The FDA has approved Moderna’s new Covid-19 vaccine, though it placed restrictions on its use that the company’s existing Covid shot does not currently face. The new vaccine, which will be marketed under the name mNexspike, will not immediately replace Spikevax. A statement from the company said both vaccines will be available on the market for the time being.  “The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from Covid-19,” Moderna CEO Stéphane Bancel said in the statement. “Covid-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”   As it did earlier this month with Novavax’s Covid vaccine, the FDA said the new Moderna shot is licensed for use only in people aged 65 and older and people aged 12 to 64 who have at least one medical condition that puts them at increased risk of becoming seriously ill if they contract the SARS-CoV-2 virus. Such conditions include diabetes, chronic obstructive pulmonary disorder or COPD, and obesity. Spikevax’s license allows its use in people aged 12 years and older. Unlike the Novavax decision, in this case the FDA met the agreed-up decision date for ruling on the Moderna application; it was May 31. The Novavax decision came a month and a half after its April 1 due date, with political staff at the agency reportedly raising concerns after FDA career staff recommended approval of the vaccine.    The approval is at least a partial victory for the company, given the skepticism about messenger RNA-based vaccines shared by health secretary Robert F. Kennedy Jr. and his political base, and some of the health department’s recent actions. Earlier this week Kennedy’s Department of Health and Human Services notified Moderna that it was canceling contracts valued at $766 million for the company to develop, test, and license prototype vaccines against several influenza subtypes that could potentially trigger a pandemic, including H5N1 bird flu. Asked to explain the decision, HHS communications director Andrew Nixon called the mRNA technology “under-tested” and raised vague concerns about the vaccine platform’s safety record. Billions of doses of mRNA-based vaccines have been administered around the globe since the Pfizer-BioNTech and Moderna Covid vaccines were the first to receive authorization in late 2020, a mere 11 months after the genetic code of the SARS-2 virus was first shared internationally.  That rollout involved close scrutiny by numerous regulatory agencies looking for evidence of adverse events that might have been linked to these vaccines. With the exception of some reports of myocarditis — inflammation of the heart muscle — in some recipients, mostly teenage boys, no significant side effects have been reported. (Covid infection can also trigger myocarditis in this demographic. In fact, it happens at a higher rate, and infection-induced cases are typically more severe than those seen post-vaccination.) The next-generation Covid vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus, which allows for the use of a smaller dose — one fifth — than is used in Spikevax.   In a Phase 3 trial testing the new vaccine against the existing one, mNexspike generated higher antibody levels, especially among older adults, the company reported.

NEW YORK, May 20 (Reuters) - The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability this fall to older adults and those with a higher risk of developing severe illness, FDA leaders said on Tuesday. FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad said based on data from tests that measure immune response in patients, they anticipate that the FDA will be able to approve the boosters for adults over the age of 65 years. It would also be available for everyone over the age of six months with one or more risk factors that put them at high risk for severe COVID-19 outcomes, they said in a piece published in the New England Journal of Medicine on Tuesday. But for healthy people between the ages of six months and 64 years, the FDA expects it would need randomized, controlled trials for drugmakers to get approval for annual shots. Prasad and Makary said that saline could be used as placebo in those trials. Vaccine makers have argued that because COVID vaccines have been changed annually to match the circulating strain of the virus, new placebo-controlled trials could delay availability of the shots until after their usefulness has passed. But Prasad and Makary say the studies are needed to provide evidence that annual shots for healthy younger Americans are evidence-based. "We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose," Prasad and Makary wrote in the piece. "This policy will compel much-needed evidence generation."   