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FDA authorizes booster doses for 12- to 15-year-olds, shortens interval for adults


A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.
Enlarge / A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.

As the ultra-transmissible omicron coronavirus variant bears down on the US, the Food and Drug Administration on Monday announced a set of sweeping changes to the availability of Pfizer-BioNTech booster doses.

The regulator expanded access to third doses by authorizing their use for kids 12 to 15 years old. The agency also shortened the interval at which adults and children 12 and up can get a booster after their second dose—moving the time from six months to only five months. Last, the FDA made third doses available to immunocompromised children ages 5 to 11 who may not mount a strong response from only the first two doses.

The FDA’s moves are motivated by omicron and backed by data from Israel, which has a booster program further along than that of the US. In fact, Israeli officials on Monday began offering fourth doses (second booster doses) of the Pfizer-BioNTech vaccine to people ages 60 and over in an effort to sustain high levels of protection in the population. The omicron variant, which is currently powering a vertical rise in cases in the US, has been found to thwart protection from only two vaccine doses, but it can still be defeated with booster doses.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster, and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”

Supporting their decision to authorize boosters for those ages 12 to 15, the FDA turned to Israeli data on more than 6,300 children in this age range who had received a booster dose. The data suggested that the booster dose provided continued protection from the current variants while raising no safety concerns. In particular, the FDA noted that there were no new cases of myocarditis or pericarditis (inflammation of the heart and surrounding tissue) in the age group.

Critical boost

The FDA also relied on Israeli data in deciding to shorten the interval between a second dose and a third. Based on data of more than 4.1 million people ages 16 and older in Israel who received a booster dose at least five months after their first two, the agency saw no safety reasons why the interval couldn’t be shortened. The FDA also pointed to peer-reviewed laboratory data, which has consistently found that a booster dose significantly increases protection against the omicron variant.

“Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant,” the FDA said in its announcement.

For now, the shortened interval only applies to the Pfizer-BioNTech vaccine, not the Moderna booster doses. However, the FDA said it will continue to review data as it comes through for other vaccines.

For immunocompromised children ages 5 to 11, the FDA said it did not rely on fresh data to authorize boosters. Instead, the agency extrapolated effectiveness data from older age groups and reviewed earlier safety data it used previously to authorize two doses for the younger pediatric group. The use of boosters in children ages 5 to 11 is limited to those with compromised immune systems, such as those who have undergone a solid organ transplant or have a condition that compromises the immune system to an equivalent degree. The agency says that for now, children ages 5 to 11 who do not have compromised immune systems do not need a booster. But again, it will be monitoring data as it becomes available.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing, and social distancing in order to effectively fight COVID-19,” Acting FDA Commissioner Janet Woodcock said in a statement.

COVID-19 cases in the US are higher than they have ever been, smashing all-time records on a daily basis. The current daily average of new cases is over 400,000, a more than 200 percent increase from two weeks ago. The Centers for Disease Control and Prevention expects that the cases will continue to climb in the coming weeks, further straining health systems.

The CDC’s advisory panel is planning to meet this week to review the FDA’s changes to booster availability, according to reporting by The New York Times. So far, the date of the meeting has not been publicly set. If the CDC’s advisers approve the FDA’s expanded uses for boosters, CDC Director Dr. Rochelle Walensky will likely sign off quickly, solidifying them as official federal recommendations.



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