Why is the Oxford-AstraZeneca vaccine, which was approved for use in the United Kingdom in December and in the European Union in January, not yet available in the United States? Every answer to that question leads to another query. It isn’t available because the Food and Drug Administration hasn’t given it an emergency-use approval, as it has for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines. Why not? Because AstraZeneca, the Anglo-Swedish pharmaceutical company that partnered with Oxford University researchers in developing the vaccine, hasn’t applied for F.D.A. approval. And why hasn’t it? Until this week, the answer was that the vaccine’s U.S. clinical trials had not been completed. But, on Monday, AstraZeneca put out a press release with what it said were key interim results of the trial, which included more than thirty thousand participants, and the data looked excellent. The vaccine appeared to be seventy-nine-per-cent effective at preventing “symptomatic COVID-19.” The press release said that no one in the trial who was given the vaccine became severely ill, was hospitalized, or died as a result of COVID-19, and that the study did not turn up any serious safety concerns.
The stage seemed to be set for an emergency-use approval by May, after an F.D.A. review of the raw data and a hearing by its vaccine-advisory committee. Then, in the early hours of Tuesday, the National Institute of Allergy and Infectious Diseases—the part of the National Institutes of Health that Anthony Fauci runs—put out an extraordinary and troubling statement. It said that the independent board monitoring AstraZeneca’s clinical trial had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.” In a response issued several hours later, AstraZeneca acknowledged that the “cut-off” for the numbers in its release had been February 17th; the company said that the data it had gathered since then seemed to be “consistent,” but that it would work to get them integrated and planned to have revised results “within 48 hours”—raising the question of why it didn’t just wait two days and get it right.
Fauci, in an appearance on “Good Morning America,” said that the independent monitoring board’s letter to AstraZeneca about its concerns, sent in an e-mail on which the N.I.A.I.D. was copied, was “harsh.” (The Times and Post reported that the letter castigated AstraZeneca, telling the company that “decisions like this are what erode public trust in the scientific process.”) What was frustrating, from his perspective, was that it looked to him as if the results actually were quite positive, but that AstraZeneca had created unnecessary doubts. “This is really what you call an unforced error,” he said. The fearful refusal of many people to be vaccinated is already a barrier to ending the pandemic. Fauci, looking for a bright side, said that members of the public should see the monitoring board’s expression of concern in a reassuring light, as the “example of a safeguard.” Perhaps they will. But AstraZeneca cannot play fast and loose with the world’s trust. (Nor, for that matter, can the N.I.A.I.D.)
And other questions have arisen along the way. Why did the U.S. trials take so long, compared with the earlier trials on which the United Kingdom, the E.U., and other countries based their approvals? Why was a U.S. trial even regarded as necessary? For one thing, the results of those earlier trials—which were announced in late November, 2020, and included eleven thousand and six hundred participants in the U.K. and Brazil—were confusing and incomplete in certain ways. Most notably, some people received two full doses, whereas others received a half dose followed by a full dose. The first data showed that the second group, with the weaker first dose, was more protected—which is not what immunologists would have expected. However, it turned out that the second group included only people who were under the age of fifty-five, throwing the results into question. Why wouldn’t AstraZeneca have controlled for age in testing two dosing regimens? Because, it turned out, the different levels had not been part of the original study design; the setup was apparently an attempt to make the best of a measuring error late in the production process. (There have been conflicting accounts of exactly how the decision to include different dosages in the trial was made.) But that explanation dribbled out; the company was not as forthright as it could and should have been. That lack of transparency did real damage and no doubt informed the N.I.A.I.D.’s reaction to the company’s latest release. As a former senior European health official told Reuters, in December, “Personally, I can say that I think their vaccine is much better than their communication.”
There were other questions about the initial trials. The participants did not seem as representative as they might have been: Why weren’t more elderly people enrolled, or more diverse populations? Why did AstraZeneca make it harder to untangle its data from the outset, by conflating results from different study sites (in the U.K. and Brazil) that dealt with the data in somewhat different ways? Whatever the explanations, those were also issues that the company should have found a way to address sooner. The clinical trial in the United States was slowed down, at one point, because of questions about the illness of a participant in the U.K. trial (which was still going on at the time). It also enrolled a more representative group of participants, which took time, as did carrying out the study carefully. AstraZeneca could have saved the world a lot of stress by making sure that its earlier trials were conducted to the highest standard; this round was its chance to make good.
