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November 11, 2022

Virus roundup: FDA authorizes new Covid-19 treatment for hospitalized patients

Daily Briefing

    HHS renews the monkeypox public health emergency (PHE), babies born during the pandemic may be slower to reach certain developmental milestones, and more in this week's roundup of monkeypox and Covid-19 news.


    • HHS last week renewed the PHE declaration for monkeypox, which was first signed on Aug. 4, for another 90 days. In a statement, HHS Secretary Xavier Becerra said that "continued consequences of an outbreak of monkeypox cases across multiple states," as well as "consultation with public health officials" pushed him to renew the PHE. Separately, an HHS spokesperson said the decision to renew was also partially based on a need to continue collecting data from states and jurisdictions and for vaccine effectiveness studies to be conducted. So far, CDC has reported more than 28,000 monkeypox cases in the United States. After peaking in August, monkeypox cases have been on the decline, with the most recent seven day moving average at 30 cases per day. (Choi, The Hill, 11/2; AHA News, 11/3)
    • "Considerable" viral transmission can occur before symptoms appear from a monkeypox infection, according to a new study published in the British Medical Journal. For the study, researchers from the UK Health Security Agency analyzed routine surveillance and contact tracing data for 2,746 people who tested positive for monkeypox between May and August. The average age of the patients was 38, and 95% reported being gay, bisexual, or men who have sex with men. Using two statistical models, the researchers found that the median serial interval, or the time between when symptoms began in one case to another, was shorter than the median incubation period, or the time between exposure and symptom onset. This suggests that "considerable" monkeypox transmission may have occurred up to four days before symptoms first appeared or were detected. Overall, up to 53% of monkeypox transmission in the study may have occurred before symptoms appeared. According to independent experts, the study's findings could have a significant impact on global infection control if it is supported by more research. "These are urgent questions that need answers," said Boghuma Kabisen Titanji, an assistant professor of medicine at Emory University. (Rigby, Reuters, 11/2)


    • Pfizer and BioNTech last week reported that their updated bivalent Covid-19 booster generated "substantially higher" immune responses against the omicron BA.4/BA.5 subvariants than their original vaccine. According to the companies, individuals ages 55 and older who received an updated booster saw a 13.2-fold increase in neutralizing antibodies, while those ages 18 to 55 saw a 9.5-fold increase. In comparison, older adults who received the original vaccine only saw a 2.9-fold increase in neutralizing antibodies. "As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages," said Pfizer CEO Albert Bourla. "These updated data also provide confidence in the adaptability of our mRNA platform and our ability to rapidly update the vaccine to match the most prevalent strains each season." (Christensen, CNN, 11/4; Johnson, Washington Post, 11/4; Branswell, STAT, 11/4)
    • The omicron subvariant BA.5 continues to be the dominant strain in the United States, but two new "escape variants," BQ.1 and BQ.1.1, are quickly gaining ground, according to CDC data. For the week ending Nov. 5, BA.5 made up 39.2% of all Covid-19 infections, while BQ.1.1 made up 18.8% and BQ.1 made up 16.5%. In addition, another omicron subvariant BF.7 made up 9% of all infections. As of Nov. 2, the country's seven-day case average was 39,016, a 4.7% increase from the previous week. According to modeling from Mayo Clinic, daily Covid-19 cases are projected to increase 39% over the next two weeks, jumping from a daily average of 35,638.9 to 49,564 by Nov. 17. Hospitalizations and deaths are projected to remain largely stable or have an uncertain forecast over the next four weeks. (Bean, Becker's Hospital Review, 11/4; Bean, Becker's Hospital Review , 11/7)
    • FDA has issued an emergency use authorization (EUA) for anakinra, an interleukin-1 receptor antagonist, to treat Covid-19 in certain hospitalized adults, including patients with pneumonia who require supplemental oxygen and are at risk of severe respiratory failure. In the randomized, double-blind, placebo-controlled SAVE-MORE trial, researchers tested anakinra on 594 patients with Covid-19 pneumonia who had a risk of developing severe respiratory failure. By day 28, the researchers found that anakinra reduced the odds of a having a worse score on the World Health Organization's Clinical Progression Scale by 64% compared to a placebo. Treatment with anakinra also reduced the risk of severe disease or death by 54% and shortened the average time until hospital and ICU discharge by one day and four days, respectively. According to the EUA, the recommended dosage of anakinra is 100 mg administered daily by subcutaneous injection for 10 days. For patients with end-stage renal disease or severe renal insufficiency, the recommended dosage is 100 mg every other day for 10 days. Common adverse reactions to anakinra include increased transaminase levels, neutropenia, rash, and injection site reactions. (Bassett, MedPage Today, 11/9)
    • Babies born during Covid-19 lockdowns may be reaching certain developmental milestones later than those born before the pandemic, according to a new study published in the Archives of Disease in Childhood. For the study, researchers at the Royal College of Surgeons in Ireland asked the parents of 309 infants born between March and May 2020 to report on their child's ability to perform 10 development milestones by age one. They then compared these responses to data collected on more than 1,600 infants born in Ireland between 2008 and 2011. Overall, the researchers found small but significant differences between the two groups for certain milestones. For example, fewer infants born during the pandemic could wave goodbye, point at objects around them, and say at least one "definite and meaningful word" by their 12-month assessment. On the other hand, these infants were more likely to be able to crawl by age one than their pre-pandemic peers. According to NBC News, this current study builds on other research that suggests the pandemic hindered infants' development. However, experts say they do not believe these delays will be permanent. "I don't think that these small differences really early on in development mean that these kids are on a life course of having developmental delays," said Lauren Shuffrey, an associate research scientist at Columbia University Medical Center, who was not involved in the study. "These are really small differences and we know that infants' and young children's brains are super malleable." (Timsit, Washington Post, 10/28; Bendix, NBC News, 10/12)

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