FDA authorizes booster dose of Moderna and Pfizer vaccines for all adults
FDA has determined that the benefits of a single booster dose outweigh the risks and that the booster provides continued protection against COVID-19.
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The U.S. Food and Drug Administration has authorized booster shots of the Moderna and Pfizer COVID-19 vaccines for all adults ages 18 and older.
On Friday, the FDA announced it had amended the emergency use authorizations for both the Moderna and Pfizer-BioNTech vaccines allowing for a single booster dose for all individuals 18 and older after completion of primary vaccination with any of the approved COVID-19 vaccines.
The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices met Friday afternoon and recommended the booster shots for all adults, which means those newly eligible should be able to get a booster vaccine before the end of the year.
The CDC recommends that adults should get a booster at least six months after their last COVID-19 vaccine. Individuals should contact the vaccination site where they got their original shots, check their local pharmacy for appointments, or contact their local or state health departments to find a location.
WHY THIS MATTERS
Today's action expands the use of booster doses to include all individuals 18 and older at least six months after completion of the primary vaccination series of the Moderna and Pfizer vaccines and at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.
Prior to today's authorizations, a single booster dose of the Moderna and Pfizer vaccines was authorized for individuals 65 and older, individuals 18–64 who are at high risk of severe COVID-19, and individuals 18–64 with frequent institutional or occupational exposure to the coronavirus.
The booster shot is half the dose of a primary series dose.
Prior to authorization, the FDA analyzed immune response data on clinical trial participants who had received both doses of either the Moderna or Pfizer vaccines. It found an antibody response against the SARS-CoV-2 virus 29 days after a Moderna booster dose and a month after the Pfizer booster. Both vaccines demonstrated a booster response, the FDA said.
The FDA said the agency did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee before it gave its approval as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines.
THE LARGER TREND
The number of COVID-19 cases in the United States is rising nationwide.
The current seven-day average of daily new cases (88,482) increased 16.1% compared with the previous week (76,223), according to CDC data released Wednesday.
Since Moderna and Pfizer-BioNTech initially submitted data on their boosters, the FDA said it has additional real-world data on the recently increasing number of cases of COVID-19 in the United States and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination.
The additional data has enabled the FDA to reassess the benefits and risks of the use of these vaccines in the general adult population.
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 and that the booster provides continued protection against COVID-19, including hospitalization and death.
Both Pfizer and Moderna are conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis, according to the FDA.
The most commonly reported side effects by individuals who received a booster dose of the vaccines were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
ON THE RECORD
"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. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death," said Acting FDA Commissioner Dr. Janet Woodcock.
"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"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."
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