There are currently three approved vaccines for COVID-19 in the U.S.: messenger RNA-based shots made by Moderna Inc (MRNA.O), opens new tab and by Pfizer (PFE.N), opens new tab and Germany's BioNTech (22UAy.DE), opens new tab, and a protein-based vaccine made by Novavax Inc. (NVAX.O), opens new tab "This is quite reasonable. The really high risk people - people over 65, people with chronic medical conditions - can still get the vaccine," said Dr. David Boulware, an infections disease specialist at the University of Minnesota. Boulware said he believed it was unlikely that vaccine makers will conduct the clinical trials to receive the broader approval. "This is going to be hundreds of millions of dollars, so they're not going to do the trial in a young population because the sample size would be huge to show benefit. I think its unlikely to be done," he said.   U.S. Health and Human Services Secretary Robert F. Kennedy Jr. is a vaccine skeptic, who has long sown doubts about the safety and efficacy of the shots. Makary and Prasad have been critical in the past of the approval process and the evidence supporting the necessity of annual COVID-19 shots for many Americans. They said the U.S. policy has been more aggressive than policies followed in Europe, Mexico and Canada. Still, they acknowledged that the 2020 development of the shots were a major scientific, medical, and regulatory accomplishment. They also called the measles-mumps-rubella vaccine a vital immunization and said it had been "clearly established as safe and highly effective."   COVID vaccines are significant products for drugmakers, even as uptake has fallen post-pandemic. In 2024, U.S. sales of COVID boosters - sold primarily by Pfizer and Moderna - topped $3.5 billion. Novavax's shot was approved last week after the FDA missed the April 1 target to make a decision on the vaccine. The FDA already limited its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. According to the U.S. Centers for Disease Control and Prevention, a wide list of conditions constitutes an additional risk, ranging from various illnesses, such as diabetes and heart disease, to behaviors like physical inactivity and substance abuse. Makary and Prasad said that under the new framework, estimates suggest that some 100 million to 200 million Americans would have access to the annual shots.   Reporting by Michael Erman, editing by Deepa Babington  

The puzzling halt in reported human bird flu cases has prompted health officials to renew calls for vigilance, even as experts grapple with several theories about the sudden drop. While officials urge continued caution, questions linger about potential contributing factors, including the impact of government cuts on case detection, increased fear among immigrant farm workers – a demographic disproportionately affected by the virus – of seeking testing due to immigration enforcement concerns, and the possibility of a natural decline in infections. “We just don't know why there haven't been cases,” said Jennifer Nuzzo, director of the Pandemic Center at Brown University. “I think we should assume there are infections that are occurring in farmworkers that just aren't being detected.” The H5N1 bird flu has been spreading widely among wild birds, poultry and other animals around the world for several years, and starting early last year became a problem in people and cows in the U.S. In the last 14 months, infections have been reported in 70 people in the U.S. — most of them workers on dairy and poultry farms. One person died, but most of the infected people had mild illnesses. The most recent infections confirmed by the Centers for Disease Control and Prevention were in early February in Nevada, Ohio and Wyoming. California had been a hotspot, with three-quarters of the nation’s infections in dairy cattle. But testing and cases among people have fallen off. At least 50 people were tested each month in late 2024, but just three people were tested in March, one in April and none in May so far, state records show. Overall, the state has confirmed H5N1 infections in 38 people, none after Jan. 14. Why bird flu cases are down During a call with U.S. doctors this month, one CDC official noted that there is a seasonality to bird flu: Cases peak in