Prepared by Professor Alan Whiteside, OBE, Chair of Global Health Policy, BSIA, Waterloo, Canada & Professor Emeritus, University of KwaZulu-Natal – www.alan-whiteside.com

Introduction

The rules in the UK were confused. Then on Monday Prime Minister Boris Johnson took the opportunity to clarify and strengthen them. I am still, and now even more, confused. I feared the situation regarding restaurants might change, so we went for dinner on Saturday at Stower Grange. If you are in, or need to be in, Norwich check it out. In fact the situation is that we can still go out for dinner. This may change with the introduction of a ‘circuit breaker’.

On Monday the South African newspaper Maverick Citizen carried an opinion-editorial piece by Nina Overton-de Klerk and Caroline Azionya: “The world is drowning in Covid-19 communication but isn’t much smarter for it”.¹ The authors point out in 1968 a pandemic

“caused by an influenza A (H3N2) virus … (was) first noted in the United States … The estimated number of deaths was 1 million worldwide and about 100,000 in the United States. Most excess deaths were in people 65 years and older”.²

They report a (recent)

“WhatsApp message did the rounds with a picture of a rock guitarist playing to thousands of waving people. It read: “In 1969 the Hong Kong virus (H3N2) killed over one million people worldwide and over 100,000 Americans. Instead of shutting everything down and ruining people’s lives, they held Woodstock.””³

This deserves thinking about.

Vaccines probably offer us the only way out of this crisis. This week’s guest section is by Mitchell Warren, the Executive Director of AVAC. This is a non-profit organization that seeks to accelerate ethical development and global delivery of HIV prevention options. He became a friend, and a fellow traveller in search of global development and truth, more years ago than I care to recall in Durban. Mitchell tackles vaccines and his measured informative input is well worth reading.

Numbers

The cumulative case data from the Johns Hopkins⁴ website show that in the ‘millionaires’ category the USA is still highest, at nearly eight million cases; followed closely by India, at about 7.2 million, (it is almost certain to overtake the States in the next week); Brazil at 5.1 million; then Russia at 1.3 million. All other countries currently have fewer than a million cases. The highest global total was on 24 September at 361,019 and this has not been exceeded. There is hope that the number of new daily cases will not rise further, but the geographical distribution will change.

The data from the Johns Hopkins Coronavirus Resource Centre shows South Africa ranks 10th in the world with close to 700,000 cases, followed by the UK at 640,000. I am going to recommend a new data source this week. I urge people to explore Our World In Data’s Coronavirus Pandemic page,⁵

“Our World in Data and the SDG-Tracker are collaborative efforts between researchers at the University of Oxford, who are the scientific editors of the website content; and the non-profit organization Global Change Data Lab, who publishes and maintains the website and the data tools that make our work possible. At the University of Oxford we are based at the Oxford Martin Programme on Global Development.”⁶

The site has a vast amount of data. It is both easy to access and manipulate and it allows comparisons to be made between countries.

Data use and misuse

There is no doubt that the battle against Covid is the greatest challenge humankind faces. Many responses have been far sighted, appropriate and kind. However, there are also too many instances of misuse of data. The Daily Maverick describes Covid as: “The perfect recipe for the perfect storm, in which four things collided”:

• ‘A society obsessed with social media, networking and AI’, where cyber networks are accessible and platforms such as Facebook and Twitter exert great influence.
• ‘A society afraid of dying and obsessed with living forever’.
• ‘A society obsessed with political correctness, ‘triggers’ and a ‘cancellation culture’. Being woke, ‘normalising’ and hashtag activism are the order of the day’.
• ‘A society where governments have become hugely concerned about losing control and people have lost faith in political leadership’. Governments are simply not believed.⁷

Covid-19 is

“a single cataclysmic force … governments clamp down, using the opportunity to reassert power and take back control via structures such as ‘command councils’ … Covid-19 communication has gone viral to an extent wholly unprecedented in mankind’s history, in the process becoming more contagious than the virus itself. Covid-19 has become an infodemic.”⁸

Evidence suggests propaganda works best with authoritative and credible communication; fearful and ill-informed audiences; a repeated one-sided message, mixing rational and socio-emotional appeal; and repetition in media, including social media.⁹ We must read carefully and try to understand and interpret data.

