The Human Vaccines Project (HVP) is a nonprofit public-private partnership with a mission to decode the human immune system and accelerate the development of vaccines and immunotherapies across major global diseases.

1. Tell us briefly about the organisation you represent and if your organisation planned any support actions during the covid-19 pandemic

The Human Vaccines Project (HVP) is a nonprofit public-private partnership with a mission to decode the human immune system and accelerate the development of vaccines and immunotherapies across major global diseases. The Project brings together leading academic research centers, industrial partners, nonprofits and governments to answer core questions about how the human immune system fights disease and pioneer a new era in human health.

The project has three pillars: the Human Immunomics Initiative, a collaboration with the Harvard T.H. Chan School of Public Health; the Newborn Immunity Initiative, a   partnership between HVP and the Telethon Kids Institute, the Newborn Immunity Initiative Cincinnati Children’s Hospital, and Université Libre de Bruxelles; and the COVID Vaccine Initiative (CVI).

The CVI seeks to learn as much as possible from the current COVID-19 pandemic to enable it to better respond to and perhaps stop the next before it starts. The CVI is working with industrial partners to understand how and why COVID-19 vaccines have been so successful, and to understand how well such vaccines work in vulnerable groups such as older adults where vaccines often do not work well. The CVI through its Global Lab Meeting and COVID Report has provided indispensable, unbiased updates from the world’s leading researchers in the COVID space. 

The CVI is now at the forefront of thinking about how to stop the next pandemic, thinking forward to a universal coronavirus vaccine capable of stopping the next pandemic before it starts.

This pandemic has taught us that an infectious disease agent can have an enormous impact on every aspect of life.

Q2. Vaccine development takes enormous time and money, that was our understanding prior to covid-19. Do you think Covid-19 has changed that for good, or is too early to say that.

As always, the future will tell. However, I am optimistic that SARS-CoV-2 and COVID-19 will change things for good. This pandemic has taught us that an infectious disease agent can have an enormous impact on every aspect of life. The human, social, cultural and economic toll is enormous. It has been estimated that the current pandemic will end up costing between USD 8 and 16 trillion globally, but there is also an estimate that it will cost USD 16 trillion for the US only. Surely this has opened the eyes of decision makers that a continuous investment in infectious disease R&D and the underlying basic mechanisms to understand infection, disease development and severity, and immune response is necessary. We now have platforms such as mRNA and others that have allowed us to develop vaccines faster than ever. These new platforms rested on decades of research and investment and are capable, as we have seen, of bringing vaccines faster to the public faster than ever. Despite these advances we still have much work to do on the research side in understanding how to generate immunity to disease that works across all populations and including the really tough diseases like HIV or malaria where we need effective vaccines.

It is important to realize here that the risks taken were financial, not on safety.  We were able to bring vaccines to market so fast because we had invested billions in the development of new platforms like mRNA in the decades before this outbreak. Second, governments around the world started building highly expensive manufacturing plants before we knew the vaccines would work at a great cost and risk to capital. Usually the vaccine industry waits to see if the vaccines look like they will work before making such an investment stretching the development time to years. So the acceleration of the cycle was really due to previous investments and willingness to take financial risk.

I believe it has been shown that a quicker vaccine development cycle and market authorization do not have to go against safety. Safety is the key issue for industry, regulatory agencies and policy makers, and the vaccines went through the standard safety testing and clinical process. That said we have to acknowledge that risks from vaccines are few, but real.  The harms coming from vaccines are almost always seen in a short time—allergic reactions being the most common by far.  So large trials with shorter observation periods are adequate to find these even if they are unusual.  We also have systems for seeking very rare events after vaccines are in use (one event per million doses), and those are now being used.  But traditional vaccine and drug development has a lot of delays that don’t really add to safety of the product. That being said, policy makers and politicians should not put pressure on industry and regulatory agencies to move faster if that would jeopardize safety. 

Secondly: Yes, population groups were missing in the clinical trials, which is common practice in vaccine R&D: children, pregnant and lactating women, people with (severe) underlying health conditions were not included in the first trials. Elderly people were included, but not in very large numbers.  This means that additional studies are needed, as we are witnessing now: studies are carried out amongst immune-depressed patients, cancer patients, people with auto-immune diseases, children etc. This is not an easy issue to be fixed in clinical trials, because the golden rule is that you enrol ‘healthy’ volunteers, usually people between 18 and 55. This needs a lot of thinking and a careful balancing of risks and benefits if you are going to enrol vulnerable populations. Again, this is where post-marketing surveillance systems or additional clinical trials after the vaccine is being distributed, can help without slowing down access to a life-saving intervention. 