the fall and early winter, possibly due to the migration patterns of wild birds that are primary spreaders of the virus. That could mean the U.S. is experiencing a natural — maybe temporary — decline in cases. It's unlikely that a severe human infection, requiring hospitalization, would go unnoticed, said Michael Osterholm, a University of Minnesota expert on infectious diseases. What's more, a patchwork system that monitors viruses in sewage and wastewater has suggested limited activity recently. New infections are still being detected in birds and cattle, but not as frequently as several months ago. “Given the fact that the number of animal detections has fallen according to USDA data, it’s not surprising that human cases have declined as well,” the CDC said in a statement. Are government cuts affecting bird flu monitoring? Dr. Gregory Gray said he wasn’t concerned about the CDC not identifying new cases in months. “I don’t think that anybody’s hiding anything,” said Gray, an infectious disease speicialist at the University of Texas Medical Branch in Galveston. But Osterholm and some other experts think it's likely that at least some milder infections are going undetected. And they worry that the effort to find them has been eroding. Resignations at the U.S. Department of Agriculture and the Food and Drug Administration’s Center for Veterinary Medicine could slow the government’s bird flu monitoring, said Keith Poulsen, director of the Wisconsin Veterinary Diagnostic Laboratory. Three of 14 experts accepted deferred resignation offers at the National Animal Health Laboratory Network, which responds to disease outbreaks with crucial diagnostic information, he said. They are among more than 15,000 USDA staff to accept the offers, an agency spokesperson said. And dozens of staff were fired at the FDA's Veterinary Laboratory Investigation and Response Network, which investigates animal diseases caused by problems including contaminated pet food. Cats in several states have been sickened and died after eating raw pet food found to contain poultry infected with H5N1. Angela Rasmussen, a virologist at the University of Saskatchewan in Canada, said "targeted surveillance has really dropped off precipitously since Trump took office."   She wonders if immigrant farmworkers are too scared to come forward. "I can’t argue with anyone who would be risking getting shipped to a Salvadoran gulag for reporting an exposure or seeking testing,” she said. The CDC characterizes the risk to the general public as low, although it is higher for people who work with cattle and poultry or who are in contact with wild birds. Earlier this month, an agency assessment said there is a “moderate risk” that currently circulating strains of bird flu could cause a future pandemic, but the CDC stressed that other emerging forms of bird flu has been similarly labeled in the past. Still, research is continuing. Texas A&M University scientists have collected blood samples from dairy workers in multiple states to test for signs of past H5N1 exposure, said David Douphrate, a workplace health and safety expert leading the project. The yearlong study is funded by a nearly $4 million grant from the CDC and is expected to conclude in July. Douphrate said he leveraged two decades of relationships with dairy producers and workers to gain access to the farms. “We have had very good participation,” Douphrate said. “They have been very willing.” Similar surveillance is “urgently needed” among domestic cats, said Kristen Coleman, a researcher at the University of Maryland at College Park who studies emerging animal diseases. She recently released a paper reviewing bird flu in infections in cats between 2004 and 2024. Barn cats that died after drinking raw milk were one of the first signs that dairy cows were becoming infected with bird flu in 2024. Since then, the Agriculture Department has confirmed more than 120 domestic cats infected with the virus across the U.S. Infections have mostly been found in cats that died. Less is known about milder infections, whether cats can recover from bird flu — or whether the virus can spill over into people. Coleman has been collecting blood samples from cats across the U.S. to see if they have evidence of previous exposure to the virus. But the process is slow and research funding is uncertain. “It's easy to downplay something because that's usually what humans do,” she said. “But what we really need to be doing is ramping up.”

