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

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.

For all vaccines authorised for supply in the UK, including COVID-19 vaccines, each 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 set by MHRA.

Once a vaccine is approved for use in the UK, the Joint Committee on Vaccination and Immunisation (JCVI), an independent body made up of scientific and clinical experts, will provide advice to the Government on which safe, effective vaccines to use, and advise on prioritisation at a population level. The committee’s membership is made up of public health and scientific experts who have considered and continue to consider the impact of COVID-19 and population prioritisation as new data emerges.

Now that the Pfizer/BioNTech vaccine has been authorised for use in children aged 12-15 in the UK, we will be guided by the advice of experts, including the JCVI, on any potential deployment of COVID-19 vaccination in children under the age of 18.

No decisions have been made by the Government on the routine COVID-19 vaccination of children. In line with the advice of the JCVI for Phase One of the vaccination programme, children/young adults aged 16-18 could be offered a vaccine if they have an underlying condition that put them at increased risk from COVID-19. However, the JCVI currently advises that children under 16 years of age, even if they are clinically extremely vulnerable (CEV), are at low risk of serious morbidity and mortality and given the absence of safety and efficacy data on COVID-19 vaccines, are not currently recommended for routine COVID-19 vaccination.

Following infection, almost all children will also have asymptomatic infection or mild disease. Therefore, only children under 16 who are at very high risk of exposure and serious outcomes, such as those with severe neuro-disabilities that require residential care, may be considered for a COVID-19 vaccination. This is given the very high risk of exposure to infection and outbreaks in residential settings. Decisions to vaccinate such children should be made on a case by case basis, with consultation taking place between clinicians, parents/carers and children. The MHRA updated its authorisation guidance in relation to the currently approved vaccines in February to allow this approach.

The JCVI continues to look at the emerging evidence on COVID-19, and will offer further advice to the Government if and when evidence is found that routinely vaccinating children under 18 years old would further reduce overall mortality, morbidity and hospitalisation which is the overarching objective of the COVID-19 vaccination programme.

Department for Health and Social Care