The Pfizer covid vaccine for children is up for approval from the US FDAQ.
The makers of the vaccine – Pfizer and BioNTech revealed that their covid vaccine for kids aged between 5-11 years has been submitted for initial review to the US Food and Drug Administration for emergency authorization.
- The company plans to submit the formal EUA approval draft proposal in the coming weeks.
- Along with the FDA, they will be also submitting the draft to other regulatory authorities like the European Medicines Agency.
First COVID Vaccine for Kids
This is pathbreaking as it’s the first covid vaccine approval for kids below 16 years of age. Earlier the Pfizer vaccine got approved for people older than 16 years and teenagers between 12-15 years.
- Earlier last week, the pharma company published the Phase 2 and 3 trial reports that showed the vaccine is safe for use in kids between 5-11 years.
- Data showed that a 2 dose regime set 21 days apart is able to create antibody response amongst the children.
- The dosage here is 10 micrograms which is smaller than the 30 micrograms one use for 12 years and above people.
The full data of the Phase 3 trial will be submitted for peer review in a scientific publication.
Vaccine Advisers for Approval
FDA has revealed that the extent of authorization depends on the data quality and the timing of the report. If everything is alright it could be approved in weeks.
In the past, they have granted EUA to the Pfizer vaccines for teenagers within a month of the data submission. However, they will cautious when dealing with children and would include vaccine recommendations as approved by vaccine advisers before the EUA is given.
Fauci Bats for Oct Approval
Speaking on the issue Dr. Anthony Fauci said that they are likely to be approved by October end.
Pfizer is planning to release the Phase 2/3 trial data for the next age group, between 2-5 years and 6-36 months by Q4 2021.