For South Africans to get their lives back, they need vaccines by winter and herd immunity against COVID-19, says a Scientists’ Collective of 15 top experts in the SA Medical Journal. The public health sector cannot achieve this alone – to avoid vaccine roll-out disaster SA also needs the private sector, labour and NGOs. “We need all hands on deck.”
Without co-ordination there would be “chaos and duplications of effort” similar to the experience at the start of the pandemic in SA, warn the scientists in a guest editorial in the February 2021 issue of SAMJ titled “The Scientists’ Collective 10-point proposal for equitable and timeous access to COVID-19 vaccine in South Africa”.
However, the scientists argue: “If we put vaccines together with all the tools we have, we could reduce mortality and stop transmission and get our lives back. We cannot afford to let this opportunity go to waste.”
There has been much controversy over an apparent lack of a plan for a vaccine roll-out. Well, the experts offer a comprehensive 10-point plan in the SAMJ.
And while there has been anxiety about the affordability of vaccination for SA, Scientists’ Collective calculations show it to be entirely possible. Based on a 40% vaccine coverage assumption, an effective strategy may cost between R2.9 and R18.6 billion.
During 2021 the cost could range between R1.4 billion and R9.3 billion. With the private sector footing the bill for its members – and all frontline health workers belong to medical aids – the budget for public sector vaccination of 20% coverage using the lowest priced vaccines would be R1.4 billion – "a ninth of what one day of the level 5 lockdown cost SA.”
The 15 experts are Glenda Gray, Shabir Madhi and Fareed Abdullah of the SA Medical Research Council; the University of the Witwatersrand’s Alex van der Heever, Bavesh Kana, Wendy Stevens, Guy Richards, Jeremy Nel and Francois Venter; James McIntyre and Marc Mendelson of the University of Cape Town; Adrienne Wulfsohn of Inkosi Albert Luthuli Central Hospital in Durban; Ian Sanne of Right to Care and Wits; Aslam Dasoo of the Progressive Health Forum; and Lucille Blumberg of the National Institute for Communicable Diseases and the National Health Laboratory Service.
The following is a shortened version of the SAMJ editorial.
Scientists’ Collective 10-point proposal
South Africa must crystallise hopes sparked by COVID-19 vaccines with a smart, ambitious and effective plan to deliver vaccines to the population in the shortest possible time frame, the scientists write.
The development of COVID-19 vaccines has been a spectacular scientific achievement, culminating in vaccines being authorised for use within 11 months of discovery of the SARS-CoV-2 virus.
Recent announcements that four COVID-19 vaccines had achieved the efficacy threshold against COVID-19 illness represents a potential sustainable turning point in the pandemic – though since writing, there has been disappointing news regarding the efficacy of the AstraZeneca vaccine over the new strain identified in SA.
“However, this will only materialise with timely, equitable and substantial access to vaccines that are suitable to being deployed globally, including in resource-constrained low- and middle-income country (LMIC) settings at an affordable price.”
COVID-19 vaccines have the ability to modify the pandemic in two ways. First, via a milder illness, which impacts on hospitalisation and death: “COVID-19 vaccine efficacy in reducing the risk of serious illness has been between 62% and 95%.” Second, by reducing the risk of infection by mass immunisation of between 60% and 70% of the population, herd immunity can be achieved and transmission of the virus interrupted.
There will be a high demand for COVID-19 vaccines in South Africa, as elsewhere, and manufacturing bottlenecks are expected. “SA therefore has to be proactive, as supplies will be limited.” It appears that more than 51% of the initial supply of COVID-19 vaccines likely to be available in 2021 has already been pre-purchased by countries such as Canada, the European block, the UK, the USA and Japan, where only 13% of the global population lives.
This reality has brought calls for an urgent review of vaccine access for countries that lack the financial muscle to be competitive for vaccine procurement on the open market.
“In SA, the government will have to work in public-private partnerships to ensure timeous access to COVID-19 vaccines. First and foremost, the government should prioritise vaccine access to health care workers and other front-line workers such as police and teachers, as well as our elderly and those at risk of severe COVID-19.”
