EMA plans guidance on adapting vaccines for COVID variants

| 10 February 2021 |  By 

The European Medicines Agency (EMA) on Wednesday said it will soon issue guidance explaining its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus.
The announcement comes just a week after the US Food and Drug Administration (FDA) said it is working on its own guidance to address these and other new variants of the virus. (Woodcock: FDA plans guidance to address new COVID-19 variants, Regulatory Focus 5 February 2021).
Several variants of the SARS-CoV-2 virus, including those first identified in the United Kingdom (B.1.1.7), South Africa (B.1.351) and Brazil (B.1.1.28), have raised international concern as they appear to be more transmissible and may impact the efficacy of certain treatments and vaccines.
“There are concerns that some of these mutations could impact to different degrees the ability of the vaccines to protect against infection and disease,” EMA said, adding that, “A reduction in protection from mild disease would however not necessarily translate to a reduction in protection from serious forms of the disease and its complications, for which we need to collect more evidence.”
EMA said it has asked manufacturers to investigate whether their vaccines offer protection against any of the new variants and to submit their findings to the agency. The agency has so far recommended three vaccines developed by Pfizer and BioNTech, Moderna and AstraZeneca and has started rolling reviews of Johnson & Johnson and Novavax vaccines.
In a forthcoming reflection paper, EMA plans to outline its expectations for the evidence needed to support changes to vaccines to tackle mutations of the virus. Specifically, EMA will detail the options for introducing new strains to existing approved vaccines; set minimum regulatory requirements for demonstrating quality, safety and efficacy; and explain which types of bridging studies will be required to prove efficacy against a new strain.
“EMA is clarifying its regulatory approach to vaccine variations that might become necessary to ensure that effective vaccines continue to be available, not only for Europeans, but for people around the world who are suffering as a result of the COVID-19 pandemic,” EMA said.
EMA is working with other regulators under the auspices of the International Coalition of Medicines Regulatory Authorities (ICMRA) to look at possible changes to the composition of vaccines, which held a meeting co-chaired by the agency on Wednesday.


© 2022 Regulatory Affairs Professionals Society.

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