FDA approves Pfizer and Moderna booster vaccines for all adults over age 18

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The agency cites studies showing that reactions and side effects are mild

As anticipated, the Food and Drug Administration (FDA) has authorized both the Moderna and Pfizer-BioNTech COVID-19 vaccine boosters for people aged 18 and older. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is slated to meet later Friday to discuss further clinical recommendations.

Prior to Friday’s authorizations, a single booster dose of the Moderna and Pfizer vaccines was authorized for those 65 years of age and older and other high-risk individuals.

With this addition, the immunization rate of the U.S. population could grow quickly. As of Thursday, a total of 195,713,107 Americans are reported to be fully vaccinated -- 58.9% of the country's population.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” said Acting FDA Commissioner Janet Woodcock, M.D. She added that getting the booster will provide added protection against the virus, including the more serious consequences that can occur, like hospitalization and death.

Eliminating confusion surrounding boosters

Since the rollout of the booster vaccines, there have been a variety of questions about the various requirements that need to be met for a person to be eligible. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, says everyone is on the same page now. 

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” he said.

The FDA said its decision to open up the availability of the two vaccine boosters was built on its analysis of immune response data, which the agency used to approve the previously authorized populations for boosters.

Risks and possible reactions to the boosters

When it comes to the FDA’s evaluation of benefits and risks, it said since Moderna and Pfizer-BioNTech initially submitted their safety and effectiveness data on a single booster dose. Additional real-world data became available primarily about the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination with these vaccines. In the end, the FDA gave the boosters the all-clear.

“The FDA has determined that the benefits of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in individuals age 18 years of age and older when used following completion of primary vaccination to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said.

As far as the types of reactions people receiving the booster may experience, the FDA said the most common side effects include the following:

  • Pain, redness, and swelling at the site on the body where the injection was given

  • Fatigue

  • Headache

  • Muscle or joint pain

  • Chills

The agency said one important reaction people should be aware of is swollen lymph nodes in the underarm. Those were observed more frequently following the booster dose than after the primary two-dose series. 

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