FDA authorizes two rapid, at-home Covid-19 tests, CDC expands list of conditions likely to cause severe cases of Covid-19, and more.
- U.S. Secretary of State Antony Blinken on Monday named Gayle Smith—who served as the coordinator of U.S. Agency for International Development under former President Barack Obama's administration—as coordinator of the Department of State's Global COVID Response & Health Security. Blinken said Smith, who has experience addressing global health crises, will lead the United States' Covid-19 vaccine diplomacy globally. Previously, Smith served as the CEO of the ONE Campaign, a global organization that works to end preventable disease and extreme poverty by 2030 (Pamuk/Lewis, Reuters, 4/5).
- CDC last week expanded the list of medical conditions more likely to cause people to experience severe cases of Covid-19. The new list includes substance use disorders and a number of conditions CDC had previously said "might" place people at an elevated risk for a severe case, including dementia, diabetes, moderate-to-severe asthma, liver disease, HIV infection, and cystic fibrosis (Tucker, Medscape, 3/31).
- FDA last week authorized two rapid, at-home Covid-19 tests to be sold over the counter. FDA in a release said consumers can now purchase Abbott's BinaxNow and Quidel's QuickVue without prescriptions to repeatedly test themselves at home. Both tests can be used on people ages 2 and older, although children will need an adult to handle their specimen samples. In addition, both tests deliver results in less than 20 minutes—with BinaxNOW, which includes two tests per kit, providing results in 15 minutes and Quidel QuickVue providing results in 10 minutes. The authorizations come after FDA in March announced a streamlined pathway for companies with authorized tests to sell over-the-counter versions of their products. Michael Mina, an assistant professor of epidemiology at the Harvard T. H. Chan School of Public Health, in a statement in response to the authorizations, wrote, "This is a huge milestone. Having an inexpensive over-the-counter test can stop the virus from spreading by detecting people who are infectious and giving them an opportunity to know their status and ideally isolate accordingly" (Diaz/Simmons-Duffin, NPR, 4/1; Alltucker, USA Today, 4/1).
- FDA last week authorized a new multidose vial for Moderna's Covid-19 vaccine that can hold up to 15 doses and clarified that vaccinators can extract up to 11 doses from the company's existing 10-dose vials. "Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly," FDA vaccine regulator Peter Marks said in a statement. "Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly" (Lim, Politico, 4/1; Associated Press, 4/1).
- HHS last week directed Johnson & Johnson (J&J) to take over production of its Covid-19 vaccine at Emergent BioSolutions' Baltimore manufacturing facility after an error resulted in the accidental contamination of 15 million of the company's vaccine doses. The doses were contaminated when workers at the plant mixed up the ingredients of two different Covid-19 vaccines—one developed by J&J and the other by AstraZeneca. Following the incident, the federal government ordered Emergent to stop manufacturing AstraZeneca's vaccine at the facility to allow J&J to focus exclusively on its vaccine production, Reuters reports. Andy Slavitt, a senior adviser to the White House's Covid-19 response team, during a news conference said, "This is not a decision that in any way has anything to do with any concerns about the AstraZeneca vaccine." In countries throughout Europe where AstraZeneca's vaccine is authorized, regulators have been investigating cases of blood clotting among people who've received the company's vaccine, including seven deaths in the United Kingdom. AstraZeneca's vaccine has not yet been authorized in the United States, but the company said it is now working with the federal government to find an alternative manufacturing facility to produce its vaccine (Loftus/Leary, Wall Street Journal, 4/2; O'Donnell, Reuters, 4/5).
- The European Medicines Agency (EMA) on Wednesday said a safety committee concluded that "unusual blood clots with low blood platelets should be listed as very rare side effects" for AstraZeneca's Covid-19 vaccine. However, regulators emphasized research showing that the vaccine was 76% effective at preventing Covid-19, noting that those benefits outweigh the risk of blood clots. "This vaccine has proven to be highly effective to prevent severe disease and hospitalization," Emer Cooke, EMA's executive director, said. "And it is saving lives" (Branswell/Herper, STAT News, 4/7).
- Pfizer and BioNTech in a release last week announced new data from an updated analysis of their Phase 3 clinical trial showing their vaccine is 91.3% effective at protecting against symptomatic Covid-19 cases up to six months after the second dose is administered. In addition, the updated analysis—which involved 927 symptomatic Covid-19 cases among the trial's 46,307 participants, including 850 among those who received a placebo and 77 among those who received the vaccine—showed the vaccine is 100% effective against severe cases of Covid-19 based on CDC's definition of severe disease and 95.3% effective based on FDA's definition. BioNTech CEO Ugur Sahin said the new data "further confirm[s] the strong efficacy and good safety" of the vaccine and provides "the first clinical results" that show the "vaccine can effectively protect against currently circulating variants," which is "a critical factor to reach herd immunity and end this pandemic for the global population" (Axios, 4/1; Hopkins, Wall Street Journal, 4/1).
- Walgreens said that starting at the end of this week, it will begin to schedule appointments for doses of Pfizer/BioNTech's Covid-19 vaccine three weeks apart as recommended by CDC after receiving complaints from customers. Until now, the company had been setting up appointments for the shots four weeks apart, which is one week more than CDC recommended, because delaying the second shot made it easier and simpler to scheduled appointments (Choi, The Hill, 4/5).