LONDON – Three large scale population surveys conducted between late June and the end of September have shown the prevalence of SARS-CoV-2 antibodies in England declined by 26.5% over three months. The findings rest on the results of more than 350,000 self-administered lateral flow blood tests that were carried out at home by volunteers who were randomly selected from general practitioner registers.
HONG KONG – Even with vaccine administration just around the corner, Indonesian President Joko Widodo has warned his ministers to not rush the launch of COVID-19 vaccines over mounting public concerns about whether those vaccines would be certified halal, or permissible under Islamic law.
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.
LONDON - The world’s first COVID-19 human challenge trial is due to start in London next year, after the government announced £33.6 million (US$42.5 million) funding for the project. In the initial phase, the aim is to establish the dose of SARS-CoV-2 needed to cause infection and to characterize the immune response to virus. That will lead on to tests of individual COVID-19 vaccines, in which volunteers will be challenged with the effective dose of SARS-CoV-2 one month after inoculation.
CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy.
DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild.
Johnson & Johnson said it has temporarily paused further dosing of its adenoviral vector-based COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant. Trial enrollment is also on hold while the company awaits a recommendation on how to proceed from the study's data safety monitoring board.
Astrazeneca plc said it has received about $486 million from the U.S. government to support the development and supply of a long-acting antibody combination under evaluation for the prevention and treatment of COVID-19. Phase III trials of the candidate, AZD-7442, are slated to begin later this month, the company told BioWorld. One trial will enroll more than 6,000 adults for the prevention of COVID-19 with additional trials set to enroll about 4,000 adults for the treatment of the infection, the Cambridge, U.K.-based company said.
LONDON – The first confirmed case of COVID-19 reinfection in the U.S. has been reported, with a patient testing positive for two distinct SARS-CoV-2 strains within 48 days, while testing negative in between contracting the two infections.
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