Moderna announces it's testing a new Covid-19 vaccine that can be stored in refrigerators instead of freezers, NIH stops a study testing the use of convalescent plasma as a Covid-19 treatment, and more.
- Moderna on Monday announced it has started testing a next-generation Covid-19 vaccine candidate, called mRNA-1283, that could potentially be stored in refrigerators rather than freezers. According to Stéphane Bancel, Moderna's CEO, the new vaccine candidate "could facilitate easier distribution and administration in a wider range of settings, including potentially for developing countries." Moderna also announced on Tuesday that it has started studying how its Covid-19 vaccine—which FDA has authorized for use in those 16 and older—affects children under the age of 12. The study is expected to include 6,750 health children in the United States and Canada. Moderna is also testing its vaccine in 3,000 children ages 12 to 17 in a separate study (Maddipatla/Chander, Reuters, 3/15; Rummler, Axios, 3/15; Grady, New York Times, 3/16; Loftus, Wall Street Journal, 3/16).
- The European Union's drug regulatory agency, called the European Medicines Agency (EMA), on Thursday released its preliminary review of blood clotting cases among people vaccinated with AstraZeneca's Covid-19 vaccine, which found the vaccine doesn't increase the overall incidence of blood clots and its benefits continue to outweigh its risks. The announcement comes after several European countries—including France, Germany, and Spain—had stopped using the vaccine after reports of blood clots in a few dozen people throughout Europe emerged. Emer Cooke, head of EMA, said the EMA's safety committee "has come to a clear scientific conclusion. This is a safe and effective vaccine." Following the announcement, France, Italy, and Germany said they would start using the vaccine again on Friday, Mar. 19, while Spain, Portugal, and the Netherlands said they would aim to resume using it next week (Cheng/Jordans, Associated Press, 3/18; Santora et. al., New York Times, 3/18).
- NIH earlier this month announced it has stopped a clinical trial testing the use of convalescent plasma as a treatment for Covid-19 patients in the ED with mild-to-moderate symptoms and at least one risk factor for a severe case of the disease. NIH said data from an independent data- and safety-monitoring board found that, while convalescent plasma didn't cause harm, it was unlikely to be beneficial to the patients in the study (Anderson, Becker's Hospital Review, 3/3; Harris, "Shots," NPR, 3/10).
- FDA on Tuesday announced it will provide developers of Covid-19 tests with a "streamlined path" to emergency use authorization of their tests, meaning the tests can be marketed for at-home use without first being tested to see how well the tests perform in asymptomatic patients. Jeff Shuren, medical device director for FDA, and Tim Stenzel, the agency's diagnostics director, in a statement said the effort "will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs, and increase consumer access to testing" (Lim, Politico, 3/16).
- HHS announced it will be limiting the distribution of Eli Lilly's Covid-19 antibody therapy in three states in response to concerns about the treatment's effectiveness against new variants of the coronavirus. Specifically, HHS is examining recommendations for use of the treatment in areas where the CAL.20C variant, first discovered in California, is prevalent. As HHS evaluates the recommendations, direct ordering of the treatment will not be permitted in California, Arizona, and Nevada, according to HHS (Khandekar, Reuters, 3/12).