SOUTH KOREA – SK Bioscience has submitted its application for the phase 3 clinical trials of its COVID vaccine, GBP510, to the to the Ministry of Food and Drug Safety (MFDS).
GBP510, a COVID-19 vaccine candidate supported by Bill & Melinda Gates Foundation (BMGF) and Coalition for Epidemic Preparedness Innovations (CEPI) and co-developed with the Institute for Protein Design (IPD) at the University of Washington will become the first COVID vaccine developed in Korea to be submitted to MFDS.
The company also plans to apply for phase 3 clinical trial in other countries in Europe and the South East Asia in partnership with the International Vaccine Institute (IVI), aiming for commercialization within the first half of 2022.
If approved, the Phase 3 clinical trial of GBP510 will be conducted on 4,000 adults at multi-country sites including 14 domestic institutions in Korea and will evaluate immunogenicity indicators such as neutralizing antibodies and any side effects.
GBP510 emerged as the first program of the Wave 2 project, which CEPI launched last year to support development of differentiated COVID-19 vaccine candidates that could address gaps in the current global vaccine development landscape.
It will also help to ensure vaccines are available in the future that are easier to deliver and address the specific needs of a diverse range of populations and settings.
Covid-19 cases rise
With this project ongoing, the country is at the moment experiencing a new surge in infections related to the delta variant.
The Korea Disease Control and Prevention Agency (KDCA) reported 826 cases, up from 762 on 1st July and the highest since Jan. 7 when the country was grappling with a third wave of COVID-19.
Almost 81% of the 765 locally transmitted cases came from the capital, Seoul, and its surrounding regions, KDCA data showed.
The government had said it would relax social distancing measures this month as daily new cases hovered around 500 and the vaccination drive accelerated.
But days before restrictions on movements were to be eased, case numbers shot up and authorities in Seoul and surrounding areas extended restrictions for another week to July 7.
The government has urged people to keep wearing masks indoors and refrain from unnecessary outings even as the inoculation drive makes progress.
Authorities are particularly concerned about a new outbreak traced to an English-language academy just outside the capital, with at least 242 cases including the Delta variant confirmed there.
The Delta variant, first detected in India, has led to spikes in cases around the world and is becoming the second-most prevalent variant in the United States forcing Britain to delay its reopening by a month.
Health officials also expressed concern that while fewer serious cases and deaths were being reported, thanks to vaccines, new clusters had been emerging linked to bars, private academies and other places frequented by young people, most of whom have yet to get a vaccine shot.
The state has 5.16 M people fully vaccinated which only stands for 10 % of its total population though it has already administered a total of 19.4 M doses. It has also a total of 159000 reported cases, 2024 deaths and 148000 recoveries.
SK bioscience is committed to enabling global equitable access to COVID-19 vaccines and has agreed that hundreds of millions of doses of this vaccine candidate will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if proven to be safe and effective.