Both BioNTech and Pfizer said Tuesday that they have acquiesced Covid-19 vaccine data on children ages 5 to 11 to the FDA (Food and Drug Administration) for primary review, but till now there are not yet looking for emergency use approval.
Companies said that a formal submission to demand EUA for the vaccine is probable to trail in the coming weeks.
They further said submissions to the European Medicines Agencies and other regulatory authorities are also prearranged.
Pfizer/BioNTech submit initial data on Covid-19 vaccine for ages 5 to 11
According to both companies, this is the first time ever submission of data to the FDA for a COVID-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has a EUA for people ages 12 to 15.
A few days ago, Pfizer released details of a Phase 2/3 trial that displayed its Covid-19 vaccine was completely safe and generated a robust antibody response in children ages 5 to 11. In this trial, the total included participants ages 50-11 were almost 2,268 and used a two-dose schedule of the vaccine administrated 21 days apart. This trial was used a 10 Microgram dose which is smaller than a 30 microgram dose that usually used for those who are above 12 years old.
The Participant’ immune reactions were measured by looking at neutralize antibody levels in their blood and matching those levels to a control group of 16 to 25 years old who were given a two-dose schedule with the larger 30-microgram dose. Pfizer said the levels associated well with older people who received the larger dose, representing a strong immune reaction in this group of children one month after the second dose
Pfizer and BioNTech said Tuesday that they plan to submit the full phase 3 trial for scientific peer-reviews publication.
FDA officials have said that after the vaccine data was submitted, the agency could approve a vaccine for younger children in a matter of weeks, not months but it totally depends on the timing and quality of the data.
FDA has progressed very fast in the past to prolong vaccine authorization to other groups However, for younger children, FDA is anticipated to organize vaccine advisers to make a solid recommendation on the vaccine before authorization. If the FDA approves it, a panel of CDC vaccine advisers will meet deliberately whether to recommend its use.
After the declaration of Pfizer and BioNTech, Dr.Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said optimistically vaccines can allow till the end of October.
The FDA proceeds with seriously the significance of getting vaccines shown to be safe and very effective in children to getting it into the children’s body, in such case children from eleven down to five” Fauci said on MSNBC’s Morning Joe Tuesday. The FDA, you never want to get forward of their decision, but I would visualize in the next few weeks, they will examine that data and expectantly they will approve it and start vaccinating children before the end of October.
BioNTech and Pfizer further said that the data on the immune response and safety for two more age-groups-children ages from 2to5 to, and 6 months to 2 years are expected as soon as possible with the fourth quarter of this year.