US FDA approves emergency use of Pfizer vaccine for children in 12-15 age group

In a major development pertaining to vaccination in the United States, the US FDA has approved the emergency use of the Pfizer-BioNTech vaccine for children in 12-15 age group. The decision comes after amending the Emergency Use Approval (EUA) that was issued on December 11, 2020, for individuals above the age of 16. FDA commissioner Dr Janet Woodcock has remarked that FDA's decision is another significant step in the fight against the COVID-19 pandemic. 

Pfizer-BioNTech vaccine approved for children in 12-15 age group

She further added that the move to vaccinate the younger population will protect them and eventually bring a sense of normalcy. In addition, she has also assured parents that FDA undertook 'rigorous and thorough review of all available data' surrounding the emergency use authorisation. 

According to the FDA, the Pfizer vaccine is safe and offers stronger protection for younger teens. This was declared after tests were conducted on more than 2,000 US volunteers aged 12 to 15. The study results concluded that no case of COVID-19 was found in fully vaccinated adolescents as compared to 18 among kids given dummy shots. Additionally, the researchers also found out that vaccinated kids developed higher levels of virus-fighting antibodies as compared to earlier studies on young adults. 

However, side effects among teens were similar to those in adults. After the vaccination, side-effects like sore arms and flu-like fever, chills or aches were found out. The decision to vaccinate children in the 12-15 age group is welcome for families in the US struggling to decide on whether activities are safe to resume when only the youngest family members remain unvaccinated. Apart from Pfizer, Moderna too has stated that preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects. Another company, Novax has also been making a vaccine that is in late-stage development and just began a study in 12 to 17-year-olds as well. 

Vaccine trials on younger children 

The next milestone regarding vaccination is to find out if the jabs work for even younger children. According to reports, Pfizer and Moderna have begun US studies in children ages 6 months to 11 years. The studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Apart from US vaccine manufacturers, AstraZeneca is also studying its vaccine among 6 to 17-year-olds in Britain while Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.  

With agency inputs