The UK has become the first country to approve the vaccine developed by Pfizer and its partner BioNTech, paving the way for immunisations to begin in the most vulnerable next week.
According to UK Health Secretary Matt Hancock, those who will receive the vaccine first will be older people in care homes, and people will be contacted by the NHS when it is their turn. The news heralds a breakthrough in medicine, with a vaccine being developed in just 10 months rather than decades.
The vaccine was approved for emergency use by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, which can allow emergency use without European Medicines Agency (EMA) approval. In general, the UK has to abide by EMA decisions until 31 December, when it stops following EU rules.
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鈥淭his is excellent news and a huge landmark in the global efforts to address this pandemic,鈥� said Michael Head at the University of Southampton, UK, in a statement. 鈥淭he regulators have clearly been satisfied with the data presented to them.鈥�
The swift approval of a vaccine is 鈥済reat news鈥�, says immunologist Eleanor Riley at the University of Edinburgh, UK. While the full results of trials haven鈥檛 yet been made public, regulators will have access to all the data before any approval, she says. 鈥淲e can be confident that it will be safe and it will work.鈥�
One challenge will be storage and distribution, said Head, as the Pfizer/BioNTech vaccine must be stored at temperatures of -70掳C, 鈥渨hich will pose significant logistical challenges for all countries that choose to use it. These are not insurmountable but certainly challenging.鈥�
Three vaccines developed in Europe and North America have been shown to be effective in phase III trials: the mRNA vaccine from Pfizer and BioNTech, another by Moderna, plus an adenovirus-based vaccine from AstraZeneca and the University of Oxford.
The companies also on 20 November. The agency has said it will hold a meeting on 10 December to assess Pfizer and BioNTech鈥檚 application, and said a decision may take weeks.
On 27 November, the UK government for emergency authorisation. The agency was already looking at data聽on this vaccine as part of a聽rolling review.
Moderna filed for emergency use authorisation in the US on 30聽November. It said that the meeting to review its vaccine 鈥渨ill聽likely be scheduled鈥� for 17聽December, meaning it is unlikely to be authorised before聽18聽December.
Vaccination in the US , the CEO of Moderna told journalists.
On 1 December, the EMA said it聽had . Similar to EUAs, this is聽where approval is given for medicines in exceptional cases, with less evidence than is normally needed. The body says it will meet to assess the Pfizer and BioNTech vaccine by 29 December and Moderna鈥檚 by 12 January.
Elsewhere in Europe, Germany is preparing for vaccination to begin in mid-December, whereas in Australia, the government is talking about rolling out vaccination in March.
In some other parts of the world, immunisation had already begun. An adenovirus-based vaccine created by Chinese firm CanSino Biologics was approved by China for use by its military in June, after phase II trials.
At least three inactivated-virus vaccines created by Chinese developers Sinopharm and Sinovac have also been approved for emergency use in China.
Sinopharm says . In September, the United Arab Emirates approved emergency use of Sinopharm鈥檚 vaccine.
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