The Pfizer / BioNTech Covid-19 vaccine has been approved for use in some children in the UK.
The vaccination is “safe and effective” for 12 to 15 year olds, said the Medicines and Health Authority (MHRA).
The MHRA said the decision follows a “rigorous review” of safety and effectiveness in this age group.
Dr. June Raine, CEO of MHRA, said, “We have carefully reviewed clinical trial data in children ages 12-15 and have concluded that the Pfizer / BioNTech Covid-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweighs any risk.
“We have put in place a comprehensive safety surveillance strategy to monitor the safety of all UK approved Covid-19 vaccines and this surveillance will include the 12-15 age group.
“An extension of an approval would only be approved if the expected safety, quality and effectiveness standards are met.
“It will now be the job of the Joint Committee for Vaccination and Immunization (JCVI) to discuss whether this age group will be vaccinated as part of the mission program.”
More than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer / BioNTech vaccine, said the chair of the human medicine commission.
Professor Sir Munir Pirmohamed said: “We have very carefully considered the younger age group and the benefits of vaccinating this population group against possible risks of side effects. These data have undergone a thorough evaluation and review, which was also specifically examined by the CHM’s Expert Advisory Group on Pediatric Medicines, who are scientific experts in this age group, and by the CHM’s Expert Working Group on Covid-19 Vaccines.
“We have concluded that based on the data we’ve seen on the quality, effectiveness, and safety of the vaccine, its benefits outweigh any risk. The MHRA will continue to review all suspected adverse reactions data obtained through the strict monitoring program under the Yellow Card program and other safety monitoring measures for all Covid-19 vaccines used in the UK.
“As part of the randomized, placebo-controlled clinical studies, over 2,000 children between the ages of 12 and 15 were examined. From seven days after the second dose, there were no cases of Covid-19 in the vaccinated group compared to 16 cases in the placebo group. In addition, data on neutralizing antibodies showed that the vaccine worked at the same level as it did in adults aged 16-25. These are extremely positive results. “