U.K. to Fast-Track Approval of Vaccines for Covid-19 Variants
(Bloomberg) -- U.K. health regulators said authorized Covid-19 vaccines that are modified for new variants of the disease will be fast-tracked through the approval system.
The Medicines and Healthcare Products Regulatory Agency issued guidance -- in step with partners in Australia, Canada, Singapore and Switzerland -- that will reduce the time taken for the new vaccines to be ready for use, according to a statement on Thursday.
Vaccine manufacturers will need to provide robust evidence that the modified vaccine produces an immune response, but time-consuming clinical trials will not be needed. Instead a small trial will be used to assess the main adverse effects which could take a few weeks rather than months.
Once the manufacturer has produced a new version of the vaccine, the MHRA could approve it in “a very efficient manner, as short as a couple of weeks,” June Raine, the agency’s chief, told reporters in a briefing. A similar fast-track approval method is already used for annual flu vaccines to keep up with mutations.
The plans are in line with those mentioned by Raine at a public MHRA board meeting last month, where she said that the threat posed by the variants meant the agency would have to act fast. The European Medicines Agency, the European Union’s drugs regulator, has also issued guidance on fast-tracking vaccine modifications for variants.
AstraZeneca Plc and partner the University of Oxford have said they hope to have new versions of their vaccine to better counter variants available by fall, while the U.K. government announced a pact with CureVac NV last month to tackle variants, pairing artificial intelligence to predict future mutations with messenger RNA technology that can rapidly generate new vaccines.
U.K. Prime Minister Boris Johnson moved to reassure the public on Monday after six cases of a Brazilian variant of the coronavirus were detected in the U.K. Surge testing is already in place for the South African variant of the virus in parts of Britain.
There are fears that these new strains could be resistant to the vaccines being rolled out across the U.K., undermining the government’s efforts to reopen England’s economy after more than two months in lockdown.
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