UK diverges from EU and US regarding fine-tuned Covid vaccine approval | Society

According to regulators, the UK will adopt different standards than in Europe and the United States when considering approval of a coronavirus vaccine tailored to combat mutants.

There is no compromise in safety or effectiveness, he said. Dr. June Rain, Head of Medicines and Healthcare Products Regulatory Agency. However, the UK does not argue that fine-tuned vaccines need to be “not inferior” to the original vaccine, as regulators in Europe and the United States do.

The UK left the European Medicines Agency (EMA) after Brexit.It used the existing provisions before leaving Give emergency permit to Oxford / AstraZeneca vaccine In December, ahead of the rest of the world.

He is currently participating in an access consortium of regulators in Australia, Canada, Singapore and Switzerland, publishing guidance on how fine-tuned vaccine use is approved.

“I would like to say that we work closely with the EMA and the FDA, but we also emphasize that the Access Consortium is a partnership at the international level,” Raine briefed on the new guidance. I mentioned in.

“Our guidance is characterized by scientific flexibility. It’s not a reduction in terminology. Flexible guidelines for using the best possible science and integrating data sources for the urgency of the situation. Allows you to adapt very quickly to changing situations. “

Dr. Christian Schneider, chief scientific officer at MHRA, said the approval process would not always be quick. “Maybe. But the main difference is the so-called clinical non-inferiority of immunogenicity.

“It basically means EMA and FDA [Food and Drug Administration in the US] In terms of immune response, it requires that the new version of the vaccine is never inferior to the previous version. “

He said the practical problem with that was not knowing where the threshold was. “When do you say that the new version is actually inferior to the previous version? This is an arbitrary margin, and even if that margin is not officially reached, the vaccine may still be effective. There is, “says Schneider.

“This is why we say we’re looking at the immune response itself, but we’re doing this using other data, such as cell-mediated immune response, cross-reactivity, and we make decisions based on that. , This can be scrutinized individually and regulated in a scientifically appropriate way. “

According to Rein, this approach is similar to the flu vaccine regulatory process and is modified to address new strains each year, requiring no new approval.

Scientists have previously stated that Covid-19 mutants resistant to current vaccine crops may emerge at some point, but manufacturers are already working on adjusting those vaccines. Oxford University states that these could be brought to trial in June. According to Raine and Schneider, the new version is expected to be ready in the fall if approved, and will take less than a few weeks.

Guidance states that manufacturers of coronavirus vaccines need to provide solid evidence that modified jabs provoke an immune response. However, long-term clinical trials are not considered necessary and are not considered to provide a regulatory understanding of their safety, quality, or efficacy.

Researchers examine antibodies in the blood after vaccination to measure protection, reducing the need to wait for people under test to become infected with the virus.

This will “significantly reduce” the time it takes to prepare a modified vaccine vaccine.

Health Minister Matt Hancock showed confidence in the vaccine on his trip to Glasgow.

When asked if his visit represented a political issue about the importance of the union to the success of the vaccine program, Hancock said, “Now is not the time for any of these constitutional debates.” But “The strength of the UK’s cooperation means that we can move on to the vaccine program as quickly as possible.”

Nicola Sturgeon recently talked about the impact of cross-border travel on the spread of new variants, but Hancock said it’s important to pay attention to the emergence of new variants, but to allow people to travel. He said he was optimistic when it came to. 4 countries by summer.

“Thanks to the speed and effectiveness of the vaccine’s deployment, we are more optimistic about spending the summer of the British Empire, which means that people can enjoy traveling across Britain, of course, Scotland. Travel rules are a matter of the Scottish government, but everyone understands that the speed of vaccine deployment can move the roadmap forward, “he said.

Guidance from the Access Consortium should show that the modified vaccine is safe and of the expected quality, as well as evidence of an immune response.

Data from original clinical trials and ongoing studies on actual use by millions of people states that they can be used to support any decision made by regulators.

Schneider said: “Our priority is to make effective vaccines available to the public in the shortest possible time without compromising safety. If you need to change to a licensed Covid-19 vaccine, this regulatory approach is exactly what you need. It should help you do that.

“The general public must be confident that a vaccine will not be approved unless the expected high safety, quality and efficacy standards are met.”

Meanwhile, research shows that the rate of decline in Covid-19 infections in the UK has slowed, with data showing that the rate has peaked in some parts of the country, while increasing in some areas. It is suggested that

A study by Imperial College London React found that 1 in 213 people still tested positive for Covid-19.

Researchers warned that infection rates should be as low as possible to maximize the likelihood that vaccination programs will work.

The study also suggested that some occupations, including teachers and transport workers, had higher infection rates than others during the national blockade.

According to the latest government data up to March 2, the UK has received 20,703,615 initial vaccinations so far.