Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
LONDON – Researchers at the Jenner Institute in Oxford have given an inside view of how they are accelerating clinical development of a COVID-19 vaccine and at the same time putting in place commercial manufacturing for when phase III efficacy data are available, expected in August or September.
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.”
DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology.
LONDON – Companies represented in the expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines have signed a pledge to strengthen collaboration and sharing of data.
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.” And the road to normalcy from the current pandemic, or any pandemic, is likely to be open only once there is a vaccine.
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
Novavax Inc., one of the first biopharma companies to reveal its efforts to develop a SARS-CoV-2 vaccine in January, has identified a prefusion protein for testing in an Australian phase I trial, slated to start in mid-May.
Evercore ISI assembled a dozen internal specialists for a webinar to talk about COVID-19 from a variety of perspectives, with opinions aplenty on transmission route, up-and-coming treatment prospects, and problems in how testing procedures are understood – or not.
HONG KONG – Chengdu, China-based Clover Biopharmaceuticals Inc. has teamed up with Emeryville, Calif.-based Dynavax Technologies Corp. on a research collaboration to develop a vaccine candidate to prevent COVID-19.
RSS
