FDA extends the shelf life of two Covid-19 vaccines, CDC finds most children hospitalized during the omicron wave were unvaccinated, and more in this week's roundup of Covid-19 news.

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• A new omicron subvariant BA.2.12.1, which has driven a recent surge in cases in New York state, now makes up roughly 20% of all new infections in the United States, according to CDC data published April 16. According to the New York State Department of Health, the BA.2.12.1 subvariant, as well as another BA.2.12 subvariant, are believed to be around 23% to 27% more transmissible than the original BA.2 subvariant, although it is not clear whether they lead to more severe disease. In addition, BA.2.12.1 may have a mutation that allows it to evade immunity and infect cells more easily. Currently, Covid-19 cases are rising across the United States, with the Northeast seeing the largest increases. Overall, the country is seeing an average of more than 31,500 new cases a day, up 14% from almost 28,000 cases two weeks ago. (Doherty, Axios, 4/19)

• Pictor, an in-vitro diagnostics company based in New Zealand, and Mobility Health announced a partnership to distribute Pictor's PictArrayTM SARS-CoV-2 Antibody Test, which can determine if a patient has antibodies to the coronavirus and if they are from vaccination or infection. To differentiate between antibodies from vaccination and those from infection, the test identifies the presence of both nucleocapsid protein antibodies and spike protein antibodies. If both types of antibodies are identified, then a person previously contracted Covid-19. If only spike protein antibodies are identified, the individual has not contracted Covid-19, and the antibodies are from vaccination alone. According to Howard Moore, Pictor's CEO, the test could help determine a person's risk for infection if they do not have a sufficient antibody response after vaccination or prior infection. In particular, Moore said the test could be used to determine whether a patient should receive additional booster doses. "You have to be somewhat careful in administering vaccination," he said. "We believe you should be careful about administering vaccines to those people who have been infected. Their antibodies level may be reasonably high." (Bardin, MedCity News, 4/13)

• The U.S. Covid-19 vaccination campaign has helped averted millions of deaths, tens of millions of hospitalizations, and even more infections, according to a new study conducted by The Commonwealth Fund and Yale University. The study, which builds on data from earlier research, used a model to analyze how vaccination efforts affected the United States and its health care system between Dec. 12, 2020, and March 31, 2022. The model accounted for U.S. population demographics, mobility patterns, age-specific risks of severe Covid-19 outcomes, and four coronavirus variants (alpha, delta, iota, and omicron). Overall, researchers estimated that the U.S. vaccination campaign averted an average of 66,159,093 infections, 17,003,960 hospitalizations, and 2,265,222 deaths. In addition, vaccination reduced health care costs, including expenses for outpatient visits, hospitalizations, intensive care, ED visits, and more, by $899.4 billion. "Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths," the study's authors wrote. "As we noted in our December analysis, vaccines spared the U.S. healthcare system an overwhelming number of COVID-19 hospitalizations. The current analysis confirms and extends the earlier results. Investing in vaccination programs also has produced substantial cost savings—approximately the size of one-fifth of annual national health expenditures—by dramatically reducing the amount spent on COVID-19 hospitalizations." (Cheney, HealthLeaders Media, 4/15)

• Johnson & Johnson (J&J) on Tuesday announced it is suspending its Covid-19 vaccine sales forecast due to a global supply surplus and uncertain demand. Previously, the company in January said the vaccine could bring in between $3 billion and $3.5 billion in sales this year, up from $2.38 billion in sales in 2021. However, the vaccine only brought in $457 million during the first quarter of the year, much lower than expected. The majority of the sales came from overseas, and the vaccine generated $75 million in sales in the United States, or around 25% less than what it made in the first quarter of 2021 when it was first authorized. Currently, Covid-19 vaccines from Pfizer-BioNTech and Moderna are more commonly used in the United States. In addition, CDC last year recommended the two mRNA vaccines over J&J's vaccine, citing the risk of a rare blood clotting problem associated with the shot. (AP/Modern Healthcare, 4/19; Vakil, The Hill, 4/19)

• FDA last week extended the shelf life for two Covid-19 vaccines and is considering the shelf life of some monoclonal antibodies. On April 7, the agency extended the shelf life of the J&J Covid-19 vaccine from nine months to 11 months. This is the third extension to the J&J vaccine's shelf life since June 2021. Similarly, FDA on April 13 extended the shelf life of two formulations of the Pfizer-BioNTech Covid-19 vaccine to 12 months when stored at -130ºF to -76ºF. In addition, FDA and HHS' Office of the Assistant Secretary for Preparedness and Response are considering extending the shelf life of the combination monoclonal antibodies bamlanivimab and etesevimab. The agencies will issue an update in early May, and health care providers may keep all unopened and correctly stored bamlanivimab and etevesimab vials until then. (AHA News, 4/18; Gleeson, Becker's Hospital Review, 4/12)

• Most children ages 5 to 11 who were hospitalized with Covid-19 during the omicron surge were unvaccinated, according to a new CDC study. For the study, CDC examined 397 children who were hospitalized for Covid-19 between Dec. 19, 2021, and Feb. 28, 2022. Overall, 87% of the children who were hospitalized were unvaccinated, 30% had no underlying medical conditions, and 19% were admitted to the ICU. In particular, Black children accounted for a plurality of unvaccinated hospitalizations at 34%, while white children came in second at 30.7% and Hispanic children made up 18.9%. According to CDC, these findings emphasize the importance of vaccinating children against the coronavirus. "Increasing vaccination coverage among children, particularly among racial and ethnic minority groups disproportionately affected by COVID-19, is critical to preventing COVID-19-associated hospitalization and severe outcomes," the study's authors wrote. (Falconer, Axios, 4/19; AHA News, 4/19)