Pfizer seeks USFDA approval of two-dose vaccine for kids under 5 years
Category: #healthcare  By Akshay Kedari  Date: 2022-02-04
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Pfizer seeks USFDA approval of two-dose vaccine for kids under 5 years

As the threat of Covid-19 infections continues to rise, Pfizer Inc. has reportedly applied to the U.S. Food and Drug Administration (FDA) for the authorization of two doses of their Covid vaccines to children aged less than five years.

It is worth noting that the outcomes of clinical trials involving the injection of two doses among children aged 2-4 years failed to report the expected level of immunity in December 2021. Despite the failure, regulators prodded the company to submit the request for authorization.

Following the underwhelming trial results, the pharmaceutical behemoth began testing for a third dose with reduced power for the same age group, the conclusions of which are scheduled for the end of March 2022.

The authorization request from Pfizer comes at a time when the highly communicable omicron variant of the coronavirus is at its peak in the U.S. and causing a large number of infections among people. Moreover, there are 19 million children under the age of five in America, and they are the only ones who are not yet eligible for vaccination.

It was recognized that children aged 6 months to 2 years had a stronger immune reaction in the trials when compared to young adults and older teenagers. The dosage issued to the children was one-tenth of that given to the adults.

According to people close to the situation, government officials reasoned that the vaccine limit for the kids should remain at two doses even if the entire age group did not show an immune response. However, some officials argued that by the time researchers receive the wishful-optimistic results for the third-dose trial, children will be ready for a third dose if they receive the initial shots this month.

The reason behind this argument was that there is a three-week gap between the first two doses and a two-month gap between the second and third.

Source credit:

https://www.business-standard.com/article/current-affairs/pfizer-applies-to-usfda-for-two-dose-vaccine-for-kids-under-5-years-122020201061_1.html

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Akshay Kedari    

Akshay Kedari

Akshay holds a Bachelor’s degree in computer engineering. Despite having a penchant for software development and the like, Akshay took to writing as a career owing to his passion for the field. Presently, Akshay writes articles for itresearchbrief.com and a few oth...

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