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Vaccines – The Future Is Here

By: Monali Barua, Senior Associate I, Dentsu Health; Nilesh Patil, Senior Research Analyst II, Dentsu Health; Kent Groves, PhD, Global Head of Strategy, Dentsu Health

How Far We Have Come!

From smallpox to polio to COVID-19, the world has triumphed in many healthcare battles over the centuries, courtesy of solid protection shields called vaccines. Vaccines have helped us fight and eradicate many life-threatening conditions.

The development of a vaccine for coronavirus within less than a year into the pandemic is a testament to how the healthcare and pharmaceutical sector has evolved. Pfizer and BioNTech co-developed the mRNA vaccine (BNT162b2) to combat COVID-19 – one of the greatest 21st Century wins of humankind. In 2021, 3 billion doses of coronavirus vaccines alone were deployed as opposed to the 2 million doses simply tested by the US Army Medical School in 1918. Globally, 70.5% of people took at least one vaccine shot for COVID-19, with 32.6% from low-income countries in 2021.

We have come a long way, and when it comes to dealing with a pandemic, we are in this together: it’s humans vs. the virus.

Everyone needs to be on the same journey.

A community of anti-vaxxers dissent from this view. In 1792, anti-vaccine propaganda started to spread, depicting vaccines as an infringement of human rights, and questioning their safety and effectiveness. Today, the same ideology is combined with a political agenda inflamed through the echo chambers of social media.

Around 31 million people on Facebook follow anti-vaccine groups, generating over $1 billion in advertising money. In countries like France, Ireland, the Netherlands, The United States, and regions like MENA (Middle East and North Africa), misinformation spiraled in anti-vaccine communities on social media during the pandemic. Recently, the Centers for Disease Control and Prevention (CDC) recommended a broad rollout of the new COVID-19 vaccine in Florida, targeting the recent variant of the omicron strain. But its governor and state surgeon issued a guidance suggesting individuals under 65 to not take the shot.

When conspiracies, opposing faiths, and political agendas interfere with healthcare, the loss is personal, as it puts human lives at risk. But along with these challenges, the healthcare and pharmaceutical industry had (and have) other issues to tackle including disrupted supply chains, equipment shortages and capacity constraints resulting in production bottlenecks and delays in vaccine delivery.  Rising costs and inflation also impact the pharmaceutical industry. As the costs of R&D to develop new, targeted vaccines increases companies must weigh the risk of novel innovation against fiscal responsibility. 

While the pandemic single-handedly came close to breaking the spirit of billions, the litany of  never-ending obstacles were overcome, and people didn’t have to wait for years for the COVID-19 vaccine. Progress, indeed!

Facing a defining moment, healthcare and technology created a new standard of collaboration.

Telehealth became the first line of defense, enabling healthcare professionals (HCPs) to manage and guide patients through phone calls and video calls. Cutting-edge technology proved to be a double booster shot in the advancement of healthcare. Machine learning and artificial intelligence helped in the quality checks and boosted clinical trials up to 46,000 at 150 sites in 6 countries. Overall, digital health solutions have helped in medical consultations, tracking the spread of the virus, and even in the manufacturing and shipment of vaccines.

Today, vaccine candidates for chronic and other diseases are either in the clinical trial stage or already approved by the regulatory bodies.

Moderna and Merck & Co. announced positive results for their Phase 2b trial of mRNA-4157/V940 for melanoma. mRNA-4157/V940, in combination with KEYTRUDA (prescriptive medicine), lowered the risk of recurrence or death (by 40%) versus KEYTRUDA alone for the treatment of patients with stage III/IV cancer following complete resection. The companies aimed to initiate a Phase 3 study in melanoma patients in 2023.  Roche and BioNTech are also looking to follow suit with their own study of melanoma.

Similarly for HPV, the US Food and Drug Administration (FDA) approved the Gardasil 9 vaccine for people aged 9 to 45. It helps prevent cancerous forms, like cervical, vaginal, mouth, genital warts, and more, in men and women. In Dec. 2022, the World Health Organization (WHO) upgraded the dosage policy for this vaccine.

The latest respiratory syncytial virus (RSV) vaccines mitigate major issues. In 2022, Pfizer bagged a Breakthrough Therapy Designation from the FDA for introducing RSVpreF for the immunization of pregnant women. The antibody provides 70-80% protection against severe disease for infants up to 6 months in its Phase III trial. By the end of 2023, antibodies such as Nirsevimab and Clesrovimab that target lower-respiratory tract infections are anticipated to be available in the market. Several vaccine candidates for the young and elderly have also passed Phase III clinical trials.

Another breakthrough is the development of microarray patches (MAPs). These are vaccine-coated, coin-sized micro patches that help us fight human papillomavirus (HPV), influenza, measles, rubella, and rabies. This progress has “the potential to revolutionize accessibility,” said Birgitte Giersing, PhD, WHO’s Immunization Department.

Finally, during the pandemic, researchers were presented with the opportunity to try a different formulation methodology by including data to detect the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD). Going forward, perhaps the ‘customizing rules according to the variant’ approach will take our success with new viruses even further.

Vaccine accessibility and distribution. The present situation is not as bleak as one may think.

In 2021, around 16 billion dosages of vaccines were supplied globally as compared to 5.8 billion in 2019, and the global market size stood at $99 billion. These included vaccines for COVID-19, seasonal influenza, shingles, Tdap, and more. As of April 2023, ~980 million COVID-19 doses were distributed in the US. Canada took the second spot globally, with 81% of citizens being vaccinated as of March 2023.

The governing bodies of several countries play a crucial role in ensuring a fair distribution of vaccines. Recently, the US Department of Health and Human Services (HHS) launched the Bridge Access Program to provide access to coronavirus vaccines to uninsured and underinsured Americans. Through this program, around 25-30 million adults will receive free coverage.

Along with the WHO, the legal responsibility is also shared with the National Regulatory Authorities (NRAs), who oversee the licensing applications, lot review, and product performance. WHO provides technical assistance to NRA for development and implementation plans. Currently, support to various countries for their NRA function assessment is being carried out. The Global Training Network on Vaccine Quality (GTN/VQ) is also available to make up for the medical gaps and national plans.

While viruses are evolving, so are the vaccines!

Today, promising vaccine trials are in progress to treat nicotine and cocaine addiction. Currently, as most vaccines are injected, it can be an unpleasant experience for many. Needle-free administration is possible for some vaccines, such as oral vaccines. Research is underway on edible plant-based vaccine materials, needle-free skin patches, and microneedle injection technologies to administer it through the skin. 

Persistent infections, such as shingles, and some non-infectious conditions, like autoimmune disorders, tumors, allergies, and drug addiction can now be addressed with therapeutic vaccines. Inhaled vaccines, for example, are already used in some cases: influenza vaccines have been manufactured as nasal sprays. One of these vaccines is available for seasonal flu every year.

The new shift is (coming) here.

The pandemic might not be the last unexpected catastrophe that the world will experience together. Technology, innovation, and better healthcare policies are the three antidotes that can redefine the future of vaccines. With smallpox in the 1790s till COVID-19 in 2021, we have made significant progress. Infections are modifying themselves daily. Nonetheless, healthcare is doing a one-up. Groundbreaking evolutions are on their way, and the secret to a healthy life is one antibody away.

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