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COVID-19 vaccine authorised by medicines regulator | |
admin | |
2020-12-02 | |
发布年 | 2020 |
语种 | 英语 |
国家 | 英国 |
领域 | 气候变化 ; 资源环境 |
正文(英文) | COVID-19 vaccine authorised by medicines regulatorThe vaccine will be made available across the UK to priority groups from next week.
Tens of thousands of people will receive an effective and high-quality COVID-19 vaccine from next week, as the UK becomes the first country in the western world to authorise a vaccine. Following rigorous clinical trials involving thousands of people and extensive analysis of the vaccine’s safety, quality and effectiveness by experts from the Medicines and Healthcare products Regulatory Agency (MHRA), Pfizer/BioNTech’s vaccine has been authorised for use in the UK. Now authorisation has been granted, Pfizer will deliver the vaccine to the UK. In making the recommendation to authorise supply, the MHRA will decide what additional quality assurance checks may be required before a vaccine can be made available. Pfizer will then deliver the vaccines to the UK as soon as possible. The NHS has decades of experience in rolling out successful widespread vaccination programmes and has put in place extensive deployment plans. In line with the recommendations of the independent Joint Committee for Vaccination and Immunisation (JCVI), the vaccine will be rolled out to the priority groups including care home residents and staff, people over 80 and health and care workers, then to the rest of the population in order of age and risk, including those who are clinically extremely vulnerable. The vaccine is given in 2 doses – 3 weeks apart – and data from clinical trials showed the vaccine is 94% effective in protecting people over the age of 65 from coronavirus, with trials suggesting it works equally well in people of all ages, races and ethnicities. There were also no serious safety concerns reported in the trials. The UK was the first country to pre-order supplies of the vaccine from Pfizer/BioNTech, with 800,000 doses being made available next week and 40 million doses ordered overall – enough to vaccinate up to a third of the population, and the majority of doses anticipated in the first half of next year. Health and Social Care Secretary Matt Hancock said:
Business Secretary Alok Sharma said:
The MHRA started the rolling review of Pfizer/BioNTech’s data in October and the government asked the regulator to assess the vaccine for its suitability for authorisation under Regulation 174 of the Human Medicines Regulations, enabling the temporary supply of medicines to be authorised in response to a public health need, which the regulator has recommended. NHS England will outline further details on deployment shortly, but the plans will include:
The global deployment of the Pfizer/BioNTech vaccine will require a huge logistical exercise over land, air and sea. Pfizer has years of proven experience in cold supply chain management and delivering temperature-controlled vaccines to locations across the world. It has developed packaging and storage innovations for the vaccine, including specifically designed, temperature-controlled thermal shippers to maintain conditions of ultra-low temperatures. Deputy Chief Medical Officer for England Professor Jonathan Van-Tam said:
As the JCVI has made clear, there will need to be flexibility in terms of operational challenges around delivery of the vaccine to those in care homes. In line with the advice, every effort will be made to supply vaccine and offer vaccinations to care home residents and we will deliver the vaccine according to clinical prioritisation and operational necessity. The vaccine will be available for free across the UK and the government is working with the devolved administrations to ensure it is deployed fairly across the UK under the Barnett formula. Through the Vaccine Taskforce, the UK has secured early access to 357 million doses of 7 of the most promising vaccine candidates so far. To date, the government has invested over £230 million into manufacturing a successful vaccine. In the Chancellor’s Spending Review, published on 25 November, it was announced that the government has made more than £6 billion available to develop and procure successful vaccines. Vaccine Deployment Minister Nadhim Zahawi said:
Chair of the government’s Vaccine Taskforce Kate Bingham said:
Background informationThe full prioritisation list is on GOV.UK and is as follows (in order of priority):
Deployment plansDespite the huge complexities, staff have been working to ensure that when it is approved and ready for use, the NHS is able to vaccinate from day one. The time between approval and deployment of a vaccine like this might typically be expected to take around a week, due to travel and extensive safety and quality control checks. The steps include:
Further informationVaccination will be managed by the health services in each nation: NHS England and NHS Improvement, NHS Wales, NHS Scotland, and Health and Social Care Northern Ireland. Until the end of December, and as part of the transition period, vaccines must be authorised via the European Medicines Agency and that authorisation will automatically be valid in the UK. However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented – Regulation 174 – allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need. Through the government’s Vaccine Taskforce, the UK has secured early access to 357 million doses of 7 of the most promising vaccine candidates, including:
Published 2 December 2020
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来源平台 | Department for Business, Energy & Industrial Strategy |
文献类型 | 新闻 |
条目标识符 | http://119.78.100.173/C666/handle/2XK7JSWQ/306096 |
专题 | 气候变化 资源环境科学 |
推荐引用方式 GB/T 7714 | admin. COVID-19 vaccine authorised by medicines regulator. 2020. |
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