Britain overtakes leapheads in approving vaccines

LONDON – Britain asked its drug regulator on Friday to consider AstraZeneca’s coronovirus vaccine for emergency approval, to face considerable uncertainty about the vaccine’s effectiveness as the government takes the lives of more than 66,000 people in the country She is trying.

The request was one of a series of steps that Britain placed before the pack of hurrying countries to assess the candidates for the coronovirus vaccine. of the country Drug regulator said on Monday The aim was to decide on emergency approval for the vaccine made by American pharmaceutical giant Pfizer and Bioentech, a German company, “in the shortest possible time.” Presumably this will be put ahead of US regulators, who plan to not make the ruling on 10 December.

In Letter last week, British health officials told hospital officials to “be ready to start vaccination from early December”. Hospital officials have already begun holding vaccine information sessions with staff members and are asking for data to help them ensure that the Pfizer vaccine – clear front- runner for approval – is safe.

And Cambridge University Hospitals told staff members that it would start “outlining the plan for booking appointments, according to an internal email, using the Pfizer vaccine from next week”.

Holding the key to the UK vaccination deadline is its regulator, the Medicines and Healthcare Products Regulatory Agency, which has long played a leading role in drug evaluation for the European Union and is now playing a more independent role Because Britain is separated from the block.

“They are very fast in a good time, quite honestly,” Dr. Penny Ward, a professor in pharmaceutical medicine at King’s College London, said of the agency. “And in this situation they are really gearing up to do this as soon as possible.”

Nevertheless, the work of evaluating AstraZeneca’s vaccine for emergency use would put the agency amid a string of tough questions.

The vaccine was developed by the University of Oxford, making it the UK’s leading homegrown vaccine and the government’s leading symbol during a scientific epidemic that has overcome many of the nation’s weaknesses. (Prime Minister’s office revealed to print Union Jack flag on vaccine injection kits) HuffPost UK reported this on Friday.)

But since then, AstraZeneca has A significant dosage error was accepted. Study participants whose vaccine was 90 percent effective were mistakenly given half the dose of the vaccine, followed by a full dose one month later. Among those receiving two full doses, effectiveness dropped to 62 percent.

And those who received smaller doses were 55 years of age or younger, making it difficult to know if the more promising results would occur among older people, particularly those prone to Kovid-19.

This has eroded the confidence of some scientists and has led to uncertainty as to whether additional testing would apparently produce excellent results. The company itself was unable to explain why the two-dose regimen performed differently – a question that some scientists said needed to be answered before the vaccine was widely distributed.

“I can understand why they have taken it forward; It still works, ”Stuart Neill, a professor of virology at King’s College London, said of the British regulators. “But we still don’t know if it works adequately.”

In the United States, which has ordered at least 300 million doses of AstraZeneca vaccine, the regulatory process is at a standstill. The company said it would seek guidance from the Food and Drug Administration should it formally submit its findings to apply for emergency authorization.

But Britain, which has ordered 100 million doses of the vaccine, is moving up the regulatory path more quickly.

This reflects close observation of AstraZeneca’s trials in Britain to its drug regulators. After Oxford scientists discovered a dosing error months ago, the UK’s drug agency gave them the green light to continue, the university has said.

Dr. Ward said American and British regulators also review their vaccines differently. US regulators ask vaccine manufacturers for the raw data, which the FDA regulates to validate the company’s results. Dr. Ward said that regulators anywhere in the UK and Europe rely more on companies’ own reports, although they are right to verify their accuracy.

Everyday hundreds of people are dying of coronovirus in UK and country hospitals, Dr. Ward said that any vaccine at the level of AstraZeneca deserves strong consideration. It is inexpensive – only a few dollars per dose – and easy to mass-produce. Unlike vaccines made by Pfizer and another American company, Modern, AstraZeneca, can be stored for months in a normal refrigerator.

And using a viral vector to provoke an immune response to coronovirus, the AstraZeneca vaccine relies on a technique with a longer track record than Pfizer and Modern, both using a technique Relying on sending genetic instructions Through a molecule called “messenger RNA”.

“Dr. Vaccine said,” A vaccine is very useful to reduce the burden of disease, especially to be useful in more severe disease, and to reduce pressure on a back-up health system. ” , Does not require very high effectiveness. “While seasonal flu vaccines are useful, their effectiveness varies widely.

Now that Britain has decided to leave the European Union, the regulatory agency of the block is no longer dependent on Britain to assess new drugs and vaccines, as it has done for many years. But analysts said Britain’s drug regulator remained a bellwester, making its rulers influential in Europe and elsewhere.

For the UK, the decisions are significant as the government bets by pre-ordering a total of 355 million doses of seven different vaccine candidates from one of the world’s most ambitious destinations.

“It’s like a series of weapons in your arsenal,” said Gino Martini, chief scientist at the Royal Pharmaceutical Society.

It is unclear whether the British regulator will decide on either Pfizer or AstraZeneca vaccines. (The government has not formally requested an emergency assessment, with the possibility of it being modernly available in the UK at least until spring.) The agency said on Friday it would “rigorously evaluate the latest data” and Said that “the protection of the public.” Always come first. “

And temporary approval of any vaccines in Britain will not limit their availability in the United States or other wealthy countries that have also ordered several millions of doses.

But scientists have insisted that public confidence in the coronovirus vaccine requires that British regulators question all candidates, and particularly AstraZeneca, well before granting temporary approval.

“I’m sure they are feeling pressured like everyone else that if there is a chance to make a change, they need to make a decision as soon as possible,” Professor Neil said. “But the problem is that there is a lot of financial competition, and who is getting the best vaccine is thrashing about. And the error in dodging raises strange questions, which need to be thoroughly investigated. “

David Kirkpatrick contributed reporting from New York.

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