Medicago

The state of the fight: 

Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
  Hetero Pharma’s generic version of Merck’s molnupiravir reduced the risk of hospitalization by over 65%.
  Britain and Japan pledged a combined $514 million to CEPI’s pandemic preparedness plan.   AUTHORIZED VACCINES

 
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine to…

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

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:

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…

The Lancet published mixed Phase 3 results this week showing that Medicago’s plant-derived, quadrivalent virus-like particle (QVLP) influenza vaccine was safe, well-tolerated and may provide “substantial protection”—though it failed to meet primary endpoints in one of the studies.

The vaccine proved non-inferiority in people 65 years and older against the comparator inactivated shot. However, in a separate study, QVLP failed to meet its primary endpoint of 70% absolute efficacy in…

The state of the hunt:

Vaccine candidates from Bharat Biotech, Medicago, Zydus Cadila and the University of Queensland entered Phase 1 or 1/2 trials this week.
  Inactivated candidates from CNBG entered Phase 3.
  India issued emergency approval of Biocon’s itolizumab for the treatment of coronavirus-related cytokine-release syndrome.

 

Vaccines

Clinical trials:

Moderna says 30,000-participant Phase 3 trials of its investigational mRNA vaccine…

The state of the hunt:

Gilead says remdesivir showed 62% reduced mortality in severe patients
  Sinovac received approval to commence Phase 3 vaccine studies in Brazil
  Pfizer CEO hopes for October FDA vaccine approval
  Hep C drugs sofosbuvir and daclatasvir showed “provocative and encouraging” results against Covid-19

 

Vaccines

Clinical trials:

Brazil regulators approved a Phase 3 trial of Beijing-based Sinovac’s inactivated vaccine…

Progress continued on vaccines, treatment and tests for Covid-19 over the past week as WHO declared the disease a pandemic and funders announced more grants.

Vaccines

On vaccines, the Coalition for Epidemic Preparedness Innovations (CEPI) announced two new grants this week: $4 million supporting Novavax’s use of recombinant protein nanoparticle technology to develop vaccine candidates, and a smaller amount to fund the University of Oxford’s candidate search using its…

Canadian biopharma company Medicago announced yesterday that it has started a Phase 3 trial of its seasonal quadrivalent influenza vaccine which it expects to launch “in time for the 2020 season.”

A Medicago press release said that the trial is taking place with 10,000 subjects in seven countries. The vaccine candidate is produced using a “novel, virus-like particle (VLP) technology” that mimics the virus’ structure without its genetic material, making it non-infectious.

Medicago…