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FDA says Pfizer COVID vaccine looks effective for young kids

PTI Oct 23, 2021

Federal health regulators said on 22nd October that kid-size doses of Pfizer's COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the US weighs beginning vaccinations in youngsters.

For our comprehensive coverage and latest updates on COVID-19 click here.


The Food and Drug Administration posted its analysis of Pfizer's data ahead of a public meeting next week to debate whether the shots are ready for the nation's roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.

In their analysis, FDA scientists concluded that in almost every scenario the vaccine's benefit for preventing hospitalisations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer's shot to be authorised.

The agency will put that question to its panel of independent advisers and weigh their advice before making its own decision. If the FDA authorises the shots, the Centres for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month -- with the first youngsters in line fully protected by Christmas.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but paediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

The FDA review found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness. However, FDA scientists noted that the study wasn't large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.

The agency used statistical modelling to try to predict how many hospitalisations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause.

In four scenarios of the pandemic, the vaccine clearly prevented more hospitalisations than would be expected from the heart side effect. Only when virus cases were extremely low could the vaccine cause more hospitalisations than it would prevent. But overall, regulators concluded that the vaccine's protective benefits would clearly outweigh" its risks.

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