ACT Accelerator

The state of the fight: 

Multiple wealthy countries outlined imminent booster dose plans, spurning a WHO plea for patience.
  Novavax pushed back its timeline for seeking U.S. FDA authorization for its vaccine and said the U.S. had paused funding for the shot’s production.
  The African Vaccine Acquisition Trust announced its first shipments of doses.

 

Approved or authorized vaccines

 
J&J’s shot offers up to 96.2% protection against death,…

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

The state of the hunt:

J&J’s vaccine became the first single-dose Covid-19 jab to receive EUL from the World Health Organization.
  A growing list of countries—including at least one COVAX AMC participant—suspended their rollouts of AstraZeneca’s vaccine over safety concerns.
  Monoclonal antibodies from Lilly and a separate mAb from GSK and Vir substantially cut the risk of hospitalization or death in people with mild or moderate Covid-19 at high risk of progression…

The state of the hunt:

J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
  The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
  Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Approved or authorized vaccines
  
Pfizer/BioNTech shot continues strong showing…

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…

The state of the hunt:

Pfizer and BioNTech submitted a U.S. FDA Emergency Use Authorization request for their vaccine.
  Lilly’s rheumatoid arthritis drug Olumiant snagged an EUA (in combo with remdesivir) as a Covid-19 treatment.
  WHO formally issued a conditional recommendation against using Gilead’s remdesivir in hospitalized Covid-19 patients.

 

Vaccines


Phase 3 candidates

Pfizer/BioNTech request EUA: Friday’s submission to the U…

The state of the hunt:

With their mRNA vaccine showing an interim efficacy rate above 90%, Pfizer and BioNTech may have the necessary data to apply for U.S. FDA Emergency Use Authorization this month.
  Eli Lilly snagged the first FDA EUA for an anti-SARS-CoV-2 monoclonal antibody.
  Indonesia and Morocco laid out plans for Covid-19 mass immunization campaigns before year-end.

 

Vaccines


Phase 3 candidates:

Pfizer/BioNTech’s shot more…

The state of the hunt:

CEPI expanded its funding for Clover Biopharmaceuticals’ S-Trimer Covid-19 vaccine candidate to $328 million.
  Humanigen touted positive interim Phase 3 results for lenzilumab and announced a cooperative R&D deal with the U.S. government.
  Russia approved a domestic version of Fujifilm’s Avigan for coronavirus outpatients, dubbing the product “the first [f]avipiravir-based drug in the world approved for the treatment of COVID-19.”

 

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:

Regulators in Brazil, Canada and Europe commenced accelerated “rolling reviews” of AstraZeneca’s vaccine candidate even as the U.S. FDA widened its probe of the shot amid safety concerns.
  Serum Institute of India doubled its commitment of affordable Covid-19 vaccine doses to the COVAX AMC, pledging up to 200 million.
  The ACT Accelerator launched a partnership to provide 120 million Covid-19 rapid antigen tests to LMICs over six months.

 …