Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, Gavi, the Vaccine Alliance, a public-private global health partnership that aims to increase access to immunisation in poor countries, and the Bill & Melinda Gates Foundation would accelerate the manufacture and delivery of up to 100 million doses of safe and effective coronavirus disease (Covid-19) for India and other low- and middle-income countries (LMICs) as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility, the Pune-based firm announced on Tuesday.
COVAX Facility seeks to pool in resources to accelerate the development of the most promising of the Coviod-19 candidates and plans to make it equitably accessible to all the participating countries, irrespective of their financial muscle.
The initiative brings the total number of vaccine doses to be covered by the partnership to an aggregate of up to 200 million doses, following the initial agreement for up to 100 million doses, which were announced in August.
Besides other tie-ups, SII also has entered a manufacturing partnership with AstraZeneca to produce the Oxford-AstraZeneca Covid-19 vaccine.
Preparations are in progress to conduct phase 3 trials of the candidate vaccine in India.
The collaboration will provide upfront capital to SII to help increase manufacturing capacity. Once a vaccine gains regulatory approval and the World Health Organisation’s (WHO) prequalification, doses can be distributed to LMICs as early as by the first half of next year.
“The collaboration further bolsters our fight against Covid-19! Through the avid support of Gavi, the Vaccine Alliance, and the Bill & Melinda Gates Foundation, we will manufacture and deliver up to an additional 100 million doses of immunogenic and safe-proven future Covid-19 vaccines to India and low-and middle-income countries in 2021,” said Adar Poonawalla, chief executive officer (CEO), SII, in a statement.
“At this stage, it is important for governments, global health and financial institutions in the public and private sector to come together in ensuring that no one is left behind in the road to recovery. This association is in line with our efforts to see that the future vaccines reach the remotest part of the world providing full immunisation coverage in a bid to contain the spread of the pandemic,” he added.
The funding will help accelerate the manufacturing by SII for candidate vaccines licenced from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and the WHO’s prequalification.
The vaccines will have a ceiling price of $3 per dose. The price point is enabled by investments made by partners such as the Coalition for Epidemic Preparedness Innovations (CEPI), the Gates Foundation and SII.
“This is vaccine manufacturing for the Global South, by the Global South, helping us to ensure no country is left behind when it comes to access to a Covid-19 vaccine,” said Dr Seth Berkley, CEO, f Gavi, the Vaccine Alliance. “The momentum behind our effort to ensure global, equitable access to Covid-19 vaccines is really building…” he added.
The Gavi COVAX AMC, which is seeking at least $2 billion in initial seed funding, will meet at least part of the cost of procurement for the vaccine doses. The Gavi board has agreed upon the final list of 92 countries that will be supported by the Gavi COVAX AMC.
Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 61 Gavi-eligible countries.
Novavax’s candidate, if successful, will be available to all 92 countries supported by the Gavi COVAX AMC. These countries align with SII’s licencing agreements with its two partners.
Gavi, SII, and the Gates Foundation’s collaboration support the efforts of the Access to Covid-19 Tools Accelerator’s vaccines pillar, also known as COVAX, co-led by Gavi, CEPI and the WHO, to accelerate the development of vaccines for the viral outbreak and ensure rapid, global access to them.
Decisions around investment in manufacturing are taken in close collaboration among these three lead organisations of the COVAX pillar.
So far, 73 higher-income economies have committed to join the programme, in addition to the 92 low-and middle-income economies that are eligible for the support.
“The Gates Foundation will provide at-risk funding of a further $150 million to Gavi, bringing the total funding provided through this collaboration to $300 million. This will be used to support the SII to manufacture potential vaccine candidates, and for future procurement of vaccines for India and low- and middle-income countries via Gavi’s COVAX AMC,” according to a statement issued by SII.
“The deal is additional to a memorandum of understanding (MoU) between AstraZeneca and Gavi, which was announced in June that will commit an additional 300 million doses of AstraZeneca’s candidate vaccine to the wider COVAX Facility, to be supplied upon licensure or the WHO’s prequalification. These two deals can help assure access to early doses for the most vulnerable on a truly global scale,” the statement added.