'Benefits outweigh risks'; UK clears Pfizer vaccine for ages 12-15
The United Kingdom on Friday decided to approve the COVID-19 vaccine developed by Pfizer-BioNTech for use among those aged 12-15 years. UK's Medicines and Healthcare products Regulatory Agency (MHRA) said that the decision was taken after a "rigorous review," adding that the benefits of the vaccine outweigh its risks. The move follows similar assessments in the European Union and the United States.
The MHRA on Friday announced that the Pfizer vaccine has been authorized for use among those aged 12-15 years after "a rigorous review of the safety, quality, and effectiveness of the vaccine in this age group." The Joint Committee on Vaccination and Immunisation (JCVI) will decide whether children in the age group should get the vaccine as part of the deployment program.
MHRA Chief Executive Dr. June Raine said in a statement, "The Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk." "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," she added.
Currently, there is no routine vaccination against COVID-19 among those under the age of 18 in the United Kingdom. The vaccine was already approved for use among people who are above the age of 16 years. Those aged 16-18 years are only allowed vaccination if they fall in a priority group, or live in the same house as someone extremely vulnerable.
The MHRA said, "No new side effects were identified and the safety data in children was comparable with that seen in young adults." The majority of adverse events were mild to moderate and were related to reactogenicity (sore arm, tiredness, etc.), the regulator added.
Last month, the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) had approved the vaccine for the age group. Both the US and Canada started vaccinating children in the age group earlier this month. Members of the EU are slated to start vaccinations in the age group this month. Germany has said the process will start from June 7.