In long-awaited data, Pfizer announced that a three-dose regimen of its Covid-19 vaccine was shown to be 80% effective in combating symptomatic Omicron infection in children aged six months to under 5 years, according to ‘ ABC News’.
However, the company cautioned that the estimate is preliminary and could be adjusted as more data is collected. The test was not large enough to estimate protection from serious illness, which experts expect will be greater.
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For all age groups, vaccine efficacy against milder infections declined in the face of the highly transmissible Omicron variant, but efficacy against serious illness and death remained high for most age groups.
Pfizer announced in December that it would not move forward with a two-dose vaccine schedule after disappointing data, choosing instead to study three doses for this age group. The company will submit the new data as part of its ongoing submission to the FDA.
For anxious parents, Pfizer News offers reassurance that the vaccine helps protect young children who are currently not eligible for vaccination.
The news does not change the general timeline of when vaccines for this age group may be available. For younger Americans, the Pfizer and Moderna vaccines are expected to be authorized in June or July, likely as a two-dose vaccine for Moderna and a three-dose vaccine for Pfizer, although Moderna is also study a third dose.
Pfizer also said its vaccine was safe, with a safety profile similar to that of placebo injections. If authorized, this vaccine would be 3 injections of 3 micrograms each. Each dose is one-tenth of the adult dose.
“We are pleased that our formulation for younger children, which we carefully selected to be one-tenth of the adult dose, was well tolerated and produced a strong immune response,” said Albert Bourla, president and chief executive officer of Pfizer, in prepared remarks. .
Moderna, meanwhile, applied for authorization from the FDA on April 28 for a two-dose vaccine for this age group. Moderna’s preliminary analysis found that its two-dose pediatric vaccine was 51% effective against symptomatic COVID-19 among children aged 6 months to less than 2 years and 27% among children aged 2 to 5 years.
Experts caution that the vaccine’s effectiveness against symptomatic infection is at a high level, and they hope that these vaccines will provide excellent protection against serious illness, just as they do for adults.
This development means Pfizer is one step closer to submitting its vaccine for emergency use authorization, likely to be reviewed by FDA advisors at the June 21 and 22 meetings and, if authorized, will be available in early July.
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