LONDON (AP) – Regulators in the UK and four other countries have announced new rules to accelerate the development of modified COVID-19 vaccines to ensure that drug manufacturers can act quickly to target emerging variants of the disease.
Previously authorized vaccines that are modified to combat new variants “will not need a new approval or ‘long’ clinical studies,” said the UK’s Medicines and Health Products Regulatory Agency Thursday.
“The clear objective is that future modifications of the vaccine that respond to new variants of the coronavirus can be made available in the shortest possible time to recipients in the UK, without compromising safety, quality or efficacy at any stage,” Dr. June Raine, chief of the agency, said in a briefing for reporters.
The new guidance is based on the model already used to modify the seasonal flu vaccine to keep up with annual changes in the virus and was issued jointly by regulators in the United Kingdom, Australia, Canada, Singapore and Switzerland. The Food and Drug Administration and the European Medicines Agency have published similar guidelines.
Under the new rules, developers will be required to provide “robust evidence” that the modified COVID-19 vaccines produce a strong immune response to the variant, as well as data showing that they are safe and meet quality standards.
This means that developers will be required to conduct small-scale tests on a few hundred people, rather than the tests on tens of thousands of individuals that were required for initial approval, said Dr. Christian Schneider, scientific director at MHRA.
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“I would like to emphasize that so far we have no evidence that vaccines in use in the UK are significantly deficient in effectiveness,” said Raine.
The announcement comes amid concerns that the virus that causes COVID-19 may mutate to create new variants resistant to existing vaccines. The United Kingdom has banned direct flights from 33 countries in an effort to prevent variants discovered for the first time in Brazil and South Africa from settling in Britain.
Vaccine manufacturers have already developed booster injections to target the new variants.
Moderna said on February 24 that it had sent a specific vaccine candidate for a variant to the United States National Institute of Health for analysis.
The coronavirus pandemic has infected more than 115 million people worldwide and killed at least 2.5 million, according to Johns Hopkins University.
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