Vaccines and sore throats

Coronavirus Daily
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Vaccines and sore throats

Pfizer and its German partner, BioNTech, have designed a Covid-19 vaccine trial that may allow them to find whether their shot works before their fastest-moving rivals, Moderna and AstraZeneca, which is working with the University of Oxford. But what will a successful test actually tell us?

Covid-19's wide range of symptoms and severity make the evaluation of vaccines tricky. Regulators have said that to be approved, vaccines should prevent at least half of symptomatic cases. Documents released by the drugmakers show each has its own approach to defining which symptoms count, and when to count them, Bloomberg's Robert Langreth reports.

Big drug studies usually allow a panel of monitors to get an early peek at the data once or twice before the planned end. They can stop the trial early if a treatment is judged overwhelmingly effective—or alternatively, a total dud.

A participant rests after joining in clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.

Photographer: Eva Marie Uzcategui/Bloomberg

Pfizer plans a first look at the data after a mere 32 coronavirus infections have accumulated in the massive 44,000-person trial. That case total, far short of the final goal of 164, could be reached as soon as Sept. 27, by some estimates.

The company has also given given itself four chances to get a preliminary result. Some trial experts say the company appears to be looking for a leg up in a race to be first with a vaccine.

"I've never seen a trial where there were four interim analyses; that may be the Olympic record," said Eric Topol, editor-in-chief of Medscape, a website offering clinical information for health-care professionals, and director of the Scripps Research Translational Institute in La Jolla, California. "It's obvious why it is being done: so you can just keep looking at the data to try to win a race."

All the drugmakers' trials will count people with Covid-19's most common symptoms—such as cough and fever—as cases, if they test positive for the virus. The rush for results raises the concerns that a vaccine may be authorized mostly on the basis of whether it prevents mild symptoms.

"We want to know this vaccine has strong efficacy," Topol said. "And that means two things: that it works in the majority of people and that it works to prevent serious infections, not sore throats or muscle aches."—John Lauerman

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What you should read

Europe's Mass Testing Is No Panacea for Virus
Strained labs slow results, contact tracing and isolation rules are ignored.
Colleges: Covid Reservoirs Ready to Spill Over
Schools are de facto sanitariums as infections sweep student populations. 
CDC Pulls Guidance About Airborne Virus Spread 
Draft said airborne particles can linger in air and travel more than six feet. 
Global Coronavirus Vaccine Plan Moves Ahead
Program has 156 participants, while U.S. and China on sidelines for now.
Hong Kong Extends Social Distancing Measures 
One-week extension comes amid persisting signs of hidden transmission.

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