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February 5, 2021

Covid-19 roundup: J&J files for emergency use authorization of its vaccine

Daily Briefing

    A study finds the Covid-19 vaccine developed in Russia is 92% effective, research indicates Eli Lilly's monoclonal antibody treatment for Covid-19 is ineffective against a coronavirus variant first discovered in South Africa, and more.

    • Johnson & Johnson (J&J) on Thursday asked FDA for an emergency use authorization of its Covid-19 vaccine candidate. The move comes shortly after J&J last week released findings from a Phase III clinical trial demonstrating that just one dose of the vaccine candidate was 66% effective at preventing moderate and severe cases of the disease on an international scale, and 72% effective at doing so in the United States, specifically. According to the New York Times, an EUA for the vaccine candidate could accelerate what's been a bumpy vaccine rollout so far in the United States, because J&J's experimental vaccine—unlike the two Covid-19 vaccines currently authorized for use in the country—requires just one dose, rather than two. In addition, J&J's vaccine candidate can be stored at normal refrigerator temperatures, rather than requiring special freezers. FDA said it would review the application on Feb. 26. For its part, J&J said it would have millions of doses ready to ship as soon as any potential authorization is issued, and the company expects to produce more than one billion doses overall in 2021 (Loftus, Wall Street Journal, 2/4; Branswell, STAT News, 2/4; New York Times, 2/5; Wang, Inside Health Policy, 2/4 [subscription required]).
    • A pre-print study published on bioRxiv suggests Eli Lilly's monoclonal antibody treatment for Covid-19 is ineffective against a variant of the novel coronavirus called B.1.351, which scientists first discovered in South Africa and that's since been detected in other countries, including the United States. However, the study suggests Eli Lilly's treatment is equally as effective against the B.1.1.7 coronavirus variant, which was first discovered in the United Kingdom and has since been detected in the United States and other countries, as it is against earlier variants of the novel coronavirus (Adams, Becker's Hospital Review, 1/28).
    • The Covid-19 vaccine developed in Russia, called Sputnik V, is 92% effective, according to a study published Tuesday in The Lancet. For the study, researchers from Sept. 7, 2020, to Nov. 24, 2020, randomly assigned 19,866 participants at 25 hospitals and clinics to receive either the vaccine or a placebo. According to the study, 0.1% of the participants in the vaccine group tested positive for the novel coronavirus after receiving their second dose of the vaccine, compared with 1.3% of the participants in the placebo group. The vaccine also appeared effective, though less so, after participants received just one dose of the vaccine, the study showed. Efficacy between 15 and 21 days after receiving the first dose of the vaccine was about 73.6%, according to the study. Further, researchers found that 98% of participants had detectable levels of antibodies against the new coronavirus at 42 days after receiving the first dose of the vaccine, compared with 15% of participants in the placebo group (Taylor/Johnson, Washington Post, 2/2; Van Beusekom, CIDRAP News, 2/2).
    • Public health officials in the United Kingdom have warned that a recently detected version of the B.1.1.7 coronavirus variant, which officials first identified in the United Kingdom but has since been detected in the United States and other countries, contains the E484K mutation, which research suggests can make the virus less susceptible to vaccines. Officials on Tuesday said they'd identified at least 11 people around the city of Bristol who were infected with the B.1.1.7 coronavirus variant featuring the E484K mutation. In a pre-print study from the University of Cambridge, researchers found that the Covid-19 vaccine developed by Pfizer and BioNTech was effective against B.1.1.7, but when the E484K mutation was added, an average of 10 times the antibody levels were needed to neutralize the virus (Sugden/Steinhauser, Wall Street Journal, 2/2; Achenbach/Booth, Washington Post, 2/2; Schnirring, CIDRAP News, 2/2).
    • Researchers at the University of Oxford have launched a new study to see if mixing Covid-19 vaccine doses from different manufacturers is safe and effective. The researchers for the study will recruit 820 participants over the age of 50 and give them doses of Covid-19 vaccines developed by Pfizer and AstraZeneca in different sequences at four and 12 weeks apart. While the study won't look at the overall efficacy of combining the vaccines, researchers will examine antibody and T-cell responses in the participants and monitor for side effects. Matthew Snape, a vaccinologist at Oxford, said the researchers expect to get some results "by June or thereabouts that will inform the use of booster doses in the general population" (Cheng, Associated Press, 2/4; Ring, Bloomberg, 2/3; Smout, Reuters, 2/3).
    • The World Health Organization (WHO) on Friday released new advice for pregnant women looking to receive a Covid-19 vaccine, saying although it still "recommends not to use" Covid-19 vaccines on pregnant women unless those women are at a high risk of exposure to the novel coronavirus or have underlying health conditions, "[b]ased on what we know about this kind of vaccine, we don't have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women." Previously, WHO specifically advised against pregnant women receiving Covid-19 vaccines because of a lack of data on the vaccines' safety and efficacy in pregnant women. Denise Jamieson, an obstetrician at Emory University and a member of the American College of Obstetrics and Gynecology's Covid-19 expert group, praised WHO's change in language, saying it "provides an important opportunity for pregnant women to get vaccinated and protect themselves from the severe risks of Covid-19" (Mandavilli, New York Times, 1/29).

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