FDA Says Pfizer COVID-19 Vaccine’s Benefits for Children 5-11 Outweigh Risks

Late Friday, federal health regulators said that doses of the COVID-19 vaccine for children between the ages of 5 and 11 seem to be highly effective in preventing symptomatic infections and don’t cause unexpected safety issues in elementary school children, as the US is weighing vaccinating youngsters. The analysis was posted by the Food and Drug Administration (FDA) ahead of a public meeting scheduled for next week for debating whether the shots can be administered safely to the 28 million youngsters in the country between 5 and 11. A panel of vaccine experts will be asked to vote on the question by the agency.

FDA scientists concluded in their analysis that in nearly every scenario, the vaccine is helpful in preventing death and hospitalizations due to COVID-19, thereby outweighing any risks of serious side effects in children. However, the agency reviewers did not call for the vaccine to be authorized. They will put this question in front of their independent experts next Tuesday and take their advice into account before making their decision. If the shots are authorized by the FDA, the Centers for Disease Control and Prevention will recommend who should get it in the first week of November, with youngsters expected to be fully protected in time for Christmas.

Israel has been closely following the guidelines of the FDA when it comes to usage of COVID-19 vaccines, even though it has not followed the US regulators when it comes to administering the booster shot of the vaccine to the general population. On Friday, Israeli media reported that if the FDA grants approval for vaccines for youngsters, Israel will also start administering it to kids between 5 and 11 from December. According to the report, the aim is that with vaccinating younger kids in the country, a significant percentage of Israel’s population would be vaccinated fully in the beginning of 2022.

Full strength doses of Pfizer vaccine are already approved for anyone 12 or older, but many parents and pediatricians are anxiously awaiting the same protection for younger kids in order to keep them in school and to keep them safe from the contagious Delta variant. Pfizer had earlier posted results indicating that its vaccine was 91% effective in preventing symptomatic infections amongst younger kids and the FDA review simply reaffirmed this. Most of the study was conducted in August and September, when the delta variant had been very dominant.

There were no unexpected or new side effects. Most of them were the usual fever, sore arms and achiness. However, the FDA scientists did say that the study wasn’t large enough for identifying any rare side effects. Overall, the regulators believe that the potential benefits of the vaccine do outweigh its risks. Even though children have a lower risk of suffering from severe illness or even death, many have been infected. Kid-size doses would be introduced, if they are approved, and they would be administered with kid-size needles. Plenty of pediatricians and primary care providers are ready to administer the shots to kids between 5 and 11 years.