IAVI

The International AIDS Vaccine Initiative (IAVI) has entered another agreement to use Batavia Biosciences’ novel HIP-Vax platform to manufacture doses for clinical trials, the Dutch CDMO announced last week. This time around, the vaccine candidate is IAVI’s Sudan ebolavirus shot.

Batavia is already using the high-volume, low-cost, small-footprint technology to produce doses for Phase 1 trials of IAVI’s Lassa fever vaccine candidate. Both candidates use a recombinant vesicular…

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has made two recent Sudan ebolavirus and Marburg virus vaccine awards.

Firstly, the International AIDS Vaccine Initiative (IAVI) said Wednesday that BARDA has given it up to $126 million to help develop its two recombinant vesicular stomatitis virus (rVSV)-vectored candidates.

Meanwhile, Sabin Vaccine Institute announced last week that BARDA has released a third tranche of $34.5 million in funding to allow…

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…