Pfizer/BioNTech vaccine against the coronavirus disease (COVID-19) has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for children aged between 12 to 15 years.
The development comes after a “rigorous review” of safety and effectiveness in that age group, said the UK’s health regulatory authority. The benefits of having the COVID-19 jab outweighed the risks, they added.
In a statement released by the MHRA, Professor Pirmohamed said that over 2000 children aged in the 12 to15 years age group were studied as part of the randomised, placebo-controlled clinical trials. “There were no cases of COVID-19 from 7 days after the second dose in the vaccinated group, compared with 16 cases in the placebo group,” he added.
“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 15-year age group,” Dr June Raine, MHRA chief executive said.
“We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side effects,” Professor Sir Munir Pirmohamed, chairman of the Commission on Human Medicines (CHM) said.
The Joint Committee on Vaccination and Immunisation (JCVI) will now advise whether this age group will be vaccinated as part of the deployment programme, Raine added.
Data on neutralising antibodies showed the vaccine is working at the same level as seen in adults aged 16-25 years, which the professor said means that the results are extremely positive.
The Pfizer/BioNTech COVID-19 vaccine is already approved for use in adults and adolescents aged 16 years and above. During the trials, no new side effects were identified and the safety data in children was comparable with that seen in young adults. “As in young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness,” MHRA said.