The European Medicines Company (EMA) introduced on Monday that it has begun evaluating a request from Pfizer/BioNTech to increase use of its COVID-19 vaccine to younger folks aged 12 to 15.
The transfer comes amid reviews that the US watchdog will authorise its use for kids by subsequent week.
“EMA’s human medicines committee (CHMP) will perform an accelerated evaluation of information submitted by the corporate that markets Comirnaty, together with outcomes from a big ongoing medical research involving adolescents from 12 years of age, with a view to resolve whether or not to advocate the extension of indication,” the watchdog mentioned in a press release.
The end result of their analysis is predicted to be introduced in June.
Of their software to the EMA submitted on April 30, Pfizer and BioNtech mentioned that knowledge from a Part three medical trial involving 2,260 US contributors aged 12 to 15 years “confirmed a vaccine efficacy of 100% in contributors with or with out prior SARS-CoV-2 an infection and sturdy antibody responses.”
They added that the vaccine was additionally well-tolerated with uncomfortable side effects just like those noticed in older folks. These embrace ache on the injection web site, fatigue, fever, headache, and chills.
In the meantime, the US Meals and Drug Administration (FDA) may give the all-clear by early subsequent week, maybe sooner, a federal official who spoke to AP information company on situation of anonymity mentioned. This might allow the vaccination of kids earlier than the beginning of the subsequent college yr.
The Pfizer/BioNTech vaccine — often known as Comirnaty — is already authorised to be used for folks aged 16 and older within the US and the European Union.
The particular person conversant in the method, who spoke on situation of anonymity to debate inner issues, confirmed the timeline and added that it’s anticipated that the FDA will approve Pfizer’s use by even youthful youngsters someday this fall.
Pfizer isn’t the one firm looking for to decrease the age restrict for its vaccine. Outcomes are also anticipated by the center of this yr from a US research of Moderna’s vaccine in 12 to 17-year-olds.
However in an indication that the findings had been promising, the FDA already allowed each firms to start US research in youngsters 11 and youthful, working their technique to as younger as 6 months previous.
Most COVID-19 vaccines permitted by authorities all over the world are for adults, who’re at greater threat, however well being officers imagine vaccinating youngsters of all ages shall be vital to stopping the pandemic. Some analysis has proven that older youngsters could play a task in spreading the virus.