Today's Comments (2022-12-21)

• govuk-puppet

  405 125 9.3 Puppet

  Discontinued Decommissioned: Puppet manifests that used to provision the legacy GOV.UK stack.

  

Thank you for your correspondence of 3 November on behalf of your constituent, Mr xxxxxx, about the safety of COVID-19 vaccines. Please accept my sincere apologies for the delay in replying. I appreciate Mr xxxxx’s concerns. Since the beginning of the COVID-19 pandemic, the Government has been involved in the global search for a vaccine. We have accepted the recommendations from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to authorise six COVID-19 vaccines for use, developed by Pfizer/BioNTech, University of Oxford/AstraZeneca, Moderna, Janssen, Novavax and Valneva. This authorisation follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, who have concluded that all the vaccines meet the regulator’s strict standards of safety, quality and effectiveness. No vaccine is authorised for supply in the UK unless the expected standards are met. Over 53 million people in the UK have now received their first dose of a COVID-19 vaccine, and over 50 million have received their second dose. In addition, over 40 million people have had either a first booster or a third primary dose. Vaccination figures for the UK are available at coronavirus.data.gov.uk/details/vaccinations. A consultation on amending the Human Medicines Regulations 2012 was held from 28 August to 18 September 2020. Following consideration of the responses, the regulations were amended and came into full effect on 7 November 2020. Our response to the consultation can be found at www.gov.uk by searching for ‘distributing vaccines and treatments for COVID-19 and flu’. The amendments are to: • strengthen existing regulations that allow for the temporary licensing of medicines and vaccines, on an exceptional basis, pending the granting of a full licence; • extend the current immunity from civil liability to companies producing the vaccines, rather than just healthcare workers and manufacturers. This will protect them from legal liability in civil cases, but does not give them blanket immunity from civil liability; • allow a wider range of trained personnel to administer COVID-19 and flu vaccines; • ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a COVID-19 vaccine, can be promoted as part of national vaccination or treatment campaigns; • make short-term provisions to facilitate the swift and safe transfer of COVID-19 and flu vaccines under NHS-authorised arrangements, by providing an exemption from the need for a wholesale dealer’s licence to meet patient need and avoid wastage; and • on the basis of consultation feedback, make three changes to the legislation to promote robust scrutiny, objectivity and assurance of safety. These amendments were made to facilitate the vaccination programmes for COVID-19 and seasonal flu. A number of the amendments were given the expiry date of 31 March 2022. Consequently, a new consultation on these amendments was launched to collect views on proposals to support the effective rollout of COVID-19 and seasonal flu vaccines by either extending or making permanent these current temporary provisions. The intention is to help give the NHS added flexibility to operate any necessary mass vaccination programmes for COVID-19 and seasonal flu. The consultation ran from 8 to 29 December. A copy of the Government’s response to the consultation can be found at www.gov.uk/government/consultations/review-of-temporary-provisions-in-the-human-medicines-regulations-2012-to-support-influenza-and-covid-19-vaccination-campaigns. Following this consultation, a statutory instrument was passed on 7 February to extend the provisions that were due to expire on 31 March. The statutory instrument can be found at www.legislation.gov.uk/ukdsi/2022/9780348231885. There are extensive checks and balances required at every stage of the development of a vaccine, and this is no different for a COVID-19 vaccine. All vaccines are tested in three phases of clinical trials to ensure that they meet the gold standard. Phase 1 involves a small group of people to ensure that there are no safety concerns and to determine the appropriate dosage for the best immune response. Phase 2 is conducted on a larger group of people to check that the vaccine works consistently and that the immune response is sufficient. Phase 3 tests the vaccines on thousands of people for scientists to assess if the vaccine is giving sufficient immunity to prevent disease. The phases are usually run in sequence but, in an effort to find safe and effective COVID-19 vaccines as quickly as possible, once safety has been ascertained through phase 1, phases 2 and 3 are being run in parallel. The data from each phase then goes to the regulator in a rolling review, rather than once the trials have completed, which means that the regulator can start looking at the results earlier than usual. Vaccines are the best way to protect people from COVID-19. Everyone should continue to get their vaccinations when invited to do so unless specifically advised otherwise by a medical professional. As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with the virus far outweigh any currently known side effects in the majority of patients. The MHRA continually monitors safety during widespread use of a vaccine and has in place a proactive strategy to do this. It also works closely with public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Part of the monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of a person’s vaccination status. This is particularly the case when very large volumes of people are vaccinated, and especially when vaccines are being given to older people and those who have underlying health issues. Companies have made decisions to begin large-scale production of vaccines that are still in trials. If these vaccines are not shown to be safe and effective and are not approved for use, the companies will have to destroy what they have manufactured. I hope this reply is helpful. Yours sincerely, MARIA CAULFIELD MP

• InfluxDB

  www.influxdata.com sponsored

  Power Real-Time Data Analytics at Scale. Get real-time insights from all types of time series data with InfluxDB. Ingest, query, and analyze billions of data points in real-time with unbounded cardinality.

  

Suggest a related project