Mistakes can damage the long-term credibility of the AstraZeneca injection

LONDON (AP) – AstraZeneca’s repeated errors in reporting vaccine data, together with the blood clot scare, can cause lasting damage to the credibility of an injection that is the basis of the global strategy to stop the coronavirus pandemic, potentially even undermining the vaccine’s confidence more broadly, Experts say.

The last stumbling block for the vaccine came Tuesday, when US officials issued an unusual statement expressing concern that AstraZeneca included “outdated information” when it reported encouraging results of a test in the United States the day before. This may have provided “an incomplete view of the effectiveness data,” according to the statement.

AstraZeneca replied that the results, which showed that his shot was about 79% effective, included information as of 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 the American authorities) to deliberately undermine confidence in the AstraZeneca vaccine,” said Dr. Paul Hunter, professor of medicine at the University of East Anglia. “But this is likely to cause more hesitation to the vaccine.”

Even if the damage is limited to AstraZeneca itself, it would have far-reaching effects, since the shot is cheaper and easier to store than many of its rivals and, therefore, should be used widely in the developing world. International health agencies have repeatedly stated that the vaccine is safe and effective, but it is not the first time that the company has faced public confidence problems.

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

Then, in the past week, more than a dozen countries have temporarily suspended the use of the AstraZeneca injection after 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 on Monday that he may not be able to resume using the vaccine because many people are rejecting it.

“People clearly say that they do not want the AstraZeneca vaccine,” said Mars Kvittum Tangen, who runs a Norwegian medical association, to the broadcaster NRK.

Last week in Bucharest, Romania, vaccination coordinator Valeriu Gheorghita said that 33,000 vaccination appointments with AstraZeneca were canceled within 24 hours and that about a third of the 10,000 people scheduled to receive the vaccine did not attend. In Belgrade, Serbia, a large exhibition center set up for people to get the AstraZeneca vaccine was almost deserted on Monday.

“Unfortunately, this has more to do with perception than with science,” said Bharat Pankhania, an infectious disease specialist at the University of Exeter in Britain.

“We have now seen, on several parameters, that the AstraZeneca vaccine offers protection and is safe,” he said. “But the narrative for the audience was not so clear.”

France is an excellent example of the confusion.

French President Emmanuel Macron initially suggested that the vaccine was not effective for older people, before turning back. Still, France only authorized the AstraZeneca vaccine for use in adults 65 and under, citing the lack of data. Then the government changed its mind, based on new data, and said it was okay for all adults. But when there were reports of rare blood clots in some vaccine containers, the government stopped using the vaccine altogether. When France restarted AstraZeneca, it prohibited shooting for anyone under 55.

The whip-causing messages come at a time when France – like much of continental Europe – is struggling to accelerate its vaccination campaign, while facing an increase in cases that are almost overwhelming its hospitals and generating threats of new blocks.

In a committee of the European Parliament on Tuesday in Brussels, Sandra Gallina, head of the European Commission’s health directory, described the situation with AstraZeneca as “a shame”. She said that difficult vaccination campaigns across Europe were “hampered by AstraZeneca’s poor performance”.

The company attributes delays in deliveries to production problems.

Even if the drugmaker clears up the latest misunderstanding, it can have a lasting impact.

Julian Tang, a virologist at the University of Leicester, pointed to the decades-old controversy over the measles vaccine as a wake-up call.

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

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

Dr. Bruce Aylward, a senior adviser to the World Health Organization, said the UN agency has a long list of countries “very interested” in getting the injection as soon as possible. “We just don’t get tired of it,” he said.

But some experts fear that skepticism in Europe could eventually launch a cloud about the vaccine worldwide. They suggested a measure that could reassure a nervous public: a green light from the US Food and Drug Administration.

“If the US regulator examines this data and authorizes AstraZeneca, it 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 will send its data to the FDA within weeks.

It is still possible for the vaccine to separate doubts. At a vaccination center in Lisbon, Rui Manuel Martins, 68, dismissed the concerns, saying that millions were immunized with very few harmful 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”.

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Associated Press writers 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.

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This story has been updated to correct that France has banned AstraZeneca for children under 55.

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