So what needs to be done for SA to get timeous and equitable access to COVID-19 vaccines?
- Expedite the registration or licensure of COVID-19 vaccines
A vaccine can only be formally used in SA if it is authorised by the South African Health Products Regulatory Authority. SAHPRA will either authorise use under an Emergency Use Authorisation (EUA), or register a COVID-19 vaccine before it can be used.
Irrespective of who provides the vaccine, SAHPRA determines the conditions for its use in SA. Access can be fast-tracked through: Section 21 authorisations; Conditional Registration during a pandemic; Full Domestic Registration following a pharmaceutical application; or Domestic Registration under an EUA, using SAHPRA guidelines that allow it to rely on the decisions of other ‘recognised’ regulatory authorities such as WHO or America’s FDA.
Once a vaccine is registered, the state can put out tenders, or use sole-source service provision to procure the vaccine from a company for the state sector, under the Public Finance Management Act. Vaccines could be made available through the public system or at out-of-pocket cost to individuals through medical aids or workplace vaccination programmes.
- Collaborative co-ordinated financing mechanisms
SA has limited public resources and fiscal resilience to foot the bill for vaccine access. Public-private partnerships will be key to strengthening the bargaining power for bulk commitment, purchase and access, say the experts.
While we can expect a distribution of vaccine costs, a single dose of the Pfizer vaccine, for example, is estimated to cost R300 or R600 for two doses per person. “Vaccinating the entire population would cost roughly R36 billion.”
At the high end the Moderna vaccine is calculated at R776 per person vaccinated, which translates into R46.6 billion to vaccinate SA. Johnson & Johnson may come in at around R233 per person vaccinated, or total R14 billion.
“Although a national vaccine strategy may fall short of the total population, it must at least achieve sufficient coverage to attain herd immunity. In order to control the pandemic in SA, we estimate that we require: at least (i) 40% to 60% of the population to be vaccinated, and/or (ii) up to 40% of people to have been infected by and recovered from COVID-19.”
“Already we are seeing high rates of exposure to SARS-CoV-2 in many communities (20% to 40% antibodies to SARS-CoV-2), although these are potentially quite localised,” writes the Collective. “Adopting the 40% vaccine coverage assumption, the cost of an effective vaccination strategy may range between R2.9 billion and R18.6 billion.
It appears unlikely that more than 20% coverage can be achieved in 2021. While this is not enough to achieve herd immunity, it should result in the vaccination of people most susceptible to severe forms of COVID, and frontline health and other high-risk workers.
“The 2021 strategy could range in cost between R1.4 billion and R9.3 billion.” The question is how to split the costs between the public and private sectors.
While the public health system faces budget cuts, “medical schemes system counter-intuitively benefited financially from the pandemic. Given a fee-for-service reimbursement system, reductions in ambulatory and hospital-based activities for medical scheme-covered members saved billions for schemes during 2020.”
These funds “could be accessed to ensure that government does not pay for any vaccine expenses that can be funded by medical schemes on behalf of their members. It is worth noting that all frontline health workers are members of medical schemes,” say the experts.
If the private sector foots the vaccination bill for its, “the budget for public sector vaccination of 20% coverage using the lowest priced vaccines on the market would be R1.4 billion, a ninth of what one day of the level 5 lockdown cost SA. During 2021, medical schemes would only need to spend R200 million to fund 20% of members. Even using the most expensive vaccine, the total cost for 2021 would come to less than one day of the general lockdown.”
- Strategic deployment for maximum impact on both the public health benefit and individual benefit
“To maximise the impact of a COVID-19 vaccine, SA needs to focus on both effective scale-up and deployment of the vaccine, in addition to strategies that will give us maximum public health impact.”
In the immediate future, with a likely limited supply of vaccine through 2021, efforts need to be focused on safeguarding healthcare systems and protecting individuals at greatest risk of morbidity and mortality. “We propose a sequential immunisation strategy that balances both public health benefit and individual benefit.”
