After COVID-19 reached a pandemic peak in January due to the omicron variant, infections in the U.S. are now hitting the lowest levels since March of 2020. During the past week, there were 195,963 confirmed SARS-CoV-2 infections in the country, according to Johns Hopkins University data. That is 5.5% fewer infections than the same week two years ago and 56% fewer than last year. Deaths are also down to 5,602 for the week, although there were lower points in the spring and summer months of 2020 and 2021.
Jiangsu Recbio Technology Co. Ltd. raised HK$765 million ($97.7 million) in a Hong Kong stock exchange IPO on March 31. Shares of the vaccine maker (HKEX: 2179) opened at HK$25 per share and rose 1.8% to close at HK25.25 apiece. The Jiangsu, China-based company plans to use about half the proceeds, or HK$317.9 million, to support development and commercialization of its HPV vaccines, including its lead asset, a phase III recombinant HPV 9-valent vaccine REC-603, a spokesperson told BioWorld. The company also plans to set up an HPV manufacturing facility in Taizhou, China.
Results from the phase IIb challenge study with its intranasal immunomodulator for influenza A, REVTx-99a, in healthy volunteers sent Revelation Biosciences Inc. shares (NASDAQ:REVB) into a tailspin, and the stock closed at $1.32, down 82 cents, or 38.3%.
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results.
Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries. Shanghai-based Nuance plans to run its own phase I and phase III trials in China to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from Bavarian Nordic's own phase III trial planned to begin in the first half of 2022.
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.
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