The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
With the World Health Organization’s COVAX facility having more COVID-19 vaccine doses available than have been requested by the countries it was designed to help, industry groups are pushing back against the proposed TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver for COVID-19 vaccines that has been agreed to by the EU, India, South Africa and the U.S.
With global COVID-19 cases on the rise once again, the World Trade Organization (WTO) said it reached consensus among four WTO members – the U.S., European Union, India and South Africa – for an IP waiver regarding vaccines, a proposal to which biopharma reiterated its objections. Meanwhile, in the U.S., the White House appealed to Congress to provide adequate funding to continue the country’s pandemic response, and Pfizer Inc. and Biontech SE submitted an application to the FDA seeking emergency use authorization for a fourth shot of its COVID-19 vaccine.
Two years ago, BioWorld reported on 30 therapeutics and vaccines in development for COVID-19, about 3,000 people had died from the disease, and societal lockdowns began. Today, therapeutics and vaccines have ballooned to 1,048, deaths are at 6 million, and the world remains on edge due to highly transmissible variants and breakthrough infections. One thing remains the same: Scientists still do not know where the SARS-CoV-2 virus originated.
SK Bioscience Ltd. is developing a vaccine intended to simultaneously immunize people against the flu and COVID-19. It is the first vaccine of its type to be developed in South Korea and will use the technology from Skycellflu, a cell-cultivated influenza vaccine developed by the Seongnam-si, South Korea-based company.
For years, a vaccine against respiratory syncytial virus (RSV) has been out of reach. But this could change thanks to several candidates in the late-stage pharma pipeline. Among them, Moderna Inc. became one of the front-runners in the race to develop a vaccine for the virus after this week announcing that its entrant in the contest, mRNA-1345, is moving into phase III development.
Odeon Therapeutics Inc. has acquired rights to two cancer candidates from Obi Pharma Inc. in a deal worth up to $200 million. The transaction gives Shanghai-based Odeon rights to develop, register, and commercialize the antibody-drug conjugate OBI-999 and a therapeutic cancer vaccine OBI-833 in mainland China, Hong Kong, and Macau.
With the first global approval by Health Canada in hand, Medicago Inc. aims to provide 20 million doses this year of Covifenz – which itself represents another first, as a plant-originated, virus-like particle, recombinant, adjuvanted COVID-19 vaccine. “Hopefully, if all goes well, we’ll be able to do it faster than the last day of the last month” of the year, said Brian Ward, medical officer of Quebec City-based Medicago, a unit of Mitsubishi Tanabe Pharma Corp., which partnered on Covifenz with Glaxosmithkline plc (GSK).
On the success of last year’s establishment of a global mRNA vaccine technology transfer hub in South Africa, the World Health Organization (WHO) announced its next step Feb. 23: the creation of a global biomanufacturing training hub in South Korea that will serve low- and middle-income countries wanting to produce biologics, such as vaccines, insulin, monoclonal antibodies and cancer treatments.
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