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Moderna Says FDA Delayed RSV Vaccine Approval to End of May
Moderna on Friday said the Food and Drug Administration has delayed the approval of its vaccine for respiratory syncytial virus to the end of May due to “administrative constraints” at the agency.
The FDA was expected to make a decision on the RSV shot on Sunday. The agency has not informed Moderna of any issues related to the vaccine’s safety, efficacy or quality that would prevent its approval, the biotech company said in a release.
Investors are watching the upcoming approval closely as Moderna tries to rebound from the rapid decline of its COVID business last year. If cleared, the RSV shot would become the company’s second product to launch in the U.S. after its once-blockbuster COVID vaccine. It would also be the third RSV vaccine to enter the market after shots from Pfizer and GSK rolled out last year.
Moderna said its RSV vaccine is still on track to be reviewed by an advisory panel to the Centers for Disease Control and Prevention during a meeting on June 26 and 27. That panel will vote on recommendations for the shot’s use and intended population, which is necessary before it enters the market.
The approval would demonstrate the versatility of Moderna’s messenger RNA platform beyond treating COVID. The biotech company is using that technology to tackle a range of diseases. Those include RSV, cancer and a highly contagious stomach bug known as norovirus.
Novavax Shares Spike Over 100% on Sanofi Deal to Commercialize COVID Vaccine, Develop Combination Shots
Novavax on Friday said it has signed a multibillion-dollar deal with French drugmaker Sanofi to co-commercialize the company’s COVID vaccine starting next year and develop combination shots targeting the coronavirus and the flu, among other efforts. Shares of Novavax spiked more than 130% on Friday from their previous day close of $4.47 apiece.
The licensing agreement will allow Novavax to lift its “going concern” warning, which it first issued in February 2023 due to having doubts about its ability to continue operating, Novavax CEO John Jacobs told CNBC in an interview.
It marks a turning point for the struggling vaccine maker and its protein-based COVID shot. Health officials view the vaccine as a valuable alternative for people who don’t want to take messenger RNA jabs from Pfizer and Moderna.
Part of the deal allows Sanofi to use Novavax’s COVID shot and flagship vaccine technology, Matrix-M adjuvant, to develop new vaccine products. Sanofi will pay Novavax an upfront payment of $500 million and up to $700 million in payments for development, regulatory and launch milestones.
Thousands of Kids Prescribed ‘Potentially Harmful’ Drugs for Acute COVID — Arkansas and Oklahoma Had Highest HCQ, Ivermectin Prescription Rates
Clinicians prescribed hydroxychloroquine (HCQ) and ivermectin inappropriately to thousands of children with acute COVID-19, according to a retrospective cohort study.
In a large U.S. all-payer database, 3,602 ivermectin prescriptions and 813 HCQ prescriptions for kids with acute COVID were identified after guidelines recommended against their use, though prescription rates for these medications were less than 1% — 0.03% for HCQ and 0.14% for ivermectin, reported Julianne Burns, MD, MSCE, of Stanford University in California, and colleagues in Pediatrics.
“Although this proportion may seem reassuringly low, the overall incidence of COVID-19 translates into ineffective and potentially harmful prescriptions for many children,” the authors noted. However, it is somewhat reassuring that there were no medical claims for related adverse drug reactions within 28 days of the prescriptions, they added.
“Low mortality and hospitalization rates in our cohort suggest these infections were less likely to be serious, further underscoring the risks of an unnecessary prescription against any perceived benefits,” they wrote.
AstraZeneca COVID Vaccine Death Linked to GP Surgery Error
A 28-year-old man who died from a vaccine-related blood clot was wrongly offered the jab due to a clinical error by a GP surgery 17 years earlier. When he was 11, Alex Reid’s weight was wrongly recorded as 22st 11lb (145kg) – suggesting he had a BMI of almost 69.
Mr Reid received his first dose of the vaccine in March 2021, but weeks later an official recommendation said under 30s should be offered an alternative due to an extremely rare chance of blood clots. Those who had already received the AstraZeneca jab as their first vaccination were advised to receive it as their second, with Mr Reid having his in May 2021.
He died on June 29, 2021, with the medical cause of death being COVID-19 vaccine-induced immune thrombotic thrombocytopenia, a prevention of future deaths report said.
His mother, Halina Reid, said: “After Alex’s death, we knew something was not right — it has taken two years and five months to get answers.” Mr Reid’s weight had been incorrectly entered in 2004 during a routine appointment for asthma when he was 11, his family said.
The prevention of future deaths report, prepared by coroner Oliver Longstaff, called for “validation rules in general practice IT systems” for when data is entered or a function that “challenges” potential errors. He wrote: “If the obviously erroneous BMI had not been recorded or had been challenged at the point of entry by the relevant IT system, Alex would not have been classed as vulnerable … and would not have died when he did.”
U.S. to Post Influenza A Wastewater Data Online to Assist Bird Flu Probe, Official Says
The U.S. Centers for Disease Control and Prevention (CDC) is planning to post data on influenza A found in wastewater in a public dashboard possibly as soon as Friday that could offer new clues into the outbreak of H5N1 bird flu in cattle herds.
CDC wastewater team lead Amy Kirby told Reuters on Thursday that the agency has identified spikes of influenza A, of which H5N1 is a subtype, in a handful of sites and is investigating the source. She said there is no indication of human infection with H5N1. Testing wastewater from sewers proved to be a powerful tool for detecting mutations in the SARS-CoV-2 virus during the COVID-19 pandemic.
Kirby said the CDC has been collecting influenza data in wastewater in about 600 sites since at least last fall to better track respiratory infections. That data can now be helpful in tracking the outbreak of H5N1 bird flu that has infected 42 dairy herds in nine U.S. states, and one dairy farm worker.
Scientists are closely watching for changes in the virus that could make it spread more easily among humans. “I’m not worried about the cows. I’m not worried about the milk. But I’m worried that there are lots of other animals that it can jump to, and eventually, it’s going to find a combination that can make it into humans if we’re not careful,” he said.
One in 8 U.S. Adults Have Now Used Blockbuster Meds Like Ozempic
U.S. News & World Report reported:
About 1 in 8 U.S. adults (12%) have tried a weight-loss drug like Wegovy, Ozempic, Zepbound or Mounjaro, a new KFF Health Tracking Poll says. About 6% are taking one right now, the poll found.
Most patients say they use the drugs (61%) to treat a chronic condition like diabetes or heart disease, which can make it easier to obtain a prescription, the report says. More than 2 in 5 using the drugs are diabetics (43%), KFF found.
Only about 22% are taking the drugs because a doctor diagnosed them as overweight or obese, but nearly 38% take the drugs solely to lose weight, the findings show.
These drugs can be costly, with list prices topping $1,000 for a month’s supply before insurance coverage, rebates and discount coupons, KFF said.
