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It’s been declared safe and effective. But missteps dog AstraZeneca’s COVID vaccine

Syringes and vial of AstraZeneca's COVID-19 vaccine
Syringes and vial of AstraZeneca’s COVID-19 vaccine at a clinic in Luton, England.
(Alberto Pezzali / Associated Press)

AstraZeneca’s release of encouraging data Monday about its COVID-19 vaccine from its U.S. trial raised hopes that the drug company could bury doubts about the shot and put a troubled rollout behind it. But hours later, U.S. officials issued an unusual statement expressing concern that the company had included “outdated information” from its study and that it may have provided “an incomplete view of the efficacy data.”

Even before this latest stumble, which AstraZeneca said Tuesday it was “looking into,” the company had made missteps in reporting data and faced a blood-clot scare over its COVID-19 shot. Health officials worried that those issues could cause lasting harm to the reputation of the vaccine, which was developed in conjunction with Oxford University and has been regarded as key to global efforts to stop the pandemic.

“I doubt it was [U.S. officials’] intention to deliberately undermine trust in the AstraZeneca vaccine,” said Dr. Paul Hunter, a professor of medicine at the University of East Anglia in England. “But this will likely cause more vaccine hesitancy.”

Hunter emphasized that it was unclear how significant this latest issue might be. But it’s not the first time the company has run into problems.

Partial results from the vaccine’s first major trial — which Britain used to authorize the vaccine in December — were clouded by a manufacturing mistake that the researchers didn’t immediately acknowledge. Insufficient data about how well the vaccine protected older people also led some countries, including Germany and France, to initially restrict its use to younger populations.

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In the U.S., officials suspended AstraZeneca’s study in 30,000 Americans for an unusual six weeks last fall, as frustrated regulators sought details about neurological problems reported in Britain. In the end, there was no evidence that the vaccine was to blame for those problems.

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On Monday, the company announced that the shot was 79% effective in stopping symptomatic COVID-19 in those large-scale U.S. trials — data that Mene Pangalos, head of AstraZeneca’s research and development in biopharmaceuticals, called “much cleaner” than previous releases.

He expressed hope that it put “to bed any doubts” about the shot.

Instead, in the early hours of Tuesday, the Data and Safety Monitoring Board of the U.S. National Institutes of Health said it was concerned by the information released.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” it said.

A study finds that the AstraZeneca-Oxford University vaccine cut coronavirus transmission by two-thirds and prevented COVID-19.

Even if the company clears up the misunderstanding — and it’s not yet clear what the U.S. experts are asking for — it could have a lasting impact.

Julian Tang, a virologist at England’s University of Leicester, pointed to the decades-old controversy over the measles vaccine as a cautionary tale.

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

He said AstraZeneca’s issues may be even tougher to overcome “because every week it seems like there’s some new concern.”

Last week, more than a dozen countries temporarily halted their use of the AstraZeneca shot after reports of rare blood clots in some people who received it. The European Medicines Agency concluded that the shot was not responsible. Although its investigation was standard procedure for when unusual potential side effects in a new drug or vaccine are detected, the process drew more unwelcome attention to AstraZeneca’s vaccine.

In Norway, a top official warned Monday that it might not be able to resume its use of the AstraZeneca vaccine because so many people were refusing it.

“People clearly say that they do not want the AstraZeneca vaccine,” Marte Kvittum Tangen, who heads a Norwegian doctors’ association, told broadcaster NRK.

Last week in Bucharest, Romania, vaccination coordinator Valeriu Gheorghita said 33,000 AstraZeneca immunization appointments had been 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 set up for people to get the AstraZeneca vaccine was mostly deserted Monday.

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“This is unfortunately more about perception than it is the science,” said Dr. Bharat Pankhania, an infectious-diseases specialist at the University of Exeter in southwest England.

“We have now seen, on several parameters, that the AstraZeneca vaccine provides protection and is safe,” he said. “But the narrative for the public has not been as clear,” he added, criticizing politicians for undermining confidence in the vaccine without evidence.

France offers a prime example of the confusion.

French President Emmanuel Macron initially suggested that the vaccine wasn’t effective for older people, before backtracking. But France then authorized the shot for use only in adults 65 and under, citing a lack of data. Then the government changed its mind, based on new data, and said it was fine for all adults and started singing its praises. Then came the reports of blood clots, after which the government suspended use of the vaccine altogether.

When France resumed use of the AstraZeneca vaccine, it did so for people under 55.

The head of the European Union’s drug regulator says there is no indication that AstraZeneca’s COVID-19 shot is linked to blood clots.

The whiplash-inducing messages come at a time when France — like much of Continental Europe — is seeing a spike in cases that is close to overwhelming its hospitals and prompting threats of new lockdowns.

Vaccine rollouts have also been slow in many other European Union countries, compared with those in Britain and the U.S. The European Commission has often blamed AstraZeneca for troubles with its vaccination drive, expressing outrage over repeated delayed deliveries and threatening to ban exports of vaccines outside the bloc. But messy logistics have also played a role.

The tepid support for the AstraZeneca vaccine in Europe stands in contrast to the position of governments in developing countries, which are desperate for supplies.

Dr. Bruce Aylward, a senior advisor to the World Health Organization, said the agency has a long list of countries “very keen” to get the shot as soon as possible. “We simply cannot get enough of it,” he said.

Poor countries face long waits for injections as the U.S. and others buy up nearly all the global supply of Pfizer and Moderna vaccines.

Some experts have worried that the skepticism in Europe could eventually cast a pall over the vaccine worldwide. They suggested one measure that could reassure a jittery public about the shot: a green light from the U.S. Food and Drug Administration.

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

AstraZeneca said it would be submitting its data to the FDA for emergency-use authorization within weeks.

At a vaccination center in Lisbon, 68-year-old Rui Manuel Martins dismissed any concerns about the shot, saying that millions had been immunized with very few ill effects.

“There’s always some cases of people rejecting any medications,” he said before receiving his first dose. “It’s better to be vaccinated rather than not.”


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