Ocugen Inc. has received IND clearance from the FDA for OCU-500, an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct a phase I trial of OCU-500 administered via inhalation into the lungs and intranasally as a spray.
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.
The research on novel vaccines against SARS-CoV-2 with improved characteristics continues. These ideal features include rapid development to target variants of concern, easy manufacturing, and an excellent safety profile while inducing humoral and cellular immune responses.
Capricor Therapeutics Inc.'s Stealthx exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of the U.S. Department of Health and Human Services' Project Nextgen initiative aimed at developing COVID-19 vaccines offering broader and more durable protection.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
The intellectual property waivers for American vaccines for the COVID-19 pandemic are still controversial, but the World Health Organization (WHO) is nonetheless seeking a similar set of waivers for therapies and tests for COVID. A subcommittee of the House Judiciary Committee met June 6 to review these waivers, and subcommittee chairman Darrell Issa (R-Calif.) said he intends to continue pushing legislation that would require the U.S. president to obtain congressional approval for agreeing to any such waivers in the future.
China's National Medical Products Administration (NMPA) has given drug clinical trial approval for two new COVID-19 vaccines against the current XBB variants developed by Westvac Biopharma Co. Ltd. and West China Medical Center at Sichuan University.
Multivalent vaccines that could improve SARS-CoV-2 immunity while also preventing infections by other viruses, such as influenza and respiratory syncytial viruses, constitute an urgent public health need. Currently approved vaccines against SARS-CoV-2 are based solely on the spike protein, which provides limited immunity against variations in spike.
