IVI

Seoul’s International Vaccine Institute announced Tuesday that the first participant has been dosed with Bharat Biotech’s BBV87 two-dose, live-inactivated chikungunya vaccine in a Phase 2/3 trial in Costa Rica.

The trial is the first in a multicountry study—backed by the Coalition for Epidemic Preparedness Innovations (CEPI) and the Indian government’s Ind-CEPI initiative—to test the Hyderabad-based company’s shot in healthy adults in areas with endemic chikungunya, the press release…

The state of the fight: 

South Africa’s Biovac will fill-finish the Pfizer/BioNTech vaccine.
  The U.S. will give $200 million to South Africa’s Aspen Pharmacare to boost vaccine capacity.
  CEPI and IVI are backing new vaccine trials in Africa.

 

Regulatory updates

Sanofi’s “Vidprevtyn” under rolling review: The EMA announced Tuesday it has begun reviewing the recombinant protein Covid-19 vaccine candidate, which uses a GSK adjuvant. Sanofi also expects real…

Seoul’s International Vaccine Institute (IVI) on Monday touted its Gates Foundation award to develop an adaptive trial design protocol for a Phase 1b/2a study of a schistosomiasis vaccine candidate.

A first-in-human safety study of SchistoShield (Sm-p80)—co-developed with Gates funding by Texas Tech and PAI Life Sciences, and using the GLA-SE adjuvant from IDRI—is slated to take place in the United States, followed by a Phase 1b safety and immunogenicity study in Burkina Faso and…

Mentions:

Seoul’s International Vaccine Institute (IVI) announced last week that South Korea-based Sumagen will pursue recombinant vesicular stomatitis virus (rVSV)-based vaccines against MERS and Crimean-Congo hemorrhagic fever with $1.2 million in funding, to include work on wider pandemic response platforms. The project is part of a collaboration between IVI and the government-sponsored Vaccine Innovative Technology Alliance Korea (VITAL-Korea) initiative.

Sumagen’s rVSV-based Covid-19…

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:

WHO issued its first EUL for a Covid-19 vaccine in recent days while Britain and the EMA authorized an additional jab and China and India cleared their first shots.
  Both Bharat Biotech and Pfizer claimed their respective vaccines are effective against newly identified SARS-CoV-2 variants.
  SII pledged to sell an initial 100 million doses to India at a “special price” of $2.74 each.

 

Vaccines


Approved or authorized…

Seoul’s International Vaccine Institute (IVI) announced Thursday that SK Bioscience’s Vi-DT typhoid conjugate vaccine (TCV) has met the primary endpoints in Phase 3 trials in Nepal.

The diphtheria toxoid-based candidate induced an immune response that was non-inferior to Bharat Biotech International Limited’s WHO-prequalified Typbar-TCV and was shown to be safe in all 1,350 participants (ages 6 months to 45 years).

IVI, which developed the Vi-DT vaccine, transferred the…

The state of the hunt:

The United Kingdom issued emergency authorization of Pfizer/BioNTech’s vaccine.
  WHO is reviewing the Pfizer/BioNTech shot for Emergency Use Listing.
  Moderna requested emergency nods for its mRNA-based vaccine from the U.S. FDA and the European Medicines Agency.

 

Vaccines


Approved or authorized vaccines

Pfizer is now seeking full British marketing authorization for its Covid-19 vaccine “in parallel” with the…

Seoul’s International Vaccine Institute (IVI) announced last week that SK Bioscience’s Vi-DT typhoid conjugate vaccine (TCV) proved safe and immunogenic in children ages 6-23 months in Phase 2 trials in the Philippines. The Lancet’s EClinicalMedicine published the results.

Findings from the study “will be critical for licensure and WHO prequalification of Vi-DT, contributing to filling the gap in supply,” the authors said. WHO prequalified its first and only TCV—from India’s Bharat…

The state of the hunt:

Phase 3 trials of AstraZeneca’s AZD1222 vaccine candidate resumed in Brazil, Britain, India and South Africa, while U.S. officials voiced safety concerns.
  The United Arab Emirates joined China in issuing emergency approval of a CNBG inactivated vaccine candidate.
  A trial of Lilly’s RA drug Olumiant in combination with remdesivir met its primary endpoint.

 

Vaccines

Phase 3 candidates:
 
Phase 3 trials resumed last…