SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
Be it viral, nucleic acid or protein vaccines, recent efforts that led to the first regulatory approvals for not only COVID-19, but also for malaria and respiratory syncytial virus, positioned infectious diseases in the headlines for much of the last four years. But despite that attention, or the threat of future pandemics, or the numerous infectious diseases for which there are no preventable vaccines and very little development activity, the level of private and public funding for biopharma companies working in the space is dismal – at least compared with that of oncology products, according to a new analysis report released by the Biotechnology Innovation Organization (BIO) on Jan. 25.
PDC*line Pharma SA has received €4.7 million (US$5.1 million) in public funding as part of a €12.5 million project to apply its allogeneic leukemia-derived dendritic cell line in the development of personalized vaccines for treating colorectal cancer.
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
It is not the first malaria vaccine, but R21, recommended for use by the World Health Organization in October, is the first that can be manufactured at modest cost and the sort of scale needed for widespread prevention of the killer disease in Africa.
A safe and effective vaccine for preventing respiratory syncytial virus (RSV), a common and sometimes serious respiratory infection, had eluded biopharma for decades. But in 2023, the world saw the first – and second – vaccine hit the market.
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld.
Astrazeneca plc, which seemed to have backed away from vaccine development after the COVID-19 pandemic, clearly took a shine to Icosavax Inc.’s virus-like particle technology and signed a deal to take over the firm for as much as $1.1 billion.