Novavax

FDA approves FluMist for self- or caregiver-administration, Novavax updates COVID-19 vaccine, GSK reports positive data for co-administered RSV and shingles vaccines, WHO adds MVA-BN mpox vaccine to prequalification list, New England ranks as most vaccinated region, pharmacist education reduces vaccine hesitancy, and Vaxcyte announces positive data for 31-valent pneumococcal conjugate vaccine.

Novavax appoints Ruxandra Draghia-Akli, MD, PhD, as EVP and Head of R&D in November 2024, leveraging her 20+ years of clinical, corporate, and global public health expertise to evaluate the company's pipeline and Matrix-M™ adjuvant technology.

U.S. government offers another round of free COVID tests by end of September, available at COVIDTests.gov. Over 900 million tests have been distributed. At-home tests provide results within 30 minutes. Vaccines, including strain-specific formulations, are also available.

The FDA authorized updated mRNA COVID-19 vaccines targeting the KP.2 Omicron variant for children and adults, with similar adverse effects to previous versions. Additionally, an updated Novavax vaccine targeting the JN.1 Omicron subvariant was approved for those aged 12 and older.

ACIP recommended 2024–2025 COVID-19 vaccination with FDA-approved vaccines for all persons aged ≥6 months, targeting currently circulating SARS-CoV-2 strains, including Omicron JN.1 lineage (JN.1 and KP.2), to provide additional protection against severe COVID-19–associated illness and death.

The global mRNA vaccine market is projected to decline at a CAGR of -4.3% from 2024 to 2034, reaching US$ 9.6 billion by 2034. Factors driving market growth include streamlined approval processes, innovations in logistics, increasing public trust, and ongoing research into long-term efficacy. Key players include Pfizer-BioNTech, Moderna, and Novartis, with North America leading in market share.

New COVID-19 boosters targeting recent strains like KP.2 were approved, aiming to enhance protection as fall approaches. Despite delays in vaccine shipments to some pharmacies, experts urge getting the booster and flu vaccine by October. High-risk individuals are especially encouraged to vaccinate early, with strategies like mask-wearing recommended for those awaiting vaccination.

Novavax (NVX-CoV2373) is a COVID-19 vaccine with mild to serious side effects like muscle pain and blood clots. It received FDA EUA for ages 12+, given as an injection. Common side effects include injection site reactions, fatigue, and headache. Serious side effects require immediate medical attention.

FDA grants EUA to Novavax's updated COVID-19 vaccine for individuals aged 12+, available in U.S. pharmacies. FDA clears first digital therapeutic, DaylightRX, for GAD treatment. Embecta receives 510(k) clearance for disposable insulin patch pump for T1D and T2D patients. FDA authorizes BioVie's IND for phase 2 trial of bezisterim to treat neurological symptoms of post-COVID-19 condition.

Novavax received EUA from FDA for its updated Covid-19 vaccine, NVX-CoV2705, targeting Omicron variant JN.1 strain, usable for individuals 12 years and older. CEO John C Jacobs highlighted the vaccine's robust cross-reactivity against JN.1 lineage viruses, aligning with FDA's recent recommendations for monovalent JN.1 vaccines.