American officials and health experts are increasingly concerned that the AstraZeneca shot, which was once billed as the world’s coronavirus vaccine because of its low price and ease of storage, is being hampered by the anti-vaccine rhetoric that has already been trained on Covid-19 shots , due to the record pace of their development could be adversely affected. In particular, the waning confidence in the AstraZeneca vaccine could wreak havoc on hard-to-reach, underserved US populations who are already skeptical of the government’s vaccination campaign – let alone people in developing countries who feel they are third or fourth best option to obtain .
“You have a company that is very likely to have a very good vaccine that has done everything it can to judge whether or not it is a good vaccine,” said one person with knowledge of the company’s vaccine trials and data that came up the UK dosing pointed to errors and the company’s attempts to cobble together experimental data from multiple dosing schedules. “Your entire approach … could kindly be labeled sloppy.”
Few would have predicted the level of suspicion and controversy that has haunted the AstraZeneca vaccine in recent months. Originally developed by Oxford University researchers, the shot was one of the first to be included in 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 competitors. The Trump administration ordered 300 million doses last May, well above original orders from other vaccine manufacturers.
But then the problems began: that fall, AstraZeneca paused its studies around the world to assess a serious illness in a UK study participant, and it took nearly two months to restart the US study. Then it became clear that in its UK study, the drug maker had mistakenly given roughly half of the intended first dose to roughly 3,000 people – and the results were actually stronger for the lower, erroneous dose.
The stumbling blocks made US officials cautious about accepting early signals that the vaccine is safe and effective, despite more than 50 other countries approving the shot and distributing it to millions this year. But the US still had AstraZeneca’s promise to provide 300 million cans and was reluctant to let go of those shots.
US government officials in discussions with POLITICO have confirmed that they will 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. However, the prospect of production problems or anything that could threaten Biden’s promise to have enough cans for every American by the end of May has hesitated the government to release AstraZeneca cans from U.S. inventory, said two people familiar with the discussion.
The government finally announced last week that it would give Mexico 2.5 million cans and Canada 1.5 million cans, but officials made no plans to share more shots around the world.
An AstraZeneca spokesman said the company plans to file an emergency in the US in the first half of April and can deliver 30 million doses immediately, 50 million more in the next few weeks if the Food and Drug Administration approves the vaccine. After that, the company plans to supply the US with 15 to 20 million cans per month.
“We are confident that our vaccine can have a noticeable impact on the course of the pandemic and protect millions of people in Europe and around the world from this deadly virus,” said an AstraZeneca spokesman. “We see successful vaccination programs around the world – and protecting the population, including the elderly, is of the utmost importance.”
Even so, confusion and anger over AstraZeneca’s botched global rollout are frustrating Government officials and vaccine experts around the world cast a shadow over the shot that could still play a massive role in the global vaccination effort.
Some experts also fear that the timing of Biden’s loans to neighboring countries sends out 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 vaccines that are less good,” said a former senior executive Food and Drug Administration official.
Peter Hotez, a vaccines expert at Baylor University who is developing a coronavirus vaccine, shares similar concerns.
“It’s great that they are sending vaccines to Canada and Mexico, but at the same time, all of these European countries are exposing them – they need to be aware of the optics here,” he said. “With this vaccine, a lot of bad things happen all at once.”
This includes 13 European countries withdrawing recommendations on vaccine use based on reports of blood clots not previously linked to the shot. All have resumed use of the vaccine last week, following assurances from the bloc’s drug agency. There are also early data from a South African study suggesting that the vaccine is ineffective against a dominant strain there, B.1.351, prompting that country to continue the suspension of the shot.
“And now some have the impression that the Biden government is just dumping their cans. It throws the tea overboard, ”said Hotez.
Europe’s mixed response to the vaccine has been an absolute disaster, especially because U.S. and European drug regulators are typically viewed as harmonious groups with similarly high standards, according to current and former U.S. health officials.
“The handling of the AstraZeneca vaccine is a pretty black spot for European drug regulators,” said the former senior FDA official. “This would … be the example of the European Union pulling all of this together and doing a great job for all Member States in a way that Member States couldn’t do independently. And that fiasco makes Brexit look pretty good. “
Even before concerns about blood clots arose last week, some European countries were beginning to restrict the use of the vaccine in the elderly and citing insufficient data in this population. Officials around the block also expressed frustration at the delays in making AstraZeneca, with some essentially blaming the company for cutting European orders get better prices elsewhere.
In public, high-ranking Biden officials are rushing to fix AstraZeneca’s image. The President’s Chief Medical Officer Anthony Fauci has endorsed the European Medicines Agency’s safety guarantees in briefings and hearings at the White House, noting that the frequency of blood clots in studies with the AstraZeneca vaccine is equivalent to its frequency in the real world was. outside of vaccine studies.
And White House coronavirus advisor Andy Slavitt highlighted the quality of the Food and Drug Administration’s vaccine trials during a press briefing at the White House on Monday. “Science will be what science is. The results will be what they will be, ”he said. “The American public needs to hear this directly, and it is important that they have great confidence in what is coming out of our independent scientific agencies.”
However, it’s not clear whether the U.S. trial data AstraZeneca revealed Monday – showing the vaccine is a solid option compared to the shots already approved by the FDA – can turn the tide of public opinion around the world. After countries like France, Germany, Spain and Italy stopped using the vaccine, African and Asian countries including the Democratic Republic of the Congo, Indonesia and Thailand followed suit, citing European concerns.
World Health Organization officials responded by gathering behind the shot, highlighting that it remains in high demand among members of the global equity effort known as the COVAX Facility. All countries in the COVAX group are moving forward, said Bruce Aylward, a senior WHO adviser working with the program.
Thailand and Indonesia resumed vaccination after a brief suspension with the Thais Prime Minister receives it last week to instill confidence. However, the Democratic Republic of the Congo, which has delayed the rollout of the 1.7 million doses it received through COVAX, has not yet announced plans to end the suspension. Meanwhile, South Africa has sold the 1.5 million cans it had been acquired from the Serum Institute of India in 14 other African countries.
“We don’t have many options for global health,” Hotez said, noting that Pfizer and Moderna have limited global deals. “What do we have? Maybe we have the J&J vaccine, and then you have the vaccines against Russia and China, which have so far bypassed WHO prequalifications.” Vaccine efficacy assessed – a critical part of his recent support for AstraZeneca amid confusion.
“We don’t have much for low- and middle-income countries,” added Hotez. “And that’s why we need it.”
Carmen Paun contributed to this report.