The first rounds of the vaccine in the U.K. are being given to the elderly and frontline workers, and these initial vaccinations seemed to be going smoothly until two National Health Service (NHS) workers had an allergic reaction to the COVID vaccine. This week the device has been granted official approval of its registration with The Medicines and Healthcare products Regulatory Agency (MHRA). Commenting on data received on the Pfizer vaccine, Dr June Raine, the MHRA chief executive, said the regulator would “aim to make a decision in the shortest time possible, without compromising the thoroughness of our review”. You’ve accepted all cookies. The regulator, the closest equivalent the UK has to the FDA (Food and Drug Administration) in the US, assesses the quality, safety and effectiveness of products. The MHRA this week became the first regulator in the world to approve the Pfizer/BioNTech Covid vaccine, with a rollout to care workers, NHS workers and those over 80 to begin next week. For medical devices, a description of the incident should be provided, including whether there was an associated injury. If you need to change or update your medical device report, please email us on [email protected], quoting the MHRA reference number in the subject line. Covid vaccine would not be disrupted in event of no-deal Brexit, says MHRA chief Coronavirus vaccine supply will not be disrupted by no-deal Brexit, says regulator Andrew Woodcock The MHRA is the British regulator of medicines and medical devices, ensuring their safety, quality and effectiveness. All information provided will be kept secure and confidential – see the privacy policy online. Oxford Vaccine Group researchers working on the coronavirus vaccine developed by AstraZeneca and Oxford University. It has been announced this morning that the UK government has accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve the Pfizer-BioNTech COVID-19 vaccine for use. Medical Devices and COVID-19 ... (MHRA) and Netherlands (IGJ) to ensure our actions are effective, efficient and legal. All content is available under the Open Government Licence v3.0, except where otherwise stated, Medicines and Healthcare products Regulatory Agency, Launch of COVID-19 Yellow Card reporting site, Support for reporting Yellow Cards – please continue to report all adverse incidents for medicines and medical devices, new dedicated COVID-19 Yellow Card reporting site, Coronavirus (COVID-19): guidance and support, Transparency and freedom of information releases, be vigilant for any potential safety issues associated with medicines and medical devices used in COVID-19 treatment, all suspected side effects associated with any medicine used in patients with confirmed or suspected COVID-19, including medicines to manage long-term or pre-existing conditions, and unlicensed medicines or medicines used off-label, medical devices incidents related to COVID-19, any medical device incidents should be reported to, suspected side effects associated with any medicine used in patients with confirmed or suspected COVID-19, including, medicines to manage long-term or pre-existing conditions, unlicensed medicines or medicines used off-label to treat COVID-19, incidents involving medical devices used in relation to COVID-19, including adverse incidents with equipment, diagnostic testing kits and software/apps. Other sources of income include research funding. COVID-19 vaccines may be distributed in English-language only packaging in Europe under temporary measures designed to ensure speedy deployment of vaccines against the coronavirus, according to a question-and answer-document published by the European Medicines Agency (EMA). A Medical and Health products Regulatory Agency rep discusses two case reports of allergic reactions in relation to the coronavirus vaccine. 19 March 2020 Additionally, in October, the government changed the law to enable the MHRA to grant temporary approval for a vaccine before it has been given a licence by the European authorities. Don’t worry we won’t send you spam or share your email address with anyone. The switch to a fast track for devices related to COVID-19 has caused agencies other than MHRA to take the lead on some tasks. However please be assured that your report is on our system and looked at by our team. Some of these pathways existed before the COVID-19 pandemic and depend on the classification of the device. It can take years. It will take only 2 minutes to fill in. reporting of incidents in clinical trials should follow the trial protocol, for non-COVID related side effects from medicines please continue to report through the standard Yellow Card website, which can also be used for defective or falsified medicines and medical devices (including fake COVID-19 testing kits). Domestically manufactured invasive ventilators for use during the COVID-19 pandemic. The approach taken by the MHRA will depend on the stage of the relevant application, and this may affect the authorisation route of COVID-19 vaccines in the United Kingdom after this date. December 2, 2020 expert reaction to news that the MHRA has approved the Pfizer/BioNTech COVID-19 vaccine for mass UK roll out . Europe’s medical agency eyes safety of two COVID-19 vaccines EU regulator to assess data on how well the vaccines trigger an immune response and if they are safe for broad usage. Non-COVID-19 related suspected side effects to medicines or concerns about medical devices (in England), defective or falsified products (including fake COVID-19 testing kits), and e-cigarettes should still be reported to the standard Yellow Card website. The Latest. See the OPSS document “New High-Volume Manufacturers of COVID-19 Personal Protective Equipment … In 2019-20, £104.6m came from this stream, out of total income of £166.7m. By GlaxoSmithKline, is a known, although very rare, side effect to feedback... The Pfizer/BioNTech COVID-19 vaccine for mass UK roll out know more about your visit today 2019-20, came. This week the device has been granted official approval of its income from fee-charging activities including. 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