Washington, June 18 (Ajit Weekly News) The US Food and Drug Administration (FDA) has authorized emergency use of the Moderna and Pfizer-BioNTech Covid-19 vaccines for children as young as 6 months, the first for kids in this age group.
For the Moderna vaccine, the FDA on Friday amended the emergency use authorization (EUA) to include use of the jab in individuals 6 months through 17 years of age, reports Xinhua news agency.
The vaccine was previously authorised for people above the age of 18.
For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include use of the jab in individuals 6 months through 4 years of age.
The vaccine had been previously authorized for use in individuals 5 years and older.
The FDA said its evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech Covid-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.
The Moderna vaccine is administered as a primary series of two doses, one month apart.
The Pfizer-BioNTech vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose.
The FDA’s decision came after a meeting of its advisors earlier this week, which voted to recommend the two vaccines.
The advisory committee meeting was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for paediatric populations, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said on Friday.
“Those trusted with the care of children can have confidence in the safety and effectiveness of these Covid-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” said FDA Commissioner Robert Califf in a statement.
The US Centers for Disease Control and Prevention (CDC) is scheduled to convene an advisors’ meeting on Saturday to vote on guidelines for pharmacies and doctor’s offices to give the shots.
CDC Director Rochelle Walensky then has to sign off on those guidelines before kids can start receiving the shots.
The White House expects vaccinations to begin as soon as June 21.
Appointments might be limited initially but every parent who wants to get their child vaccinated should be able to do so within weeks, according to Ashish Jha, who oversees the Biden administration’s Covid-19 response.
–Ajit Weekly News