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LONDON – Britain on Friday asked its drug regulator to consider AstraZeneca’s coronavirus vaccine for emergency approval, moving forward amid considerable uncertainty about the vaccine’s effectiveness as the government tries to corner a pandemic that has killed more. than 66,000 people in the country.
The application was one of a series of steps Britain has taken to lead the group of countries rushing to screen candidates for coronavirus vaccines. The country’s drug regulator said on Monday that it intended to decide on an emergency approval for a vaccine made by US pharmaceutical giant Pfizer and a German company, BioNTech, “in the shortest possible time.” That would potentially put him ahead of US regulators, who plan to issue a ruling no earlier than Dec. 10.
In a letter last week, British health officials told hospital executives to be “ready to start vaccinating in early December.” Hospital executives have already started holding vaccine information sessions with staff members, asking for data to help them reassure them that the Pfizer vaccine – the seeming favorite for approval – is safe.
And Cambridge University Hospitals told staff members that they would begin vaccinating them “starting next week with the Pfizer vaccine,” according to an internal email, outlining a plan to book appointments.
The regulatory body, the Medicines and Healthcare Products Regulatory Agency, holds the keys to Britain’s vaccination schedule, which has long played a leading role in evaluating medicines for the European Union and is now taking on a further role. independent as Britain separates from the bloc.
“They’re pretty fast at best, honestly,” Dr. Penny Ward, visiting professor of pharmaceutical medicine at King’s College London, said of the agency. “And in this situation, they have really been preparing to do this as quickly as possible.”
Still, the job of evaluating AstraZeneca’s vaccine for emergency use will put the agency in the middle of a tangle of tough questions.
The vaccine was developed by the University of Oxford, making it Britain’s leading local vaccine and the government’s most important symbol of its scientific prowess during a pandemic that has exposed many of the country’s weaknesses. (The prime minister’s office went so far as to explore printing the Union Jack flag on vaccine injection kits, HuffPost UK reported Friday.)
But since then, AstraZeneca has recognized a key dosing error. Study participants in whom the vaccine was 90 percent effective had mistakenly received a half dose of the vaccine, followed a month later by a full dose. Among those who received two full doses, efficacy dropped to 62 percent.
And the people who received the smallest dosing regimen were 55 or younger, making it difficult to know whether the most promising results would hold up among older people, who are especially vulnerable to Covid-19.
That has eroded the confidence of some scientists and created uncertainty about whether further tests would confirm the seemingly spectacular results. The company itself could not explain why the two dosage regimens behaved so differently, a question that some scientists said needed an answer before a wide distribution of the vaccine.
“I can understand why they have carried it forward; it still works, ”Stuart Neil, a professor of virology at King’s College London, said of the British regulators. “But we still have no idea if it works well enough.”
In the United States, which ordered at least 300 million doses of the AstraZeneca vaccine, the regulatory process is stalled. The company said it will seek guidance from the Food and Drug Administration on whether it should formally submit its findings to request an emergency authorization.
But Britain, which has ordered 100 million doses of the vaccine, is accelerating the regulatory path much faster.
That reflects their drug regulators’ close observation of the AstraZeneca trials in Britain. After Oxford scientists discovered the dosing error months ago, Britain’s drug agency gave them the green light to continue, the university said.
US and British regulators also conduct their vaccine reviews differently, Dr. Ward said. US regulators are asking vaccine manufacturers for raw data, which the FDA re-analyzes to validate the company’s results. Regulators in Britain and elsewhere in Europe rely more on reports from the companies themselves, Dr. Ward said, although they reserve the right to verify their accuracy.
With hundreds of people still dying from the coronavirus each day in Britain and the country’s hospitals under enormous stress, Dr. Ward said any vaccine as effective as AstraZeneca deserved special consideration. It’s inexpensive, just a few dollars per dose, and easy to mass-produce. Unlike the vaccines made by Pfizer and another American company, Moderna, AstraZeneca can be stored for months in normal refrigerators.
And by using a viral vector to elicit an immune response to the coronavirus, the AstraZeneca vaccine is based on a technique with a longer track record than Pfizer and Moderna, which use technology that relies on sending genetic instructions through a molecule known as a “messenger.” RNA “.
“A vaccine doesn’t need very, very, very high effectiveness to be helpful in reducing the burden of disease, particularly the most serious diseases, and to relieve pressure on a supported healthcare system,” said Dr. Ward, noting that seasonal flu vaccines are useful even though their effectiveness varies widely.
Now that Britain has decided to leave the European Union, the bloc’s regulatory agency is no longer dependent on Britain to take the lead in evaluating new drugs and vaccines, as it did for many years. But analysts said Britain’s drug regulator remains a benchmark, making its rulings influential in Europe and elsewhere.
For Britain, the decisions are crucial in part because the government has hedged its bets by pre-ordering a total of 355 million doses of seven different vaccine candidates, among the most ambitious launches in the world.
“It’s like having a wide variety of weapons in your arsenal,” said Gino Martini, chief scientist at the Royal Pharmaceutical Society.
It is unclear when British regulators will decide on the Pfizer or AstraZeneca vaccine. (Since Moderna’s vaccine is unlikely to be available in Britain until at least the spring, the government has not formally requested an emergency evaluation.) The agency said Friday that it would “rigorously evaluate the latest data” and that “the safety of the public will always come first.”
And the temporary approval of any vaccine in Britain will not limit its availability in the United States or other wealthy countries that have also ordered many millions of doses.
But scientists have emphasized that it is essential to the public’s faith in coronavirus vaccines that British regulators thoroughly examine questions about all candidates, and especially AstraZeneca, before granting temporary approval.
“I’m sure they feel the pressure like everyone else that if there is a possibility that this will make a difference, then they should make a decision as soon as they can,” said Professor Neil. “But the problem is that he is getting entangled in a lot of financial competition and chest blows over who has the best vaccine. And the dosing error raises uncomfortable questions that need to be thoroughly investigated. “
David Kirkpatrick contributed reporting from New York.
