New vaccine in Phase III clinical trial globally
A new candidate vaccine against the mutating virulent SARS-CoV2, which has at least four identified dominant variants, is on its way to its Phase III clinical trial targetting 4,000 adult volunteer-participants from various parts of the globe.
“The vaccine candidate, GBP510, consists of the active element-protein antigen which mimics part of the SARS-CoV2 Spike protein and adjuvant, an ingredient that helps create stronger response in people receiving the vaccine,” Dr. Averyan Vasylyev told Gulf Today on Tuesday evening.
Vasylyev is the Gulf regional medical director of the British-American pharmaceutical company GlaxoSmithKline: “ The aim is to have “more effective and safe vaccines against the SARS-COV2 infection which would allow for more people to have access to protect from COVID19 disease.”
As of 14:27 GMT of Sept. 7 (Tuesday), the SARS-CoV2 had victimised 222,180,532 individuals worldwide with 198,785,372 recoveries and 4,592,893 fatalities.
According to Vasylyev, the participating countries have yet to be identified for “country allocation is a very sophisticated process to ensure that participating research centres can produce high quality research data within the shortest time frame.”
The 4,000 targeted participants was decided on “to ensure diverse demographical exposure.”
The Phase III clinical trial of the GBPS10, “whose active ingredient was constructed from self-assembling nanoparticle proteins that carry on their surface information for the immune system to effectively recognise the virus and produce neutralising antigens,” comes in the wake of the massive call by concerned individuals, led by the World Health Organisation (WHO), for an equitable distribution of and access to approved COVID19 vaccines in both rich and poor countries.
As of Tuesday and out of the numerous candidate vaccines since about second quarter of 2020, only seven have earned the green light from the WHO. These are Moderna (approved for use in 71 countries), Pfizer BioNTech (98 countries), Jansenn-Johnson & Johnson (62 countries), Oxford Astra Zeneca (121 countries), Covishield (45 countries), Sinopharm (64 countries), and Sinovac (39 countries).
Vasylyev said the GBP510 global Phase III clinical trial was decided on and would be pursued since findings of the first two clinical trials had proved its “clinical efficacy and protection level. He explained that the candidate vaccine “in combination with the adjuvant was able to back up for high levels of neutralising antibodies--five to eight times higher compared to sera (serum) from people (who had recovered from COVID-19 with no safety concerns to date.”