In a press release, the company said that its 3-vaccine vaccine met all the “immunoblotting” criteria required for FDA approval.
Pfizer said the vaccine was well tolerated in 1,678 children under 5 years of age in the study, with a similar safety profile to placebo doses.
The vaccine was found to be 80% effective against the symptomatic COVID-19 micron micronutrient in children aged 6 months to 5 years, according to the preliminary analysis.
This vaccine will be three vaccines of 3 micrograms each. The company says each dose is one-tenth of the adult dose, selected on the basis of safety, tolerability and immunosuppression.
Pfizer announced in December that it would not proceed with a two-dose vaccine after disappointing data, instead of choosing to study three doses for this age group. The company will submit the new data as part of its ongoing “rolling” submission to the FDA.
Moderna, meanwhile, has asked the FDA for approval on April 28 for a two-dose vaccine for this age range. Preliminary analysis by Moderna found that the two-dose pediatric vaccine was 51% effective against symptomatic COVID-19 in children 6 months to 2 years of age and 27% in children 2 to 5 years of age. This is approximately the same effect observed in adults during micron growth.
Experts expect these vaccines to offer excellent protection against serious diseases, as they do for adults.
Pfizer data do not affect the known schedule, as vaccines from both Pfizer and Moderna are expected to be approved and available for this age group in June or July.
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Pfizer says its 3-shot COVID vaccine for young children 80% effective against symptomatic omicron in new data Source link Pfizer says its 3-shot COVID vaccine for young children 80% effective against symptomatic omicron in new data