American authorities and health experts are increasingly concerned that the injection of AstraZeneca, previously advertised as the world’s coronavirus vaccine for its low price and easy storage, could be hampered by the anti-vaccine rhetoric already trained for Covid-19 injections. because of the record pace of its development. Declining confidence in the AstraZeneca vaccine in particular can have devastating results among populations in the United States, difficult to reach and under-served, already skeptical of the government’s vaccination campaign – not to mention people in developing countries who may feel that are getting the third or fourth best option.
“You have a company that most likely has a very good vaccine, which has done everything possible to confuse, assessing whether it is a good vaccine or not,” said a person with knowledge of the company’s vaccine trials and data that pointed to the dosage. in the UK error and the company’s attempts to gather test data from various dosing regimens. “Their whole approach … could be described, kindly, as sloppy.”
Few would have predicted the level of suspicion and controversy that has plagued the AstraZeneca vaccine in recent months. The injection, originally developed by researchers at Oxford University, was one of the first to be subjected to clinical tests. At the beginning of the pandemic, AstraZeneca executives suggested that doses could be available as early as October 2020, far ahead of other vaccine candidates. The Trump administration ordered 300 million doses last May, far and above initial orders from other vaccine manufacturers.
But then the problems started: that fall, AstraZeneca stopped testing worldwide to assess a serious illness in a study participant in the United Kingdom, and the test in the United States took almost two months to restart. Then it became clear that the drugmaker had mistakenly administered about 3,000 people in its UK test about half of the first intended dose – and the results were actually stronger for the lower and wrong dose.
The stumbles have left American officials cautious about accepting the first signs that the vaccine is safe and effective, even as more than 50 countries have approved and distributed the vaccine to millions this year. But the United States still had a promise from AstraZeneca to provide 300 million doses and was reluctant to give up those injections.
US government officials recognized in talks with POLITICO that they do not need the AstraZeneca vaccine to meet President Joe Biden’s goal of vaccinating all adults, provided that Pfizer, Moderna and Johnson & Johnson deliver the promised doses. But the prospect of production problems or anything that could threaten Biden’s promise to have enough doses for all Americans by the end of May made the government reluctant to release any dose of AstraZeneca from the US stock, two people said familiar with the discussion.
The government finally announced last week that it would give 2.5 million doses to Mexico and 1.5 million to Canada, but the authorities have not articulated plans to share more doses worldwide.
An AstraZeneca spokesman said the company plans to apply for emergency use in the United States in the first half of April, and can supply 30 million doses immediately, 50 million more in the coming weeks if the Food and Drug Administration releases the vaccine . After that, the company plans to be able to supply the United States with 15 to 20 million doses per month.
“We are confident that our vaccine can have a real and tangible impact on the course of the pandemic, protecting millions of people in Europe and around the world against this lethal virus,” said an AstraZeneca spokesman. “We are seeing successful immunization programs around the world – and protecting populations, including older age groups, is of paramount importance.
Still, the confusion and anger surrounding AstraZeneca’s sloppy global implementation has frustrated government officials and vaccine experts around the world, casting a shadow over the shot that may still play an important role in immunization efforts around the world.
Some experts also fear that the timing of Biden’s lending to neighboring countries is sending an unwanted message.
“The last thing you want to do is create a perception that there are two classes of people in the world: those who receive good vaccines and those who receive less good vaccines,” said a former senior employee of the Food and Drug Administration.
Peter Hotez, a vaccine specialist at Baylor University developing a coronavirus vaccine, shares similar concerns.
“It is great that they are sending vaccines to Canada and Mexico, but at the same time all these European countries are suspending – they need to be aware of the optics here,” he said. “You have a lot of bad things going on with this vaccine at the same time.”
This includes 13 European countries that withdrew recommendations for the use of the vaccine amid reports of blood clots that have so far been unrelated to the injection; all resumed using the vaccine after guarantees from the bloc’s drug agency last week. There is also initial data from a trial in South Africa suggesting that the vaccine is not effective against a dominant strain there, B.1.351, which prompted that country to continue withholding the vaccine.
“And now you have the impression that the Biden government is just pouring out its doses. It’s throwing tea in the sea, ”said Hotez.
Europe’s mixed reaction to the vaccine has been an absolute disaster, especially since US and European drug regulators are typically seen as harmonious groups with equally high standards, current and former US health officials said.
“The handling of the AstraZeneca vaccine is a black 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 couldn’t independently do. And what this fiasco does is make Brexit really good. “
Even before concerns arose last week about blood clots, some European countries began to restrict the use of the vaccine in the elderly, citing insufficient data on this population. Employees across the bloc also expressed frustration at AstraZeneca’s delays in manufacturing, with some basically accusing the company of cutting European orders to get better prices elsewhere.
Publicly, senior Biden officials are rushing to fix AstraZeneca’s image. The president’s medical director, Anthony Fauci, supported the European Medicines Agency’s safety guarantees at White House briefings and Congressional hearings, pointing out that the incidence of blood clots in AstraZeneca vaccine tests was on par with their frequency in the world. real, outside of vaccine studies.
And White House coronavirus advisor Andy Slavitt emphasized the quality of the Food and Drug Administration’s vaccine analyzes during a White House press conference on Monday. “Science is going to be what science is. The results will be what they will be, ”he said. “The American public will need to hear this directly and it is important that they have great confidence in what comes out from our independent scientific agencies.”
But it is not clear whether data from the American trial that AstraZeneca revealed on Monday – which shows that the vaccine is a solid option compared to vaccines already authorized by the FDA – could turn the tide of public opinion around the world. After countries like France, Germany, Spain and Italy suspended the use of the vaccine, African and Asian countries, including the Democratic Republic of Congo, Indonesia and Thailand followed suit, citing Europe’s concerns.
World Health Organization officials reacted by meeting behind the shot, stressing that demand is still high among members of the global action effort known as COVAX Facility. All countries in the COVAX group are moving forward with this, said Bruce Aylward, a senior adviser to WHO who is working with the program.
Thailand and Indonesia resumed vaccination after a brief suspension, with the Thai prime minister receiving it last week to inspire confidence. But the DRC, which delayed the release of 1.7 million doses it received through COVAX, has yet to announce plans to end its suspension. Meanwhile, South Africa has sold 1.5 million doses that it has purchased from the Serum Institute of India to 14 other African countries.
“We don’t have many options for global health,” said Hotez, noting that Pfizer and Moderna closed limited global deals. “What do we have? We have the J&J vaccine, perhaps, and then you have the vaccines from Russia and China that have so far circumvented WHO prequalifications,” referring to the process the World Health Organization uses to assess the safety and efficacy of a vaccine – a critical point part of his recent support for AstraZeneca in the midst of confusion.
“We don’t have much for low- and middle-income countries,” added Hotez. “And that is why we need this.”
Carmen Paun contributed to this report.