Pfizer sends Covid vaccine data for kids aged 5-11 to FDA as Fauci hopes to start child vaccinations by end of October

Pfizer has sent the FDA trial results after testing its Covid vaccine on kids aged five to 11, calling the data promising as White House pandemic adviser Anthony Fauci suggested regulatory approval could come in a matter of weeks.

The American Big Pharma firm and its German partner BioNTech announced the move in a Tuesday press release, saying the Food and Drug Administration had received the trial data, which will be used to determine whether to authorize jabs for younger patients. 

“In the trial, which included 2,268 participants 5 to [11] years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen,” the companies said in a joint statement, adding that the results were comparable to those recorded during its trial for those aged 16 to 25. 

These data have been shared with the FDA for the Agency’s initial review. A formal submission to request Emergency Use Authorization (EUA) of the companies’ Covid-19 vaccine in children 5 to [11] years of age is expected to follow in the coming weeks.

While the earlier trial administered doses of 30 micrograms (μg) to the older age group, the younger recipients were given a lower dose of just 10μg, which the companies said “was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children.”

Responding to news that the FDA had received Pfizer’s data, White House adviser Fauci said he believes the agency will give its blessing for the 5-11 age group sometime in the coming weeks. 

“The FDA, you never want to get ahead of their judgement, but I would imagine in the next few weeks they will examine that data and hopefully they’ll give the OK so we can start vaccinating children, hopefully before the end of October,” he told MSNBC on Tuesday, adding that the regulator “takes very seriously the importance of getting vaccines shown to be safe and effective… into the arms of children.”

Though the health adviser stressed the need to not “get ahead” of US regulators and ‘the science,’ President Joe Biden appeared to do just that when he announced a universal booster roll-out for all American adults last month, even setting a hard, September 20 date – well ahead of formal FDA approval. 

An advisory board at the agency later voted against that plan overwhelmingly, with 16 opposing and only three in favor, and the regulator ended up authorizing additional doses only for those aged 65 and older, as well as others in certain higher-risk categories. It is unclear when the FDA will ultimately give the greenlight for the universal booster plan originally outlined by the president. 

Pfizer and BioNTech initially announced their trial results for the 5-11 age group last week, saying they showed a “favorable safety profile and robust neutralizing antibody responses” and that the data would “provide a strong foundation for seeking authorization” for younger recipients. The two firms also noted on Tuesday that, as the FDA reviews their data, they will also submit the results for peer-reviewed publication.

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