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 2,000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. There were no cases of Covid-19 from seven 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.