Oct. 22, 2021 — Pfizer says its vaccine for youngsters is 90% efficient at stopping COVID-19 infections.
The Pfizer vaccine for teenagers ages 5 to 11 is 10 micrograms, roughly one-third of the dose given to adolescents and adults.
In information introduced to the FDA forward of the company’s evaluate of its pictures for youngsters, the corporate described the interim outcomes of two ongoing research testing the security and effectiveness of its 10-microgram pictures.
The vaccine effectiveness information comes from a examine of greater than 2,000 youngsters ages 5 to 11. Two-thirds of the youngsters had been randomly assigned to obtain a child-sized dose of the Pfizer-BioNTech vaccine, whereas the opposite third was sorted into the placebo group.
The examine acquired underway because the Delta variant grew to become dominant world wide. As of the primary week of October, 16 contributors within the placebo group had gotten a symptomatic, lab-confirmed COVID-19 an infection, in contrast with simply three who caught COVID within the vaccinated group.
In line with the corporate’s evaluation of its personal research, unwanted side effects seen within the examine had been almost all gentle. The most typical facet impact reported was ache on the web site of the shot. Youngsters within the group that acquired the vaccine additionally had fatigue, complications, fever, and chills at larger charges than had been seen within the placebo group. These had been commonest after the second dose. Some pores and skin reactions had been seen within the examine, like itching and rashes, however these had been principally gentle and went away inside just a few days.
Youngsters additionally might have swollen lymph nodes after their vaccinations, as adults typically do, however these reactions had been non permanent.
One little one developed a tic, a recurring involuntary muscle twitch or vocal sound, that got here one week after their second dose of the vaccine. It was judged by examine investigators to be associated to the vaccine. The corporate says it was going away by the point the examine was being revealed.
Reassuringly, no instances of coronary heart irritation referred to as myocarditis had been discovered within the examine. Myocarditis is uncommon and non permanent, but it surely requires hospital care. The very best charges of myocarditis have been seen in males youthful than 30. That group has a danger of about 11 instances for each 100,000 doses given, in accordance with a current examine within the New England Journal of Medication.