Reasons to hope and reasons to keep perspective on a vaccine

vaccinations

(CDC, Unsplash)

This article is brought to you thanks to the collaboration of The European Sting with the World Economic Forum.

Author: Stéphane Bancel, Chief Executive Officer, Moderna


  • There are 123 SARS-CoV-2 vaccines under development and seven that have entered human trials.
  • Any potential vaccines need to be manufactured to scale in this pandemic setting.
  • We must assess the potential speed with which a vaccine candidate can move towards approval.

In the face of an immense burden of disease and an unfathomable death toll from COVID-19, the world today has an intense need for hope. A degree of hope does come in some regions from diminishing numbers of cases, hospitalizations and deaths, caused by extreme restrictions on commerce, travel and social interaction.

Additional hope, sometimes ill-informed, comes from the development of potential therapeutics and vaccines. According to the Milken Institute, there are some 200 therapeutics being developed as possible treatments for COVID-19; and a remarkable 123 vaccines under development to prevent against infection by SARS-CoV-2, the virus responsible for causing COVID-19.

 

The company I lead, Moderna, Inc., is a clinical stage biotechnology company whose vaccine candidate against SARS-CoV-2, called mRNA-1273, was the first to enter human clinical trials in the United States, back on March 16. To date, this vaccine continues to progress positively through clinical trials. As such, a great deal of hope and public attention has been focused on our company and on this innovative potential medicine.

What I would like to do is to encourage you not to abandon hope in the context of the COVID-19 pandemic but ask that you tie your hope firmly to advancements in medical science. This will prevent you from reacting to well-meaning but potentially misguided enthusiasm or doubts. I will also suggest where specifically to look for validated elements of hope. My comments will focus on vaccines, since that is where my experience resides with respect to COVID-19.

My initial piece of guidance is this: be cautious of the sheer count of vaccine candidates. One hundred and twenty-three is a big number, but starting to develop a vaccine candidate is far different from bringing one to use in large populations. Our perspective at Moderna is that the only competitor we are racing against is the SARS-CoV-2 virus and the resulting devastation it brings. To us, more vaccines are welcome in this battle – and they are critical to addressing the level of human need around the world.

Don’t take false hope from the number of vaccine candidates; vaccines must move from development into clinical trials with humans, as an early step in progress towards eventual use. As of today, thankfully, there are at least seven vaccine candidates against the SARS-CoV-2 virus that have already entered human trials.

Beside ours, the six others come from the Beijing Institute of Biological Products, BioNTech (BNT162), CanSino Biologics (Ad5-nCoV), Inovio Pharmaceuticals (INO-4800), Sinovac Biotech, and University of Oxford (ChAdOx1 nCoV-19). This progress in a record timeframe is indeed encouraging – and a legitimate, medical reason for hope – but, as a number, seven is a long way from 123.

Public and private development landscape of SARS-CoV-2 vaccine.
More than 70% of the groups leading vaccine research are from private firms.

Now, within the set of potential vaccines that do make it into human trials, here are additional elements that I encourage you to watch for in order to engender true hope:

First, watch for specific early clinical indicators of safety and effectiveness. Vaccine candidates will typically be tested early on in animals, both to look for biological reactions that are consistent with appropriate immune system responses, as well as to see if the vaccine can prevent disease. Immune responses are assessed in the lab. Testing whether the vaccine can prevent disease will generally be done by challenging animals with the virus itself, and observing whether vaccinated animals actually avoid getting the disease.

Then, in humans, early trials will be conducted in relatively small numbers of healthy individuals. Those participants will be followed closely – first to assess safety and second to assess the production of neutralizing antibodies. Safety is relatively straightforward, since one is looking for the absence of serious adverse events. The presence of neutralizing antibodies indicates that the vaccine is creating substances that would be expected to defend a cell from the invading virus. In this case, it would be an indication that the vaccine may have rendered SARS-CoV-2 no longer infectious.

Next, to generate real hope, you must assess any potential vaccines in the context of whether they can be manufactured to scale in this pandemic setting. In the face of COVID-19, sponsors of vaccine candidates who cannot create product at the scale of tens or hundreds of millions of doses per month are probably not relevant in bolstering our hope at a global level. For our company, which has been previously in an R&D mode, recognizing this fact meant needing to execute a strategic production/supply agreement with a global partner that could rapidly amplify our volume to as much as a billion doses of vaccine per year.

Finally, the last element to secure hope is that you must assess the potential speed with which a vaccine candidate can move towards approval. In this case, I would be less concerned that a company has commercial rights to sell its vaccine, but more that relatively broad access to the vaccine may be granted to high-risk or other populations through widespread clinical trials, or through regulatory action by various governments. In the case with Moderna, we know that these regulatory paths are complex and, unless addressed early and with focus and scientific rigour, can create inadvertent delays in getting critical vaccines to vulnerable populations around the world.

What is the World Economic Forum doing about the coronavirus outbreak?

A new strain of Coronavirus, COVID 19, is spreading around the world, causing deaths and major disruption to the global economy.

Responding to this crisis requires global cooperation among governments, international organizations and the business community, which is at the centre of the World Economic Forum’s mission as the International Organization for Public-Private Cooperation.

