Pfizer and BioNTech submitted initial trial data for their Covid-19 vaccine in the 5-11 year age group and said that they would be making a formal request to US regulators for emergency use in the coming weeks.
The US Food and Drug Administration (FDA) stated earlier this month that it would look to complete its data review for this age group as soon as possible which could mean an authorization of the shot for children by the end of October.
The companies have yet to start the official process for authorization which could slow down the decision. According the Wall Street Journal, the FDA may not make its decision until sometime between Halloween and Thanksgiving. A Pfizer spokesperson has said that the company expects to start and complete its application very soon.
Data from the Pfizer trials showed that the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-25 year olds. According to Pfizer, the safety profile was also comparable to the older age group.
Both the Pfizer and Moderna vaccines have been linked by regulators the rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said that no instances of heart inflammations were seen in the trial participants.
Sources: IOL, CNBC
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