A new study indicates that more than a third of Covid-19 patients are still experiencing symptoms months later, Pfizer-BioNTech submits clinical data on its Covid-19 vaccine in children to FDA, and more in this week's roundup of Covid-19 news.
- Merck and Ridgeback Biotherapeutics announced that their antiviral Covid-19 drug, molnupiravir, is effective at reducing the risk of hospitalization and death when given to patients in the early stages of infection, the Wall Street Journal reports. In a clinical trial, the drug reduced the risk of hospitalization or death in study participants with mild to moderate Covid-19 by around 50% and is likely effective against coronavirus variants, including delta. The drug introduces errors to the coronavirus's genetic code, limiting its ability to copy itself. According to Merck CEO Rob Davis, the company plans to submit the drug for FDA authorization in the next few weeks. "The ability to take what is a devastating disease like Covid-19 and potentially make it a manageable situation through what is a very convenient round of administration, which is an oral pill you can take at home, has important implications for the ability to manage the ongoing pandemic," Davis said. (Hopkins/McKay, Wall Street Journal, 10/1; Castronuovo, The Hill, 9/30)
- According to data from the Rural Policy Research Institute, Covid-19 mortality rates for rural Americans are now more than double those for urban Americans, Kaiser Health News (KHN) reports. According to KHN, higher rates of new Covid-19 cases and lower vaccination rates have contributed to rural Americans' increased mortality from Covid-19. In addition, hospitals in rural areas are struggling to care for patients amid worsening staff shortages and difficulties transferring patients to other hospitals for specialty care. Alan Morgan, head of the National Rural Health Association, said, "From what I'm seeing, that mortality gap [between rural and urban Americans] is accelerating." (Weber, Kaiser Health News, 9/30)
- FDA and CDC this week made changes to the leadership of their Covid-19 and vaccine teams. At CDC, Henry Walke, who has led the agency's Covid-19 response for more than a year, is stepping down and will be replaced by Barbara Mahon, deputy chief of the agency's enteric-disease branch. According to Politico, CDC Director Rochelle Walensky has had difficulty staffing the agency's pandemic response team, in part because of burnout and fatigue after almost two years of combating Covid-19. Separately, FDA on Monday promoted Peter Marks to acting director of the Office of Vaccines Research and Review, as Marion Gruber, the office's director, and Philip Krause, her deputy, plan to retire. According to The Hill, Gruber and Krause contributed to a paper published in The Lancet arguing against the necessity of Covid-19 booster shots, breaking away from FDA's official stance. ("KHN Morning Briefing," Kaiser Health News, 9/28; Banco/Owermohle, Politico, 9/27; Coleman, The Hill, 9/27)
- The World Health Organization (WHO) on Tuesday reported a decline in new Covid-19 cases and deaths worldwide. According to WHO, there were approximately 3.3 million new coronavirus infections and around 55,000 deaths in the last week, a 10% decrease in both figures. The areas that experienced the largest declines were the Americas, the Middle East, and the Western Pacific. According to CDC data, the weekly average of Covid-19 cases in the United States has declined over the past two weeks from just under 150,000 daily new cases to around 95,000 cases. Scott Gottlieb, former FDA commissioner, said this could be the "last major surge" in the country, but cautioned that pandemic is not over yet. "I don't think this has run its course," he said. "This has been a highly regionalized epidemic from the very beginning ... but I think on the back end of this delta surge of infection around the country, after we get through this, this may be the last major wave of infection." (Barnes, The Hill, 9/29; Weixel, The Hill, 9/30)
- A study published in PLOS Medicine found that around 36% of Covid-19 patients continued to experience symptoms of the disease three to six months after being diagnosed, NPR reports. For the study, researchers from the University of Oxford analyzed anonymized EHR data from 273,618 Covid patients, a majority of whom were located in the United States. They identified nine "core" long-term Covid-19 symptoms, including pain and fatigue, abnormal breathing, cognitive dysfunction, and depression and anxiety. According to the authors, "over one in three patients had one or more features of long Covid recorded between three and six months after a diagnosis of Covid-19." Separately, a CDC study found that people who tested positive for Covid-19 reported having long-term symptoms 1.5 times more often than people who tested negative, The Hill reports. Using data from a survey conducted April 9-23 by Porter Novelli Public Services, researchers found that 65.9% of respondents who had initial symptoms of Covid-19 and tested positive reported symptoms lasting longer than four weeks, compared with 42.9% of respondents with initial symptoms who tested negative. According to the researchers, fatigue was the most commonly reported symptom among those who tested positive for Covid-19 at 22.5%. (Neuman, NPR, 9/29; Coleman, The Hill, 9/29; Coleman, The Hill, 9/9)
- CDC on Wednesday issued "an urgent health advisory" imploring people who are pregnant or planning to become pregnant to get vaccinated against Covid-19, Axios reports. Currently, only 31% of pregnant people have been vaccinated, with lower rates among Black (16%) and Hispanic/Latino (25%) populations. According to CDC, Covid-19 increases the risk of poor pregnancy outcomes, including preterm birth, stillbirth, and admission of an infected newborn into the ICU. "I strongly encourage those who are pregnant or considering pregnancy to talk with their health care provider about the protective benefits of the Covid-19 vaccine to keep their babies and themselves safe," CDC Director Rochelle Walensky said. Research has shown Covid-19 vaccines are effective at protecting pregnant people from the coronavirus and do not increase the risk of miscarriage or birth defects. (Rabin, New York Times, 9/30; Gonzalez, Axios, 9/29; Diaz, NPR, 9/30; Schnell, The Hill, 9/23; Dave, Bloomberg, 9/22; Adams, Becker's Hospital Review, 9/8)
- Pfizer and BioNTech on Tuesday submitted data from clinical trials to FDA showing their Covid-19 vaccine is safe and effective in children ages five to 11, the New York Times reports. The companies said they plan to submit a formal request for emergency use authorization (EUA) of their vaccine in this age group "in the coming weeks." A person familiar with FDA's approval process said Pfizer-BioNTech's vaccine could be authorized around Thanksgiving, although the authorization could occur earlier in November, AP/Modern Healthcare reports. According to a Gallup poll published Tuesday, 55% of Americans with children under 12 said they would vaccinate their child against Covid-19, and more than half of all parents said they are worried their child will get Covid-19. (Chappell, NPR, 9/28; LaFraniere et al., New York Times, 9/28; AP/Modern Healthcare, 9/28; Mastrangelo, The Hill, 9/28)