Thirdly, improving communication around vaccine campaigns in general. Vaccine hesitancy is a big issue worldwide. WHO identified vaccine hesitancy as one of the top 10 threats to global health. The challenge for public health authorities stretches beyond COVID-19. I believe that we are entering a completely new paradigm around vaccination. Social media and social networks have become important shapers of the frame, as we have seen in so many countries with the introduction of the HPV vaccine; opinion makers and leaders – whether in media, science, politics, religion – can make or break vaccination programs; lack of consistency and trust are critical issues. 

On top of that, given the enormous amount of time spent on reporting on COVID-19, people are becoming more knowledgeable about vaccines and vaccine development: herd immunity, level and duration of efficacy; side effects; halting trials because of (serious or severe) adverse events.  The public also is gaining an understanding of gaps in our knowledge after a vaccine has been licensed such as the level of protection against new virus variants, the efficacy of a vaccine in the aging population and in people with pre-existing morbidity. Last but not least, the top 3 categories for vaccine hesitancy (scientific evidence; knowledge and awareness; religion/culture/gender/socio-economic) remain relatively constant, but even the most cited category (scientific evidence – risk benefit) only accounted for less than a quarter of all categories cited, emphasizing the complexity and variability of vaccine hesitancy globally. So this is a daunting challenge for public health authorities. 

I believe it is key to (re)establish trust. And trust is created by being honest / transparent, fair, reasonable and realistic. A recent study showed that the most important determinant for being vaccinated is that people believe and are confident that vaccines are important for their own safety and health. That in my opinion is going to be critical. Communicate clearly and consistently about the impact of vaccination on life expectancy; invest in understanding why some are hesitant and some confident; invest in making immunisation accessible, affordable and acceptable. Understand community dynamics and social and peer group pressure. I believe it is critically important to involve social and behavioral scientists in order to understand the social and behavioural dynamics.

Q4. What are the barriers that prevent vaccine development and a well-coordinated global effort. If you were to suggest top three recommendations for a healthier and safer world through timely vaccine development, what would they be?

• Sharing real-time information if an infectious agent is identified as the cause of a (potential) pandemic in order to start working on a vaccine
• Communicate as much as possible and don’t shy away from saying sorry, if new insights require different approaches. 
• Develop a MoU between biopharma and the international community (WHO, World Bank) on advance market and advance purchase commitments, and other innovative financing mechanisms.

Obviously, our ability to decode the human immunome. The recent convergence of technological advances in biomedical, computing and engineering sciences will lead to the next revolution in health, including but not limited to vaccine discovery and development.

The microbiome is made up of around 100,000 billion microbes, which is more than all the human cells of your body. Most of these microbes are bacteria, and they are vital to your health.

Q6. Are all viruses bad? About 8% of the human genome is ancient viruses! What is the relationship of life in general and humans with viruses? Are we against them all the time?

Viruses may have a bad reputation. Because of the SARS-CoV-2 pandemic, their reputation seems worse than ever before. However, we would not survive if our body did not host its share of viruses. Wishing to be ‘virus free’, actually is a bad idea. The great majority of viruses are actually not ‘interested’ in humans at all, but in bacteria. These ‘bacteriophages’, or bacterial viruses destroy bacteria and keep bacteria populations under control. 

Everybody carries around a huge number of microbes, known as the microbiome. The microbiome is made up of around 100,000 billion microbes, which is more than all the human cells of your body. Most of these microbes are bacteria, and they are vital to your health. Nevertheless, these bacteria need to be kept under control. That is why the bacteriophages in your body outnumber the bacteria 10 to 1. Nature uses bacteriophages as a sort of ‘biological pest control’ for bacteria, which prevents humans from being overwhelmed with bacteria. We would die without viruses.

Q7. Any message that you would like to share with the readers of our magazine.

Stay safe and stay healthy.  Remember that behavioural modifications limiting exposure of you and those around you are a crucial protection against COVID-19 that can work together with vaccines to defeat this pandemic.

Interviewed by Sachin Gaur, Executive Editor, InnoHEALTH Magazine