Don't offer covid-19 vaccine to 5-11 year olds until phase 3 trials complete

Do not roll out covid-19 vaccines to 5-11 year olds until phase 3 trials for that age are complete & there is a clear risk benefit analysis for the individual child, based on health only. They should not be vaccinated solely for the benefit of the wider population.

The Pfizer trial for 5-11 year olds was only on 4.5k children & they were followed for 2 months after the 2nd dose, therefore there is no long-term safety data. One study suggests an increased risk of myocarditis in teenage boys, though this is yet to be peer reviewed and is based on self-reporting of suspected symptoms in the US. We feel the current under-11s trial is too small to evaluate this risk. Children rarely get serious symptoms or die of COVID.

On 22 December 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the paediatric formulation of the Pfizer COVID-19 vaccine for use in the UK for children aged 5-11 on the basis that it met required safety, quality and effectiveness standards.

Any vaccine for deployment in the UK must first go through the usual rigorous testing and development processes set by the UK’s independent medicines regulator, the MHRA. They ensure medicines, devices and vaccines work effectively and are safe for use. Each COVID-19 vaccine candidate is assessed by teams of scientists and clinicians on a case-by-case basis, and is only authorised once it has met robust standards of effectiveness, safety and quality. There are extensive checks and balances required by law at every stage of the development of a vaccine. The data looked at includes all the results from laboratory studies, clinical trials, manufacturing and quality controls and testing of the product. The public should be very confident that all tests were completed to the very highest standards.

All vaccines approved and used in the UK have published results from the final phase 3 clinical trials for peer review. All vaccines were deemed safe and effective by the MHRA and were therefore approved for use. However, as is common practice in the industry, manufacturers continue safety monitoring of trial participants after the vaccine has been approved and rolled out. For example, when Pfizer’s phase 3 results were published, Pfizer set out that it would continue to follow up trial participants for a further two years.