NIH

The state of the fight: 

South Africa’s Afrigen has produced the first batch of its version of Moderna’s mRNA-based vaccine.
  Afrigen also secured a $45 million grant from the U.N.-backed Medicines Patent Pool.
  Moderna’s Spikevax notched full approval in the U.S.

REGULATORY UPDATES

 
Pfizer and BioNTech have begun rolling data submission for authorization of their Comirnaty shot in children between ages 6 months and 5 years “at the request” of the U.S…

Moderna and the International AIDS Vaccine Initiative (IAVI) have dosed the first participants in a Phase 1 trial of an experimental mRNA-based HIV vaccine (mRNA-1644) and boost candidate (mRNA-1644v2-Core), according to a joint press release issued last week.

The trial builds off a previous proof-of-concept study showing that a compound (developed by IAVI and Scripps Research) in mRNA-1644 generated a B-cell response in 97% of recipients. Both trials are part of a Gates Foundation-…

The state of the fight: 

WHO issued an Emergency Use Listing for Serum Institute of India’s version of Novavax’s vaccine.
  The U.S. CDC recommended mRNA-based vaccines over J&J’s.
  Data on the effectiveness of monoclonal antibody therapies against the Omicron variant began pouring in.

AUTHORIZED VACCINES  

A U.S. CDC advisory panel recommended mRNA-based vaccines over the J&J jab, citing blood clot side effects stemming from the single-dose…

Ten pharma companies have joined a U.S. FDA and U.S. National Institutes of Health initiative to streamline the gene therapy development process for rare diseases.

Armed with $76 million from the NIH and private partners, the Bespoke Gene Therapy Consortium will pursue a standardized therapeutic development model based on the adeno-associated virus (AAV) vector. The initiative will support four to six clinical trials, each focused on a different rare disease, according to an FDA press…

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…