CDC announces it is looking into rare cases of myocarditis following vaccination from mRNA Covid-19 vaccines, the World Health Organization says Covid-related deaths likely underreported, and more.
- President Biden on Wednesday issued a statement ordering U.S. intelligence agencies to investigate how the coronavirus originated, saying the CIA and other intelligence agencies have yet to reach a consensus on how the virus came to be. According to the New York Times, the announcement indicates the Biden administration "takes seriously" the chance that—rather than originating via animal-to-human transmission outside of a lab, as is the prevailing theory—the virus may have accidently leaked from a lab. "I have now asked the intelligence community to redouble their efforts to collect and analyze information that could bring us to a definitive conclusion," Biden said, adding the agencies have 90 days to report back to him (Shear et al., New York Times, 5/26).
- FDA on Wednesday issued an emergency use authorization (EUA) for the monoclonal antibody drug developed by GlaxoSmithKline (GSK) and Vir Biotechnology for treatment against early Covid-19, making it the third monoclonal antibody treatment to receive FDA authorization. The drug, known as sotrovimab, has been shown in lab tests to neutralize variants of the coronavirus first identified in Brazil, California, New York, India, South Africa, and the United Kingdom. According to the New York Times, FDA authorized the drug based on a study of 583 people in the early stages of Covid-19 that found patients who received the drug had an 85% lower risk hospitalization or death when compared with those who received a placebo. In a release, GSK said the drug will be available in the United States "in the coming weeks" (Robbins, New York Times, 5/26; Walker, Wall Street Journal, 5/26; Chen, Axios, 5/26).
- CDC's Advisory Committee on Immunization Practices (ACIP) last week announced it is reviewing a few rare cases of myocarditis, or heart inflammation, in some young adults after receiving both doses of mRNA Covid-19 vaccines. ACIP has not concluded that the cases are related to the vaccines. However, the committee said that when it does occur post-vaccination, it typically affects adolescents and young adults, presents more often in males than females, happens more often after the second dose rather than the first, and usually occurs within four days of vaccination. Most of the myocarditis cases that occur appear to be mild, ACIP said, and CDC's follow-up is ongoing (Mandavilli, New York Times, 5/22; Rummler, Axios, 5/23; Anilkumar, Reuters, 5/22).
- The number of Covid-19 deaths are likely underreported globally and in the United States specifically, according to a pair of new reports. In the first report, the World Health Organization said data suggests roughly 3 million people have died from Covid-19 in 2020, accounting for roughly 1.2 million more than the 1.8 million officially reported—a discrepancy the agency linked to many countries' limited capacity to test people for infection and track Covid-related deaths. Samira Asma, assistant director of the WHO's data division, added that altogether, between 6 million and 8 million people may have now died from the pandemic, either directly or indirectly. Meanwhile, a second report, published in PLOS Medicine, assessed county-level Covid-19 and all-cause death data from the National Center for Health Statistics between Jan. 1 and Dec. 31, 2020, and determined that Covid-19 may have killed 20% more people in the United States than previously reported (Van Beusekom, CIDRAP News, 5/21; Revill/Farge, Reuters, 5/21; Weixel, The Hill, 5/21; Cumming-Bruce, New York Times, 5/21).
- Pfizer-BioNTech, Moderna, and Johnson & Johnson (J&J) last week pledged to donate more than 2.3 billion doses of their vaccines to low- and middle-income countries over this year and next. Pfizer-BioNTech pledged one billion doses both in 2021 and 2022, while J&J and Moderna pledged 200 million and 100 million, respectively, this year (Associated Press, 5/21; Reuters, 5/21).
- FDA on Tuesday said it may refuse new EUA requests through the rest of the pandemic for any Covid-19 vaccine candidates if the drugmakers have not already started conversations with FDA about the candidate. As of now, only vaccines made by Pfizer-BioNTech, Moderna, and J&J have received EUAs for use in the United States. Of the other manufacturers that have begun discussions with FDA, Novavax said it likely won't seek authorization for its vaccine in the United States until the third quarter of 2021, Medicago said it is still engaged in conversations regarding an EUA for its vaccine, and AstraZeneca said it may opt to skip seeking an EUA in favor of pursuing full approval (Reuters, 5/25).
- Two doses of either Pfizer-BioNTech's or AstraZeneca's Covid-19 vaccine provides effective protection against the B.1.617.2 coronavirus variant first discovered in India, according to a new study led by Public Health England. Specifically, the Pfizer-BioNTech vaccine was 88% effective against symptomatic Covid-19 from the variant two weeks after the second dose, while AstraZeneca's was 60% effective. The vaccines were similarly effective against the B.1.1.7 variant first discovered in the United Kingdom, with the Pfizer-BioNTech vaccine showing 93% effectiveness against symptomatic infection from the variant and AstraZeneca's showing 66% effectiveness. However, both vaccines were less protective against either variant after just one dose, with both showing 33% efficacy and 50% efficacy against symptomatic disease from B.1.617.2 and B.1.1.7, respectively, three weeks after the first dose (Ellyatt, CNBC, 5/24).