Valneva

Valneva announced Wednesday that the U.S. FDA has granted its VLA1553 single-shot chikungunya vaccine candidate (currently in Phase 3) Breakthrough Therapy Designation—adding to the PRIority MEdicines (PRIME) designation the EMA awarded the French company’s jab in 2020 and the FDA Fast Track status it received in 2018.

The state of the hunt: 

WHO cleared Sinovac’s vaccine for emergency use.
  Gavi’s COVAX AMC funding summit exceeded its goals, securing $2.4 billion in commitments.
  India ordered 300 million doses of a yet-to-be-authorized Bio E vaccine candidate. Approved or authorized vaccines

Sinovac’s inactivated vaccine notched WHO Emergency Use Listing on Monday, leaving the shot, CoronaVac, eligible for supply through the COVAX Facility. Less-demanding storage requirements…

Vaccine makers Vaccitech and Valneva separately filed plans last week for initial public offerings on Nasdaq.

Oxford-based Vaccitech is the Jenner Institute spinout that owns the technology underlying the AstraZeneca/Oxford Covid-19 vaccine. Its pipeline includes a Phase 1 MERS vaccine and a preclinical zoster shot.

France’s Valneva, already listed on Euronext and proposing to list American depositary shares via a new offering, is seeking regulatory clearance to advance its…

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


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’s vaccine…

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:

India inked vaccine supply deals with Bharat Biotech and SII.
  BioNTech upped its 2021 production target for Comirnaty to 2 billion doses—but the Pfizer/BioNTech vaccine faced near-term production slowdowns and delivery lags.
  An African Union-backed supply initiative locked up 270 million vaccine doses for the continent.

 

Vaccines


Approved or authorized vaccines

Sinovac’s inactivated jab notched its first…

The state of the hunt:

Moderna’s became the second Covid-19 vaccine to receive U.S. FDA Emergency Use Authorization.
  COVAX has secured nearly 2 billion doses of vaccines but faces a “very high” failure risk, according to Reuters.
  Canada, Saudi Arabia and the United States have begun immunization campaigns using Pfizer/BioNTech’s jab.

 

Vaccines


Approved or authorized vaccines
 
The U.S. FDA granted Emergency Use Authorization (EUA…

Valneva announced Friday that the European Medicines Agency has granted its VLA1553 chikungunya vaccine candidate (now in Phase 3) a PRIority MEdicines (PRIME) designation. The U.S. FDA granted the shot Fast Track status in 2018.

In a separate announcement, the French biotech touted initial results Tuesday showing that its VLA15 Lyme disease vaccine candidate—co-developed with Pfizer—has met Phase 2 endpoints. The shot was well-tolerated, seroconversion rates exceeded 90%, and…

The state of the hunt:

Vaccine candidates from Novavax and J&J’s Janssen subsidiary entered Phase 3.
  Chinese regulators are reviewing inactivated vaccine candidates from CNBG for conditional authorization.
  Fujifilm’s flu drug Avigan (favipiravir) met its primary endpoint in a Phase 3 trial for treatment of Covid-19.

 

Vaccines

Phase 3 candidates:
 
China weighs approval of CNBG shots: State regulators are reviewing CNBG’s two…