Pfizer-BioNTech is ready with its formulation for the kid’s Covid-19 vaccine. On Tuesday, Pfizer-BioNTech submitted its data about the Covid-19 vaccine to the Food and Drug Administration for review.
A Step Towards Kids Vaccine Against Covid-19
The Pharma giants on Tuesday said, “we are ready with our formulation for the Covid-19 vaccine for kids aged 5-11.” They added that they have submitted its data to FDA for initial review and are not expecting emergency use authorization.
The company, in a statement, said, “We will prepare a separate request for submitting EUA ( Emergency use Authorization)for the vaccine.” They are also planning to submit data to the European Medicines Agency and other regulatory authorities.
Pfizer-BioNTech’s kid’s Covid-19 vaccine is the first of its kind so far. Pfizer-BioNTech’s Covid-19 vaccine is also being used in adults above 16 years of age. It also has the authority to be used in adults of age 12 to 15 under EUA.
Pfizer CEO said, ” The amount of time the authorities will take to approve the kid’s Covid-19 vaccine is unpredictable. They must take all the time they need to study and analyze. This decision will be regarding the young kids so delays can be acceptable, but right decisions should come out.”
Pfizer released its data last week regarding its Phase 2 and 3 trials of the kid’s Covid-19 vaccine. The results showed that the vaccine is highly effective and safe. It indicated that in children aged 5 to 11 the vaccine had a robust antibody response.
Pfizer’s trial for the kid’s vaccine included more than 2,500 kids of the change 5 to 11. These kids were given two doses of the vaccine after 21 days. Each dose had ten micrograms of the vaccine. Adults above 12 are receiving 30 micrograms of the vaccine in each dose.
The immune responses of the kids were then compared to a control group of 16 to 25 years old, who had the larger doses of the vaccine. Reports suggested that kids had an equivalent immune response to adults. The studies prove that the vaccine imposed a robust immune response in kids if both doses were administered within a week.
Pfizer and BioNTech will submit the complete data of their Phase 3 trial for reviewing and publication.
FDA stated that if good quality data is submitted timely, the authority can approve the vaccine for kids within weeks. The time the authority needs for approval depends upon the quality of data and the timing of data submission.
The FDA also allowed Emergency Use Authorization to the vaccine for people aged 12 to 15. The Emergency Use Authorization was granted on the tenth of May. However, the Covid-19 vaccine got a green flag for use among people aged 16 and above on the ninth of April.
Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said that he expects the vaccine will be ready for the citizens by the end of October.
Pfizer also said, “we are working on the Covid-19 vaccines for two more age groups: 2 to 5 years and six months to 2 years, and by the end of this year, we will be ready with its data too.
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