All Adults May Receive Booster Vaccines, But Who Should?
What should pharmacists tell younger adults who are unsure if they should get a COVID-19 vaccine booster shot? The answer is easy if they are 50 and older; the CDC recommends that they get boosted if enough time has passed since their initial vaccination. Here is more information on recommendations for who should get the shot, as opposed to who may get one.
SILVER SPRING, MD – Even though the Food and Drug Administration has authorized booster shots for all adults after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine, guidance from public health officials is more nuanced than that.
The national Centers for Disease Control and Prevention advises that people 18 years and older who received Pfizer-BioNTech or Moderna COVID-19 vaccines may get a booster, and explains who specifically should.
Recently, the FDA expanded the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines, which authorized the use of a single booster dose for all individuals 18 years of age and older after their initial vaccine.
The CDC further advises that patients should get a booster in the following circumstances:
- If they are 50 years and older
- If they are 18 or older and living in a long-term care setting
Anyone else 18 or older is allowed to get a booster but it is not specifically recommended.
As with the older cohort which already was receiving boosters, the shots should be received at least six months after completing the primary COVID-19 vaccination series. The booster can be any FDA-authorized product and not necessarily the same as the initial vaccine series, CDC states.
Guidance is somewhat different for those who received the single-dose Johnson & Johnson’s Janssen vaccine. The CDC recommends boosters for all adults 18 or older at least 2 months after the initial shot.
“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 Janet Woodcock, MD, in reference to the recent agency action.
Before the expanded authorizations, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for administration to those 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
“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 Peter Marks, MD, PhD, 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.”
The EUA for a single booster dose for individuals 18 years of age and older for the Moderna (administered as half of the dose of a primary series dose) and Pfizer-BioNTech COVID-19 vaccines is based on the FDA’s analysis of immune response data that supported use in the previously authorized populations for boosters.
- For the Moderna COVID-19 vaccine booster dose, immune response data came from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose. An effect was demonstrated when their immune response was compared to 1,055 study participants.
- For the Pfizer-BioNTech COVID-19 vaccine booster dose, immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose was provided. The antibody response against the SARS-CoV-2 virus one month after a booster dose was compared to the response one month after the two-dose primary series in the same individuals, demonstrating an effect.
The FDA points out that, since those studies, additional real-world data have underscored how cases of COVID-19 in the United States have increased and also on the low-risk myocarditis and pericarditis after vaccination. Essentially, the FDA 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 – as well as the risk of hospitalization and death from COVID-19 itself -- in adults.
Both Pfizer and Moderna are conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis.