The intense public scrutiny is vaccine safety at work.
By Keren Landman
Dr. Landman is an infectious diseases epidemiologist and journalist.
The most important thing to know about AstraZeneca’s Covid-19 vaccine is that it’s safe and it works — in spite of the missteps that have marred nearly every stage of its rollout.
New data shared Monday shows the vaccine was 79 percent effective in preventing symptomatic infections in a trial of over 32,000 people, and the company says it will prepare to apply for emergency authorization from the Food and Drug Administration in the coming weeks.
These findings should help bolster confidence in the vaccine after the last week’s disaster for AstraZeneca: As coronavirus cases rose in a third surge across Europe, reports began to emerge that a handful of people who received AstraZeneca’s vaccine experienced rare but serious and unusual blood clotting. More than a dozen nations suspended use of the vaccine. The European Medicines Agency quickly reaffirmed the benefit of getting the vaccine and said the clotting cases would be investigated further.
As AstraZeneca’s drama has played out in public, many public health advocates have watched with horror, afraid they are witnessing the legitimacy of global vaccine development being destroyed. But this process, warts and all, is how vaccine safety is supposed to work. And if the AstraZeneca vaccine deserves people’s confidence after months of stumbles, this process is how it will earn it.
From the very beginning, AstraZeneca made errors that have led to a loss of trust. When it first reported early clinical trial results of the vaccine it developed in partnership with the University of Oxford, the company was swiftly met with criticism over the trials’ design and how the data was shared. A subset of the people in the trial had been given the wrong — but ultimately more effective — dose of the two-shot vaccine by mistake; the company had inappropriately pooled data from differently designed, multinational studies; and company personnel had consistently shared safety and efficacy data with industry analysts and investors before disseminating information to the public.
By the end of November, as Pfizer-BioNTech and Moderna awaited emergency use authorization for their vaccines in the United States, AstraZeneca was enduring widespread criticism for its lack of transparency and rigor. Its vaccine is still not approved in the United States, where the F.D.A.’s review process is typically more intense and time-consuming than that of other countries’ regulators. The clinical trial data released on Monday is an important step toward the vaccine’s application for emergency authorization.
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