CEPI continues to expand the global manufacturing network for its COVID-19 vaccine portfolio through agreements to secure vaccine manufacturing capacity with Biofabri in Spain, and GC Pharma in the Republic of Korea. CEPI aims to reserve capacity for the production of drug product at multiple vaccine manufacturers around the world to support our goal to produce 2 billion doses of safe and effective vaccine by the end of 2021 for global distribution through COVAX.
Under the terms of the agreements, both Biofabri and GC Pharma will reserve manufacturing capacity exclusively for the production of drug product of COVID-19 vaccines designated by CEPI. One or more CEPI-supported vaccine candidates will be manufactured at each facility, and it is anticipated that vaccines manufactured under these agreements would be procured and distributed through the COVAX Facility, a global initiative which will enable equitable access to COVID-19 vaccines for all participating countries.
The agreements with Biofabri and GC Pharma are the latest in a series of strategic investments that CEPI is making to accelerate the manufacture of COVID-19 vaccines at scale, in parallel to the clinical development of COVID-19 candidate vaccines. CEPI has already reserved capacity for manufacturing of drug substance, and has secured a supply of glass vials to hold up to 2 billion doses of vaccine. CEPI’s investments are designed to ensure that, once proven safe and effective, vaccines can be made available to those who need them most as quickly as possible.
Biofabri will reserve manufacturing capacity for CEPI-designated COVID-19 vaccines from November 2020 to May 2022 with an option to extend or expand the reservation. During this period, it is estimated that the reserved capacity could produce more than 500m doses of vaccine.
GC Pharma will reserve manufacturing capacity for CEPI-designated COVID-19 vaccines from March 2021 to May 2022 with an option to extend or expand the reservation. During this period, it is estimated that the reserved capacity could produce more than 500m doses of vaccine.
It is sadly inevitable that demand for COVID-19 vaccines will vastly outstrip supply in the short term, leaving the majority of people unprotected. There is finite global capacity to manufacture vaccines, so we must act now to secure the necessary capacity to produce doses of vaccine which will be made globally accessible through COVAX. With our COVAX partners, our goal is to produce 2 billion doses of vaccine by the end of 2021 and distribute them to those who need them most in countries of all income levels: this is the fastest and fairest way of ending the acute phase of the pandemic. Investing in vaccine manufacturing – including reserving production capacity in advance – is crucial for COVAX to ensure fast and equitable access to COVID-19 vaccines.
This recently signed agreement with CEPI, of key importance in these moments, highlights the necessity for many stakeholders to collaborate in the struggle against the pandemic. This also strengthens the position of Zendal as a biotechnology group qualified and capable of carrying out the entire production process of a vaccine, from the production of bulk antigen to the fill and finish for its eventual placing in the market. For us, this and other Covid projects in which we are involved, imply endorsement of the work developed over many years by our team in the field of biotechnology and vaccines.
GC Pharma has been striving for the improvement of human health for more than 50 years, by developing specialized technology for the production of plasma derivatives, vaccines, and recombinant proteins. Based on these technologies, a COVID-19 treatment made by the fractionation of convalescent plasma (hyperimmune anti-SARS-Cov-2 immunoglobulin) is already under clinical development within the company. We are now extremely pleased to be able to continue carrying out this mission against the pandemic, with the production of COVID-19 vaccines with CEPI. In order to solve the problems faced by humanity, cooperation is always the best approach. It seems most prudent that the production of COVID-19 vaccines should take place through globally led initiatives such as CEPI and COVAX. In an attempt to prevent the continued spread of COVID-19 around the world, GC Pharma is proud to be able to offer its new state-of-the-art fill finish facilities for vaccine drug product production, in order to help meet COVAX’s 2 billion dose target.
CEPI, alongside Gavi and the World Health Organisation, co-leads the vaccines pillar of the ACT Accelerator – known as COVAX – which is working to accelerate research and development for promising vaccine candidates, manufacture doses at scale, and ensure rapid global access. Decisions around investment in manufacturing are taken in close collaboration between the three lead COVAX organisations.
In response to the COVID-19 pandemic, CEPI is supporting the research and development of a diverse portfolio of vaccine candidates based on a range of vaccine approaches. Of the nine vaccine candidates currently in the CEPI portfolio, eight have entered clinical trials out of 42 globally. CEPI has raised US$1.3bn in support of COVID-19 vaccine research and development, but urgently needs $800m in additional funds to continue to support the development of safe and effective vaccines which will be made globally available through COVAX.
Created in 1967, GC Pharma (formerly Green Cross) was the first biotech company to be founded in South Korea; it has now grown to be the 2nd largest pharmaceutical company in the country, operating extensively in the production of vaccines, plasma derivatives, and recombinant proteins. The company’s hyperimmune anti-SARS-Cov-2 immunoglobulin treatment is currently in late state clinical testing in Korea. GC Pharma’s experience in vaccines goes back to the 1980s, when the company paved the way in global vaccine development with the world’s 1st epidemic haemorrhagic fever vaccine; the world’s 2nd varicella vaccine; and the world’s 3rd hepatitis B vaccine. More recently, over the last 11 years, 217 million doses of GC Pharma’s WHO prequalified trivalent and quadrivalent influenza vaccines (GCFlu) have been distributed to 46 countries worldwide. The company also supplies over 60% of the vaccine demands of South Korea and PAHO. A recent collaboration with CEPI in the fight to deliver COVID-19 vaccines will see GC Pharma’s new state-of-the-art sterile fill finish facility (the W&FF plant) employed in the production of vial-based vaccine drug products. When fully online, the total annual capacity of the facility will be 8 billion doses.
Zendal is the corporate brand of the biotechnological group that consists of seven companies focussed on research, development, manufacturing and marketing of biologicals vaccines for both human and animal healthcare and other high added valued products in the area of health. The companies found under its umbrella brand are CZ Vaccines, Biofabri, Probisearch, Vetia, Petia, Zinereo and Bialactis. The company from O Porriño (Spain) counts on a team made up of 300 personnel, most of them very highly qualified.