A preprint study finds the monkeypox vaccine is 79% effective against infection, nearly 90% of physicians believe there is a lack of clinical guidelines for long Covid, and more in this week's roundup of monkeypox and Covid-19 news.
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- FDA last week authorized the first commercial monkeypox test kit for emergency use. The test, which was developed by Abbott, detects monkeypox in lesion swab specimens. Currently, only laboratories that have been certified to perform moderate or high complexity tests under the Clinical Laboratory Improvement Amendments are authorized to perform the test. To validate the test, Abbott assessed its ability to correctly identify the presence of monkeypox at two and four times the limit of detection. Overall, the test correctly detected the virus in all 36 positive samples and correctly reported the absence of the virus in 35 negative samples. According to MedTech Dive, other companies, including Becton Dickinson, are also preparing to enter the market with their own monkeypox tests. (AHA News, 10/10; Taylor, MedTech Dive, 10/10)
- According to a preprint study from Israel, the Jynneos monkeypox vaccine is 79% effective against infection. For the study, researchers analyzed data from patients who were eligible for monkeypox vaccination in the Clalit Health Services system between July 31 and Sept. 12. Of the 1,970 eligible patients, 873 (44%) received the first dose of the Jynneos vaccine and completed at least 25 days of follow-up. Overall, 15 unvaccinated patients contracted monkeypox during the study period compared to three vaccinated patients, resulting in an estimated vaccine effectiveness rate of 79%. According to the researchers, the findings "suggest that a single dose of MVA [monkeypox vaccine] is associated with a significantly lower risk for MPVX infection in high-risk individuals." (CIDRAP News, 9/26; Arbel et al., Research Square, 9/23)
- Earlier this month, HHS Secretary Xavier Becerra signed a declaration allowing pharmacists to administer monkeypox vaccines. The declaration amended the 2005 Public Readiness and Emergency Preparedness Act to authorize any pharmacist, pharmacy intern, or pharmacy technician "who is licensed or certified" to administer monkeypox vaccines and treatments, whether it is "intramuscular, intradermal, or subcutaneous injection, dermal/percutaneous scarification, intranasal or oral administration." According to Becker's Hospital Review, the American Society of Health System Pharmacists (ASHP) has advocated for this change for months. "For both vaccines and therapeutics, time is of the essence, and pharmacists and their team are best positioned to quickly ramp up patient services," said Tom Kraus, ASHP's VP of government relations. The American Pharmacists Association praised HHS' decision, but the organization's interim CEO Ilisa Bernstein said that they have "yet to see what plans are in place to ensure a sustainable model for pharmacists and pharmacies to offer the monkeypox vaccine and treatments." (Twenter, Becker's Hospital Review, 10/3)
- Federal regulators on Wednesday authorized updated Covid-19 booster shots for children as young as 5. A third of a dose of Pfizer-BioNTech's updated booster was authorized for use in children ages 5 to 11. Moderna's updated booster was authorized at its full dose for adolescents ages 12 to 17 and at a half dose for children ages 6 to 11. According to Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis, the updated boosters are "extremely important" to keep children healthy and in school, and parents should know that "there is no concern from the safety perspective with the bivalent vaccines, whether Moderna or Pfizer." Ashish Jha, the White House Covid-19 coordinator recommends people get vaccinated with the booster before Halloween if possible. "Why Halloween? Because it takes a couple of weeks for your immune system to generate the benefit from that vaccine," Jha said. "And that means you will be ready by Thanksgiving and certainly by the holidays." (Scribner, Axios, 10/12; AP/Modern Healthcare, 10/12; Joseph, STAT, 10/12)
- The Biden administration on Tuesday appointed Pamela Hamamoto, a former ambassador to the United Nations, to lead U.S. negotiations at the World Health Organization's (WHO) proposed global pandemic accord, which aims to address some of the largest Covid-19 missteps. In a joint statement, HHS Secretary Xavier Becerra and Secretary of State Antony Blinken said Hamamoto will "assume management and oversight of U.S. engagement" at the pandemic accord. The goal of the negotiations is to reach an agreement that "effectively strengthens global health collaboration, improves systems for monitoring disease or pandemic outbreaks, bolsters national health security capacities, and enhances equity in pandemic preparedness and responses," Becerra and Blinken said. According to The Hill, WHO and other member countries have advocated for a legally binding agreement to ensure changes, but the United States has not been as receptive to the idea. (Weixel, The Hill, 10/12)
- According to a new survey published by Sermo, nearly 90% of physicians worldwide believe there is a lack of guidelines to help providers diagnose and treat patients with long Covid. For the survey, Sermo surveyed more than 1,100 global physicians between Sept. 22 and Sept. 26. Overall, 62% of the surveyed physicians said they are seeing an increase in long Covid symptoms among their patients, and 71% said they are seeing more patients express concerns about long Covid. However, 86% of physicians said there is a lack of clinical guidance to help them diagnose long Covid, and 87% said there is a lack of clinical guidance on how to treat long Covid. "Long Covid is a secondary pandemic crisis challenging both physicians and patients alike," said Claudia Martorell, a member of Sermo's medical advisory board. "Long Covid's complexities and lack of clinical guidelines on how to treat it is of increasing frustration to many physicians trying to help patients in their practices." (Gleeson, Becker's Hospital Review, 10/12; Business Wire, 10/11)