The UK health regulator has received the request from Pfizer Inc on its covid-19 vaccine among 12- to 15-year olds. If the anti-virus drug will be approved, it paves the way for accelerating inoculation of children in the country.
The US regulators authorised the vaccine made by Pfizer and BioNTech SE for use in children as young as 12, while the British health regulator is hesitating. Taking into account the side effects of one of the vaccines, made by AstraZeneca, the UK MHRA takes its time.
This week, the drugmaker has submitted data on the efficacy of the vaccine in 12 to 15 years olds for review by the British health regulator. In addition, Pfizer has said it expects to have safety and efficacy data on the vaccine for children aged 2 to 11 in September when it plans to ask for that age group to be included in the emergency approval.
In March, Pfizer and BioNTech said their Covid-19 vaccine was safe, effective and produced robust antibody responses in 12- to 15-year olds, citing a trial of 2,260 adolescents, which resulted in 100% efficacy in preventing the infection.
earlier, Pfizer had asked Britain’s Medicines and Healthcare products Regulatory Agency for approval for the jab.