NIH

The string of good news for Sanaria’s PfSPZ-CVac malaria vaccine candidate continued Wednesday with promising Phase 1 data based on human challenges.

The research, published in the journal Nature, found that two versions of the chemoprophylaxis-attenuated whole-organism vaccine regimen protected volunteers three months following dosing, according to a press release from the U.S. National Institutes of Health, which helped conduct the trial: seven out of eight volunteers who received…

Mentions:

San Diego-based Qpex Biopharma announced last week that it has begun a Phase 1 study of QPX9003, its next-generation intravenously administered synthetic polymyxin for infections caused by drug-resistant gram-negative pathogens (including Acinetobacter species and P. aeruginosa).

In other AMR news, the U.S. National Institutes of Health has awarded HelixBind $3.3 million to support testing of its RaPID/BSI diagnostic platform for sepsis-related bloodstream infections, the biotech…

The U.S. National Institutes of Health announced Tuesday the launch of a first-in-human Phase 1 trial of FluMos-v1, a nanoparticle universal influenza vaccine candidate developed by the U.S. National Institute of Allergy and Infectious Diseases.

Healthy adults age 18-50 will receive either the candidate vaccine or a shot of Flucelvax, the cell-based quadrivalent seasonal flu vaccine from Seqirus, per the press release.

In animal models, FluMos-v1 performed “as well as or slightly…

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:

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:

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:

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:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…

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:

Two versions of the AstraZeneca/Oxford vaccine secured EUL from the World Health Organization.
  J&J has applied for both WHO and EMA authorization for Janssen’s Covid-19 vaccine.
  The Pfizer/BioNTech shot remains stable at higher temperatures than previously believed.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech are testing their vaccine in pregnant women through a 4,000-participant…