Up to now, the Pfizer Inc.-Biontech SE COVID-19 vaccine has had a lock on the U.S. pediatric market, for ages 5 to 17, but that could change as early as next week.
Everest Medicines Ltd. has formed a partnership with China Resources Pharmaceutical Group (CR Pharma) to co-launch an independent company to focus on the development of messenger RNA (mRNA) vaccines. The new entity will take over rights Everest obtained through a collaboration with Providence Therapeutics Holdings Inc. They include the full technology platform and Everest’s mRNA manufacturing infrastructure.
When the U.S. FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) April 6 to advise on a path forward to the next generation of COVID-19 vaccines and boosters, there was a lot of talk about all the unknowns.
Citing the lack of clear evidence that vaccine protection against severe COVID-19 disease is substantially waning in the EU in people younger than 80, the European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded that it’s too early to consider using a fourth dose, or second booster, of mRNA COVID-19 vaccines in the general population.
Alnylam Pharmaceuticals Inc. has filed suits against both Pfizer Inc. and Moderna Inc. over alleged infringements of its patent on biodegradable cationic lipids that it said "are foundational to the success of the mRNA COVID-19 vaccines."
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Novavax Inc.’s Nuvaxovid, making it the first protein-based COVID-19 vaccine to be approved for commercial use in the country. The regulatory win for Novavax adds to emergency use authorizations (EUA) for the product, also known as NVX-CoV2373, in India, Indonesia and the Philippines, as well as an emergency use listing from the World Health Organization. On Jan. 12, the company said it expects to submit an EUA request to the FDA after one month.
Preliminary data from a phase IIIb study of Johnson & Johnson’s Ad26.COV2.S COVID-19 vaccine showed a homologous booster dose was 85% effective against hospitalization in participants from South Africa.
Astrazeneca plc has confirmed it is working with Oxford University to produce a vaccine against the Omicron variant of the SARS-CoV-2 virus. The Cambridge, U.K.-based pharma was one of the first to get a COVID-19 vaccine okayed by regulators, after acquiring rights to the shot from Vaccitech plc, a spin-out from Oxford University’s Jenner Institute specialist vaccine unit.
While the world grapples for a clear picture of the Omicron variant and how to handle it, Moderna Inc., Biontech SE and Adagio Therapeutics Inc. stepped out with stock advances, building on momentum from the end of last week, while eyeing 2022 as a launch date against the variant.
