Abstract
As developers seek approval for their covid-19 vaccines, the race is on to get the shots into our arms, writes Michael Le Page
PEOPLE in Europe and the US could start to be vaccinated against the coronavirus in the coming weeks. Pharmaceutical firms Pfizer – with its partner BioNTech – and Moderna have asked for approval for their vaccines in Europe and the US. If regulators give the go-ahead, they could be in use soon after.
“It's great news,” says immunologist Eleanor Riley at the University of Edinburgh, UK. While the full results of trials haven't yet been made public, regulators will have access to all the data before any approval, she says. “We can be confident that it will be safe and it will work.”
Three vaccines developed in Europe and North America have been shown to be effective in phase III trials: an mRNA vaccine from Pfizer and BioNTech, another by Moderna, plus an adenovirus-based vaccine from AstraZeneca and the University of Oxford.
In the UK, vaccination could begin by 7 December, according to newspaper reports. The Financial Times says the UK could issue an emergency use authorisation for the Pfizer and BioNTech vaccine this week and that use could begin soon after that.
The companies filed for emergency use authorisation (EUA) in the US on 20 November and said they had initiated rolling submissions – in which regulators review data as it becomes available to allow decisions to be made faster than normal – with several authorising bodies globally. This includes those of the European Union and the UK. The US Food and Drug Administration will hold a meeting on 10 December to assess Pfizer and BioNTech's application, but the agency said a decision may take weeks.
In general, the UK has to abide by European Medicines Agency (EMA) decisions until 31 December, when it stops following EU rules. However, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK can allow emergency use without EMA approval.
On 27 November, the UK government asked the MHRA to evaluate the AstraZeneca and University of Oxford vaccine for emergency authorisation. The agency was already looking at data on this vaccine as part of a rolling review.
Moderna filed for emergency use authorisation in the US on 30 November. It said that the meeting to review its vaccine “will likely be scheduled” for 17 December, meaning it is unlikely to be authorised before 18 December.
In the UK, vaccination could begin as early as 7 December, according to reports
Vaccination in the US could begin within a day of approval, the CEO of Moderna told journalists.
On 1 December, the EMA said it had received applications for conditional marketing authorisation from Pfizer and BioNTech and Moderna. Similar to EUAs, this is 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's 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 has 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 around a million people have been inoculated so far. In September, the United Arab Emirates approved emergency use of Sinopharm's vaccine.
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