UK regulator, vaccine makers discuss virus variants

UK regulator, vaccine makers discuss virus variants
UK regulator, vaccine makers discuss virus variants

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Jeddah - Yasmine El Tohamy - LONDON: The UK’s medicine regulator has discussed with vaccine manufacturers the need for “potential modifications” to vaccines to ensure they protect against the new coronavirus variants emerging around the world.

The Medicines and Healthcare products Regulatory Agency (MHRA) said that “there was no evidence that vaccines failed to work against new variants,” but that it had made the issue a priority.

AstraZeneca, which partnered with Oxford University to manufacture a vaccine, said scientists had begun work on a modified vaccine in case it was necessary.

A spokesman said: “It is known that viruses constantly change through mutation, leading to the emergence of new variants.

“These changes are being monitored closely by scientists.

“The University of Oxford and labs across the world are carefully assessing the impact of new variants on vaccine effectiveness, and starting the processes needed for rapid development of adjusted vaccines if these should be necessary.”

Public Health England’s Porton Down laboratory and specialist academic facilities are now researching whether available vaccines are less effective against new coronavirus variants, including those detected in the UK and South Africa.

Studies have suggested that antibodies from former patients and vaccine recipients are still effective against the B117 variant found in the UK, but the 501Y.v2 variant from South Africa could be more resistant. The protective effect of T-cells, which are induced by vaccines and previous coronavirus infections, is also important, but is still being investigated.

“We have no evidence that the vaccines being used do not work against the new coronavirus strains, but we are making this issue a priority,” an MHRA spokesperson said.

“We are in discussion with vaccine manufacturers on potential modifications that may be needed for current vaccines to be effective against new variants, if required.”

Due to the evolutionary nature of viruses, the emergence of new variants has been expected, as has the need for vaccines to be updated.

Influenza vaccines are updated each year to match forms of the flu ahead of time. A decision on the correct flu vaccine to produce takes place around February. Production and testing then takes several months, with a license given only when regulators have reviewed quality, safety and efficacy data.

The MHRA is meeting with its independent expert working group of the Commission on Human Medicines as part of decisions regarding the regulation of vaccines. “Bridging studies” will likely be necessary to give regulators confidence that modifications will not compromise safety.

The spokesperson said: “We can say at this stage that it is unlikely that a full new approval process will be needed.

“No vaccine will be authorized for supply in the UK unless the expected standards of safety, quality and effectiveness are met.”

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