Vaccine Safe for Children Aged 5 to 11 Years, Says Pfizer

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As per the results of its Phase 2/3 trial, Pfizer has announced its vaccine as safe in children aged 5 to 11 years.

Pfizer and BioNTech’s joint vaccine has been at the forefront of the fight against COVID-19. The mRNA-based vaccine has proven successful at preventing infections and deaths in both clinical trials and the real world. Moreover, the Pfizer vaccine has also received FDA approval for use in children aged 12 years and above. Encouraged by these results, earlier this year, the company began vaccine trials in children under 12 years. Now, based on the results the vaccine manufacturer has announced its vaccine as safe and effective in children aged 5 to 11. This is the first time that a US COVID-19 vaccine has released results for this age group.

The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.

Dr Ugur Sahin, CEO and co-founder of BioNTech

In the recent press release, Pfizer released data from its vaccine’s Phase 2/3 trial in children. The study included 2,268 children aged 5 to 11 years. As part of the study, they received two 10 µg doses of the vaccine, three weeks apart. This is one-third the dose administered to 16- to 25-year-olds, who formed the control group. One month after the second dose, researchers measured the antibody response in the children.

In Time for Winter

According to the Phase 2/3 trial results, the children had a similar immune response as the control group consisting of teens and adults. Moreover, the researchers did not report any adverse outcomes among the participants.

Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

Pfizer’s statement

Over the past few months, pediatric COVID-19 cases have risen sharply in the United States. Therefore, researchers are pushing for greater vaccine coverage. Especially, in time for the winter season when cases of RSV and flu virus are expected to increase. Thus, putting children at higher risk of infections.

Pfizer now plans to submit its data to the FDA and other health regulators for authorization of the vaccine in younger children.

Source: Pfizer


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