New PR blunder undermines AstraZeneca’s efforts to restore confidence in vaccine

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It is the latest in a series of blunders that have undermined global confidence in shooting. When the United States announced last week that it would ship millions of doses of AstraZeneca to neighboring countries, European regulators were actively working to assuage safety concerns; A total of 13 EU countries have suspended use of the vaccine over unfounded fears that it will cause blood clots. And AstraZeneca had already drawn criticism after a dosage error clouded the results of its UK trial. Today, more than half of those polled in France, Germany and Spain think shooting is dangerous, according to a YouGov survey published Monday.

US officials and health experts are increasingly concerned that AstraZeneca’s vaccine, once touted as the global coronavirus vaccine for its low price and ease of storage, could be slowed down by anti-vaccine rhetoric already formed on Covid-19 shots due to the record pace of their development. Crumbling confidence in the AstraZeneca vaccine in particular could have devastating results among hard-to-reach and underserved U.S. populations already skeptical of the government’s vaccination campaign – not to mention people in developing countries. who may feel like they are getting the third or fourth best option. .

“You have a company that most likely has a very good vaccine, that has gone out of its way not to appreciate whether it is a good vaccine or not,” said a person with knowledge of vaccine trials and tests. data from the company that reported the UK dosage. error and the company’s attempts to tinker with test data from multiple dosing regimens. “Their whole approach… could be described, nicely, as sloppy.”

Few would have predicted the level of suspicion and controversy that has hung over the AstraZeneca vaccine in recent months. The shot, originally developed by researchers at the University of Oxford, was one of the first to go into clinical trials. At the start of the pandemic, AstraZeneca executives suggested that doses could be available as early as October 2020, well ahead of other vaccine candidates. The Trump administration ordered 300 million doses last May, well above the initial orders it has placed with other vaccine makers.

But then the problems started: This fall, AstraZeneca suspended worldwide trials to assess serious illness in a UK study participant, and the US trial took almost two months to restart. Then it became clear that the drugmaker mistakenly gave around 3,000 people in its UK trial about half of the first scheduled dose – and the results were in fact stronger for the lowest mistaken dose.

The stumbles have made U.S. officials reluctant to accept early signals that the vaccine is safe and effective, even as more than 50 other countries have approved and distributed the vaccine to millions of people this year. But the United States still had AstraZeneca’s promise to deliver 300 million doses and was loath to let those injections go.

U.S. government officials have acknowledged in conversations with POLITICO that they do not need the AstraZeneca vaccine to meet President Joe Biden’s goal of immunizing all adults as long as Pfizer, Moderna, and Johnson & Johnson deliver the doses promised . But the prospect of production issues or anything that could threaten Biden’s promise to have enough doses for every American by the end of May has made the administration reluctant to release doses of AstraZeneca from the US stockpile, said two people close to the discussion.

The administration finally announced last week that it would give 2.5 million doses in Mexico and 1.5 million in Canada, but officials have not formulated plans to share more doses globally.

A spokesperson for AstraZeneca said on Monday that the company plans to apply for emergency use in the United States during the first half of April and could deliver 30 million doses immediately, with 50 million more over the next several weeks if the Food and Drug Administration clears the vaccine. After that, the company predicts that it will be able to supply the United States with 15-20 million doses per month.

“We are convinced that our vaccine can have a real and tangible impact on the evolution of the pandemic, protecting millions of people in Europe and around the world against this deadly virus,” said a spokesperson for AstraZeneca. “We are seeing successful vaccination programs around the world – and the protection of populations, including older groups, is of paramount importance. “

On Tuesday morning, hours after the NIH press release suggesting issues with the company’s efficiency data, AstraZeneca said its press release was “based on a pre-defined interim analysis with a February 17 data deadline. “.

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis,” said AstraZeneca. “We will immediately contact the Independent Data Safety Oversight Board (DSMB) to share our primary analysis with the most recent efficacy data. We intend to publish the results of the main analysis within 48 hours.

Confusion and anger over AstraZeneca’s botched global rollout has frustrated government officials and vaccine experts around the world casting a shadow over the shot that could still play a huge role in vaccination efforts around the world.