One example I have become aware of is ‘The Great Barrington Declaration’. It is purported to have been signed by thousands of respectable scientists (although by whom is not clear). The website says,

“The Great Barrington Declaration – As infectious disease epidemiologists and public health scientists we have grave concerns about the damaging physical and mental health impacts of the prevailing COVID-19 policies, and recommend an approach we call Focused Protection”.¹⁰

They note damage caused by lock-downs and argue keeping them in place

“until a vaccine is available will cause irreparable damage, with the underprivileged disproportionately harmed … (we should) minimize mortality and social harm until we reach herd immunity”.¹¹

This argument had some appeal at the beginning of the pandemic. This particular declaration is discredited by both the logic and the source. The original, private, meeting was hosted at the American Institute for Economic Research (AIER), a libertarian free-market think-tank (also known for climate change denial) in Great Barrington. Nefeez Ahmed, a journalist writing in Byline Times, an outlet with the strapline ‘What the Papers Don’t Say’ says,

“The Declaration itself – which calls for only the elderly and vulnerable to be quarantined while encouraging young people to contract the virus – was signed by an initial batch of some 35 scientists”.¹²

Reading the declaration I don’t find any encouragement for the young to actually catch the virus, rather a suggestion that they should “be allowed to resume life as normal”.¹³ Effectively it is a call to return to the concept of herd immunity. But we neither know what herd immunity looks like, nor when it will be achieved. The apparent speed with which Donald Trump recovered, linked with these arguments, and activities of the right wing in the USA, does not bode well.

What is happening with Covid-19 is a reminder of AIDS dissidents of 2000. They could be divided into ‘the crazies,’ of whom no more needs to be said; the ‘bewildered and naïve’, some were open to evidence, but all had dubious motives for their denialism; and finally there were ‘the dangerous’. These last were those who came with their own agendas, often driven by a combination of distorted Darwinism, survivalism, and conspiracy. Of course, there must be debate, science must be examined, and hypotheses tested. My advice to readers of my work is ignore anything from the AIER.

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Go As Fast As You Can – But Always Follow the Science

Science, not politics, must lead to COVID vaccine approvals and delivery
By Mitchell Warren¹⁴

COVID-19 has devastated communities and health systems around the world – but has created an historic global effort, leading to the unprecedented development of more than 165 potential vaccines against COVID-19. Equally impressive innovations are speeding vaccine testing within a rigorous scientific framework. Manufacturing and transportation capacity are being scaled up to distribute millions of doses of future COVID vaccines to those who need them most.

But developing COVID-19 vaccines at “pandemic speed” depends both on an unprecedented global research effort, and on innovative strategies to shorten the vaccine testing and distribution timeline. Each strategy should be weighed against relative risks and benefits, along with its potential to speed vaccine research. Speed is important, but not at the expense of ethics, safety, robust engagement, equitable access, and scientific rigor, including independent peer and regulatory review.

It seems every day brings an update – another vaccine enters into large-scale phase 3 trials; confusion about regulatory processes; concern about growing vaccine nationalism; and ever-present worry that politics will push researchers, developers, policy makers and regulators to move not just fast, but recklessly. Here is my list of key questions to try and make sense of it all:

1. Is one vaccine enough?

Simultaneous testing of large numbers of candidates across multiple vaccine platforms increases the chances of quickly finding a safe and efficacious vaccine. The current pipeline of COVID vaccines includes well over 150 candidates, with over 40 already in human clinical trials. Because of the extraordinary global interest in developing safe, effective and easy-to-manufacture COVID-19 vaccines as quickly as possible, the candidates represent a broad array of approaches – DNA, RNA, live-attenuated, inactivated, subunit and viral vector vaccines – some have been used for common current vaccines, while others are novel approaches. My organization, AVAC, created a COVID-19 Vaccine Pipeline Cheat Sheet. It offers advocates an at-a-glance view of the products, funders, research phase and considerations for some of the front-runner candidates, as well as refresher on the different platforms. (Editor’s note: this cheat sheet is highly recommended, it gives the basic information in an easy format).

