MedPath

Haemagglutinin-strain A(H1N1)

Generic Name
Haemagglutinin-strain A(H1N1)
Brand Names
Afluria Tetra, Agriflu, FluLaval Tetra, Fluad, Fluad Pediatric, Fluviral, Fluzone High-Dose Quadrivalent, Fluzone Quadrivalent, Influvac Tetra
Drug Type
Biotech

Osivax Initiates Phase 2a Booster Trial of Broad-Spectrum Influenza Vaccine OVX836

• Osivax has dosed the first participant in a Phase 2a clinical trial evaluating OVX836 as a booster for its broad-spectrum influenza vaccine candidate. • The trial assesses the safety and immunogenicity of a booster dose in participants previously vaccinated with OVX836 three to five years prior. • OVX836 targets the nucleoprotein, a conserved internal antigen of influenza A, aiming for a broader and more universal immune response. • Topline results from the randomized, double-blind study, conducted at Ghent University Hospital, are expected by the end of 2025.

Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccines

• Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine, evaluating immunogenicity and safety. • The trial compares the CIC and stand-alone influenza vaccines to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine in adults aged 65 and older. • Novavax is collaborating with the FDA to explore potential accelerated approval pathways for both vaccine candidates, aiming for clarity by Q2 2025. • The Phase 3 trial includes approximately 2,000 participants and builds upon positive Phase 2 data, with initial results expected by mid-2025.

2024-2025 Respiratory Vaccine Guidelines: Key Updates for COVID-19, Flu, RSV, and Pneumococcal Vaccines

• CDC data indicates rising COVID-19 cases and predicts seasonal respiratory disease burden for 2024-2025 to be similar or slightly lower than previous season, emphasizing urgent need for vaccination. • New COVID-19 vaccine formulations target Omican JN.1 and KP.2 variants, with updated recommendations including second doses for those 65+ and immunocompromised individuals. • Significant changes include transition to trivalent flu vaccines, expanded RSV vaccination guidelines for 75+ age group, and lowered pneumococcal vaccination age recommendation to 50 years.

EMA's CHMP Recommends 10 New Medicines, Including Novel Therapies and Biosimilars

• The European Medicines Agency's CHMP has recommended 10 new medicines for marketing approval, encompassing five new drugs, one orphan drug, two biosimilars, and two generics. • Novel therapies such as Alhemo (concizumab) for hemophilia and Wainzua (eplontersen) for hereditary transthyretin-mediated amyloidosis received positive opinions. • Biosimilars Absimky (ustekinumab) and Imuldosa (ustekinumab) were recommended for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. • The CHMP reaffirmed its negative recommendation for Masitinib AB Science for amyotrophic lateral sclerosis due to concerns about data reliability and efficacy.

FDA Halts Novavax's COVID-19 and Influenza Vaccine Trials Due to Safety Concerns

• The FDA has placed a clinical hold on Novavax's combination COVID-19 and influenza vaccine, along with its standalone influenza vaccine, following a serious adverse event report. • The adverse event, motor neuropathy, was reported in a Phase 2 trial participant outside the U.S. who received the combination vaccine in January 2023. • Novavax is collaborating with the FDA to provide necessary information and resolve the clinical hold, aiming to commence Phase 3 trials as soon as possible. • The clinical hold does not affect Novavax's standalone COVID-19 vaccine, which remains available on the U.S. market.

EMA Recommends Approvals for Novel Therapies Targeting Cancer, Hemophilia, and Neurological Disorders

• The EMA's CHMP recommended ten new medicines for approval, including Alhemo for hemophilia and Wainzua for hereditary transthyretin-mediated amyloidosis. • Positive opinions were adopted for two influenza vaccines, Fluad and Flucelvax, and for Siiltibcy, a diagnostic for Mycobacterium tuberculosis infection. • CHMP recommended extensions of indication for twelve already authorized medicines, expanding treatment options for various conditions. • The committee elected Bruno Sepodes as its new chair and Outi Mäki-Ikola as its new vice-chair, effective September and October 2024, respectively.
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