New York – Pfizer announced on Friday (Oct 22) that its Covid-19 vaccine made with BioNTech showed 90.7 per cent efficacy in a clinical trial involving children aged five to 11 years old.
Details of the clinical trial were published ahead of a scheduled panel meeting of experts on Tuesday (Oct 26) whether to recommend the United States Food and Drug Administration (FDA) to authorize the shot for the age group.
Should the vaccine be authorized, it will be the first to be made available to the young age group, with doses being made available in the US by early November.
FDA said on Friday that the benefits of administering the Pfizer-BioNTech Covid-19 vaccine outweigh the risks of rare cases of heart inflammation, reported Reuters.
Rare cases of heart inflammation called myocarditis, especially affecting young men, have been linked to the Pfizer-BioNTech and Moderna Covid-19 vaccines.
According to the FDA, if the number of myocarditis cases would be similar to those observed among 12- to 15-year-olds, Covid-19-related hospitalizations prevented still outnumber myocarditis-related hospitalizations.
Pfizer noted that the lower dose to be administered to the younger age group would lower the risks of myocarditis.
The 5- to 11-year-old age group would be given two doses of a 10-microgram dose, a third of the dose given to those aged 12 and older.
The clinical trial consisted of 2,268 participants, with 16 children who received a placebo testing positive for Covid-19 compared to three who were vaccinated, resulting in a 90 per cent efficacy rate.
Upon FDA approval, the US Centers for Disease Control and Prevention will convene on Nov 2 and 3 to make recommendations on how the shots would be given.
In a news release on Oct 21, Pfizer and BioNTech announced that a booster shot of their Covid-19 vaccine on those 16 years old and older showed a 95.6 per cent efficacy rate against the virus.
In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against Covid-19 to the high levels achieved after the second dose./TISG
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