2. How is vaccine development going so fast?

The traditional approach to vaccine testing runs preclinical and then Phase I, II and III studies in sequence, sometimes with gaps between each study. To speed timelines, some COVID-19 vaccine studies are advancing to the next phase of research as soon as data show the vaccine is promising and safe, even while the previous study phase is still underway. This accelerated approach has long been championed by AIDS and TB vaccine advocates – but those processes remain much slower with far fewer financial resources and much less pharmaceutical company involvement. The COVID-19 vaccine response has ushered in a new era of collaboration in research and research funding. Based on models developed in HIV research, collaboratives such as the WHO-led ACT Accelerator, the US government’s ACTIV consortium and Operation Warp Speed and others are pursuing different approaches to speed COVID-19 vaccine development, by collaborating on COVID-19 vaccine science and funding. This includes advance purchase commitments, where public-sector and philanthropic funders negotiate a price and plan to purchase and distribute vaccines, before the vaccine testing process is completed. There are both risks and benefits to this expedited research – check out our guide here.

3. But is it safe?

Going fast cannot mean a license to go recklessly – the safety of those people receiving a vaccine at any point must be the primary priority, for any and every vaccine, and especially given the high political profile of COVID-19. Every trial has an independent Data Safety and Monitoring Board (DSMB) that reviews the data on an ongoing basis. Given the current politicization, the nine leading pharmaceutical companies recently signed a pledge to follow the science in development of COVID-19 vaccines, and promise to prioritize safety. But don’t just believe the companies – at least two of the most promising vaccine candidates in large-scale trials have paused their trials to investigate serious adverse events seen by the DSMB – these pauses are not uncommon and actually give us confidence that safety is, indeed, being put first.

4. Can I trust the process?

Regulatory review by agencies such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) is traditionally a methodical, rigorous process that can take many months. HIV advocates played a vital role in speeding review of new treatment and prevention options for HIV and AIDS. This created the compassionate use and emergency access systems being used today to help ensure rapid access to potential prevention and treatments for COVID-19. But regulatory review can only be accelerated to a point; it must be based on adequate data and allow for the thoughtful, informed and unbiased decision-making that is central to the product approval process. The FDA is currently under the most scrutiny given US politics, and here is our Regulatory Approval Primer for Vaccine Advocates. And my colleague Uché Blackstock of Advancing Health Equity and I recently wrote this commentary about Science, not politics, must lead to COVID vaccine approvals.

5. If we build it, will they come?

In our commentary, Dr. Blackstock and I argued why undue political pressure to speed the introduction of COVID vaccines is bad news, and threatens scientifically proven systems to protect public safety and research integrity – for COVID vaccines and for the vaccine enterprise generally. The consequences of any vaccine approval that appears to have been influenced by politics would be particularly grave for Black and Latinx communities in the US and marginalized populations around the world, who have real reasons to distrust both politicians and drug testing processes, and who are also at significantly increased risk for COVID infection and illness. The rapid development of safe and effective COVID vaccines could help end this pandemic and strengthen worldwide faith in vaccines. But that can’t happen unless we take the signals of diminishing public faith in the process seriously and eliminate any sign of political interference in vaccine testing or approval. To protect health around the world, and advance health equity, we must insist on a COVID vaccine effort that is fast, transparent, thorough and safe, and guided by science, not politics.

6. Will the first one be the best one

The world will undoubtedly need more than one COVID-19 vaccine, especially to ensure enough manufacturing capacity. Plus, the first product to have a regulatory approval may not be the best – or the easiest to manufacture, the cheapest, or the easiest to deliver. But the first approval may challenge how to design and conduct future trials, as a placebo-control may not be ethical once we have an initial approval. Again, HIV researchers and advocates have grappled with these challenges for decades, so this is not new, nor a bad thing, but adds a degree of complexity to our future.

