A new study suggests the B.1.1.7 coronavirus variant isn't more deadly than older strains, FDA authorizes the first at-home Covid-19 antibodies test, and more.
- Moderna on Tuesday announced that its Phase III clinical trial showed its Covid-19 vaccine was more than 90% effective at protecting against Covid-19 and more than 95% effective at preventing severe Covid-19. The new results, published in the New England Journal of Medicine, showed that antibody activity from the vaccine lasted six months after the second dose. However, Moderna noted that these results are preliminary and that it will share updated data throughout the year. Moderna CEO Stéphane Bancel in a release said the company is "looking forward to having the clinical data from our variant-specific booster candidates, as well as clinical data from the Phase 2/3 study of our Covid-19 vaccine in adolescents" (Lovelace Jr., CNBC, 4/14; Rummler, Axios, 4/13).
- A recent study of 496 Covid-19 patients has found the B.1.1.7 variant of the coronavirus, first discovered in the United Kingdom, appears to spread more easily than the original strain of the virus but does not lead to more severe cases of Covid-19. According to the study, published in The Lancet Infectious Diseases, those infected in late 2020 with B.1.1.7 had more of the virus present in their bodies than those with older strains of the virus, but those hospitalized with B.1.1.7 did not see higher mortality rates or worse overall outcomes than those with older strains. Overall, the researchers found the B.1.1.7 variant was around 40% to 70% more transmissible than previous variants (Abbott, Wall Street Journal, 4/12; Reuters, 4/13; Diaz, NPR, 4/13; Walker, MedPage Today, 4/12).
- FDA earlier this month authorized the first at-home Covid-19 antibody test, developed by Symbiotica. The test allows users to collect blood samples from a finger prick and send the samples to a lab to be tested for Covid-19 antibodies. Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said the test will "play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior Covid-19 infection" (Anderson, Becker's Hospital Review, 4/7).
- Pfizer and BioNTech on Friday requested that FDA expand its emergency use authorization for their Covid-19 vaccine to include children ages 12 to 15 in light of Phase III trial results that showed none of the more than 2,000 adolescents who received the vaccine in the trial experienced symptomatic Covid-19 or any serious side effects. The data from the trial also showed that the 12- to 15-year-olds produced higher levels of antibodies on average than older adolescents and young adults did. If FDA expands its authorization, Pfizer and BioNTech's Covid-19 vaccine would be the first authorized for use in children 12 to 15 years old (Anthes, New York Times, 4/9; Erman/Roy, Reuters, 4/9; Owermohle, Politico, 4/9).
- Regeneron Pharmaceuticals on Monday said it will be asking FDA to allow its antibody therapy to be used as a preventive treatment for Covid-19. Currently, the therapy is authorized as a treatment for adults with mild-to-moderate Covid-19 and children ages 12 and older who have tested positive for the new coronavirus and are at high risk of severe Covid-19. However, a Phase III trial of 1,505 people, run in partnership with NIH, found that Regeneron's therapy reduced the risk of symptomatic Covid-19 by 81%, and that those who received the treatment who did develop symptoms saw those symptoms resolve two weeks faster than those who received a placebo (Lovelace, CNBC, 4/12; Herper, STAT News, 4/12; Walker, Wall Street Journal, 4/12).
- Gilead Sciences on Monday said it halted the late-stage trial of its intravenous Covid-19 treatment—called Veklury—among high-risk non-hospitalized Covid-19 patients. Gilead said the decision to halt the trial wasn't a result of safety or efficacy concerns, but rather that the development of a multiple-day injection that needs to be administered in a health care setting no longer meets an unmet need for non-hospitalized Covid-19 patients (Reuters, 4/12).