An ampoule containing component 2 of the Gam-COVID-Vac (Sputnik V) vaccine against COVID-19 is kept in one of the outpatient clinics in Vladivostok, Russia. (YNA)
GC Pharma has once again risen as a potential contract manufacturer to a foreign vaccine, this time for Russia’s Sputnik V.
Company officials, however, refrained from commenting, citing the sensitivity of the issue.
The interest for Sputnik V in South Korea was ignited after Jeong Eun-kyung, head of Korea Disease Control and Prevention Agency, said Monday that the country was open to considering the Russian vaccine, citing uncertainties over virus variants and the supply of vaccines.
“We will continue to review the need to secure more vaccines,” Jeong said in a public briefing.
Russia’s Sputnik V vaccine -- also known as Gam-COVID-Vac after its developer Gamaleya Research Institute of Epidemiology and Microbiology -- was once scorned for a seemingly hasty authorization by the Russian authorities.
The distrust dissipated as of Feb. 2, after the Lancet medical journal published a successful interim report for a phase 3 clinical trial of Sputnik V. Sputnik V was found to have efficacy of 91.6 percent protection against COVID-19, especially with an impressive 91.8 percent for those aged over 60.
This is a point of appeal for Korea, where the first vaccination will begin with AstraZeneca jabs, whose efficacy for seniors has been disputed.
Sputnik V also has affordable pricing and favorable storage requirements.
The Russian Direct Investment Fund that promotes the vaccine had announced in November that one dose of the Sputnik V for international markets will be less than $10. The lyophilized, dry version of the vaccine can be stored at refrigerated temperatures of 2 to 8 degrees Celsius.
What stands out for Sputnik V is that the vaccine uses two different human adenoviral vectors for its first and second doses, to be given 21 days apart.
This is intended to counter any pre-existing adenovirus immunity in the population, according to the scientists behind the research.
Sputnik V is the only one among the major COVID-19 vaccines in development to date, that uses this approach.
“The development of the Sputnik V vaccine has been criticized for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19,” the Lancet said.
Russia is reportedly negotiating to include Sputnik V in the list of vaccines provided globally by the COVAX facility.
But it remains uncertain whether a Korean CMO will be appointed for the production.
GC Pharma continues to resurface as a potential candidate due to its contract with the global Coalition for Epidemic Preparedness Innovations, to exclusively reserve its fill finish facility for at least a 500 million doses of COVID-19 vaccines designated by CEPI from March 2021 to May 2022.
It is the immediacy of this contract initiation that is pushing the industry insiders to speculate about GC Pharma’s imminent role in the fight against the pandemic. Which vaccine CEPI will require GC Pharma to bottle is a matter still unknown to the public.
GC Pharma was previously rumored to be in talks with Moderna for mRNA vaccine contract manufacturing. The company later reiterated that it only has the fill finish CMO capacity, meaning it can only bottle the already-made drug substance.
Since the rumor with Moderna, however, GC Pharma inked a memorandum of understanding with Binex, a professional CMO in Korea that is believed to have the ability to manufacture the active ingredient in the vaccine.
By Lim Jeong-yeo (firstname.lastname@example.org)
An earlier version of this article stated that Sputnik V had been submitted for approval with the European Medicines Agency, but the EMA has since clarified that this was untrue. -- Ed.