There are several common misconceptions about immunisation worldwide and their root causes tend to be similar across borders, underlining that many people’s concerns are shared.

For example, some misconceptions exist about vaccine safety. These are usually caused and amplified by misinformation and a general lack of understanding of how vaccines are rigorously tested for safety and efficacy before being approved and made available. It’s, therefore, crucial for healthcare providers to communicate the extensive testing that vaccines undergo and to discuss the systems in place for monitoring vaccine safety post-approval.

Other misconceptions involve people believing that vaccines are not necessary. This misconception can lead to complacency and a decrease in vaccination rates, potentially causing the resurgence of these diseases, as we have recently seen with measles. It’s, therefore, crucial to continue highlighting the role of vaccines in keeping these diseases at bay and protecting global public health.

Advocating adult vaccinations for individual and community health

The reality is that COVID-19 still poses a global public health risk, especially to the elderly and vulnerable segments of the population. People continue to face serious outcomes from COVID-19, including implications such as long COVID and hospitalisation. The data shows that vaccine protection for COVID-19 wanes over time, prompting the need for seasonal vaccination, especially as new variants emerge. As the virus is here to stay, countries need to think about preparedness and the role that vaccines can play in protecting the population in terms of matching the emerging variants.

RSV is a common seasonal respiratory virus that typically leads to cold-like symptoms but can also result in acute respiratory infection and lower respiratory tract disease – particularly in children and older adults. Data supports the importance of vaccination against RSV as globally, it affects an estimated 64 million people and causes 160,000 deaths each year. The economic burden of RSV infections on healthcare systems has also been found to be substantial, underscoring the need for RSV preventive strategies to reduce this burden.

Vaccination against influenza is another important public health measure to prevent illness and protect individuals and communities, particularly those more vulnerable, such as young children, the elderly, and individuals with weakened immune systems. Preventing influenza cases also helps reduce the burden on healthcare facilities, allowing them to focus on other medical needs. Moderna currently has one investigational influenza vaccine in Stage 3 clinical trials (mRNA 1010) and another four in Stage 2 trials.

We are also developing combination vaccines for influenza, COVID-19, and RSV to safeguard public health. These viruses kill and hospitalise many people each year, so if we can combine them into a single vaccine, the potential impact on public health and compliance will be huge.

Moderna emphasises the importance of adult vaccinations through our work in developing mRNA vaccines that offer hope against emerging infectious diseases. We also advocate for vaccinations by engaging in public education campaigns to raise awareness about the benefits of immunisation and by partnering with authorities and healthcare organisations to ensure vaccine accessibility.

Improvements in public health outcomes — success stories

Collaboration has a significant role in advancing mRNA vaccines for a wide variety of diseases, including infectious disease prevention. In the Middle East, we’ve successfully partnered with governments and relevant health authorities to ensure access to and the successful roll-out of COVID-19 vaccination in countries like Saudi Arabia, Qatar, and Kuwait, among others.

Beyond our role in supporting immunisation, we also believe there is major potential for partnerships and technology/knowledge sharing in the Middle East. In countries like Saudi Arabia, for example, we understand the national vision values partnerships between public, private, non-profit, and international organisations to achieve the aspirations of creating a knowledge-based economy.

In March 2022, as part of our global public health strategy, we launched a new program, mRNA Access, which offers researchers worldwide use of our mRNA technology to explore new vaccines against emerging or neglected infectious diseases.

To further expand the potential impact of mRNA vaccines, the mRNA Access program is dedicated to opening our preclinical manufacturing capabilities and research and development expertise to global partners so that together, we can explore the possibility of mRNA to tackle the world’s greatest public health threats.

Optimised supply and distribution of doses

Our mRNA pipeline reflects the ongoing progress we are making on clinical programs currently in development to create mRNA medicines for a wide range of diseases and conditions. Our pipeline covers infectious disease vaccines (including Phase 3 trials against RSV, influenza, and a next-generation COVID-19+Flu combination), latent and public health vaccines, and therapeutics.

Through our ongoing research and development, we expect to continue to meet the evolving needs of the endemic COVID-19 market by advancing next-generation COVID-19 vaccines. In this regard, our next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, recently met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-COV2 compared to previously licensed vaccines. The storage, shelf life, and pre-filled syringe presentation of mRNA-1283 is expected to enhance the supply of vaccines, alleviate the burden of healthcare providers, and help increase access in markets such as the Middle East, with more extreme weather conditions.

Additionally, we are currently working on a range of combination vaccines for COVID-19, RSV, and Influenza, which, if approved, may help to contribute to a better uptake of vaccination and increased protection for populations around the world.

Presence in Saudi Arabia and the Middle East region

Moderna is committed to advancing public health in the Kingdom and the broader Middle East region. Over the years, we have collaborated with health authorities and regional partners to ensure access to our COVID-19 vaccine.

In the near term, we are ready to support the Kingdom and the wider Middle East region with the rollout of our updated COVID-19 vaccine to support vaccination campaigns this year and beyond.

From a longer-term perspective, we believe our mRNA platform can help solve the region’s greatest health challenges—from diseases impacting millions to medicines personalised to the individual level. To this end, we want to bring future mRNA innovation across areas such as respiratory syncytial virus (RSV), rare diseases, and oncology to the region.

