Vaccine Development Gets Down To The Details

Stat: Will This Be The Most-Watched FDA Meeting Ever? 
The FDA’s panel of outside vaccine experts will meet Thursday to discuss approval standards for an eventual Covid-19 vaccine. These meetings are typically attended only by the nerdiest biotech investors and FDA lawyers, but this one is expected to attract so much attention that the FDA is setting up a Youtube stream for the event instead of its typical (often rage-inducing) internal streaming service. (Florko, 10/20)

WBUR: NIH Director 'Guardedly Optimistic' About COVID-19 Vaccine Approval By End Of 2020
Coronavirus cases appear headed for a new surge in the U.S., which could eclipse the explosion of cases in July.Much of the new surge is driven by cases in the Midwest and Great Plains states. (Doubek and Inskeep, 10/20)

Stat: Health Experts Push Vaccine Makers To Release Covid-19 Trial Protocols
Amid concerns over a lack of transparency Covid-19 product development, more than two dozen academics and health policy experts are urging federal officials and several vaccine makers to fully disclose all information concerning their clinical trial protocols and agreements. In an open letter, they acknowledged that sharing such details is unusual, but in this instance, such a step would help to ensure accountability, advance scientific understanding, and build public trust, especially at a time when the race to develop a safe and effective Covid-19 vaccine has become highly politicized by the Trump administration. (Silverman, 10/20)

Meanwhile, vaccine distribution obstacles loom —

Nature: How Obesity Could Create Problems For A COVID Vaccine
Researchers are still unsure whether or not obesity will affect vaccine efficacy. And there might be ways to counteract problems if they arise. But scientists are also concerned that clinical trials might not be well designed to capture such issues promptly. “It‘s something the experts need to really look at,” says Ryan. (Ledford, 10/20)

The Boston Globe: Colder Than Antarctica In Winter: Super Cooling Concerns For The Possible First COVID-19 Vaccine
The race to create safe and effective vaccines against the coronavirus is facing another complex challenge: how to safely deliver tens of millions of doses to all corners of the world while ensuring they remain in super cold storage until ready for use. Just how cold? As in minus 103 Fahrenheit for the first vaccine expected to be given the green light. That’s nearly four times colder than your home freezer, colder even than Antarctica in winter. (Lazar, 10/20)

In global vaccine news —

AP: Chinese Drugmaker Setting Up Vaccine Production Lines
A state-owned Chinese drugmaker is setting up production lines to supply 1 billion doses of two possible coronavirus vaccines that are being tested on 50,000 people in 10 countries, the company chairman said Tuesday. Testing by SinoPharm Group is “in the last kilometer of a long march,” chairman Liu Jingzhen said at a news conference. He gave no indication when results are expected. (10/20)

Reuters: Chinese City To Offer COVID-19 Vaccine Candidate As Emergency Use Expands 
A city in China’s Zhejiang province will offer experimental coronavirus vaccines to its residents, as China broadens an emergency use programme to people in non-priority groups. Residents aged between 18 and 59 in the city of Shaoxing, who are not in priority groups, can apply online for inoculation, the city’s health commission said on Tuesday on its WeChat account. It did not name the vaccine, say when inoculation would start or how many doses would be offered. (10/21)

Reuters: Five South Koreans Die After Getting Flu Shots, Sparking Vaccine Fears
Five people have died after getting flu shots in South Korea in the past week, authorities said, raising concerns over the vaccine’s safety just as the seasonal inoculation programme is expanded to head off potential COVID-19 complications. Authorities said there was no reason to believe the deaths were linked to the vaccine but an investigation, including post mortems, was underway. (10/21)