New Delhi: The European Union’s drug regulator on Monday (May 2) said that it was evaluating a request by Pfizer Inc and BioNTech to extend approval for administering their COVID-19 vaccine for children ranging from age 12-15. The comments were made by the human medicines committee of the European Medicines Agency (EMA).
The EMA will analyse the data that has been submitted by Pfizer and BioNTech and may announce a decision on it by June. The agency may also ask for extra data on the vaccines if they are not satisfied by the submissions.
In a statement Friday, the two pharmaceuticals said their request is based on an advanced study in more than 2,000 adolescents that showed their vaccine to be safe and effective. The children will continue to be monitored for longer-term protection and safety for another two years.
The companies’ vaccine is currently approved for use in people ages 16 years and older. Extending that approval to the younger age group could offer younger and less at-risk populations in Europe access to the shot for the first time. Most COVID-19 vaccines approved by authorities around the world are for adults, who are at higher risk, but health officials believe vaccinating children of all ages will be critical to stopping the pandemic. Some research has shown that older children may play a role in spreading the virus.
Currently, there are no COVID-19 vaccines that have been granted authorisation for people below the age of 18.
With inputs from PTI