The development of coronavirus vaccines tweaked to target new variants will be fast-tracked in the UK and four other countries, Britain’s regulator has said, adding that “robust evidence” on effectiveness and safety will still be required for authorisation.
The approach, similar to the regulatory process for the modified flu vaccine, will not need a brand new approval or “lengthy” clinical studies, the Medicines and Healthcare Products Regulatory Agency (MHRA) said on Thursday.
This will "significantly reduce" the length of time it takes for the vaccines to be ready, with concern mounting over the threat posed by the South African and Brazilian variants and their ability to partially evade the body’s immune response.
Under the new guidance, developers will need to provide clear evidence their adapted vaccines produce a strong immune response to the variant and meet the high safety standards outlined by the MHRA.
“This is based on scientific principles and does not cut any corners on safety or effectiveness,” said Dr Christian Schneider, chief scientific officer at the MHRA.
Source: The Independent, 4 March 2021
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