Vaccination significantly reduced the number of infections, hospitalizations, and deaths among Medicare beneficiaries; Covid-19 survivors may be at higher risk of kidney disease; and more in this week's roundup of Covid-19 news.
- Johnson & Johnson (J&J) on Tuesday asked FDA to authorize booster shots of its Covid-19 vaccine for patients 18 and older, Modern Healthcare reports. According to the New York Times, FDA has scheduled an Oct. 15 meeting of its expert advisory committee to review booster data from J&J and recommend whether the agency should authorize booster doses of the vaccine. "Both J&J and FDA have a sense of urgency because it's Covid and we want good data out there converted into action as soon as possible," Mathai Mammen, head of research for J&J's Janssen unit, said. According to J&J data released last month, a second dose of its vaccine, given two months after the first, increased protection against moderate-to-severe Covid-19 to 94% in the United States. (AP/Modern Healthcare, 10/5; LaFraniere, New York Times, 10/4; Loftus, Wall Street Journal, 10/5)
- The White House on Wednesday said the country will significantly expand its supply of at-home rapid Covid-19 tests, The Hill reports. FDA on Monday authorized a new rapid Covid-19 test from ACON Laboratories, which is expected to double the availability of such tests in the next few weeks. In addition, a $3 billion investment—$2 billion of which was announced in September— will be used to purchase millions of tests and supply them to community health centers, schools, and other areas. According to Jeff Zients, the White House Covid-19 response coordinator, the United States is "on track to quadruple the amount of at-home rapid tests available for Americans by December." Zients added that the government also plans to expand the availability of free Covid-19 testing by doubling the number of pharmacies offering the service from 10,000 to 20,000—bringing the total number of free testing sites nationwide to 30,000. (Sullivan, The Hill, 10/6; Neel/Huang, "Shots," NPR, 10/6; Frieden, MedPage Today, 10/6; Alltucker, USA Today, 10/5; Sullivan, The Hill, 10/4)
- AstraZeneca on Tuesday asked FDA to grant emergency use authorization for a long-acting antibody drug to prevent Covid-19 in high-risk populations, the New York Times reports. According to the company, the treatment reduced the risk of symptomatic Covid-19 by 77% in a trial where most participants either had medical conditions that put them at higher risk of severe disease or were not producing sufficient antibodies after being vaccinated. If authorized, the drug would be the first antibody treatment used as a preventive measure against Covid-19. "Vulnerable populations such as the immunocompromised often aren't able to mount a protective response following vaccination and continue to be at risk of developing Covid-19," Mene Pangalos, an EVP at AstraZeneca, said. "With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines." (Strasburg, Wall Street Journal, 10/5; Bengali, New York Times, 10/5; AP/Modern Healthcare, 10/5)
- An HHS study found that vaccinations helped avert an estimated 265,000 infections, 107,000 hospitalizations, and 39,000 deaths from Covid-19 among Medicare beneficiaries from January to May, Axios reports. For the study, researchers analyzed data from 25.3 million Medicare recipients in 48 states. Overall, the researchers found that increasing vaccination rates led to estimated decreases in cases, hospitalizations, and deaths across all racial and ethnic groups. In particular, American Indian and Alaska Native Medicare beneficiaries saw the largest decreases, Axios reports. In addition, the researchers found that vaccinations may have prevented 5,600 Covid-19 deaths among Medicare beneficiaries in nursing homes—a population who has been disproportionately affected by the disease. "This report reaffirms what we hear routinely from states: Covid-19 vaccines save lives, prevent hospitalizations and reduce infection," HHS Secretary Xavier Becerra said. (Chen, Axios, 10/5; Coleman, The Hill, 10/5; Lagasse, Healthcare Finance News, 10/6; Jeong, Washington Post, 10/6)
- Pfizer and BioNTech on Thursday asked FDA to authorize their Covid-19 vaccine for children ages five to 11, the Wall Street Journal reports. FDA has been reviewing the clinical trial data submitted by the companies last month, and the agency's expert advisory committee will publicly discuss the findings at an Oct. 26 meeting. If authorized, children would receive two shots of the vaccine three weeks apart, like adolescents and adults, but at a lower dosage. Children as young as six months would be the only age group left awaiting vaccine authorization, and Pfizer has said results from a study in these younger children could come by the fourth quarter of 2021. (Hopkins, Wall Street Journal, 10/7)
- The United States last week surpassed 700,000 Covid-19 deaths, the New York Times reports, with most deaths occurring among the unvaccinated. Around 100,000 people have died from Covid-19 since mid-June when the delta-driven surge began in the United States. Meanwhile, more than five million deaths from Covid-19 have occurred worldwide, Reuters reports. According to a Reuters analysis, it took just over a year to reach 2.5 million Covid-19 deaths, but the next 2.5 million occurred in just under eight months. Over the last week, an average of 8,000 global Covid-19 deaths were reported daily, and more than half of the weekly reported deaths occurred in the United States, Russia, Brazil, Mexico, and India. (Bosman/Leatherby, New York Times, 10/1; Chen, Axios, 10/2; B/Abraham, Reuters, 10/2)
- A study published in the Journal of the American Society of Nephrology found that Covid-19 patients are at an increased risk of developing acute kidney injury, chronic kidney disease, and end-stage kidney disease. For the study, researchers from the Clinical Epidemiology Center analyzed 89,216 Covid-19 patients and 1,637,467 controls to determine the risks of several kidney outcomes following Covid-19 infection. The researchers found that Covid-19 patients, regardless of the severity of their disease, were at an increased risk of developing kidney disease, with the greatest risk found in patients who required intensive care. According to the researchers, an estimated 13.44 per 1,000 Covid-19 patients will develop some form of kidney injury or disease—which would equal more than half a million people in the United States. "Covid-19 will substantially contribute to a rise in the incidence of acute kidney injury and chronic kidney disease," Ziyad Al-Aly, one of the study's authors, said. "Health care providers, health systems, and governments must be aware of this reality, and must develop strategies for early identification and treatment of these patients." (Al-Aly, MedPage Today, 10/6)