Circular RNAs (circRNAs) are a family of non-coding RNAs that originate from a non-canonical splicing event (backsplicing) that forms covalently closed continuous loops. An analysis of the human immunodeficiency type 1 virus (HIV-1) complex splicing pattern indicated that the virus had the potential to generate at least 15 distinct circRNAs. The predicted HIV circRNAs were amplified utilizing divergent PCR primers and confirmed by RNase R digestion and sequencing. A predictive circRNA-miRNA interaction modeling approach and a series of validation assays determined that two cellular miRNAs, miR-6727-3p and miR-4722-3p, functionally interact with a sequence present in 8 of the HIV circRNAs. Expression of miR-6727-3p and miR-4722-3p restricted HIV-1 replication while a circRNA containing the sequence recognized by miR-6727-3p and miR-4722-3p increased the production of infective virions. Additionally, miR-6727-3p and miR-4722-3p expression was upregulated following HIV-1 infection of primary CD4+ T cells. Overall, the data presented shows that HIV-1 generates circRNAs which promote viral replication by sequestering and inhibiting the functions of miR-6727-3p and miR-4722-3p.   Publishes in NPJ Viruses (March 28, 2025): https://doi.org/10.1038/s44298-025-00105-0 

TUESDAY, May 13, 2025 (HealthDay News) — U.S. health officials are telling travelers aged 60 and older to avoid a chikungunya vaccine while they investigate possible side effects. The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued the warning late last week. The concern focuses on the Valneva vaccine, known as Ixchiq, The Associated Press reported. Valneva is a specialty vaccine developer based in France. Chikungunya is a tropical illness spread by mosquito bites. It causes fever and painful joints. About 100 to 200 U.S. travelers get the illness each year. The government previously recommended the vaccine for adults traveling to areas where chikungunya may be common, including countries in Central and South America, Asia, India and Africa. The vaccine uses a weakened version of the virus.   The AP reported that a panel of CDC advisers recently learned of six seniors who developed serious heart or brain symptoms within a week of vaccination. Most had other health problems.  Officials also received reports of more than 10 similar cases in other countries. European regulators are also investigating, AP reported. A CDC advisory panel has now urged caution for adults aged 65 and older considering the Ixchiq vaccine.  They also recommended a second vaccine, Vimkunya by Bavarian Nordic, for people 12 and older traveling to areas with chikungunya outbreaks. CDC officials have not yet made a final decision on the new recommendations.   SOURCE: The Associated Press, May 12, 2025  

An outbreak detection program found the presence of the measles virus in samples of Houston wastewater in early January 2025, before cases were reported, new findings show.  The findings were possible because almost three years earlier, a team of researchers, including from Baylor College of Medicine, the School of Public Health at University of Texas Health Science Center-Houston, the Houston Health Department and Rice University, had developed an outbreak detection program that analyzes genetic material.  A study using the program then detected the virus in samples collected on Jan. 7 from two Houston water treatment facilities that serve more than 218,000 residents. A parallel investigation confirmed on Jan. 17 that two travelers who contracted the virus resided in the same area serviced by the sampled water treatment plants. More information about the travelers and the facilities was not immediately available. “In such cases our next step is always validating the signal with a second method, and we were able to do so through a collaboration with the Houston Health Department and Rice University,” said Dr. Sara Javornik Cregeen, a member of the team and an assistant professor in the Alkek Center for Metagenomics and Microbiome Research at Baylor. “They tested for the virus presence in samples from the same date and collection site and confirmed the signal using another technique, PCR.”    The findings are timely as the number of measles cases is increasing in Texas and nationally. As of May 9, Texas had 709 confirmed cases of measles since the outbreak started in late January, leading to 89 hospitalizations and the deaths of two children. The program’s ability to detect the disease’s presence before the cases were reported shows it could help officials to get ahead of potential outbreaks.  Prior to finding the diseased samples, 821 samples of Houston wastewater were negative for the measles virus over 31 months.  “Because no other cases have been reported and the detections occurred in the same area where the travelers resided, it is reasonable to assume that the measles signal detected in wastewater is from the two infected cases, which underscores the high sensitivity of the method,” said Dr. Anthony Maresso, a member of the team and a professor in molecular virology and microbiology at Baylor.    The researchers are not currently detecting measles viruses in wastewater in Houston, but they are in West Texas cities, where most of the state's cases are concentrated.   “With lessons learned from the Houston measles detection event, we are now working with our public health partners to gather data on the current measles outbreak in West Texas,” said team member Dr. Michael Tisza, an assistant professor of molecular virology and microbiology at Baylor. “Although not reported here, our program has been monitoring measles in wastewater from those sites as well, hoping the information can help officials get ahead of this virus.”  The team continues to test wastewater despite ongoing negative results. The results will continue to be reported at the team’s publicly available health dashboard.