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.
1. Do not vaccinate children against COVID-19 until Phase 3 trials are complete
14/05/2021 - Petitions
Found: risk vs benefit calculation does not support giving COVID-19 vaccines, which use novel technologies and
2. Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons and Drug-Eluting Stents to the MHRA
18/02/2021 - Medicines and Healthcare products Regulatory Agency (MHRA)
- View source
Expert advisory group (EAG) membership
Found: 114aCOVID-19 - SARS-CoV-2
NOTIFIABLEThe virusCOVID-19 disease first emerged as a presentation of severe
Found: UK COVID
-19 vaccines delivery
1. Ministerial foreword
Found: 114aCOVID-19 - SARS-Cov-2 NOTIFIABLEThe virusCOVID-19 disease first emerged as a presentation of severe
1. Health and Social Care Update
22/03/2021 - Lords Chamber
1: to make a Statement on the support that we are giving to the NHS and social care to help recover from - Speech Link
2: to update the House on vaccine supply and the rollout, and set out the facts, given some of the speculation - Speech Link
3: Throughout the vaccination programme, the pace of rollout has always been determined by the availability - Speech Link
2. Coronavirus Vaccine
03/12/2020 - Lords Chamber
1: control, we have been striving, too, to develop the vaccines that can give us hope and let us eventually release - Speech Link
2: different vaccine candidates. We have backed seven vaccines and ordered 357 million doses on behalf of the - Speech Link
3: volunteers who stepped up and took part in clinical trials, and the MHRA itself, which made sure that this - Speech Link
3. Covid-19 Vaccine
10/11/2020 - Westminster Hall
1: considered covid-19 vaccine.Is locking down the nation the only way of combatting covid-19? Whatever - Speech Link
4. Covid-19: Vaccination
14/12/2020 - Westminster Hall
1: e-petition 323442, relating to vaccination for Covid-19.It is a pleasure to serve under your chairmanship - Speech Link
5. Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020
07/01/2021 - Lords Chamber
1: than a million people in Britain infected with Covid. A third are asymptomatic, and most are highly infectious - Speech Link
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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.
The Government will continue to evaluate evidence and assess expert opinion before making a decision on routinely vaccinating children under 18 years old.
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