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.” →

Johnson & Johnson has paused the large late-stage clinical trial of its coronavirus vaccine because of an “unexplained illness” in one of the volunteers, the company said on Monday.

The company did not say whether the sick participant had received the experimental vaccine or a placebo. The pause was first reported by the health news website Stat. On Tuesday morning, shares of Johnson & Johnson fell about 2 percent on the S&P 500.

Continue reading “Johnson & Johnson pauses its coronavirus vaccine trial because of a volunteer’s ‘unexplained illness.’” →

The United States may be within months of a profound turning point in the country’s fight against the coronavirus: the first working vaccine.

Demonstrating that a new vaccine was safe and effective in less than a year would shatter the record for speed, the result of seven-day work weeks for scientists and billions of dollars of investment by the government. Provided enough people can get one, the vaccine may slow a pandemic that has already killed a million people worldwide.

Continue reading “First, a Vaccine Approval. Then ‘Chaos and Confusion.’” →