Agencies in Canada, Singapore and Switzerland will also back plan for modified vaccines to be rolled out without new approval
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Authorised vaccines that are modified to protect against new variants will not need to start a new approval process or undergo in-depth clinical studies, regulators in the UK, Australia, Canada, Singapore and Switzerland have said.
Manufacturers will need to provide “robust evidence that the modified vaccine produces an immune response, but time-consuming clinical studies that do not add to the regulatory understanding of a vaccine’s safety, quality or effectiveness would not be needed”, bringing the process into line with that already used for updated flu jabs.
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 robust 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.
Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety. Should any modifications to authorised Covid-19 vaccines be necessary, this regulatory approach should help to do just that.
The announcement today also demonstrates the strength of our international partnerships with other regulators and how our global work can help ensure faster access to life-saving vaccines in the UK and around the world.
While worrisome coronavirus variants identified in Brazil, South Africa, and California have mutations that might help them resist antibody treatments and vaccines, the immune system’s T cell responses to the variants are unaffected in recovered patients and in people who have received the Moderna Inc or Pfizer Inc/BioNTech vaccines, new data show.
Reuters: The T cells induced by vaccines can recognise pieces of the virus spike protein, while T cells induced by previous infection recognise multiple parts of the virus, including the spike and other proteins, said Alessandro Sette of the La Jolla Institute for Immunology.
“These pieces are largely not changed/mutated in the variants,” he explained. “This means that the T cell responses recognise the ‘ancestral’ sequence and the variants equally well.”
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