Johnson & Johnson began their largest trial yet testing a coronavirus disease 2019 (COVID-19) vaccine; a study finds college openings fueled COVID-19 cases; the FDA is expected to release stricter vaccine authorization guidelines.
Johnson & Johnson announced it began large clinical trials of its experimental vaccine for coronavirus disease 2019 (COVID-19) on September 21, The New York Times reports. The vaccine does not need to be frozen and may only require 1 shot instead of 2. The company plans to enroll 60,000 participants, making it the largest phase 3 trial of all vaccines currently being tested. Paul Stoffels, MD, chief scientific officer at Johnson & Johnson, said the company may be able to determine the vaccine’s safety and efficacy by the end of the year. A manuscript with data from earlier phases of the trial will be posted online soon.
A study conducted by researchers at 4 universities concluded reopening college campuses led to an additional 3000 COVID-19 cases each day, Kaiser Health News reports. According to the draft study, researchers tracked cellphone data and matched it to reopening schedules at 1400 schools and to county infection rates. Of the schools included, nearly 900 opened primarily with in-person classes, and a correlation between attempted in-person instruction and greater disease transmission rates was established. Data were collected between July 15 and September 13, 2020. Each university reopening led to an additional 1.7 infections per day per 100,000 individuals in a county.
The FDA is expected to release more stringent guidelines for emergency vaccine authorization in light of the race to procure a safe and effective vaccine for COVID-19, according to The New York Times. If the guidelines are approved by the White House, they could be released as early as this week. Individuals familiar with the draft said the guidelines would lay out more specific criteria for clinical trial data and recommend the data be vetted by a committee of independent experts prior to any FDA authorization. When released, the guidance would be the most detailed description yet by the federal government on how the vetting process will be carried out.