Everest Medicines and Providence Therapeutics have reported that their Covid-19 vaccine, PTX-COVID19-B, obtained approval to be part of the World Health Organization (WHO) Solidarity Trial Vaccines (STV) programme.
The inclusion comes after a recommendation from an independent advisory group.
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A messenger ribonucleic acid (mRNA) vaccine, PTX-COVID19-B encodes the SARS-CoV-2 S protein encapsulated in a lipid nanoparticle.
The global, randomised STV clinical trial is assessing the efficacy and safety of potential Covid-19 vaccine candidates.
Based on pre-defined eligibility requirements, an independent vaccine prioritisation advisory group chooses the vaccines.
The criteria features a vaccine’s safety, its potential for efficacy, stability, ease of manufacturing for global supply and administration.
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By GlobalDataSponsored by and funded by the WHO, the trials are currently enrolling subjects in selected study centres in the Philippines, Mali and Colombia.
The panel has so far reviewed the data from nearly 20 vaccines and included two vaccines of Medigen and Inovio, respectively, in the trial.
Individuals of the age 16 years and above residing in regions with greater Covid-19 incidence rates but were not infected or have not been inoculated form part of the trial.
All subjects in the trial will be followed up weekly for a minimum of one year on receiving the vaccines.
Everest Medicines CEO Kerry Blanchard said: “The STV trial complements the joint efforts of Everest and Providence in generating a robust safety and immunogenicity data set design.
“We hope this can help accelerate approval with regulatory bodies around the world.”
According to interim results from the Phase I trial of PTX-COVID19-B, the vaccine was found to offer robust virus neutralisation ability and induced antibodies levels in line with already approved Covid-19 mRNA shots.
Furthermore, treatment with PTX-COVID19-B was found to be safe and well-tolerated in the trial.
In September this year, Everest and Providence entered a definitive agreement to licence rights to the latter’s mRNA Covid-19 shots in some emerging markets in Asia.