- Transparent communication of the access plan to the public to promote trust and address the issue of vaccine hesitancy
“Myths and misconceptions abound when it comes to the COVID-19 vaccine, and government needs to take special measures to share its plans and strategies to source and deliver the vaccine to the target population in a fair and rational manner,” says the collective.
“It needs to know (and to explain) how it will navigate the complex mechanisms of competitive pricing, patent protection, generic manufacturing and licensure in a way that benefits SA, how it will leverage the contribution our scientists have made to development of these vaccines, and how it will participate in global pooled procurement mechanisms such as COVAX.”
Countries such as Canada have ordered more vaccines than they need, “so possible proactive strategies could include engaging with countries with surpluses to ensure we don’t fall to the back of the queue in favour of poorer countries, despite our burden of disease.”
“In SA there is currently wide speculation about vaccination plans, with some of the opinion that SA has no plan, no money, and no clue about how to finance and distribute a vaccine.”
To build confidence, the scientists urge government structures dedicated to vaccine roll-out “to immediately embark on further engagement with the relevant stakeholders to draft a roadmap as to how SA will access and roll out vaccines”.
Included should be the issue of vaccine hesitancy, the scientists write. Structured education and awareness programmes should be crafted with science communication entities and the media, with experts informing the public about the benefits of vaccination. Informal communication methods should be optimised.
There should also be a concerted effort by national government to build trust and share information on plans to procure vaccines. “These are important issues. Vaccine hesitancy has the ability to undermine our efforts to control COVID-19 in SA, as a vaccine can only work if the greater proportion of the populace firmly believe in the benefits.”
- Access strategy: ‘Don’t put all your eggs in one basket’
There are three components to an access strategy, and each has its pros and cons.
Access mechanisms
COVAX, launched in April 2020, brings together governments, global health organisations, manufacturers, scientists, the private sector, civil society and philanthropy. It aims to have two billion doses of vaccine available by the end of 2021 – “enough to protect those at high risk and vulnerable people such as frontline workers”.
COVAX is largely aimed at supporting affordable access to LMIC. Upper-middle countries and high-income countries will cross-subsidise funding for those with lower resources.
“However, many high-income countries have already entered into bilateral agreements with manufacturers (pharmaceuticals), which are likely to consume more than 50% of COVID-19 vaccines that will be available in the first half of 2021,” say the scientists.
South Africa, as an upper-middle-income country, will pay the same vaccine price as high-income countries. Inadvertently, COVAX would undermine government’s “ability to access a large number of doses of COVID-19 vaccines at a more competitive price through bilateral agreements than what will be sourced through the COVAX facility”.
This is an oddity that SA cannot afford, says the collective. “The poor will subsidise the poorer. The rich countries will not blink an eye, as most of them have already secured more than a fair size of their share of COVID-19 vaccines.”
“COVAX will give countries access to sufficient vaccines to vaccinate between 5% and 20% of their population. It is also not clear that we will be able to choose what vaccine we get.”
Other access mechanisms include ‘bilaterals’ with Pharma. Some companies promised break-even prices and tech transfer to manufacture vaccines locally. “The state should prioritise these deals,” say the scientists. There should be a programme to ensure local manufacture capacity. “This is unlikely to happen before 2022.”
COVID-19 vaccine trials undertaken in SA should enable government to negotiate early access to meaningful quantities of vaccines at an affordable price with the companies whose vaccines are being evaluated. Further, bilaterals with countries such as Russia and China “are potential strategies to access vaccines”.
Vaccine choice
Different vaccines will have different mechanisms of action and different outcomes. “The volume of vaccine available for distribution is critical. Data on the impact of COVID-19 vaccine on severe infection and death are accumulating, and may influence.
“Our choice of vaccine will impact on public health outcomes. It is important to note that individual benefit may be different depending on the vaccine choice.”
Tech transfer and manufacturability
“For SA, the ability to be involved in a tech transfer deal will consolidate local access. Ease of manufacture will influence volume of doses. Local manufacturing scale-up is unlikely to happen in SA in 2021. SAHPRA has yet to accredit a vaccine manufacturing site in SA.”
