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Access Consortium's guidance on strain changes in authorised COVID-19 vaccines

This guidance lays out the information required by the Access consortium to approve any modifications to authorised COVID-19 vaccines, should virus mutations make them less effective at preventing the disease.

Authorised COVID-19 vaccines that are modified in response to new variants will not need a brand new approval or “lengthy” clinical studies, reducing the time taken for the modified vaccine to be ready for use.

Key points to consider:

  • Vaccine manufacturers would need to provide robust evidence that the modified vaccine produces an immune response in a sufficient number of people, but time-consuming clinical studies that do not add to the regulatory understanding of a vaccines safety, quality or effectiveness would not be needed as researchers are now better able to measure protection by looking at antibodies in the blood following vaccination.
  • Alongside data on the immune response, the vaccine manufacturer would also be expected to provide evidence showing the modified vaccine is safe and is of the expected quality.
  • In addition, data from the original clinical trials and the ongoing studies on real-world use in millions of people could be used to support any decision by the regulators.

This approach is based on the tried and tested regulatory process used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating each year.

Access Consortium's guidance on strain changes in authorised COVID-19 vaccines122 KB

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