AstraZeneca’s Latest Stumble Again Clouds European Vaccinations

LONDON – AstraZeneca announced this week, Workhorse had achieved nearly 80 percent efficacy in the global vaccine rollout A Gold-Standard American Trial This was met with relief by many countries that relied on it.

The British Health Secretary, Matt Hancock, recently told the British Health Secretary, Matt Hancock, part of a campaign to calm people’s nerves after scaring them with a safety shot, “When you get the call, do the job.”

But by Tuesday, that campaign was called off once again, at least for the time being. For AstraZeneca, it appears that this was another episode of public relations, part of a series of recent crooks and communication blunders by the company that scientists said sold one of the most powerful and unavoidable vaccines against coronoviruses Was attempted

In a very unusual move, US health officials said on Tuesday that the company’s US test findings were accounted for. Not entirely right, Suggesting that AstraZeneca used only the most favorable data to produce clearly spectacular efficacy results.

Those comments caused new friction between AstraZeneca and US officials as the company dies to a reputable authority from the Food and Drug Administration. But more tentatively, he threw a gulf in the efforts of elected leaders around the world to rebuild confidence in one shot, whose low prices and easy storage requirements made it the backbone of many countries’ campaigns to end the epidemic. Have given.

“It’s eroding confidence,” said Simon Clarke, associate professor in cellular microbiology at Reading University. “When you pump things up, and then people don’t question it improperly, it erodes trust.”

Confidence in the vaccine was drowned across Europe after a very small number of recent report recipients Abnormal blood clots develop.

In France, Germany, Italy and Spain, more people now believe that the vaccine is unsafe than that safe, Turnout, A flick for a shot that remains the continent’s best hope for saving people’s lives in the meantime Increasing sequence of new infections. Millions of doses are sitting unused in refrigerators across the continent, with doctors reporting few Cancellation of injection Fear about side effects.

Despite the intoxicating news about the vaccine, European and global regulators consider it safe and effective. More than 11 million doses have been administered in the UK alone, almost all of them without serious side effects, Hospitalization And Help the country to emerge From the terrible winter wave of infection.

Nevertheless, the American trial of AstraZeneca was hotly anticipated. The largest of its kind for the shot, it was expected to provide the clearest, most complete picture of the vaccine’s efficacy. US officials saw this as an unsymmetrical test of the vaccine’s performance.

And health officials around the world were seeing this as an important guide to their own rollout: it would supply important data on older people, which were not even represented in earlier trials, and the overall efficacy of the vaccine A more accurate reading was made, which was lower than other key shots from earlier tests.

As AstraZeneca announced its results on Monday, stating that the vaccine had 79 percent efficacy in stopping the symptomatic Kovid-19, lawmakers cited it as part of their runaway efforts to arouse public confidence in the vaccine.

By Tuesday, scientists said, it seemed as if AstraZeneca had pierced those efforts. Instead of stitching questions about the shot, it came to mind Communication problems that have scared the company Since last year, there has been delays in the regulatory process in some areas and hesitation among some recipients.

So far, only 55 percent of AstraZeneca dose has been given to the European Union, put in people’s arms, According to the block’s data, Is lower than the rate of use for other vaccines. Some seven million doses are still sitting in the refrigerator.

While some countries have administered more than 70 percent of their doses, others are struggling to get them off the shelves: Germany and France have supplied nearly half of AstraZeneca’s supply, and Luxembourg administered only a third. is.

Scientists said such a public dustbin is overseeing a test among American medical experts and the company sponsoring it was highly unusual.

“It’s usually done privately,” said Stephen Evans, a professor of pharmacopaediology at the London School of Hygiene and Tropical Medicine, about disagreements between a data and safety monitoring board – expert testing and overseeing a vaccine manufacturer We do. “So this is unprecedented, in my opinion.”

In its first public comment, AstraZeneca said the results published on Monday reflected its US trial data as of 17 February. It said preliminary evaluation of more complete test data showed that “the results were consistent with interim analysis,” but said it would share greater efficacy results within 48 hours.

Scientists said that the problem may yet become a technical matter that did not change their assessment of the vaccine. US officials did not suggest that any security issues were averted, a subject of intense interest in the wake of concerns in Europe.

Nevertheless, it fired off the sail of the European MPs’ public campaign to restore confidence in the shot. In recent times, several political leaders, including Britain’s Prime Minister Boris Johnson and France’s Prime Minister Jean Castex, have received the vaccine in a bid to show people that it was safe.

“I really didn’t feel a thing,” Mr. Johnson told reporters. “I cannot recommend it highly enough.”

The offense on Tuesday was the latest in a series of rogues created for the thorny relationship between AstraZeneca and US and European regulators – and, scientists said, made redundant Public confusion about a vaccine This appears to be highly effective.

In early September, the company quietly halted its global trials after a participant fell ill in the UK. But American regulators were not revealed until the story broke in public. Subsequently, it was grounded for about seven weeks to provide evidence to the FDA that the company’s lethargy was not associated with any disease. AstraZeneca has stated that it shares data in a time bound manner.

By the end of November, the company was riding high again: it released results from initial clinical trials in the UK that showed the vaccine was up to 90 percent effective.

But those results, too, were quickly clouded by uncertainty. AstraZeneca later admitted that there was confusion over the vaccine dose initially received by some study participants, making it more difficult to interpret the findings.

Britain, which has long vaccinated domestic vaccines, Shot in the end of December.The first is dependent on the results of the clinical trial. EU drug regulator did the same, But a month later.

European Union officials said the delay in data quality occurred partly between regulators and AstraZeneca.

And even after the vaccine was authorized, many European countries had initially restricted it to younger people, citing a lack of sufficient data about its efficacy in older people. That problem had to be solved by the American trial, which had a better representation of older people.

Neither European nor British regulators gave any indication on Tuesday that problems with AstraZeneca’s US data would have any effect on the rollout there. Those agencies relied on a different set of data from non-US trials to authorize the vaccine.

“We are in touch with the company regarding this further information,” the European Medicines Agency said in a statement on Tuesday, and the EMA will assess related data.

Matina Stevis-Gridneff contributed reporting from Brussels.

Source link

Leave a Comment