Coronavirus: Access Consortium statement on authorisations of modified Covid-19 vaccines for variants
15 March 2021 – Authorised COVID-19 vaccines that are modified in response to new variants will not need “lengthy” clinical studies, according to new guidance, developed by the MHRA in consultation with its Access Consortium partners. The guidance lays out what information the medicines regulators would need in order to approve any modifications to authorised COVID-19 vaccines, should virus mutations make them less effective at preventing the disease. According to the guidelines, which add to the earlier Access Consortium statement on COVID-19 vaccines evidence, vaccine manufacturers must provide robust evidence that the modified vaccine elicits an immune response.
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