The Global COVID-19 Pledging Conference for CoVax Alliance of 4 May 2020, culminated in the creation of the Access to COVID-19 Tools Accelerator (ACT-A), a global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. President Ramaphosa, of South Africa, was elected as co-Chair of ACT-A Facilitation Council during the meeting held on 10 September 2020.
COVAX is the vaccines pillar of the ACT-A and is co-led by the Global Alliance for Vaccines and Immunisation (Gavi), the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO. It aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world.
The COVAX pillar aims to offer advance purchase agreements for vaccine candidates meeting technical threshold criteria. COVAX aims to procure a cumulative 2 billion doses by the end of 2021 including an emergency buffer (10% of doses). The aim is to ensure that participating countries receive allocations of a vaccine as quickly as possible by procuring the highest possible volume of vaccine from each manufacturer at economically efficient prices tiered for countries according to GDP. This will allow globally fair and equitable allocation of vaccines. Gavi is managing the activities around access to vaccines.
Gavi has created the COVAX Facility through which self-financing economies and funded economies can both participate. Within this, a funding mechanism, the Gavi COVAX Advance Market Commitment (AMC), will support access to COVID-19 vaccines for 92 lower-income economies. The COVAX Facility will negotiate for and provide all participating countries access to the same vaccine as and when they become available, based on the participant’s selected quantity. Gavi approached the Department of Health with an offer to participate in this investment opportunity to ensure access to vaccines against COVID-19. On 31 August 2020, the Director-General of the National Department of Health submitted a non-binding expression of interest in the COVAX South Africa rollout.
The COVAX Facility is offering Self-financing countries two different options to participate in. (1) In the “Committed Purchase” option, participating countries make a lower upfront payment, but need to make firm guarantees to procure doses from the Facility without the option to opt-out of specific candidates. (2) In the “Optional Purchase” option, participating countries make a larger upfront payment, but can opt-out of vaccine allocations while they still reserve the option for later vaccines.
In order to gain access to vaccines rapidly, South Africa agreed to participate in the Committed Purchase option of the COVAX to vaccinate at least 10% of South Africa’s population. Initially, the supply of vaccines will be constrained and specific criteria need to be applied to prioritise those who should be eligible for vaccination. For example, those at high risk of exposure such as our frontline health care workers and the medically vulnerable.
It is expected that South Africa will receive the first batch of vaccines in quarter two of 2021.
2.2. Advance Purchasing agreements with individual vaccine producers
Whilst the COVAX facility is the favoured option South Africa also needs to explore all options to ensure that the process of rolling out vaccines is safe and cost-effective, by engaging with vaccine producers. Mechanisms such as advance purchase agreements, direct purchase agreements, and open tender procedures need to be explored, to secure sufficient supplies of the appropriate vaccines to provide herd immunity in South Africa. It is also envisaged that it might be necessary to obtain more than one kind of vaccine to cover the needs and requirements of different groupings.
3. Supporting local manufacturing
With limited vaccine manufacturing capacity around the world, individual countries will have to prioritise their own requirements in the interest of securing access to the vaccine as a matter of national security.
An opportunity exists as a result of the COVID-19 pandemic, for South Africa to expand its scope of production in response to the need for more global capacity for COVID vaccine manufacturing. It, therefore, becomes imperative that South Africa harnesses and stimulates its own capability for local production while serving as a primary vaccine and health product supplier to the rest of Africa in response to this and future pandemics.
3.1. Vaccine manufacturing capability for Covax Alliance
Sub-Saharan Africa has only four vaccine manufacturers with limited and specific manufacturing potential. In South Africa, Biovac is a specialist vaccine company with product development, formulation, and filling capability designed specifically for vaccines. It is licensed to formulate, fill (in vials and prefilled syringes), pack, and label vaccines. The country has other sterile manufacturing capacities in the form of intravenous bags, vials, and ampoules. The companies that have these installed capacities are Adcock Ingram, Aspen Pharmacare, Fresenius Kabi, and PharmaQ. These companies have licensed sterile manufacturing capability mainly dedicated to injectable intravenous pharmaceuticals i.e small molecules.
All of the above manufacturers need to receive the active pharmaceutical ingredient (also known as drug substance) from suppliers outside South Africa, with the blending/formulation taking place locally as well as the filling in the right primary container i.e vial or ampoules.
Two companies are currently involved in setting up to do the drug product manufacturing for COVID-19 vaccines, using the active pharmaceutical ingredients from vaccine developers and manufacturers outside South Africa. The ability to locally formulate, fill and finish vaccines will assist in the reduction in the trade balance, provide high skilled employment, and in the long run, ensure the security of supply of vaccines. These companies are:
Biovac was originally formed as a Public-Private Partnership with the South African government. It currently takes responsibility for approximately 70 percent of South Africa’s vaccine needs and was in the process of expanding its manufacturing efforts before the pandemic.
Biovac’s current activities are limited to the development of bacterial vaccines, sterile formulation and filling as well as labeling, packaging and cold chain distribution.
Concerning the COVID-19 vaccine, it is engaged in both bilateral discussions as well as with the Coalition for Epidemic Preparedness Initiative (CEPI) for the formulation, fill-finish activities.
Aspen is a South African-based pharmaceutical company with a global footprint. They have recently expanded their sterile capability mainly for sterile pharmaceutical products i.e small molecules.
Aspen Pharmacare and Johnson & Johnson (J&J) have made an announcement wherein Aspen will dedicate some of its vial manufacturing capacity to manufacture (fill-finish) for J&J its candidate COVID-19 vaccine. This presents additional fill-finish capacity and vaccine access for the country to leverage. Source – SA Government
A multinational collaboration, including the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI, the Gates Foundation, and governments, formed the Access to COVID-19 Tools (ACT) Accelerator, to raise financial support of accelerated research and development, production, and globally-equitable access to COVID-19 tests, therapies, and licensing of vaccines, which are in a specific development program called the “COVAX Pillar”. The COVAX Pillar has the goal of facilitating licensure of several COVID-19 vaccines, influencing equitable pricing, and providing equal access for up to 2 billion doses by the end of 2021 to protect frontline healthcare workers and people with high-risk of COVID-19 infection, particularly in low-to-middle income countries. During 2020, major changes in the overall effort of developing COVID‑19 vaccines since early in the year have been the increasing number of collaborations of the multinational pharmaceutical industry with national governments, and the diversity and growing number of biotechnology companies in many countries focusing on a COVID-19 vaccine. According to CEPI, the general geographic distribution of COVID‑19 vaccine development involves organizations in North America having about 40% of the world’s COVID-19 vaccine research, compared with 30% in Asia and Australia, 26% in Europe, and a few projects in America and South Africa.
Covax Alliance Financial Contributions
As of December 2020, US$2.4 billion had been raised for the overall ACT Accelerator, with nine vaccine candidates being funded by COVAX and CEPI – the world’s largest COVID-19 vaccine portfolio – with 189 countries committed to the eventual deployment plan.
Earlier in 2020, the WHO had a telethon which raised US$8.8 billion in pledges from forty countries to support rapid development of vaccines. In December, the Gates Foundation donated another US$250 million to the WHO ACT Accelerator to “support the delivery of new COVID-19 tests, treatments, and vaccines, particularly in low- and middle-income countries” during 2021, making the Foundation’s total donation of US$1.75 billion toward the COVID-19 response. The Global Research Collaboration for Infectious Disease Preparedness (GLoPID-R) is working closely with the WHO and member states to identify priorities for funding specific research needed for a COVID‑19 vaccine, coordinating among the international funding and research organizations to maintain updated information on vaccine progress and avoid duplicate funding.