The European Union’s drug regulator mentioned Monday it has begun evaluating a request by Pfizer Inc and BioNTech to increase approval of their coronavirus vaccine to incorporate youngsters ranging in age from 12 to fifteen.
The European Medicines Agency’s human medicines committee will perform an accelerated evaluation of information submitted by Pfizer and BioNTech and is anticipated to succeed in a call in June, except it requires further info, the company mentioned.
In a press release Friday, the 2 prescription drugs mentioned their request relies on a sophisticated examine in greater than 2,000 adolescents that confirmed their vaccine to be secure and efficient. The youngsters will proceed to be monitored for longer-term safety and security for one other two years.
The corporations’ vaccine is at the moment accepted for use in folks ages 16 years and older. Extending that approval to the youthful age group might supply youthful and fewer at-risk populations in Europe entry to the shot for the primary time.
Most COVID-19 vaccines accepted by authorities all over the world are for adults, who’re at increased threat, however well being officers imagine vaccinating youngsters of all ages will probably be essential to stopping the pandemic. Some analysis has proven that older youngsters might play a task in spreading the virus.