AstraZeneca
AstraZeneca confirms strong vaccine protection after US rift
AstraZeneca insisted Wednesday that its COVID-19 vaccine is strongly effective even after counting additional illnesses in its disputed U.S. study, the latest in an extraordinary public rift with American officials.
In a late-night press release, AstraZeneca said it had recalculated data from that study and concluded the vaccine is 76% effective in preventing symptomatic COVID-19, instead of the 79% it had claimed earlier in the week.
Just a day earlier, an independent panel that oversees the study had accused AstraZeneca of cherry-picking data to tout the protection offered by its vaccine. The panel, in a harsh letter to the company and to U.S. health leaders, said the company had left out some COVID-19 cases that occurred in the study, a move that could erode trust in the science.
Also Read: AstraZeneca: US data shows vaccine effective for all adult
Data disputes during ongoing studies usually remain confidential but in an unusual step, the National Institutes of Health publicly called on AstraZeneca to fix the discrepancy.AstraZeneca had been counting on findings from a predominantly U.S. study of 32,000 people to help rebuild confidence in a vaccine that, despite being widely used in Britain, Europe and other countries, has had a troubled rollout. Previous studies have turned up inconsistent data about its effectiveness, and then last week a scare about blood clots had some countries temporarily pausing inoculations.
Now the question is whether the company’s newest calculations end the tension.
Also Read: US: AstraZeneca may have used outdated info in vaccine trial
Earlier Wednesday, Dr. Anthony Fauci, the top U.S. infectious disease expert, told reporters he hoped that when all the data was publicly vetted by federal regulators, it would dispel any hesitancy caused by the spat. He predicted it would “turn out to be a good vaccine.”
AstraZeneca’s newest calculations were based on 190 COVID-19 cases that occurred during the study, 49 more than it had included earlier in the week. The vaccine appears especially protective against the worst outcomes, with no severe illnesses or hospitalizations among vaccinated study volunteers compared to eight severe cases among those given dummy shots, the company said. It didn’t provide a breakdown of the rest of the cases.
European authorities had questioned how protective the vaccine is in older adults. In the U.S. study, it was 85% effective in volunteers 65 and older, the company said. The study didn’t turn up safety concerns.
The updated information “confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” AstraZeneca research chief Mene Pangalos said in a statement. He said the company looks forward to “the rollout of millions of doses across America.”
The study hasn’t ended so additional COVID-19 cases can accrue. AstraZeneca cautioned that 14 additional possible cases already are being examined, which could lead to further changes in the data.
The company intends to seek Food and Drug Administration clearance of the vaccine within a few weeks. The FDA will publicly debate all the evidence with its outside advisers before making a decision.
Missteps could mar long-term credibility of AstraZeneca shot
AstraZeneca’s repeated missteps in reporting vaccine data coupled with a blood clot scare could do lasting damage to the credibility of a shot that is the linchpin in the global strategy to stop the coronavirus pandemic, potentially even undermining vaccine confidence more broadly, experts say.
The latest stumble for the vaccine came Tuesday, when American officials issued an unusual statement expressing concern that AstraZeneca had included “outdated information” when it reported encouraging results from a U.S. trial a day earlier. That may have provided “an incomplete view of the efficacy data,” according to the statement.
AstraZeneca responded that the results, which showed its shot was about 79% effective, included information through Feb. 17 but appeared to be consistent with more up-to-date data. It promised an update within 48 hours.
An independent panel that oversees the study scolded the company in a letter Monday for cherry-picking data, according to a senior administration official. The panel wrote to AstraZeneca and U.S. health leaders that it was concerned the company chose to use data that was outdated and potentially misleading instead of the most recent findings, according to the official, who discussed the contents on the condition of anonymity given the sensitivity of the matter.
Also read: US: AstraZeneca may have used outdated info in vaccine trial
“This will likely cause more vaccine hesitancy,” said Dr. Paul Hunter, a professor of medicine at the University of East Anglia.
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 thus is expected to be widely used in the developing world. International health agencies have repeatedly said the vaccine is safe and effective, but it’s not the first time the company has run into problems with public trust.
Partial results from its first major trial — which Britain used to authorize the vaccine — were clouded by a manufacturing mistake that researchers didn’t immediately acknowledge. Insufficient data about how well the vaccine protected older people led some countries to initially restrict its use to younger populations before reversing course. U.S. officials suspended an AstraZeneca study for an unusual six weeks while they sought details about problems reported in Britain before deciding the vaccine wasn’t to blame. Meanwhile, the European Union has complained about delays in vaccine deliveries from the company.
Also read:Smithsonian obtains vial from 1st US COVID-19 vaccine dose
Then 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 the shot did not increase the overall incidence of clots, but the unwanted attention appears to have left a mark.
In Norway, a top official warned Monday it might not be able to resume its use of the vaccine because so many people were rejecting 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 on Monday.
“This is unfortunately more about perception than it is the science,” said Dr. Bharat Pankhania, an infectious diseases specialist at Britain’s University of Exeter.
“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.”
Also read:A rapid COVID-19 vaccine rollout backfired in some US states
France is a prime example of the confusion.
French President Emmanuel Macron initially suggested the vaccine wasn’t effective for older people, before backtracking. Still, France only authorized AstraZeneca’s vaccine for use in adults 65 and under, citing a lack of data. Then the government changed its mind, based on new data, and said it’s fine for all adults. But when there were reports of rare blood clots in some vaccine recipients, the government suspended use of the shot all together. When France restarted AstraZeneca, it banned the shot for anyone under 55.
The whiplash-inducing messages come at a time when France — like much of continental Europe — is struggling to speed up its vaccination drive while also facing a spike in cases that is close to overwhelming its hospitals and prompting threats of new lockdowns.
At a European Parliament committee Tuesday in Brussels, Sandra Gallina, head of the European Commission’s health directorate, described the situation with AstraZeneca as “a shame.” She said the struggling vaccination campaigns across Europe were “made much more difficult by the bad performance of AstraZeneca.”
The company has blamed delays in its deliveries on production issues.
Even if the drugmaker clears up the latest misunderstanding, it could 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 the (measles, mumps and rubella) vaccine caused autism,” he said. But despite the retraction of the paper that made that claim, Tang said some people still worry about the vaccine.
The tepid support for the AstraZeneca vaccine in Europe stands in contrast to governments in the developing world that are desperate for supplies.
Dr. Bruce Aylward, a senior adviser at the World Health Organization, said the U.N. 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.
But 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: 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 within weeks.
It’s still possible the vaccine can bury the doubts. At a vaccination center in Lisbon, 68-year-old Rui Manuel Martins dismissed the concerns, saying 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.”
US: AstraZeneca may have used outdated info in vaccine trial
Results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have included “outdated information” and that could mean the company provided an incomplete view of efficacy data, American federal health officials said early Tuesday.
A spokesman from the drug company said Tuesday it was “looking into it.”
Also read:Smithsonian obtains vial from 1st US COVID-19 vaccine dose
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that some experts hoped would help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
In the study of more than 30,000 people, the company reported that the vaccine was found to be 79% effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease. AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.
Also read:A rapid COVID-19 vaccine rollout backfired in some US states
But just hours after those encouraging results were reported, the U.S. National Institute of Allergy and Infectious Diseases issued an unusual statement.
The agency said the Data and Safety Monitoring Board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
“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,” the statement added.
The company aims to file an application with the Food and Drug Administration in the coming weeks, and the government’s outside advisers will then publicly debate the evidence.
Also read:How do we know the COVID-19 vaccines are safe?
Authorization and guidelines for use of the vaccine in the United States will be determined by the FDA and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
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