Pfizer Seeks Approval for First Ever Covid Vaccine for Kids under 5 years
by Pharmchoices
In a request submitted to the Food and Drug Administration, Pfizer and BioNTech are seeking emergency approval for a Covid vaccine that will be suitable for children between 6 months to under 5 years.
Pfizer submitted updated clinical trial data to health officials on Friday.
In the application, the company stated that the first two lower doses (3 micrograms each) vaccine will precede the third dose.
The application for the third dose will be filed by the companies in the coming months. Pfizer will submit additional data to the FDA concerning the third dose in the coming months. Pfizer and BioNTech have been testing the third dose for younger children in recent months.
A December analysis shows that two-shots are safe protective in children between 2 to 4 years but do not elicit the same immune response as seen in teens, and adults.
According to the statement of Pfizer CEO Albert Bourla, “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
On February 15, the FDA will meet with the Vaccines and Related Biological Products Advisory Committee to discuss if approval will be made. The Centers for Disease Control and Prevention’s vaccine advisory group will also have a meeting.
Covid-19 affects over one million children under the age of 4. Vaccination has been available for children between 5-11 years.
