One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
Minervax Aps has closed a €72 million (US$76.6 million) financing round, enabling it to accelerate phase II development of its group B streptococcus (GBS) vaccine for the prevention of stillbirth and serious infections in newborns and complete the program next year.
Both neutralizing antibodies and antibody effector functions are needed for protection against re-infection with respiratory syncytial virus (RSV), which may explain why it has been challenging to design an effective vaccine against the virus. As reported in the Dec. 12, 2022, issue of Cell, researchers carried out a human challenge study where volunteers were given a candidate vaccine for RSV, Ad26, or placebo.
A new vaccine that uses the native-like HIV-1 envelope (Env) trimer CH505 and a Toll-like receptor (TLR) 7/8 agonist adjuvant, successfully evaluated in macaques, generated potent polyclonal neutralizing antibodies (nAbs) and a high protection against the infection of the homologous simian-human immunodeficiency virus (SHIV).
After political leaders across the globe made patents and other intellectual property (IP) safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
European regulators have added several safety messages to approved COVID-19 vaccines, including a warning that Novavax Inc.’s Nuvaxovid could produce severe allergic reactions.
Now that Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19, it’s time for the CDC to weigh in. Once its Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine and make a policy recommendation, the vaccine will be available on the market.
COVID-19 is the unwanted gift that keeps on giving. The U.S. CDC unwrapped one of those “presents” in a July 12 report that showed the threat of antimicrobial-resistant (AMR) infections has worsened — with resistant hospital-onset infections and deaths in the U.S. each increasing at least 15% during the first year of the pandemic.
Lenzilumab, Humanigen Inc.’s lead candidate, undershot statistical significance on the primary endpoint in the U.S. NIH-sponsored ACTIV-5/BET-B study of treating hospitalized COVID-19 patients. The Short Hills, N.J.-based company’s stock (NASDAQ:HGEN) crumpled in the wake of the results.
