Medical and public health experts determine when to recommend a booster

You may have been hearing talk about COVID-19 booster doses. Currently, certain groups of people who got the Pfizer COVID-19 vaccine are recommended to get booster doses six months after their original series.

This week, the U.S. Food and Drug Administration (FDA) will consider whether to recommend that individuals who were vaccinated with Johnson & Johnson and Moderna COVID-19 vaccines should get booster doses.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is a committee of experts who will decide whether to recommend the booster doses. The VRBPAC has two days of meetings  scheduled on Oct. 14 and 15 to consider whether to amend the Emergency Use Authorization of the Johnson & Johnson and Moderna vaccines to include a recommendation for booster doses. This committee will consider each vaccine individually.

We’ve written about the steps in the vaccine emergency use authorization process. But what do these groups consider?

The decision to recommend a booster for people who received these vaccines depends on how significant the decrease in immunity is for each vaccine. Like the Pfizer vaccine, the VRBPAC may decide that only certain groups of people need a booster. Immunity may be waning more quickly in some people than others. This could mean that the people who are losing immunity should be given a booster to boost their immunity. 

VRBPAC members will hear presentations of data from the companies that manufacture these vaccines. They will also consider the FDA’s own analysis of the data. They will look at data that show whether there are significant decreases in immunity in people who have received the Johnson & Johnson COVID-19 vaccine and the Moderna COVID-19 vaccine individually, and whether a booster dose significantly boosts their immunity; then, decisions will be made separately for each vaccine.

“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic. It’s critical that as many eligible individuals as possible get vaccinated as soon as possible. Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

“The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations.”

Once the VRBPAC decides, the committee will make a recommendation to the FDA. If the FDA decides to recommend boosters, the decision will be considered by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). The ACIP is an independent panel of medical and public health experts. Before recommending, ACIP reviews all available clinical trial information, including descriptions of:

  • Who is most at risk for COVID-19, in particular for more severe disease
  • Who received the vaccine (age, race, ethnicity, underlying medical conditions)
  • How different groups responded to the vaccine
  • What side effects people had

From these data, ACIP will then vote on whether to recommend the vaccine. If the ACIP votes to recommend the boosters, they will make an official recommendation to the director of the CDC, who will decide whether to move forward.

In the western states, if the CDC director recommends moving forward with boosters, the Western States Scientific Safety Review Workgroup (WSSSRW) will review the data and issue a recommendation for vaccine administration in Oregon, Washington, Utah and California.

Once the WSSSRW has issued its recommendation, Oregon Health Authority (OHA) will issue guidance for the administration of the vaccine.  Then Governor Brown, with the guidance of health advisors, may authorize the booster doses.

Later this month, the VRBPAC will also consider whether the Pfizer-BioNTech COVID-19 vaccine should be granted Emergency Use Authorization (EUA) for children who are five through 11 years of age. The same process will be used to determine whether this vaccine should be recommended for children.