Research Roundup: J&J starts phase 3 trials, a point-of-care COVID-19 antibody test, and global vaccine distribution
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Johnson & Johnson (J&J) has moved into phase 3 trials for its COVID-19 vaccine candidate, making the company the fourth vaccine maker to enter late-stage trials in the United States and the first to do so with a single-dose vaccine candidate. In addition to being single-dose, J&J’s vaccine candidate can be stored at refrigerator temperatures for three months, making it more accessible to countries with less health care infrastructure than vaccines that require freezing. The phase 3 trial will be run at sites in the United States, Brazil, Mexico, South Africa, and other countries, and will include significant representation of people over the age of 60 and minorities at disproportionate risk of infection, according to J&J. The company is enrolling up to 60,000 volunteers and has said the trial could yield results by the end of the year, allowing it to seek emergency use authorization in early 2021.
The US Food and Drug Administration (FDA) recently authorized for emergency use the first COVID-19 antibody test designed for use at point of care, instead of requiring samples to be shipped and tested at a laboratory. The fingerstick blood test—manufactured by Assure Tech, represented by Azure Biotech in the United States—provides results for two types of coronavirus antibodies within 15 minutes, using a lined strip similar to a pregnancy test. During an independent evaluation run in June, the test was found to have no false-negative results and a 1.2 percent false-positive rate. FDA Commissioner Stephen Hahn emphasized in a statement that point-of-care tests are more convenient, require less resources, and will decrease the time spent running antibody tests, in comparison with tests requiring lab processing.
Achieving equitable distribution of a COVID-19 vaccine, once available, will require overcoming substantial financing and misinformation hurdles, according to global health and development leaders who spoke at the United Nations General Assembly. While optimistic that a vaccine will be developed and can end the COVID-19 pandemic, leaders noted the importance of ensuring delivery to all in need, including communities at highest risk. One global mechanism working to ensure such equitable distribution is the COVID-19 Vaccine Global Access (COVAX) Facility, which intends to help ensure a vaccine reaches vulnerable populations by guaranteeing all participating low- and middle-income countries receive enough vaccines to cover 20 percent of their population. The COVAX Facility also includes 64 high-income countries and is working to raise US$2 billion to help produce 1 billion vaccine doses by the end of 2021.