over toward getting vaccinated," he said, adding that he expected companies, governors and schools to use the full FDA approval to impose vaccine mandates. "We already know that there are many businesses and universities that have moved toward vaccine requirements."

About 60% of eligible people in the United States are now fully vaccinated, according to figures from the U.S. Centers for Disease Control and Prevention.

Three in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to receive full approval from the FDA, according to a June poll by the Kaiser Family Foundation.

The Pentagon also plans to make COVID-19 vaccinations mandatory for the country's 1.3 million active-duty troops by the middle of next month or when the FDA gives full approval to the vaccine, whichever comes first.

For the 45 percent of unvaccinated Americans who have steadfastly said they will not get the vaccine, full approval will likely prompt new restrictions, including limitations on employment and an increase in health insurance premiums, the Times reported.

Some states and municipalities could follow the lead of New York City, which will soon require at least one vaccine dose for those seeking to enter indoor restaurants, gyms or cultural events.

The FDA updated its authorizations of the Pfizer and Moderna vaccines last week to allow third "booster" doses for some immunocompromised people, a decision backed by the CDC.

Regulators are still reviewing Moderna's application for full approval for its vaccine, and a decision could come at least several weeks after the one for Pfizer. Moderna is planning to submit its data in support of a booster shot in September, the Times reported.

Risk of Heart Condition in Young Who Get Moderna Shots Greater Than Thought

The Moderna coronavirus vaccine may be linked to a higher risk of a rare heart condition called myocarditis in younger adults than believed, emerging reports show.

Federal health officials are investigating the new data, according to two people familiar with the review who emphasized the side effect is still rare, the Washington Post reported.

Vaccination is still by far the healthier option, since the CDC's vaccine advisers have already said that getting COVID-19 puts someone at much greater risk of heart inflammation and other serious medical problems than getting the vaccine does.

But officials from the FDA and the CDC are honing in on data from Canada that suggests the Moderna vaccine may carry a higher risk of this rare condition for young people compared to the Pfizer vaccine, particularly for males under 30. They are also analyzing U.S. data to determine whether the same is happening in the United States, the Post reported.

The Canadian data suggests there might be a 2.5 times higher incidence of myocarditis in those who get the Moderna shot compared with the Pfizer vaccine, the Post reported. Myocarditis is an inflammation of the heart.

One of the people familiar with the investigation emphasized that the agencies must do more research before deciding whether to issue any new or revised warning for the Moderna vaccine. In June, the FDA added a warning label for the Pfizer and Moderna shots about an increased risk of myocarditis.

"We have not come to a conclusion on this," the person told the Post. "The data are not slam bang."

Moderna did not respond to a request for comment.

In a statement, the CDC said its "Advisory Committee on Immunization Practices has and continues to review reports of myocarditis and pericarditis following COVID-19 mRNA vaccination. CDC, FDA, and our vaccine safety partners are actively monitoring these reports, including reviewing data and medical records, to learn more and understand any relationship to COVID-19 mRNA vaccination."

Officials want to be careful not to cause alarm, especially when they are trying to persuade more people to be vaccinated amid a surge of cases fueled by the fast-moving Delta variant, the newspaper added.

In late June, health officials first said there is a "likely association" between the Moderna and Pfizer vaccines and a raised risk of the rare heart condition in teens and young adults. However, heart issues are far more likely if a person develops COVID-19, so vaccination remains the healthier option.

The CDC and the U.S. Department of Health and Human Services, together with 15 of the country's leading medical and public health organizations — including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association and the American Nurses Association — issued a joint statement after that June meeting saying that they "strongly encourage everyone 12 and older" to get the shots because the benefits far outweigh potential harms.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19.

SOURCES: The New York Times; Washington Post; CNN

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