These side effects need to be continuously balanced against the expected benefits in preventing illness. On 3 September 2022 the Joint Committee on Vaccination and Immunisation (JCVI) issued a statement describing which COVID-19 vaccines would be used for those eligible to receive an autumn COVID-19 vaccine booster.Īll vaccines and medicines have some side effects although not everybody gets them. ![]() Data are available on the impact of the vaccination campaign in reducing infections, illness and mortality in the UK. In trials, these vaccines elicited strong antibody responses to the SARS-CoV-2 virus and to variants of concern, sufficient to protect against COVID-19. COVID-19 vaccine Novavax (Nuvaxovid), approved by the MHRA on 3 February 2022, and indicated for use in those aged 12 years and above is also being used as a booster dose in the small proportion of patients who are unable to receive mRNA vaccines.Īll COVID-19 vaccines used in the autumn 2022 UK booster programme have been authorised for supply by the MHRA following a thorough review of quality and immunogenicity data in line with international regulatory standards. Both bivalent vaccines are active against the original strain of the SARS-CoV-2 virus and the Omicron BA.1 variant. On 15 August and 3 September 2022 respectively, the Moderna bivalent vaccine (Spikevax bivalent Original/Omicron BA.1) and the Pfizer/BioNTech bivalent vaccine (Comirnaty Original/Omicron BA.1) were approved by the MHRA as booster vaccines in those aged 12 years and above. View our existing record for a summary of information received via the Yellow Card scheme on these three vaccines as well as safety investigations carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) on these products. Safety monitoring throughout the deployment showed that the most common adverse reactions for all the COVID-19 vaccines were mild and self-limiting ‘reactogenicity’-type events such as fever, fatigue and injection site pain. Up to 23 August 2022, 53 million people received a first dose of COVID-19 vaccine, 50 million received a second dose and 40 million received a third or booster dose. Three COVID-19 vaccines - the monovalent COVID-19 Vaccine Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and monovalent COVID-19 Vaccine Moderna – were used in the primary and booster vaccination campaigns up to the end of August 2022. A national immunisation campaign has been underway since early December 2020. Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. Over the course of the pandemic over 178,407 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19). Any new assessments or safety issues regarding vaccines used in the primary and initial booster campaigns will also be included in this record, however previous and known information on these vaccines will remain available as a record only and can be viewed on the government website. Since January 2023, the MHRA revised the format of the Summary of Yellow Card reporting to focus on the COVID-19 vaccines administered from the beginning of the Autumn 2022 booster campaign. ![]() We would ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report via the Yellow Card website. Additionally, monthly updates of Adverse Drug Reaction (ADR) data will continue with the new interactive COVID-19 vaccine reports. Robust safety monitoring and surveillance of any COVID-19 vaccines used in the UK will continue along with timely communication on any updated safety advice when needed. ![]() This report is therefore the last regular publication of the Summary of Yellow Card reporting for COVID-19 vaccines. ![]() The Commission on Human Medicine (CHM) has advised that given the end of the Autumn 2022 booster campaign and the stable safety profile of the COVID-19 vaccines, the MHRA should transition to routine data publication and communication of safety concerns for COVID-19 vaccines. In Canada, you can report an adverse event at the Government of Canada website. In the USA, the Centres for Disease Control (CDC) and the Food and Drug Administration (FDA) manage the Vaccine Adverse Event Reporting System (VAERS) database, which allows individuals to send in reports through the website: Vaccine Adverse Event Reporting System (VAERS) In the UK, the Medicines and Healthcare products Regulatory Advisory (MHRA) uses the Yellow Card System to monitor reports, and any individual who suspects an adverse reaction can report it directly onto their website: Medicines and Healthcare products Regulatory Advisory (MHRA)
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