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

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.

Serious adverse events following vaccination are extremely rare in this age group. The MHRA closely monitors the safety of COVID-19 vaccine exposures in individuals under 18 years old. The MHRA’s Yellow Card Reporting Scheme enables the regulator and the public to monitor any side effects a vaccine may have. The nature of Yellow Card reporting means that reported events are not always proven adverse effects. The majority of cases of myocarditis were reported after the second dose and international data from adult programmes suggest that a longer interval between doses (greater than the 3 to 4 week schedule widely used in the US) is associated with a lower reporting rate of myocarditis following vaccination. This association is expected to also apply to the paediatric dose and formulation when used in children. In the latest report from the Therapeutic Goods Administration in Australia, there is a footnote which says: “To 27 February 2022, from about 1.2 million vaccine doses given, no likely cases of myocarditis have been reported in children aged 5-11 years” COVID-19 vaccine weekly safety report - 03-03-2022 | Therapeutic Goods Administration (TGA)

The MHRA maintains that the risk-benefit is favourable for the vaccine. The available data indicates that cases of myocarditis following vaccination are typically self-limiting and resolve within a short time.

The Government has accepted advice from the independent expert Joint Committee on Vaccination and Immunisation (JCVI) to offer two 10 microgram doses of the Pfizer COVID-19 vaccine to children aged 5-11. Deployment of this vaccine will be carried out using the Pfizer paediatric formulation, which is specially designed for children aged 5-11 and is at a lower dose compared to 30 micrograms doses used in individuals aged 12 and above. The COVID-19 vaccine has been given to millions of children and young people around the world. Data from these countries shows that the vaccine is safe and effective.

The Government will continue to provide information and encouragement to the parents and carers of the eligible children to ensure that they make the best decision for their children, whatever it may be. This is a voluntary offer, and every parent will have the opportunity to make an informed choice based on their own personal circumstances. In doing so, the priority remains for the NHS to offer vaccines and boosters to adults and vulnerable young people.

When formulating advice in relation to childhood immunisations, JCVI has consistently held that the main focus of its considerations should be the potential benefits and harms of vaccination to children and young people themselves. Overall, JCVI agreed that the potential health benefits of vaccination are greater than the potential health risks, due to this being part of a pandemic response.

The UK Health Security Agency (UKHSA) has put in place a safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines. This surveillance will be extended to include the 5-11 age group and will include age-specific monitoring of potential safety concerns. Any information indicating a possible new safety concern in this age group will be thoroughly evaluated including review by the independent expert working group for COVID-19. Updated advice for healthcare professionals and patients would be issued where appropriate.

Department of Health and Social Care