The UK government has secured early access to 355 million doses of various coronavirus vaccines currently under various stages of trials – the most, 100 million, are of the vaccine currently in advanced trial stage at the University of Oxford.
Officials said early access had been secured to over 355 million vaccines doses through agreements with vaccine developers at various stages of trials. The UK has invested over £230 million into manufacturing any successful vaccine.
Health secretary Matt Hancock said on Friday that recent news from Pfizer and Oxford trials was promising. “The likely big numbers, if it comes off, and I stress on the ‘if’… will be next year for a Covid vaccine. But we still hold out hope that we might get some going in December this year,” he said.
Mass vaccination at over 40 centres across the UK has been planned by the National Health Service, with retired doctors and nurses joining the initiative.
The regulator, Medicines and Healthcare products Regulatory Agency (MHRA), said there are two routes to obtain a Covid-19 vaccine approval: through a full marketing authorisation or through a temporary authorisation route known as regulation 174.
As regulation 174 is a public health-related measure, manufacturers cannot apply for this authorization; it is the government that requests the MHRA approval for specific products as part of a public health response.
The MHRA will apply the key criteria of safety, quality and efficacy before authorising the use of a vaccine under either route after receiving the full results of the trials.
This means that, for both routes, once the data is submitted, MHRA scientists and clinicians will carefully and scientifically review the safety, quality and effectiveness data – how it protects people from Covid-19 and the level of protection it provides.
The data must include: results from the lab and clinical trials in humans; manufacturing and quality controls; product sampling; and testing of the final product.
“The safety of the public will always come first. A Covid-19 vaccine will only be approved for use via either route once it has met robust standards on safety, effectiveness and quality through clinical trials,” the MHRA said.
After thoroughly reviewed the data via either route, the MHRA will seek advice from the independent advisory body, the Commission on Human Medicines, which will critically assess the data before advising the UK government on the safety, quality and effectiveness of any potential vaccine.
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