Do not vaccinate children against COVID-19 until Phase 3 trials are complete

A risk vs benefit calculation does not support giving COVID-19 vaccines, which use novel technologies and are still in Phase 3 trials, to healthy children.

Any rollout should not start until trials are complete and all findings are published and peer-reviewed on long-term safety data.

Healthy children are at low risk from COVID-19 yet face known and unknown risks from COVID-19 vaccines. Rare, but serious, adverse events and deaths are being reported to monitoring systems around the world. Official guidance is updated as the side-effects become more apparent. Giving COVID-19 vaccines to healthy children to protect adults is unethical and unjustifiable. The Government has an ethical duty to act with caution and proportionality.

No decision has been made by the Government regarding the routine inclusion of children under 18 years within the COVID-19 vaccination programme at a population level. The Government will be guided by the advice of the UK’s independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), whose role is to ensure medicines, devices and vaccines work effectively and are safe for use. MHRA have now authorised the use of Pfizer/ BioNTech vaccine in children aged 12-15. This follows a rigorous review of the safety, quality and effectiveness of the vaccine in this age group by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM). 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 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. No new side effects were identified and the safety data in children was comparable with that seen in young adults. As in young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.

Any vaccine must first go through the usual rigorous testing and development process and meet strict standards of safety, quality and effectiveness before it can be deployed. There are extensive checks and balances 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 are completed to the very highest standards.