The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said on Thursday that revised new Covid-19 vaccines could be quickly tracked for approval to combat new strains of the virus.
H MHRA issues new guidelines with ACCS consortium – regulatory body affiliation in Australia, Canada, Singapore and Switzerland.
The regulator said the official Covid-19 vaccines that are modified in response to new variants will not require brand new approval or lengthy clinical studies.
But the guidelines state that vaccine manufacturers will need to provide strong evidence that improved shots produce immune responses.
Researchers can now measure such protection from vaccines by observing antibodies in the blood after inoculation, reducing the need to wait and see if people in a test are infected with the disease or through clinical trials.
The manufacturer will also be expected to provide evidence showing that the improved vaccine is safe and of the expected quality.
Data from the original clinical trials of vaccines and ongoing studies on their real-world use can also be used by regulators to support any decision.
Without compromising on safety, it is our priority to deliver effective vaccines to the public as soon as possible. M.H.R.A. No. Chief Scientific Officer, Dr. Christian Snyder said that if there is a need to make changes to the official Covid-19 vaccines, this regulatory approach should help to do so.
“The announcement today also demonstrates the strength of our international partnerships with other regulators and how our global work can ensure rapid access to life-saving vaccines in the UK and around the world,” Snyder said.
He added: “The public should have confidence that no vaccine will be approved unless the expected high standards of safety, quality and effectiveness are met.”
“To date we have no evidence that vaccines used in the UK lack effectiveness,” said MHRA chief regulator June Raine.
He added: “One clear goal is that future vaccine changes in response to new types of coronavirus may soon be made available to UK recipients without compromising at any stage on safety, quality or efficacy.”
According to the guidelines, the quick-tracking approach is to be used and tested on seasonal flu vaccines, which need to be modified each year to match the strain that spreads each year.
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