FDA clears recalls for 12-15 year olds, shortens interval for adults [Updated]

Original story 12:41 p.m. EST: As the ultra-transmissible variant of the omicron coronavirus hits the United States, the Food and Drug Administration on Monday announced a set of radical changes to the availability of Pfizer-BioNTech booster doses.

The regulator has broadened access to third doses by authorizing their use for children aged 12 to 15. The agency has also shortened the interval at which adults and children 12 and older can be boosted after their second dose, from six months to just five months. Finally, the FDA has made third doses available to immunocompromised children aged 5 to 11 who may not produce a strong response from the first two doses only.

The FDA’s actions are motivated by omicron and supported by data from Israel, which has a more advanced recall program than that of the United States. In fact, Israeli officials on Monday started offering fourth doses (second booster doses) of Pfizer-BioNTech vaccine to persons aged 60 years and over with the aim of maintaining high levels of protection in the population. The omicron variant, which is currently fueling a vertical increase in cases in the United States, has been shown to thwart the protection of just two doses of the vaccine, but it can still be defeated with booster doses.

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

Supporting its decision to allow booster shots for 12 to 15 year olds, the FDA turned to Israeli data on more than 6,300 children in that age group who had received a booster dose. The data suggests that the booster dose provided continued protection against the current variants while not raising any 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 when deciding whether to shorten the interval between a second dose and a third. Based on data from more than 4.1 million people aged 16 and over in Israel who received a booster dose at least five months after their first two, the agency saw no safety reason for which the interval could not be shortened. The FDA also pointed to peer-reviewed lab data, which has consistently shown that a booster dose significantly increases protection against the omicron variant.

“Allowing the booster vaccination at five months rather than six months could therefore offer better protection earlier to individuals against the highly transmissible variant of omicron,” the FDA said in its announcement.

At this time, the shortened interval only applies to the Pfizer-BioNTech vaccine, not the Moderna booster doses. However, the FDA said it will continue to review the data as it arrives for other vaccines.

For immunocompromised children aged 5 to 11, the FDA has said it is not relying on new data to authorize the boosters. Instead, the agency extrapolated efficacy data from the older groups and looked at past safety data it previously used to authorize two doses for the younger pediatric group. The use of boosters in children aged 5 to 11 is limited to those with weakened immune systems, such as those who have had a solid organ transplant or who have a disease that compromises the immune system to an equivalent degree. . The agency says that at this time, children aged 5 to 11 who do not have compromised immune systems do not need a booster. But again, it will monitor the data as it becomes available.

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

The cases of COVID-19 in the United States are higher than they have ever been, breaking all-time highs daily. The current daily average of new cases is over 400,000, an increase of over 200% from two weeks ago. The Centers for Disease Control and Prevention expects cases to continue to rise in the coming weeks, straining health systems even more.

Update 3:04 pm EST: CDC Advisory Board to Meet Wednesday 5 January, to review changes made by the FDA to the availability of boosters. If CDC 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.