Centers for Disease Control & Prevention

Bengaluru: Novavax shares surged more than 17 per cent before the bell on Monday, following the long-delayed approval of its COVID-19 vaccine from the U.S. health regulator, albeit with new conditions. The U.S. Food and Drug Administration approved the vaccine, Nuvaxovid, but limited its use to older adults and people over 12 years with conditions that put them at risk due to the illness. The conditions on the label are medically unusual but consistent with the chatter to date, said BTIG analyst Thomas Shrader . Analysts at Leerink Partners echoed the view. The approval is in line with expectations and "no more restrictive than we expected" from the Centers for Disease Control and Prevention's vaccine advisory committee, ACIP, they said. The vaccine's future was called into question after the FDA missed its April 1 deadline to approve the shot - a more traditional protein-based vaccine unlike its messenger RNA-based rivals. U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, also expressed concerns about the vaccine's efficacy in a CBS interview. Novavax missed out on the pandemic vaccine windfall - enjoyed by rivals Moderna and Pfizer, which make messenger RNA-based vaccines - due to manufacturing issues and regulatory hurdles. The FDA's full approval of Nuvaxovid triggered a $175 million milestone payment to Novavax from Sanofi, related to their licensing deal in 2024. Novavax expects to be ready for the commercial delivery of the shot in the U.S. this fall in partnership with Sanofi, pending strain recommendation. Novavax, along with its competitors, will need to seek additional approval to alter the strain of the virus its vaccine targets for the upcoming COVID-19 immunization season. This is set to be discussed at a meeting of FDA vaccine advisers later this week. Through last close, Novavax shares have fallen 16.3 per cent so far this year. (Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)

The recommendation from the FDA and CDC comes after the latter agency’s Advisory Committee on Immunization Practices (ACIP) recommended in April that the vaccine carry a precaution when used in adults ages 65 and older. On the heels of similar moves in France and the European Union, U.S. health authorities are calling for a pause in the use of Valneva’s chikungunya vaccine in older adults.The FDA and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of the single-dose shot, dubbed Ixchiq, in U.S. individuals age 60 and older as investigations into serious adverse event (SAE) reports play out on both sides of the Atlantic.The recommendation from the FDA and CDC comes after the latter agency’s Advisory Committee on Immunization Practices (ACIP) recommended in April that the vaccine carry a precaution when used in adults ages 65 and older, Valneva noted in a Monday press release.Additionally, the European Medicines Agency (EMA) last week rolled out its own Ixchiq restriction in older adults, as well as in people with compromised immune systems.The EMA—which unveiled its vaccine pause roughly one week after a similar move by French health authorities—has kicked off a safety review of Ixchiq following reports of 17 serious adverse events, including two deaths, in vaccine recipients between the ages of 62 and 89.“As highlighted by FDA/CDC, adverse events may not be causally related to vaccination, yet thorough evaluation of these cases is critical to ensure the safe use of Ixchiq, of which over 40,000 doses are estimated to have been utilized to date, worldwide,” Valneva said in its latest release on the U.S. pause recommendation.The company added that it’s working closely with global health authorities and expects formal reviews of post-marketing safety reports in all regions where Ixchiq is approved.  Just last month, Ixchiq scored marketing authorization in Brazil, marking the shot’s first approval in a country where chikungunya is endemic. Besides the U.S., Brazil and Europe, Ixchiq is also approved in Canada.Valneva stressed that it’s committed to safety and working closely with regulatory bodies to provide “timely information about all known SAEs.” Most of the safety flags have cropped up in elderly people with underlying medical conditions, the company explained.Despite potential safety concerns, Valneva is sticking by its vaccine, which became the first ever approved for the chikungunya virus when it won an FDA nod in November 2023. Ixchiq was specifically approved for adults who are at increased risk of exposure to the virus, which is carried by mosquitoes in tropical regions around the world.

The National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS) announced a new research collaboration on Wednesday, launching Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.'s initiative to uncover the root causes of autism spectrum disorder (ASD). Through the partnership, the agencies will build a platform using real-world data from claims, electronic medical records and wearables to enable advanced research.According to a recent HHS survey, ASD now affects 1 in 31 children in the US. In a private address to FDA staff last month, Kennedy shared his intent to investigate the etiology of the condition. This followed reports that the Centers for Disease Control and Prevention (CDC) planned to investigate the alleged link between autism and certain vaccines — a theory that has been extensively studied and repeatedly disproven.To conduct the current study, CMS and NIH will sign an agreement to ensure that Medicare and Medicaid data from patients with autism will be shared safely. This autism-focused project will serve as a test case for future NIH research. The agencies say they will build a secure system that enables them to share data quickly, without compromising security. Lessons learned from this initiative will be applied to a larger platform that researchers will use to study healthcare utilisation, the underlying biological mechanisms of chronic diseases, how those diseases are treated and their economic burden.In the autism study, researchers will look at patterns in autism diagnoses across time, the efficacy of specific medical and behavioural interventions, demographic and geographic inequalities in healthcare access and the financial impact of autism on families and healthcare systems."This partnership is an important step in our commitment to unlocking the power of real-world data to inform public health decisions and improve lives," said NIH Director Jay Bhattacharya. "Linking CMS claims data with a secure real-world NIH data platform, fully compliant with privacy and security laws, will unlock landmark research into the complex factors that drive autism and chronic disease — ultimately delivering superior health outcomes to the Americans we serve."