Both Pfizer and BioNTech said in a statement on Tuesday that they have sought a request from the US Food and Drug Administration (FDA) to initiate a rolling submission for Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 vaccine which would include six months to four years of age, in response to the urgent public health need in the population.
Pharmaceutical giants, Pfizer and BioNTech have sought emergency authorization for the COVID-19 vaccine for kids. The vaccines could be used for children between six months to four years of age, ANI reported.
Both Pfizer and BioNTech said in a statement on Tuesday that they have sought a request from the US Food and Drug Administration (FDA) to initiate a rolling submission for Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 vaccine which would include six months to four years of age, in response to the urgent public health need in the population.
The Pfizer-BioNTech vaccine would become the first Covid-19 vaccine for kids under the age of five. Both companies have said that they expect to complete the EUA submission in the coming days.
The Chairman and Chief Executive Officer, Pfizer, Albert Bourla said that the hospitalization of children under 5 due to Covid has soared and the company’s mutual goal with the FDA is to be prepared with future variant surges by giving parents options of helping protect their kids for the virus.
According to the company, three doses of the vaccine will be needed for children as much as 6 months to 4 years of age for achieving the highest level of protection against the current and other potential future variants. In case, two doses are authorized, parents will have an opportunity of getting their kids vaccinated till the third dose is potentially authorized.
BioNTech, MD, CEO and Co-founder, Ugur Sahin said their vaccine had already demonstrated a safe and tolerable efficacy profile, conducted in real-world studies and multiple clinical trials for all age groups starting from 5 years old.
He added by saying if the vaccine gets authorized, the company would be excited about the prospects of offering the parents the opportunity of helping their kids aged 6 months to 4 years.
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