Additional COVID-19 Booster Doses Authorized for Age 50 Years and Older Cohort

Washington, D.C.—Pharmacists should be prepared to provide a second booster dose to older adults, as well as to adults and adolescents with certain types of immunocompromising conditions.

The FDA has authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 years and older and certain immunocompromised individuals. A single booster dose for specific immunocompromised individuals following completion of a three-dose primary vaccination series was previously authorized by the FDA, but the new action makes the additional shot available to other populations at higher risk for severe disease, hospitalization, and death.

"Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns," the agency said in a press release.

Emergency use authorizations were amended to state:

• A second booster dose of the Pfizer-BioNTech COVID-19 or Moderna COVID-19 vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

• A second booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered to individuals aged 12 years and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. That includes patients who have undergone solid organ transplantation or who are living with conditions that are considered to have an equivalent level of immunocompromise.

• A second booster dose of the Moderna COVID-19 vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals aged 18 years and older with the same certain kinds of immunocompromise.

"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," explained 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."

The FDA said it will continue to evaluate data and information as it becomes available to determine whether a second booster dose is appropriate in other groups.

Meanwhile, a key FDA advisory committee will meet in early April to discuss the possible expansion of additional booster vaccines against COVID-19 as well as whether vaccines need to be updated to respond to specific variants.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet virtually on April 6, according to the FDA. Other agencies, including the CDC and the National Institutes of Health, will participate in the meeting.

"As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences," explained Dr. Marks. "Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat. Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward."

Part of the impetus for the meeting, which will involve no voting, is that both Moderna and Pfizer-BioNTech has sought FDA emergency use authorization for a fourth booster dose for some people.

Moderna submitted an amended application to include its Spikvax COVID-19 vaccine for a fourth booster dose for people aged 18 years and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. The FDA only granted it so far for those aged 50 years and older.

Pfizer Inc. and BioNTech SE sought authorization for an additional booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. In that case, the companies got more than they requested.

"The submission is based on two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating," the companies wrote in a press release. "These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness."

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