IAVI

Batavia Biosciences announced last week that it has successfully manufactured shots for Phase 1 trials in Africa and the U.S. of the recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine being developed by the International AIDS Vaccine Initiative (IAVI).

The Dutch company, which initially partnered with IAVI in 2018, said it manufactured rVSVΔG-LASV-GPC using its HIP-Vax platform, which “enables the production of high volumes of vaccine doses in a small…

The International AIDS Vaccine Initiative and Spanish biopharma Biofabri announced on Wednesday that they will collaborate on Phase 3 efficacy studies for the novel tuberculosis vaccine candidate MTBVAC. The trials are scheduled to start in several African countries this year.

Biofabri licensed MTBVAC for commercialization from Spain’s University of Zaragoza.

Mentions:

The International AIDS Vaccine Initiative (IAVI) announced Monday $27.4 million in additional funding to conduct Phase 2b trials of its recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine (rVSVΔG-LASV-GPC) in Liberia, Nigeria and Sierra Leone.

According to the press release, the European & Developing Countries Clinical Trials Partnership and the Coalition for Epidemic Preparedness Innovations (CEPI) provided the grant, which builds on an earlier $10.4…

Mentions:

The International AIDS Vaccine Initiative (IAVI) and Scripps Research announced promising results last week from a Phase 1 trial of a novel vaccine approach for HIV.

The eOD-GT8 60mer vaccine compound elicited the targeted antibody response in 97% of participants who received the shot, according to the press release. The Gates Foundation-funded project seeks ultimately to develop a multistep vaccine regimen aimed at eliciting many different types of broadly neutralizing antibodies (…

The state of the hunt:

Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
  J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
  Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Vaccines


Approved or authorized vaccines

AstraZeneca/Oxford’s…

The state of the hunt:

Pfizer/BioNTech’s vaccine won U.S. FDA Emergency Use Authorization.
  The inactivated vaccine from CNBG’s Beijing subsidiary secured UAE registration.
  Bharat Biotech and SII requested Indian authorization of their respective jabs.

 

Vaccines


Approved or authorized vaccines
 
The Pfizer/BioNTech vaccine extended its regulatory lead this week with new authorizations, including a U.S. nod.
 
The U.S.…

The state of the hunt:

Gavi made a preliminary deal with GSK and Sanofi, securing up to 200 million doses of their vaccine candidate for the COVAX Facility.
  British regulators began expedited reviews of vaccines from AstraZeneca and Pfizer, and South Korea also began an initial review of the AstraZeneca candidate.
  A trial of an investigational Lilly mAb failed against advanced Covid-19 cases, and a trial of a Regeneron mAb cocktail in people requiring high-flow…

The state of the hunt:

The U.S. FDA approved Gilead’s Veklury (remdesivir) for hospitalized Covid-19 patients 12 and older.
  IAVI, Merck and Serum Institute of India will collaborate to develop anti-SARS-CoV-2 monoclonal antibodies they plan to make accessible to LMICs.
  AstraZeneca resumed U.S. Phase 3 trials of its AZD1222 Covid-19 vaccine candidate.

 

Vaccines

Phase 3 candidates:
 
J&J is “preparing to resume recruitment” for the…

Citing the government’s need for “national preparedness” for future epidemics, Regeneron announced last month that the U.S. Biomedical Advanced Research and Development Authority will pay the New York-based company an estimated $335 million over five years, starting in 2022, for doses of its Ebola monoclonal antibody (mAb) treatment, REGN-EB3.

Meanwhile, the International AIDS Vaccine Initiative (IAVI) released a report this week stating that the United States, Canada and Europe…

The 23rd International AIDS Conference took place virtually last week due to Covid-19, but it still produced its usual slew of progress announcements on HIV/AIDS treatments.

GSK subsidiary ViiV presented final Phase 2b/3 data affirming that long-acting injectable cabotegravir showed “superior efficacy” in preventing HIV among cisgender men and transgender women who have sex with men compared with Gilead’s blockbuster daily pre-exposure prophylaxis (PrEP) pill, Truvada.

Also,…