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Additional COVID-19 vaccine booster dose: For everyone age 50+ and immunocompromised age 12+

Today, the US Food and Drug Administration (FDA) authorized and the US Centers for Disease Control and Prevention (CDC) recommended a second booster dose of mRNA COVID-19 vaccine (that is, either Pfizer-BioNTech or Moderna) for everyone age 50 and older at least four months after their prior booster dose, with a strong recommendation for everyone age 65 or older and for those age 50 and older with underlying medical conditions.

For those who are immunocompromised, an additional Pfizer-BioNTech vaccine booster dose is authorized for anyone age 12 and older and an additional Moderna vaccine booster dose is authorized for anyone age 18 and older, at least four months after their prior booster dose of any authorized vaccine.

At the option of the recipient, booster doses can be of a different brand as prior doses, for example following a Pfizer-BioNTech dose with a Moderna dose.

For persons who are younger than age 50 and are not immunocompromised, the recommendation of a single booster dose after a two-dose primary sequence remains unchanged. According to the FDA, a first booster dose provides significant and substantial protection against hospitalization and death, including against circulating variants such as Delta and Omicron, for most people, but data from Israel shows that a second booster is of value for those whose immune systems are less robust because of age or other reasons.

Separately, regardless of age every adult who received both a primary single dose and booster dose of Johnson and Johnson (Janssen) vaccine at least four months ago may now receive a second booster dose using an mRNA (Pfizer-BioNTech or Moderna) vaccine.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

Marks of the FDA held a media briefing available on YouTube, and among other issues said that in coming months there may be a need for variant-specific vaccines but this is not yet known.

CDC Director Rochelle P. Walensky, MD, MPH, said, “Today, CDC expanded eligibility for an additional booster dose for certain individuals who may be at higher risk of severe outcomes from COVID-19. Boosters are safe, and people over the age of 50 can now get an additional booster four months after their prior dose to increase their protection further. This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time. CDC, in collaboration with FDA and our public health partners, will continue to evaluate the need for additional booster doses for all Americans.”

In response to an inquiry from Motif, the RI Department of Health (RIDOH) restated the new federal recommendation and said, “If you have questions about whether a second booster dose is right for you, talk to your healthcare provider.” RIDOH confirmed that the additional booster dose, which is identically formulated to primary doses, would be available from any state-run facility or private pharmacy from which vaccine is ordinarily available.