Pfizer/BioNTech study indicates effective and safe use of COVID-19 vaccine in 5-11 year olds

Pfizer Inc and BioNTech SE announced on Monday that their COVID-19 vaccine elicited a strong immunological response in children aged 5 to 11, and that they want to seek approval to use the vaccine in that age group in the United States, Europe, and abroad as soon as feasible.

In a Phase II/III clinical trial, the vaccine elicited an immunological response in individuals aged 5 to 11 that matched what they had previously seen in those aged 16 to 25, according to the firms. Furthermore, the safety profile was equally equivalent to that of the older age group.

Sources told Reuters earlier this month that US health officials expect regulators will make a decision on whether the shot is safe and effective in younger children within three weeks of the businesses submitting a request for permission.

Although there is no evidence that the Delta virus is any more deadly in children than it is in adults, with schools already open across the country, a quick approval might help prevent a potential influx of cases.

Comirnaty, the company's vaccine, is already approved for use in children as young as 12 years old in numerous countries, including the United States. In December 2020, the vaccine was approved for emergency use in people aged 16 and up in the United States, and it obtained full approval in that age range last month.

The vaccine was given in two doses of 10-micrograms to children aged 5 to 11, which is one-third the dose level provided to persons aged 12 and up.

Moreover, data on how well the vaccine works in children aged 2 to 5 years and children aged 6 months to 2 years will be available in the fourth quarter of this year.

The firms may subsequently publish vaccine efficacy from the trial, according to a Pfizer spokesman, but there had not been enough cases of COVID-19 among the participants to make that conclusion.

In an adult clinical trial, the vaccine was roughly 95 percent effective, but Pfizer claims that immunity begins to fade a few months after the second dosage.

The vaccination was well-tolerated, according to the firms, with adverse effects similar to those seen in participants aged 16 to 25.

Regulators have linked the Pfizer and Moderna vaccines to rare cases of heart inflammation in adolescents and young adults, particularly young men. According to Pfizer, the trial participants showed no signs of heart inflammation.

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Source: The Peninsula