LONDON – The announcement this week that the AstraZeneca shot, the workhorse of the global vaccine vaccine, has achieved nearly 80 percent effectiveness in a US standard gold test has been highlighted by the many countries that rely on it.
‘If you get a call, get a slap’, British Health Secretary Matt Hancock urged as part of a campaign by European lawmakers to calm people’s nerves following a recent scare for safety.
But by Tuesday, the campaign, at least for the moment, had been thrown off course again. For AstraZeneca, it was apparently another delivery of PR whiplash, part of a series of recent crimes and communication errors by the company that scientists say are trying to sell people on one of the most powerful and indispensable coronavirus vaccines.
In a very unusual move, U.S. health officials said Tuesday that the company’s version of the U.S. trial findings was not entirely accurate, suggesting that AstraZeneca used only the most favorable data to deliver seemingly spectacular efficacy results.
These comments have created new friction between AstraZeneca and US officials, even as the company seeks a coveted authorization from the Food and Drug Administration. But more urgently, they have thrown a wrench into the efforts of elected leaders around the world to rebuild confidence in a shot, whose low price and easy storage requirements have made it the backbone of many countries’ campaigns to end the pandemic. .
“It weakens self-confidence,” said Simon Clarke, associate professor of cellular microbiology at the University of Reading. “If you inflate things and people do not unreasonably question them, then it weakens confidence.”
Belief in the vaccine has already plunged across Europe after recent reports that a very small number of recipients had unusual blood clots.
In France, Germany, Italy and Spain, more people believe that the vaccine is unsafe than it is safe, showed mooda blow that is the best hope is to save people’s lives during an increasing surge of new infections. Millions of doses are sitting unused in refrigerators across the continent, and doctors report that some people cancel injections for fear of side effects.
Despite the drumming of worrying news reports about the vaccine, European and global regulators have considered it safe and effective. More than 11 million doses have been administered in Britain alone, almost all without serious side effects, which has put hospitalizations under pressure and helped the country recover from a terrible winter infection.
Nevertheless, there is strong expectation about AstraZeneca’s US trial. It was expected to be the largest of its kind for the shot, and to provide the cleanest and most complete picture of the effectiveness of the vaccine. U.S. officials see it as an indisputable test of the vaccine’s action.
And health officials around the world saw it as an important guide for their own implementation: it would provide important data on older people, who had not been so well represented in previous trials, and a more careful reading of the overall effectiveness of the vaccine, which from earlier trials seemed to be lower than that of other front shots.
Once AstraZeneca announced its results on Monday, saying the vaccine was 79 percent effective in preventing symptomatic Covid-19, lawmakers began citing it as part of their young efforts to increase public confidence in the vaccine.
According to scientists, by Tuesday it looked as if AstraZeneca had hit a hole in the efforts. Instead of pursuing questions about the shot, it made the communication problems that plagued the company since last year come to mind, slowing down the regulatory process in some regions and causing hesitation among some recipients.
So far, only 55 percent of the AstraZeneca doses delivered to the European Union have been placed in the arms of people, according to the group’s figures, which are significantly lower than the use rate for other vaccinations. About seven million doses are still sitting in refrigerators.
While some countries have administered more than 70 percent of their doses, others are struggling to get it off the shelves: Germany and France have given about half of their stock AstraZeneca, and Luxembourg has administered only a third.
Scientists have said that such a public fabrication between the US medical experts who oversee a trial and the company that sponsors it is extremely unusual.
“It’s usually done privately,” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, about any differences of opinion. “I think it’s unprecedented.”
In its first public comment, AstraZeneca said the results published Monday reflect its U.S. trial data through Feb. 17. It is said that its preliminary assessment of more complete trial data shows that ‘the results were consistent with the interim analysis’, but said that within 48 hours it will share more topical efficacy results.
Scientists have said that the problem may be another technical issue that does not change the assessment of the vaccine. U.S. officials have not suggested any security issues be withheld, a topic of intense interest following concerns in Europe.
Nevertheless, it quickly took the wind out of the sails of the public campaign of European legislators to restore confidence in the lap, which was developed with the University of Oxford. Over the past few days, a number of political leaders, including Britain’s Prime Minister Boris Johnson and France’s Prime Minister Jean Castex, have received the vaccine themselves in an attempt to show people that it is safe.
“I literally felt nothing,” he said. Johnson told reporters. “I can not recommend it too highly.”
The stumbling block on Tuesday was the latest in a series of crimes that have sparked a thorny relationship between AstraZeneca and US and European regulators – and according to scientists, it has created unnecessary public confusion over a vaccine that appears to be very effective.
In early September, the company quietly halted its global trials after a participant in Britain fell ill. But U.S. regulators did not find out until the story broke in public. Subsequently, the company’s reluctance to provide the FDA with evidence that the vaccine was not linked to disease, grounded it for nearly seven weeks. AstraZeneca said it shared data on time.
By the end of November, the company had become high again: the results of early clinical trials, including in Britain, revealed that the vaccine was 62 percent or 90 percent effective, depending on the way the doses were given.
But also the results were quickly clouded by uncertainty. AstraZeneca later admitted that there was initial confusion about the dose of vaccine received by some study participants, making it more difficult to interpret the findings.
Great Britain, which has long advocated home-made vaccination, approved the shot at the end of December. The European Union’s medical regulator did the same, but a month later.
EU officials said the delay was partly due to back-and-forth between regulators and AstraZeneca over the quality of the data.
And even after the vaccine was approved, a number of European countries initially restricted it to younger people, citing a lack of adequate information on its effectiveness in older people. The problem was supposed to be solved by the American trial, in which older people were better represented.
Neither European nor British regulators indicated on Tuesday that the problems with AstraZeneca’s US data would have any impact on implementation there. The agencies relied on a separate 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 EMA will assess the relevant data as soon as the company submits it to us.”
Matina Stevis-Gridneff reported from Brussels.