- In today’s Recommendations for Industry, we discuss TAG’s weekly matrix and the “gentle swell” of COVID in the U.S. Read more below.
- CDC: 58% of Americans have had COVID-19. New COVID-19 seroprevalence data from CDC show that the Omicron surge infected a huge swath of Americans, with overall seroprevalence rising from 33.5% in December of 2021 to 57.7% in February 2022. The increase was seen most dramatically in children. In children ages 0 to 11, seroprevalence rose from 44.2% to 75.2%, and those 12 to 17, from 45.6% to 74.2%.
- Global COVID deaths drop to lowest since early pandemic months. Weekly COVID-19 deaths dropped to the lowest level since March 2020 and continue to drop, with just over 15,000 deaths reported to the WHO last week. However, because countries are reducing their testing, and the WHO is receiving less information on transmission and evolution, countries are urged to keep a close eye on cases and virus changes.
- FDA Approves First COVID-19 Treatment for Young Children. As discussed Tuesday, FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include certain pediatric patients 28 days of age and older. Before now, Veklury was only approved to treat certain adults and pediatric patients 12 years and older with COVID-19.
- Moderna seeks U.S. authorization for COVID-19 vaccines for kids 5 and under. Moderna has requested FDA authorization for low doses of its COVID-19 vaccine for children younger than 6, submitting data for two low-dose shots. Currently, only children ages 5 or older can be vaccinated in the U.S., using Pfizer’s vaccine, leaving 18 million younger tots unprotected.
- COVID-19 pills to become more widely available in U.S. The Biden administration plans to expand access to free treatments to help patients avoid hospitalization and make it easier to get COVID-19 treatments. The plan is to double the 20,000 pharmacies, community health centers and hospitals where the antivirals are now available for patients. People can take Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir, also known as Lagevrio, at home shortly after they develop symptoms.
- GAO Report: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference. Since the onset of the COVID-19 pandemic, there have been allegations of political interference affecting scientific decisions at several HHS offices and agencies. Through semi-structured interviews and a confidential hotline, employees at CDC, FDA, and NIH told GAO they observed incidents that they perceived to be political interference but did not report them fearing retaliation, being unsure how to report issues, or believing agency leaders were already aware. Some respondents from CDC and FDA stated they felt that the potential political interference resulted in the alteration or suppression of scientific findings, or it may have resulted in the politically motivated alteration of public health guidance or delayed publication of COVID-19-related scientific findings. GAO made 7 recommendations for executive action focused on developing reporting procedures and training by the four agencies.
- CIDRAP to develop vaccine roadmap for future coronavirus threats. CIDRAP has received $1 million in grants to create a Coronavirus Vaccines Research and Development (R&D) Roadmap for developing vaccines that provide broad protection against betacoronaviruses or a subset of betacoronaviruses, which mainly circulate in bats and rodents, but can spill over into human populations. CIDRAP’s director, Michael Osterholm, said the roadmap “will provide a framework for the development of broadly protective coronavirus vaccines to ensure that we are prepared to respond” to future SARS-CoV-2 variants or other viruses with pandemic potential.
- Distribution facility recalls 121K pounds of ground beef. Lakeside Refrigerated Services, a Swedesboro, N.J. establishment, is recalling approximately 120,872 pounds of ground beef products that may be contaminated with E. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The problem was discovered during routine FSIS testing of imported products. There have been no confirmed reports of illness or adverse reactions due to consumption of these products.
Recommendations for Industry
Number of Factors Keeping U.S. COVID Rates Low
TAG’s COVID matrix for the week is showing a gentle swell of COVID cases across the country – as TAG expected and predicted. There are no dramatic surges, and while we’ve seen some increase in hospitalizations, it is not proportional, to any extent, to the number of cases. The low rate of increase is likely due to a number of factors, with people having such minor symptoms that they don’t test, people not reporting low-symptomatic but positive home tests, and CDC’s seroprevalence data showing that 58% of the country has had COVID.
We would expect the gentle swell to continue to increase slightly as it moves westward in the U.S. but would not expect anything dramatic to occur or be concerned about. Thus, TAG recommendations continue as they have in recent weeks – stay the course.
In Case You Missed It:
- In Tuesday’s Recommendations for Industry, we discussed the current and projected status of COVID-19 vaccines. Read more here.
- COVID-19 Was Third Leading Cause of Death in U.S. last year. In 2021, COVID-19 was the third leading cause of death in the U.S., as the Delta and Omicron waves drove the pandemic’s death toll up by nearly a quarter over 2020, according to a provisional report released Friday by CDC. Older people were generally more likely to die from COVID-19 during 2021, with people age 85 and older dying at a rate over 12 times higher than the general population, a trend generally consistent with 2020 figures. As of Thursday, April 21, the cumulative number of COVID-19 deaths in the U.S. was 987,601, according to the CDC.
- FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. This makes Veklury the first approved COVID-19 treatment for children less than 12 years of age.
- The WHO recommends Pfizer’s Paxlovid for patients with non-severe COVID-19 who are at highest risk for hospitalization. The recommendation is based on new data from several randomized controlled trials published in the BMJ. The agency also issued a conditional recommendation for the use of remdesivir (Veklury) for the same patient population.
- Studies suggest current vaccines boost immune response against Omicron. Despite being developed to fight the original COVID-19 strain, a third dose of mRNA vaccine boosts the immune system substantially to better fight infections caused by the Omicron variant relative to the standard 2-dose primary series, according to two new studies in Nature and JAMA Network Open.
- Extending the time between COVID-19 vaccine doses to over 10 weeks was associated with SARS-CoV-2 antibody levels up to 11 times higher than with an interval of 2 to 4 weeks in never-infected participants, according to a preprint paper to be presented at the upcoming annual congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID).
- Moderna released trial results that suggest a version of its vaccine designed to target variants offers better, longer-lasting protection. Researchers combined Moderna’s existing vaccine with one designed to attack the Beta variant, and found it provided a stronger defense against several variants.
- The U.S. is extending a vaccine rule for international travelers at its land borders. International travelers arriving at land ports of entry or ferry terminals in the United States must continue to show proof of full vaccination against the coronavirus. But unlike entering air travelers, land and ferry travelers will still not have to show a recent negative coronavirus test.
- Weekly CDC Flu Report
- Influenza activity varies by region. Activity is highest in the northeast, south-central and mountain regions of the country.
- Clinical Lab – 8.9% positive for influenza this week
- 2.1% of visits to a health care provider were for respiratory illness
- 3,243 patients admitted to hospitals with influenza
- 7.1 % of deaths attributed to pneumonia, influenza, or COVID-19 (above threshold)
- 3 influenza-associated pediatric deaths reported this week for a total of 22 so far this season
- CDC issued a nationwide health alert to notify clinicians and public health authorities about a cluster of children identified with hepatitis and adenovirus infection – asking all to be on the lookout for symptoms and to report any suspected cases of hepatitis of unknown origin to their local and state health departments. CDC is working with the Alabama Department of Public Health to investigate a cluster of nine cases of hepatitis of unknown origin in children 1 to 6 years old, all of whom were previously healthy.
- The World Health Organization says at least one death has been reported in connection with a mysterious liver disease outbreak affecting children in Europe and the U.S. The WHO has received reports of at least 169 cases of “acute hepatitis of unknown origin” from a dozen countries. “It is not yet clear if there has been an increase in hepatitis cases, or an increase in awareness of hepatitis cases that occur at the expected rate but go undetected,” WHO said in a statement.