Missteps could spoil the long-term credibility of the AstraZeneca shot


LONDON (AP) – AstraZeneca’s repeated mistakes in reporting vaccine data, coupled with a fear of a blood clot, could cause lasting damage to the credibility of a vaccine that is at the center of the global strategy to stop the pandemic of coronavirus, which could even undermine confidence in the vaccine overall, experts say.

The latest vaccine stumble came on Tuesday, when US officials issued an unusual statement expressing concern. that AstraZeneca had included “outdated information” when it reported encouraging results from a trial in the United States the day before. That may have provided “an incomplete view of the efficacy data,” according to the statement.

AstraZeneca responded that the results, which showed that their shot was approximately 79% effective., included information up to February 17, but appeared to be consistent with more up-to-date data. He promised an update within 48 hours.

“I doubt it was the intention (of US officials) to deliberately undermine confidence in the AstraZeneca vaccine,” said Dr. Paul Hunter, professor of medicine at the University of East Anglia. “But this will probably raise more questions about vaccines.”

Even if the damage is limited to the AstraZeneca itself, it would have far-reaching effects, as the injection is cheaper and easier to store than many of its rivals and is therefore expected to be widely used around the world. Developing. International health agencies have repeatedly said the vaccine is safe and effective, but this is not the first time the company has struggled with public trust.

The partial results of its first major trial, which Britain used to license the vaccine, were marred by a manufacturing error that the researchers did not immediately recognize. Insufficient data on how well the vaccine protected older people led some countries to initially restrict its use to younger populations before reversing course. US officials suspended an AstraZeneca study for an unusual six weeks while they sought details about reported problems in Britain before deciding that the vaccine was not the culprit. Meanwhile, the European Union has complained about delays in the company’s vaccine deliveries.

Then last week, more than a dozen countries temporarily stopped the use of the AstraZeneca injection following reports of rare blood clots in some people who received it. The European Medicines Agency concluded that the injection did not increase the overall incidence of clots.But the unwanted attention seems to have left a mark.

In Norway, a senior official warned Monday that he may not be able to resume using the vaccine because so many people reject it.

“People clearly say they don’t want the AstraZeneca vaccine,” Kvittum Tangen, who runs an association of Norwegian doctors, told NRK Marte broadcaster.

Last week in Bucharest, Romania, vaccination coordinator Valeriu Gheorghita said 33,000 AstraZeneca immunization appointments were canceled in 24 hours and that about a third of the 10,000 people scheduled to receive the vaccine did not show up. In Belgrade, Serbia, a sprawling exhibition center created for people to receive the AstraZeneca vaccine was virtually deserted on Monday.

“Unfortunately, it’s more about perception than science,” said Dr Bharat Pankhania, an infectious disease specialist at Britain’s University of Exeter.

“We have now seen, on various parameters, that the AstraZeneca vaccine provides protection and is safe,” he said. “But the narrative for the public has not been that clear.”

France is an excellent example of confusion.

French President Emmanuel Macron initially suggested that the vaccine was ineffective for older people, before backtracking. Still, France only licensed the AstraZeneca vaccine for use in adults 65 and younger, citing a lack of data. Then the government changed its mind, based on new data, and said it’s okay for all adults. But when there were reports of rare blood clots in some vaccine recipients, the government discontinued use of the injection entirely. When France restarted AstraZeneca, it banned shooting for anyone under the age of 55.

The whiplash-triggering messages come at a time when France, like much of continental Europe, is struggling to accelerate its vaccination campaign, while at the same time facing a surge in cases that is close to overwhelming its hospitals. and generate threats of new closures.

At a European Parliament committee on Tuesday in Brussels, Sandra Gallina, director of the European Commission’s health directorate, described the situation with AstraZeneca as “a disgrace”. He said that fighting vaccination campaigns across Europe were “made much more difficult by the poor performance of AstraZeneca.”

The company has attributed the delays in its deliveries to production problems.

Even if the druggist clears up the latest misunderstanding, it could have a lasting impact.

Julian Tang, a virologist at the University of Leicester, pointed to the decades-long controversy over the measles vaccine as a warning.

“There was absolutely no evidence to prove that the vaccine (against measles, mumps and rubella) caused autism,” he said. But despite the retraction of the document that made that claim, Tang said some people still worry about the vaccine.

The tepid support for the AstraZeneca vaccine in Europe contrasts with governments in the developing world that are desperate for supplies.

Dr. Bruce Aylward, senior adviser to the World Health Organization, said the UN agency has a long list of countries “very interested” in receiving the vaccine as soon as possible. “We just can’t get enough,” he said.

But some experts have worried that skepticism in Europe could eventually tarnish about the vaccine around the world. They suggested a measure that could reassure a nervous public: a green light from the US Food and Drug Administration.

“If the US regulator looks at this data and authorizes AstraZeneca, that will carry a lot of weight,” said Jimmy Whitworth, professor of international public health at the London School of Hygiene and Tropical Medicine.

AstraZeneca said it would submit its data to the FDA in a few weeks.

It is still possible that the vaccine could bury the doubts. At a vaccination center in Lisbon, Rui Manuel Martins, 68, dismissed the concerns, saying that millions had been immunized with very few ill effects.

“There are always some cases of people rejecting any medication,” he said before receiving his first dose. “It is better to be vaccinated than not vaccinated.”

__

Associated Press journalists Jan M. Olsen in Copenhagen, Angela Charlton in Paris, Stephen McGrath in Bucharest, Romania, Jamey Keaten in Geneva, Dusan Stojanovic in Belgrade, Serbia, Helena Alves in Lisbon, Samuel Petrequin and Raf Casert in Brussels and Lauran Neergaard in Washington contributed to this report.

___

This story has been updated to correct that France has now banned AstraZeneca for anyone under the age of 55.

.

Source link