Over the next four years, we will explore the opportunity to have a direct presence in the region and support governments and public health authorities with pandemic preparedness. The COVID-19 pandemic and other health emergencies have shown that countries must be ready to respond to infectious disease threats with tailored preparedness plans.

To this end, we have recently worked with several governments to facilitate in-country mRNA vaccine manufacturing capabilities to support health security. This will help countries respond quickly to emerging crises with locally manufactured COVID-19 and other respiratory vaccines. Some announced agreements in this space have been with Canada, Australia, and the UK.

We remain dedicated to working with the relevant authorities and local communities to tailor our healthcare solutions to their needs, ensuring that we are a strong partner in improving health outcomes throughout the Middle East.

Final thoughts…

The potential of the mRNA platform to transform medicine, not only in the Middle East but worldwide, is very real. After all, Moderna was built on the guiding premise that if using mRNA as a medicine works for one disease, it should work for many diseases.

The platform goes beyond a single pathogen, disease, or pandemic. It is about human health and maximising the impact of mRNA medicines and therapeutics. As mRNA is an information molecule, our hypothesis has always been this. If we invest in science over time, we can create many applications of this technology, potentially changing how medicine is made.

As for the mRNA story in the Middle East and the role it will play in transforming medicine for the long term, this is only just the beginning. In time, we expect mRNA-based therapies to become the first line of treatment for many diseases specific to the region, such as cancer.

Recent breakthroughs in cancer immunotherapy have demonstrated that powerful antitumor responses can be achieved by activating antigen-specific T cells in a variety of cancer settings. We also expect mRNA to play a major role in treating rare diseases and autoimmune diseases.

Dan Staner is the VP, General Manager Germany & Switzerland & Head of Middle East region at Moderna.

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What if our ability to get novel medical devices from the lab to patients swiftly determined the direction of healthcare? With the US in focus, will the policies on medical device development become a reality in a market expected to grow at a compound annual growth rate (CAGR) of 6.1 per cent from US$184.61 billion in 2022 to US$291.04 billion by 2030?

The medical device sector, which includes anything from basic bandages to sophisticated imaging systems and robotic surgical instruments, faces leaps and hurdles like every other sector. Historically, the path from innovation to market has been fraught with regulatory hurdles, lengthy approval processes, and significant financial investments. These challenges have often stifled innovation and delayed the availability of life-saving technologies to patients.

In recent years, concentrated efforts have been made to expedite the regulatory procedure without sacrificing patient safety. The FDA in the US has launched several programs to expedite approval procedures for medical devices. Initiatives such as the Breakthrough Devices Program aim to accelerate the creation, evaluation, and approval of medical devices that offer more efficient diagnosis or treatment for serious or terminal illnesses. Thus far, these measures have yielded encouraging outcomes. Devices eligible under the Breakthrough Devices Program receive priority consideration and increased interaction with FDA representatives. This reduces the possibility of expensive delays by giving manufacturers critical input early in the development cycle and accelerating the approval process.

Several important activities and policies have and will influence the medical device development scene in 2024. A new era of rapid innovation, notably in AI-enabled devices and advanced imaging technologies, has been ushered in with the streamlining of regulatory procedures, aided by the FDA's accelerated approval processes and the Medical Device Development Tools (MDDT) program. For instance, the FDA's Medical Device Development Tools (MDDT) program marked a significant milestone with the inclusion of Apple Watch's atrial fibrillation (AFib) history feature. This qualification, a first of its kind for "digital health technology’, enables the Apple Watch to contribute invaluable data to clinical studies. 

The policy agenda of AdvaMed continues to spotlight the significance of a robust supply chain and legislative support, like the VALID Act, in guaranteeing precise diagnostic tests. Additionally, AdvaMed promotes startups and small enterprises by providing money for research and advantageous tax laws, which advances industry innovation. The US, China, and Japan are leading the way in industry growth despite macroeconomic problems. This growth is strengthened by initiatives to ensure fair access to innovative medical technology and to promote diversity in clinical trials.

Beyond regulatory reforms, new policies are strengthening innovation through increased funding and public-private collaborations. The US government has allocated significant funds and grants to support research and development within the medical device industry. Early-stage innovation is greatly aided by initiatives like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH).

Moreover, collaborations between government agencies, academic institutions, and private companies are becoming increasingly common. The medical device market is expected to develop even more, which indicates that flexible rules are desperately needed in the ever-changing healthcare environment. This is backed by several compelling reasons, including the growing number of people with chronic conditions, the ageing population, and the growing need for minimally invasive operations.

The COVID-19 pandemic showed that, with the right rules in place, the healthcare industry can develop swiftly and serve as a grim reminder of the importance of strong healthcare systems.

While legislators try to create adaptable legal structures, the US becomes a leader in medical innovation by prioritising improving patient outcomes while reducing healthcare costs. The industry's anticipated growth is contingent upon continued legislative support, highlighting its critical role in shaping the future of healthcare.

Jennifer Orisakwe is a health researcher and data storyteller, who loves to explore the ways actions (and inactions) of healthcare stakeholders affect decision-making and outcomes.

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