The company has announced that their Pfizer vaccine is safe for children ages 5 to 11 years old. The drug reportedly recorded a 90.7% efficacy rate against symptomatic COVID-19 in the children.
The company disclosed these data through a document posted on Thursday (Oct 21) ahead of a meeting with advisers of the U.S Food and Drug Administration (FDA) scheduled Tuesday (Oct 26). Advisors of the FDA constituted the FDA’s Vaccines and Related Biological Products Advisory Committee, to further discuss on the authorisation of this drug.
The date recoded a high degree of protective efficacy within the children against the COVID-19 virus. This was during a period when the Delta variant was rampant in the United States.
Companies Pfizer and BioNTech then submitted application to the FDA for emergency use authorisation (EUA). The application constuted a two-dose regimen of a 10-microgram dose for children ages 5 to 11, with administration of the two doses set to three weeks apart.
By Tuesday (Oct 26), the committee voted in favour of the administration of the drug, now known as the first COVID-19 vaccine for children below 12 years of age. The votes were 17 to 0, with 1 abstention.
Prior to this, the administration of the Pfizer-BioNTech vaccine fully applied to children 16 years and older, while an EUA was granted for children ages 12 to 15.
Once granted authorisation, the drug will be the first COVID-19 drug for younger children.
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