These scientific questions became, unfortunately, interlaced with one that joined politics and business: AstraZeneca has not delivered as many doses as the European Union ordered—why not? The answer is that the company’s contract with the United Kingdom gave that country priority, even for doses manufactured in the E.U. The E.U. has responded by imposing some export controls, and threatening more. European authorities seemed to be alternately casting doubt on the company and trying to get more of its product. The bitterness of Brexit seeped into the discussion. Fairly or not, AstraZeneca began to seem like the vaccine of discord.
This is a tragedy, because the AstraZeneca vaccine does appear to be very, very good. It is also inexpensive and can be kept in a normal refrigerator. But there are caveats. According to a study published last week in The New England Journal of Medicine, it does not appear to be effective against the coronavirus variant that is now predominant in South Africa. Indeed, South Africa’s health ministry has sold its AstraZeneca stockpile to other African countries, and is focussed on the Johnson & Johnson vaccine instead. (Meanwhile, the Biden Administration is planning to lend some of the U.S.’s AstraZeneca supply, which the federal government had acquired in anticipation of an approval, to Canada and Mexico, where it is in use; the idea is that those countries will repay the loan with doses from future deliveries.)
Then came the question of blood clots. Last week, a number of countries in Europe—including France, Germany, Italy, and Spain—and in other parts of the world suspended use of the AstraZeneca vaccine after reports of a very small number of recipients developing rare blood clots: cerebral venous sinus thrombosis, or C.V.S.T., and disseminated intravascular coagulation, or D.I.C. Some of the C.V.S.T. cases were tied to deaths. To many observers, the suspension seemed like an extreme example of overcautious regulatory-state bureaucracy, or, worse, rank hysteria, or even an attempt by Europeans, still resentful about being put in line behind Britain, to slander a good vaccine—sour grapes on a spectacular scale. In any population, there are going to be people with dangerous blood clots, and on the whole the number of these incidents among the twenty million or so people in the U.K. and Europe who have received the vaccine seemed, if anything, lower than might have been expected.
But that caricature of the European regulators isn’t quite fair, either. Even if a suspension of all AstraZeneca vaccinations was an overreaction, simply dismissing the questions about the blood clots would have been an underreaction verging on negligence. (The other vaccines approved in the E.U.—Pfizer-BioNTech, Moderna, and Johnson & Johnson—were still being administered.) A closer look at the numbers shows that the C.V.S.T. and D.I.C. clotting incidents showed up more frequently than expected in a specific subgroup of people receiving the vaccine: women under the age of fifty-five. (The general population of vaccine recipients skews older in many countries.) The absolute numbers are still so small—a couple dozen—that they may be a result of very bad luck, or some other factor. Still, whatever further studies show, the controversy is a reminder of the importance of paying attention to diverse populations in medical research. Last week, the European Medicines Agency, the F.D.A.’s counterpart, said, “A causal link with the vaccine is not proven, but is possible and deserves further analysis.” However, the E.M.A. also noted that it is well established that COVID-19 itself is linked to a great many more dangerous clotting incidents. Its conclusion: the benefits of the vaccine “outweigh the risks.” And the E.M.A. directed the practical measure of updating warning labels about what symptoms doctors and vaccine recipients should watch for, to further reduce and address that potential risk.
According to AstraZeneca, the U.S. clinical trials did not turn up any such clotting incidents—though, given their rarity, that is not necessarily dispositive. (It is notable that the N.I.A.I.D.’s statement mentioned a problem with the data about “efficacy,” rather than safety.) Perhaps AstraZeneca rushed the release to quell safety doubts in Europe. If so, it could hardly have come up with a more self-destructive move—especially because, by Monday, most countries that had suspended their use of AstraZeneca resumed it, relying on the E.M.A.’s judgment. Chancellor Angela Merkel, of Germany, said that she would be glad to take the AstraZeneca shot when she becomes eligible. Moon Jae-in, the President of South Korea, was filmed getting an AstraZeneca shot. Countries around the world are facing a new wave of cases, and confidence in vaccines is seen as crucial. But polls show that distrust in AstraZeneca in the E.U. has risen significantly. As The Economist put it, “European citizens seem spooked.” That context explains why AstraZeneca’s Monday press release felt so hopeful, and why the possibility that the company has again fumbled a release of results is so disappointing.
Perhaps the most important AstraZeneca questions are also the central questions of the pandemic: How do we balance benefits and risks, in a way that allows everyone to move forward together out of the pandemic miasma? Transparency and good information are crucial. There is a difference between managing risks and denying that risks exist. And how is trust in public-health measures, including vaccination programs, built and sustained? One place to start is with clinical trials that are carefully designed and conducted, even if they take more time, and results that are accurately reported. Can AstraZeneca manage that?
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