- Supply-chain management
Supply-chain planning and management will depend on the cold-chain requirements of the particular vaccine, “the complexity of which will increase as we move from 2°C to 8°C to –80°C”. Planning and management should ensure review of holding hubs, distribution models and costs. Transport conditions will need to be sophisticated, with cold-chain monitoring and delivery confirmation.
“There are several systems that could be co-opted to assist: current medicine delivery routes, and laboratory transport capacity in both the public and private sectors. Significant planning and innovative delivery mechanisms will be required. New design applications for monitoring the process are already available for review.”
- Alternative delivery systems close to the target audience
“Alternative delivery options include the delivery and network services of large e-commerce platforms that have efficient and cost-effective mechanisms to move material across the country with strong monitoring systems,” the Collective argues.
With many airlines grounded as a result of travel restrictions, for a brief period planes could be repurposed to rapidly transport vaccines to large metropoles for distribution.
“Substantive effort has been placed in developing track-and-trace systems in communities, and these could easily be repurposed for distribution of vaccines.” Given the speed needed and high levels of population, it would be unwise to rely only on the health system.”
As it is common cause that health workers should be the first target group, “it is obvious that the first batch of vaccines should be administered to health workers through the public and private healthcare systems”. Thus the bill could be shared by the public and private sectors.
“The elderly and those with comorbidities will be a more difficult group to access, and multiple strategies will need to be employed to reach them, including clinics where they receive chronic medication, social grants delivery points, old-age homes and churches.
“Community health worker outreach teams have huge potential here. This is a massive operation and will require detailed planning and resourcing.”
Schools and universities could play an important role in reaching young populations, which globally are unable to abide by non-pharmaceutical interventions. Targeting this population could be key to breaking cycles of transmission in many communities and families.
These programmes could take a year or two, so it “imperative that new innovations are considered”, the scientists write. Accelerating access should be the overall objective.
Thinking outside the box, such as using Independent Electoral Commission infrastructure, organisation and IT capability or South African Social Security Agency outlets, could “get vaccine to millions of people in one day. All that would be needed is an ID document that is scanned to record participation and a nurse in the polling booth. Many thousands of people could be vaccinated in a single day.”
- Simple data systems that capture proof of vaccination
Digital technologies to monitor vaccine uptake and use of doses will be critical to ensure continuity and integrity of the logistic supply chain, says the Collective. “These could be linked to electronic dashboards that provide a nationwide view of vaccine uptake, which could then be further useful to monitor incidence of disease.
“Similar dashboards already exist to monitor diagnosis of infectious diseases such as tuberculosis. Data systems would also enhance the country’s ability to evaluate long-term safety and efficacy of the vaccine.”
- Dealing with anti-vaxxers and conspiracy theorists
The anti-vaccination movement (anti-vaxxers) and the propagation of conspiracy theories are impediments to SA’s ambitions to achieve herd immunity using vaccination as an accelerator.
“We need to build basic, simple communication of the evidence, delivered to the public in a way that maximises its transfer and its impact. That will include bringing all facets of society with us on this journey and ensuring that trusted givers of information are prioritised, be they traditional healers, respected leaders in civil society, religion and government, role models, ‘influencers’, clinicians, public health specialists or scientists.”
- Going to scale to end our epidemic
Several vaccines have demonstrated effectiveness, the scientists said. SA needs herd immunity to control the epidemic, and vaccines by winter in order to return to normal.
“If we put vaccines together with all the tools we have, we could reduce mortality and stop transmission and get our lives back. We cannot afford to let this opportunity go to waste. We need all hands on deck. Without co-ordination, we will see chaos and duplications of effort similar to those that were evident at the beginning of our local epidemic.
“We cannot only rely on the National Department of Health and the public sector. We need the private sector, labour and entities such as Médecins Sans Frontières, the Red Cross and Gift of the Givers to support the national roll-out of vaccines. This is an endeavour that requires all our resources and effort.”
[link url="http://www.samj.org.za/index.php/samj/article/view/13163/9676"]SA Medical Journal commentary – The Scientists’ Collective 10-point proposal for equitable and timeous access to COVID-19 vaccine in South Africa (Open access)[/link]
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