1. Johnson & Johnson begins phase 3 trial of single-shot COVID-19 vaccine
Johnson & Johnson has launched a phase three trial for its COVID-19 vaccine candidate and will enroll up to 60,000 participants. This is the fourth coronavirus vaccine candidate to enter phase three clinical trials in the United States but the first candidate hoping to provide protection with only one shot. Experts said a vaccine requiring just one dose would prove advantageous for delivering it to as many people as possible quickly. Johnson & Johnson CEO Alex Gorsky called this a "pivotal milestone," and the company said that if the vaccine proves to be safe and effective, it's expecting that "the first batches" could be "available for emergency use authorization in early 2021."
The Washington Post The New York Times
2. At-home coronavirus test delivers results in 15 minutes
Computer vision startup Gauss and biotech company Cellex have created the first COVID-19 test that can be done fully at home, Axios reports. While existing at-home tests still require sending test samples to a lab for analysis, this one coordinates with an app to deliver results at home in just 15 minutes. To take the test, people follow a video and swipe a nasal swab through both nostrils, then put it in a tube of solution. Drops of that solution head into a rapid test cassette, which delivers lines as a visible test result. People then take a picture of those lines and upload it to Gauss' app, and it uses AI to determine results in about 15 minutes, Axios describes. The Food and Drug Administration still has to approve the test, though it could grant it an emergency use authorization, which would get it out into the world earlier by avoiding much of the typical approval process.
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Axios
3. Moderna will likely know by November if its coronavirus vaccine works
Moderna is aiming to have its coronavirus vaccine available to the public early next year. Stephane Bancel, CEO of the Cambridge, Massachusetts-based biotech company, told The Boston Globe that Moderna originally planned to determine its vaccine's effectiveness in October. But because infection rates have been slowing, that's becoming "less and less probable." "We've said November," Bancel said. Determining a vaccine's effectiveness requires a good amount of coronavirus infections out there, as a developer needs to know if the vaccine protects people from a virus better than a placebo. The Food and Drug Administration requires a vaccine to prevent at least 50 percent of infections to be considered effective. More than 25,000 people are currently enrolled in Moderna's phase three trial across the country. If everything pans out, Bancel said Moderna will seek an emergency use authorization from the FDA to speed up the vaccine's approval process. Then Moderna can ship the doses it has already produced to the federal government.
The Boston Globe
4. FDA approves startup's portable coronavirus test kit
Visby Medical, a startup in Silicon Valley, last week became the first company to receive an Emergency Use Authorization from the Food and Drug Administration for a portable PCR coronavirus test kit, Reuters reports. PCR testing, considered one of the most accurate diagnostic tools for infectious diseases, usually requires a large, expensive machine to run results, but Visby's product can reportedly fit in a person's palm. The medical equipment company's founder and CEO Adam de la Zerda said he hasn't settled on a price for the kit, but the goal is to make it affordable. For now, the EUA will allow Visby's kit to be used in clinical labs, where it can process a nasal swab and detect COVID-19 in 30 minutes. Eventually Visby aims to sell it directly to consumers for in-home use, per Reuters.
Reuters
5. The FDA will reportedly roll out tougher standards for COVID-19 vaccine approval
The Food and Drug Administration is poised to roll out new, rigorous standards for an emergency approval of a coronavirus vaccine. The standards are expected to be much tougher than those used for the controversial emergency clearances of potential COVID-19 treatments hydroxychloroquine and convalescent plasma. Manufacturers will be asked to follow vaccine trial participants for at least two months after they receive their second shot, two individuals familiar with the situation told The Washington Post. The agency will also reportedly be looking for at least five severe COVID-19 cases in the placebo group for each trial, as well as some cases of the disease in older people to see if the vaccine works. The new standards would make it less likely for a vaccine to be approved by November, but they also could ease any growing concerns about vaccine safety.
The Washington Post