7. Who should get the vaccine? And who decides?

As complex as vaccine research and development is, vaccine delivery is even more so. In many respects, any regulatory approval is not the beginning of the end, but, rather, the end of the beginning. This is especially true for a vaccine that will be needed by billions of people. There many logistics questions: Are there enough glass vials and needles? Can companies make such large volumes in a matter of months? But who will buy these vaccines? And, most importantly, who will ensure that there is equitable distribution? Already, many wealthy countries have made advanced market commitments to buy billions of doses. This buying power has led to concerns of “vaccine nationalism” and crowded out any potential for equity and public health strategy. As we know too well, COVID anywhere can quickly become COVID everywhere. WHO, GAVI and CEPI have joined efforts to create the COVAX Facility to, hopefully, mitigate against these risks and ensure global equitable access.

8. A vaccine is essential, but not sufficient

Even as we look towards a safe, effective, affordable and accessible COVID-19 vaccine sometime in 2021 (we hope), we already have critically important public health measures available today can help reduce the global burden – wear a mask; wash your hands; remain physically distant (while socially connected); and contact tracing. These measures will be just as important even when we have a safe and effective vaccine, while the world grapples with delivery challenges.

This is not unique to COVID-19; we have important lessons from 40 years of HIV – we need a comprehensive, integrated and sustained response, even if we had a vaccine (which, sadly, we still don’t) and especially when we don’t. We must act with urgency to develop vaccines because they are essential; and we must act comprehensively since a vaccine alone won’t be enough.

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Conclusion

In this blog I have not written about the dire situation in the UK. Numbers of infections are climbing very rapidly. There are signs of panic from some leaders, while mistrust of the government and their policies is growing. There is talk of another complete lockdown (at the moment the nation is operating on a tiered lockdown system with levels from zero to three. The same confusion is true in the USA, with the added complication of the Teflon President and the looming election.

It is not just in the UK and USA that numbers are growing. In several European countries and cities, the curves are in the wrong direction. My task for next week will be to try to drill down on this in more detail, but readers if there are things (topics or areas) you want covered, please do let me know and I will do my best.

References

AVAC’s COVID news brief http://www.avac.org/covid-news-brief

Totally Under Control is a new documentary released yesterday. Filmed and edited in secret over the last five months this documentary follows the Trump administration response to COVID-19. You will have to Google to find out how to watch it, I have not got that far.

Thank you for reading, reposting and providing comments. What I write is public domain so please share, forward and disseminate. My contact is: awhiteside@balsillieschool.ca

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1. Nina Overton-de Klerk and Caroline Azionya, ‘The world is drowning in Covid-19 communication but isn’t much smarter for it’ MAVERICK CITIZEN OP-ED 12 October 2020 http://www.dailymaverick.co.za/article/2020-10-12-the-world-is-drowning-in-covid-19-communication-but-isnt-much-smarter-for-it/
2. https://www.cdc.gov/flu/pandemic-resources/1968-pandemic.html
3. Nina Overton-de Klerk and Caroline Azionya op.cit.
4. Johns Hopkins University https://coronavirus.jhu.edu/map.html
5. https://ourworldindata.org/coronavirus
6. https://ourworldindata.org/about
7. Nina Overton-de Klerk and Caroline Azionya op.cit.
8. Ibid.
9. Ibid. and to add I find I am irrationally annoyed at the lack of change on websites I visit frequently
10. https://gbdeclaration.org/
11. Ibid.
12. Nafeez Ahmed, ‘Climate Science Denial Network Behind Great Barrington Declaration,’ 9 October 2020 https://bylinetimes.com/2020/10/09/climate-science-denial-network-behind-great-barrington-declaration/
13. https://gbdeclaration.org/
14. Mitchell Warren is the Executive Director, AVAC is a non-profit organization that seeks to accelerate the ethical development and global delivery of new HIV prevention options. http://www.avac.org AVAC is producing a COVID news brief see http://www.avac.org/covid-news-brief