Dr June Raine, MHRA Chief Executive said:
“We have carefully reviewed clinical trial data in
children aged 12 to 15 years 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 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.
“No extension to an authorisation would be approved
unless the expected standards of safety, quality and
effectiveness have been met.
“It will now be for the Joint Committee on Vaccination
and Immunisation (JCVI) to advise on whether this age
group will be vaccinated as part of the deployment
programme.”
Professor Sir Munir Pirmohamed, Chair of the Commission
on Human Medicines 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. There has been a thorough assessment
and review of this data which was also looked at
specifically by the CHM’s Paediatric Medicines Expert
Advisory Group who are scientific experts within this
age group, as well as the CHM’s COVID-19 Vaccines
Benefit Risk Expert Working Group.
“We have concluded that based on the data we have seen
on the quality, effectiveness and safety of the
vaccine, its benefits do outweigh any risk. The MHRA
will continue to scrutinise all of the suspected side
effects data received through the rigorous surveillance
programme in place through the Yellow Card scheme
and other safety surveillance measures for all of the
COVID-19 vaccines used in the UK.
“Over 2000 children aged 12-15 years 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. In addition, data
on neutralising antibodies showed the vaccine working
at the same level as seen in adults aged 16-25 years.
These are extremely positive results.”
Background