Some experts are also concerned that the timing of Biden’s loans to neighboring countries sends an unintended message.

“The last thing you want to do is create a perception that there are two classes of people in the world: those who get good vaccines and those who get poorer vaccines,” said a former senior food official. and Drug Administration.

Peter Hotez, a vaccine expert at Baylor University who is developing a vaccine for the coronavirus, shares similar concerns.

“It’s great that they are sending vaccines to Canada and Mexico, but doing it at the same time that all these European countries are suspending it – they have to be aware of the optics here,” he said. . “You have a lot of bad things happening to this vaccine at the same time.”

These include 13 European countries withdrawing their recommendations to use the vaccine amid reports of blood clots that so far have not been linked to the vaccine; all have reinstated the use of the vaccine after being reassured last week by the drug agency of the block. There is also early data from a South African trial suggesting the vaccine is not effective against a dominant strain there, B.1.351, which has led that country to continue with its suspension of the vaccine.

“And now some feel like the Biden administration is just throwing away its doses. It’s throwing the tea overboard, ”Hotez said.

Europe’s mixed reaction to the vaccine has been an absolute disaster, especially because U.S. and European drug regulators are generally seen as harmonious groups with equally high standards, U.S. and former health officials have said. .

“Handling the AstraZeneca vaccine is a pretty dark mark for European drug regulators,” said the former senior FDA official. “This was going to be… the example of the European Union putting it all together and doing a great job for all Member States, in a way that Member States could not do independently. And what this fiasco does is make Brexit look pretty good. “

Even before concerns emerged last week about blood clots, some European countries started restricting the use of the vaccine in the elderly, citing insufficient data on this population. Bloc officials have also expressed frustration at AstraZeneca’s manufacturing delays, with some essentially accusing the company of cutting European orders. get better prices elsewhere.

Publicly, senior Biden officials are rushing to fix AstraZeneca’s image. The President’s Chief Medical Officer, Anthony Fauci, backed the European Medicines Agency’s safety guarantees during White House briefings and Congressional hearings, stressing that the incidence of blood clots in AstraZeneca vaccine trials was comparable to their frequency in the real world, outside of vaccine studies.

And White House coronavirus adviser Andy Slavitt highlighted the quality of the Food and Drug Administration’s vaccine reviews during a White House press briefing on Monday. “Science will be what science is. The results will be what the results will be, ”he said. “The American public will need to hear this firsthand and it is important that they have great confidence in what is coming out of our independent scientific agencies.”

But it’s not clear whether the U.S. trial data AstraZeneca revealed on Monday – which shows the vaccine to be a strong option over injections already cleared by the FDA – can turn the tide of public opinion in the world. After countries like France, Germany, Spain and Italy suspended use of the vaccine, countries in Africa and Asia, including the Democratic Republic of the Congo, Indonesia and Thailand, followed suit. not, citing Europe’s concerns.

World Health Organization officials responded by rallying to the shot, pointing out that it is still in high demand by members of the global equity effort known as the COVAX Facility. All of the countries in the COVAX group are moving forward, said Bruce Aylward, WHO senior adviser who works with the program.

Thailand and Indonesia resumed vaccination after brief suspension, Thai the prime minister receives last week to inspire confidence. But the DRC, which has delayed the deployment of the 1.7 million doses it received via COVAX, has not yet announced its intention to end its suspension. Meanwhile, South Africa has sold the 1.5 million doses it had acquired from the Serum Institute of India to 14 other African countries.

“We don’t have a lot of options for global health,” Hotez said, noting that Pfizer and Moderna have limited global agreements. “What do we have? We have the J&J vaccine, maybe, and then you have the Russian and Chinese vaccines which have so far bypassed the WHO prequalifications, ”referring to the process the World Health Organization uses to assessing the safety and effectiveness of a vaccine – a critical part of its recent support for AstraZeneca amid the confusion.

“We don’t have a lot for low- and middle-income countries,” Hotez added. “And that’s why we need it.”

Carmen Paun contributed to this report.

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