The Forum has created the COVID Action Platform, a global platform to convene the business community for collective action, protect people’s livelihoods and facilitate business continuity, and mobilize support for the COVID-19 response. The platform is created with the support of the World Health Organization and is open to all businesses and industry groups, as well as other stakeholders, aiming to integrate and inform joint action.

As an organization, the Forum has a track record of supporting efforts to contain epidemics. In 2017, at our Annual Meeting, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched – bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines. CEPI is currently supporting the race to develop a vaccine against this strand of the coronavirus.

My hope is that this message does not bring you undue concern about the potential for vaccines to prevent COVID-19, but instead gives you the tools to build legitimate confidence in where we and other companies are in combatting this pandemic. I can assure readers that I and my colleagues at Moderna share a humble confidence as we battle this enemy, and we approach every day with enthusiasm and unlimited energy in contributing in every way we can.

the sting Milestone

Featured Stings

Can we feed everyone without unleashing disaster? Read on

These campaigners want to give a quarter of the UK back to nature

How to build a more resilient and inclusive global system

Stopping antimicrobial resistance would cost just USD 2 per person a year

New EU rules ensure better protection for 120 million holidaymakers this summer

European Border and Coast Guard: 10 000-strong standing corps by 2027

Google succumbs unconditionally to EU’s “right to be forgotten” ruling

COVID-19 will hit the developing world’s cities hardest. Here’s why

Tributes for ‘role model’ former UN refugee agency chief, Sadako Ogata

The big five EU telecom operators in dire straights

AI can wreak havoc if left unchecked by humans

Clamp down on illegal trade in pets, urge Public Health Committee MEPs

As conflicts become more complex, ‘mediation is no longer an option; it is a necessity’, UN chief tells Security Council

We are ‘burning up our future’, UN’s Bachelet tells Human Rights Council

Hydrogen isn’t the fuel of the future. It’s already here

5 ways COVID-19 has changed workforce management

Terrorism and migrants: the two awful nightmares for Europe and Germany in 2016

EU job-search aid worth €2 million for 500 former shipbuilding workers in Spain

France pushes UK to stay and Germany to pay

Where EU air pollution is deadliest

China rare earth prices soar on their potential role in trade war

Harmonised Unemployment Rates (HURs), OECD – Updated: February 2020

UN spotlights wellbeing of seafarers on International Day

‘Much more’ can be done to raise awareness about the plight of persons with albinism: UN chief

UN-backed intercultural dialogue forum urged to keep working to ‘bridge gap between the like-minded’

EU joint response to disasters: deal reached with Council

Combatting terrorism: Parliament sets out proposals for a new EU strategy

This South Korean city once had the biggest coronavirus outbreak outside of China. Now it’s reported zero new cases

Commission moves to ensure supply of personal protective equipment in the European Union

5 crises that could worsen under COVID-19

Finland has just published everyone’s taxes on ‘National Jealousy Day’

ITU Telecom World 2017: exploring smart digital transformation

European Parliament calls on Russia to end occupation of Georgian territories

5 neuroscience hacks that will make you happier

RescEU: MEPs vote to upgrade EU civil protection capacity

All for equality – 2020 is a pivotal year for Gender Equality

Deeper reforms in Korea will ensure more inclusive and sustainable growth

UN Climate Action Summit concludes with insufficient EU and global pledges

Milk, fruits and vegetables distributed to schoolchildren thanks to EU programme

China’s cities are rapidly becoming more competitive. Here’s why

Security Council must ‘come together’ to address the plight of children trapped in armed conflict, says UN envoy

EU Migrant Crisis: Italian Coast Guard Headquarters and Italian Navy to give host national opening addresses at Border Security 2016 in Rome

New EU-UK agreement is welcome but thorough scrutiny remains, insist lead MEPs

Coal addiction ‘must be overcome’ to ease climate change, UN chief says in Bangkok

EU27 leaders unite on Brexit Guidelines ahead of “tough negotiations” with Theresa May

How to get young people in Europe to swipe right on voting

This is Amsterdam’s ambitious plan to turn its transport electric

Reforms in Latvia must result in stronger enforcement to tackle foreign bribery and subsequent money laundering risks

Parliament boosts consumer rights online and offline

What is systemic racism, and how can we combat it?

EU Council approves visa-free travel for Ukraine and cement ties with Kiev

Powering a climate-neutral economy: Commission sets out plans for the energy system of the future and clean hydrogen

Marginalized groups hit hardest by inequality and stigma in cities

OECD joins with Japan to fight financial crime by establishing new academy

The business case for diversity in the workplace is now overwhelming

EU Parliament and Council: Close to agreement on the bank resolution mechanism

Poor quality is healthcare’s silent killer. Here’s what we can do about it

ECB asks for more subsidies to banks

Global trade is broken. Here are five ways to rebuild it

Intervene, don’t overthink – the new mantra of systems design

We need natural solutions to fight ocean and climate risk

EU Parliament: No EU-US trade agreement without safe data

The MWC14 Sting Special Edition

Italy and Greece zeroed their fiscal deficits, expect Germany’s response

More Stings?

Advertising

Speak your Mind Here

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s