LONDON (AP) – AstraZeneca’s repeated missteps in reporting vaccine data coupled with a blood clot could permanently damage the credibility of an injection that is at the heart of the global strategy to stop the coronavirus pandemic, and possibly even the confidence of the vaccine wider undermines, experts say.
The final stumbling block to the vaccine came on Tuesday, when US officials issued an unusual statement expressing concern that AstraZeneca had included “outdated information” when it reported encouraging results from a US trial the day before. This may have provided “an incomplete picture of the efficacy data”, according to the statement.
AstraZeneca replied that the results showed that the shot was about 79% effective, including information through February 17, but appeared to be consistent with more current data. It 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, a professor of medicine at the University of East Anglia. “But this will likely lead to more hesitation about the vaccine.”
Even if the damage is limited to AstraZeneca itself, it would have far-reaching consequences as the shot is cheaper and easier to store than many of its rivals and is therefore expected to be widely used in the developing world. International health authorities have repeatedly said the vaccine is safe and effective, but it’s not the first time the company has had issues with public confidence.
Partial results of the first major trial – which Britain used to approve the vaccine – were clouded by a manufacturing flaw that researchers did not immediately recognize. Insufficient data on how well the vaccine protected older people prompted some countries to initially restrict its use to younger populations before changing course. US officials suspended an AstraZeneca investigation for an unusual six weeks as they sought details of issues reported in Britain before deciding the vaccine was not to blame. Meanwhile, the European Union is complaining about delays in the company’s delivery of vaccines.
Last week, more than a dozen countries temporarily stopped using 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 blood clots, but the unwanted attention seems to have left a mark.
In Norway, a top official warned on Monday that it might not be able to resume because so many people turned it down.
“People are clearly saying they don’t want the AstraZeneca vaccine,” Marte Kvittum Tangen, who heads a Norwegian doctors’ association, told NRK broadcaster.
Last week, vaccination coordinator Valeriu Gheorghita in Bucharest, Romania, said 33,000 AstraZeneca vaccination appointments were canceled within 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 where people could get the AstraZeneca vaccine was largely abandoned on Monday.
“Unfortunately, this is more about perception than science,” said Dr. Bharat Pankhania, an infectious disease specialist at the British University of Exeter.
“We have now seen on several parameters that the AstraZeneca vaccine provides protection and is safe,” he said. “But the story to the public was not that clear.”
France is a textbook example of the confusion.
French President Emmanuel Macron initially suggested the vaccine was ineffective for older people before he pulled out. Yet France has only approved the AstraZeneca vaccine for use in adults aged 65 and under, citing a lack of data. Then the government changed its mind, based on new data, saying it’s fine for all adults. But when there were reports of rare blood clots in some vaccine recipients, the government suspended all use of the injection. When France restarted AstraZeneca, recording was banned for anyone under 55.
The whiplash-inducing reports come at a time when France – like much of continental Europe – is struggling to speed up its vaccination program, while also facing a spike in cases nearly overwhelming its hospitals and threatening new lockdowns.
During a European Parliament committee on Tuesday in Brussels, Sandra Gallina, head of the European Commission’s Health Directorate, described the situation with AstraZeneca as “a disgrace”. She said struggling vaccination campaigns across Europe “were made much more difficult by AstraZeneca’s poor performance.”
The company has due to production delays in deliveries.
Even if the medicine man resolves the last 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 cautionary tale.
“There was absolutely no evidence to prove that the vaccine (measles, mumps and rubella) caused autism,” he said. But despite retracting the paper making that claim, Tang said some people still have concerns about the vaccine.
The lukewarm support for the AstraZeneca vaccine in Europe is in stark contrast to governments in developing countries desperate for supplies.
Dr. Bruce Aylward, a senior advisor to the World Health Organization, said the UN agency has a long list of countries that are “very keen” to get the chance to take a photo as soon as possible. “We just can’t get enough,” he said.
But some experts fear that skepticism in Europe could eventually throw a veil about the vaccine worldwide. They proposed a measure that could reassure a nervous public: green light from the U.S. Food and Drug Administration.
“If the US regulator looks at 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 would submit its data to the FDA within weeks.
It is still possible that the vaccine can dispel the doubts. At a vaccination center in Lisbon, 68-year-old Rui Manuel Martins dismissed concerns, saying that millions of people had been vaccinated with very few ill effects.
“There are always cases where people reject drugs,” he said before getting his first dose. “Better to get vaccinated than not.”
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.
This story has been updated to correct that France has now banned AstraZeneca for anyone under 55.