FDA expands use of Pfizer vaccine, green-lights boosters for children 12-15

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The U.S. Food and Drug Administration has authorized Pfizer-BioNTech's COVID-19 booster shots for children 12 to 15 years old, the agency revealed Monday.

Additionally, the FDA shortened the time between the completion of primary vaccination of the Pfizer offering and a booster dose to at least five months. The new guidance also allows for a third primary series dose for certain immunocompromised children 5 through 11 years old.

The agency has determined that the protective health benefits of a single booster dose of the Pfizer shot outweigh the potential risks in those who fall under that age group. The boosters, according to the FDA, provide continued protection against COVID-19 and the associated consequences that may occur, such as hospitalization and death.

In determining the new guidance, the FDA reviewed real-world data from Israel, including safety data from more than 6,300 people in that age range who received a booster dose of the vaccine at least five months following the completion of the primary two-dose vaccination series.

The new data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population. The data, the agency said, shows there are no new safety concerns following a booster, and there were no new cases of myocarditis or pericarditis reported to date.

As regards the booster interval, no new safety concerns emerged from a population of more than 4.1 million people ages 16 and older in Israel who received a booster dose at least five months following the initial vaccination series.

On top of that, peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer vaccine greatly improves an antibody response, allowing a person to better counter the Omicron variant. Authorizing booster vaccination to take place at five months rather than six months may, therefore, provide better protection – and sooner – against Omicron, which is highly transmissible.

While the action applies specifically to the Pfizer vaccine, the FDA is reviewing data related to the other vaccines, including the Moderna and Johnson & Johnson shots.

THE IMPACT: THE IMMUNOCOMPROMISED

Children 5 to 11 years old who have undergone solid organ transplantation, or who have been diagnosed with conditions considered to have an equivalent level of immunocompromise, may not respond adequately to the two-dose primary vaccination series, according to the FDA. Because of that, a third primary series dose has now been authorized for the group.

The FDA previously authorized a third primary series dose for use as part of the primary immunization series in individuals 12 years old and older. The potential effectiveness of an additional dose in children ages 5 to 11 was extrapolated from data in adults.

The agency used prior analyses conducted as part of the authorization process for healthy children to inform safety in this population, determining that the potential benefits of a third primary series dose at least 28 days following the second dose of the two-dose regimen outweighed the potential and known risks of the vaccine. To date, the FDA and Centers for Disease Control and Prevention have seen no new safety signals in that age group.

Children ages 5 to 11 who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but the FDA will continue to review information and communicate with the public if data emerges suggesting booster doses are, in fact, needed.

The most commonly reported side effects by individuals who received a booster dose or an additional dose as part of a primary series were pain, redness and swelling at the injection site, as well as 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 second dose of a two-dose primary series.

THE LARGER TREND

Back in December, the FDA had signaled its intent to actively work with federal partners, international regulators and medical product companies to quickly address any potential impacts of the new Omicron variant on the tools being used to fight the pandemic.

The FDA said at the time it was working quickly to evaluate the potential impact of the variant on currently available diagnostics, therapeutics and vaccines.

According to the FDA, it's been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic and has worked with medical product developers when a new variant emerges that could impact product performance.

The FDA has previously limited the scope of use of certain monoclonal antibodies, depending on variants circulating in certain areas; updated fact sheets for healthcare providers with information about how known variants impact certain therapeutics; and communicated with the public about tests affected by viral mutations.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com