The first at-home rapid Covid-19 test is shipped to major pharmacies in the United States, two coronavirus variants discovered in California are found to be more contagious than the original coronavirus strain, and more.
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- Preliminary data from CDC published in the New England Journal of Medicine has found that Covid-19 vaccines are safe in pregnant women, and that side effects from the vaccine are consistent with the side effects among non-pregnant people. The study was based on reports from more than 35,000 women in the United States who had received either Pfizer/BioNTech's vaccine or Moderna's vaccine while pregnant. None of the women in the study received Johnson & Johnson's (J&J) Covid-19 vaccine. Separately, the American Society for Reproductive Medicine said that, based on data it has been observing for more than a year, Covid-19 vaccines are "safe and effective" in pregnant women (Tanner, Associated Press, 4/21; Walker, MedPage Today, 4/21; Anthes, New York Times, 4/21).
- Eli Lilly has requested FDA cancel its emergency use authorization for the drugmaker's Covid-19 antibody, bamlanivimab. In a statement, Eli Lilly said the request is not due to any safety concerns, but rather in light of new coronavirus variants spreading in the United States that could be resistant to bamlanivimab alone. Eli Lilly said hospitals should instead order bamlanivimab alongside etesevimab and pair the two together. According to Eli Lilly, the antibody cocktail of bamlanivimab and etesevimab neutralize more coronavirus variants than bamlanivimab on its own (Reuters, 4/16).
- BinaxNOW, the rapid at-home Covid-19 test developed by Abbott Laboratories, on Monday was sent to major pharmaceutical stores including CVS, Walgreens, and Walmart, to be sold over the counter. In March, FDA gave the test authorization for use on children as young as two and all people 15 or older. The test can be taken by both symptomatic and asymptomatic patients and can provide results within 15 minutes, Abbott said. The tests will be sold in two-packs for $23.99 (Pezenik/Pereira, ABC News, 4/19).
- The Emergent BioSolutions plant in Baltimore that contaminated 15 million J&J Covid-19 vaccines after inadvertently mixing them with ingredients from AstraZeneca's Covid-19 vaccine was found to be unsanitary, with poorly trained staff who did not follow proper manufacturing procedures, according to an FDA report released Tuesday. While the contaminated doses have all been quarantined, investigators said they were concerned additional doses from the plant may have also been contaminated. Emergent said, "While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them" (Weixel, The Hill, 4/19; LaFraniere et al., New York Times, 4/21; AP/CBS News, 4/22; Owermohle/Banco, Politico, 4/21).
- Two coronavirus variants first discovered in California—B.1.427 and B.1.429—are around 20% more infectious than the original strain of the virus, according to a new study from UCSF, UC Berkeley, and the California Department of Public Health published in Cell. For the study, researchers looked at the variants in 2,172 samples from 44 counties in California and found the two variants are very similar, sharing at least one specific mutation. The researchers found the variants seem to be more transmissible and are less susceptible to antibodies produced by Covid-19 vaccines or previous infections (Arredondo, San Francisco Chronicle, 4/21).
- Merck on Thursday said a clinical trial of its antiviral pill for treating early Covid-19, called molnupiravir, has shown "encouraging" results. However, the pill has not been shown to help hospitalized patients, meaning it needs to be used very early in the course of the disease. According to Roy Baynes, CMO at Merck, a 302-patient study of the drug in non-hospitalized Covid-19 patients found the percentage of patients who were hospitalized or died from Covid-19 was lower among patients who received the molnupiravir than among the placebo group (Herper, STAT News, 4/15; Griffin/Koons, Bloomberg, 4/15).
- Remdesivir, the antiviral drug developed by Gilead Sciences under the brand name Veklury, has been found to be as safe and effective for use in pediatric Covid-19 patients as it is with adult Covid-19 patients, according to a study published Wednesday in Pediatrics. The study of 77 children in the United States, United Kingdom, Italy, and Spain found that, within four weeks of treatment, 88% of the children in the study had a decreased need for oxygen support while 83% had recovered and 73% were discharged (Lapid, Reuters, 4/21).