The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.

Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts.

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Late-stage coronavirus vaccine trials run by AstraZeneca and Johnson & Johnson have resumed in the United States after the companies said on Friday that serious illnesses in a few volunteers appeared not to be related to the vaccines.

Federal health regulators gave AstraZeneca the green light after a six-week pause, concluding there was no evidence that the experimental vaccine had directly caused the neurological side effects reported in two participants. The AstraZeneca news was first reported by The Wall Street Journal.

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As the first coronavirus vaccines arrive in the coming year, government researchers will face a monumental challenge: monitoring the health of hundreds of millions of Americans to ensure the vaccines don’t cause harm.

Purely by chance, thousands of vaccinated people will have heart attacks, strokes and other illnesses shortly after the injections. Sorting out whether the vaccines had anything to do with their ailments will be a thorny problem, requiring a vast, coordinated effort by state and federal agencies, hospitals, drug makers and insurers to discern patterns in a flood of data. Findings will need to be clearly communicated to a distrustful public swamped with disinformation.

Continue reading “The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?” →

This week, two high-profile, late-stage clinical trials — Johnson & Johnson’s test of a coronavirus vaccine and Eli Lilly’s study of a Covid-19 drug — were put on pause because of possible safety concerns. Just a month earlier, AstraZeneca’s vaccine trial was paused after two volunteers became seriously ill.

Clinical trials experts said these delays were comforting, in a way: They show that the researchers were following proper safety procedures. But for now, details about the nature of the volunteers’ illnesses are scant. And although pauses of vaccine trials are not unusual, some experts said that pausing treatment trials — like that of Eli Lilly’s antibody drug — is rarer, and perhaps more worrisome.

Continue reading “3 Covid-19 Trials Have Been Paused for Safety. That’s a Good Thing.” →