More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
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.
Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.
Rnaimmune Inc., which in April raised a $10 million seed round to support its discovery and development of RNAi therapies, said it is now studying the neutralizing effects of its mRNA-based COVID-19 vaccine candidate on the Omicron variant.
Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19 and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19.
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide Clover Biopharmaceuticals Ltd. with an additional $36.9 million to support development of SCB-2019, a recombinant trimeric Spike-protein subunit COVID-19 vaccine.
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.
In a couple of deals worth more than $500 million, Everest Medicines Ltd. is picking up Asian rights to Providence Therapeutics Holdings Inc.’s mRNA candidates, including rights to a mRNA COVID-19 vaccine candidate currently in phase II testing.
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
Sinovac Biotech Ltd. said booster shots of its Coronavac vaccine against SARS-CoV-2 induce strong immune responses in adult and elderly populations following a considerable loss of antibodies six to eight months after completing the current two-dose regimen.
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