U.S. officials and health experts are increasingly concerned that the shot of AstraZeneca, once considered the world’s coronavirus vaccine due to its low cost and ease of storage, could be dragged through the anti-vaccine rhetoric already trained on Covid-19 shots. become, their development. Crumbling confidence in the AstraZeneca vaccine in particular could have devastating results among hard-to-reach Americans who are already skeptical about government vaccination – not to mention people in developing countries who feel they have the third or fourth best option .
‘You have a company that most likely has a very good vaccine, that has done everything possible to refurbish and appreciate whether it is a good vaccine or not,’ says a person familiar with the company’s vaccination trials and data referring to the dosage in the United Kingdom. error and the company’s efforts to combine trial data from various dosing regimens. “Their whole approach can be kindly described as sloppy.”
Few people would have predicted the level of suspicion and controversy caused by the AstraZeneca vaccine over the past few months. The survey, originally developed by researchers at the University of Oxford, was one of the first to be placed in clinical trials. Early in the pandemic, AstraZeneca executives suggested that doses would be available as early as October 2020, far ahead of other vaccine competitors. The Trump administration ordered 300 million doses last May, far above the initial orders it placed with other vaccine manufacturers.
But then the problems began: In the fall, AstraZeneca suspended its trials around the world to assess a serious illness in a UK participant, and the US trial took almost two months to begin again. Then it became clear that the drug manufacturer had mistakenly given about 3000 people in his British dissertation about half of the intended first dose – and the results were actually stronger for the lower, incorrect dose.
The obstacles have prompted U.S. officials to accept early signals that the vaccine is safe and effective, even though more than 50 other countries have approved the shot this year and handed it out to millions. But the US still had a promise from AstraZeneca to give 300 million doses and was disgusted to let the shots go.
U.S. government officials have admitted in talks with POLITICO that they do not need the AstraZeneca vaccine to meet President Joe Biden’s goal of vaccinating all adults as long as Pfizer, Moderna and Johnson & Johnson deliver their promised doses. But the prospect of production problems or anything that could threaten Biden’s promise to have enough doses for every American by the end of May has made the government reluctant to release any dose of AstraZeneca from US stocks, two people familiar with the discussion said. said.
The administration finally announced last week that it would give 2.5 million doses to Mexico and 1.5 million to Canada, but officials have not made plans to share more shots worldwide.
A spokesman for AstraZeneca said the company plans to apply for emergency use in the United States in the first half of April, and that it could deliver 30 million doses immediately in the next few weeks, with 50 million more if the food and drug administration cleans the vaccine. . Thereafter, the company plans to supply the United States with 15 to 20 million doses per month.
“We are confident that our vaccine can have a real, tangible impact on the course of the pandemic and protect millions of people in Europe and worldwide from this deadly virus,” a AstraZeneca spokesman said. “We see successful vaccination programs around the world – and the protection of populations, including older age groups, is paramount.”
Confusion and anger surrounding AstraZeneca’s global deployment frustrated government officials and vaccine experts around the world, casting a shadow over the shot that could still play a major role in global immunization efforts.
Some experts are also concerned that the timing of Biden’s lending 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 less good vaccinations,” said a former food and safety official. drug administration said.
Peter Hotez, a vaccination expert at Baylor University who is developing a coronavirus vaccine, shares similar concerns.
‘It’s great that they send vaccines to Canada and Mexico, but at the same time all these European countries are suspending it. They need to have knowledge of the optics here, ‘he said. “There are a lot of bad things happening to this vaccine at the same time.”
These include 13 European countries withdrawing recommendations to use the vaccine amid reports of blood clots that have so far not been linked to the shot; everyone reinstated the use of the vaccine after the insurance agency’s insurance agency of the block last week. There are also early data from a South African trial indicating that the vaccine is not effective against a dominant strain there, B.1.351, which led to the country suspending the suspension.
‘And now you have the impression with some people that the government in Biden is just dumping its doses. It throws the tea overboard, ”Hotez said.
Europe’s mixed response to the vaccine has been an uncomfortable disaster, especially as U.S. and European drug regulators are typically seen as harmonious groups with similarly high standards, current and former U.S. health officials said.
“The handling of the AstraZeneca vaccine is a black spot for European drug regulators,” the former senior FDA official said. “It would be … the example of the European Union to put it all together and do an excellent job for all the Member States, in a way that the Member States could not do independently. And what this fiasco is doing is that Brexit looks pretty good. ”
Even before there were concerns about blood clots last week, some European countries began restricting the use of the vaccine in the elderly, citing insufficient data in the population. Officials around the bloc have also expressed frustration over the delays in manufacturing AstraZeneca, with some mainly accusing the company of downsizing European orders to get better prices elsewhere.
In public, Biden’s top officials are restoring the image of AstraZeneca. The President’s Chief Medical Officer, Anthony Fauci, supported the European Medicines Agency’s assurance safety in the White House briefings and congressional hearings, pointing out that the incidence of blood clots in trials with the AstraZeneca vaccine was equal to its frequency in the real world, outside vaccine studies.
And White House Coronavirus Adviser Andy Slavitt highlighted the quality of reviews of the Food and Drug Administration’s vaccine on Monday during a White House press briefing. “Science is going to be what science is. The results will be what the results will be, ”he said. “The American public will have to hear it directly, and it’s important that they have a lot of confidence in what comes out of our independent scientific agencies.”
But it is not clear whether the US trial data that AstraZeneca revealed on Monday – which shows that the vaccine is a good option compared to the shots already approved by the FDA – could turn public opinion around. After countries such as France, Germany, Spain and Italy suspended the use of the vaccine, countries in Africa and Asia, including the Democratic Republic of the Congo, Indonesia and Thailand, followed suit, citing European concerns.
World Health Organization officials responded by pulling behind the bar and emphasizing that it is still a major demand among members of the global stock effort, known as the COVAX facility. Bruce Aylward, a senior WHO adviser working on the program, continues with all countries in the COVAX group.
Thailand and Indonesia resumed after a brief suspension, and the Thai prime minister received it last week to instill confidence. But the DRC, which has delayed the launch of the 1.7 million doses it received from COVAX, has not yet announced plans to end its suspension. Meanwhile, South Africa has sold the 1.5 million doses it has received from the Serum Institute of India to 14 other African countries.
“We do not have many options for global health,” Hotez said, noting that Pfizer and Moderna have entered into limited global transactions. ‘What do we have? We may have the J&J vaccine, and then you have the Russian and Chinese vaccinations that have so far bypassed the WHO pre-qualifications, ”referring to the process used by the World Health Organization to determine the safety and efficacy of a vaccine. a critical issue part of its recent support to AstraZeneca amid confusion.
“We do not have much for low- and middle-income countries,” Hotez added. “And that’s why we need it.”
Carmen Paun contributed to this report.