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Chris Hardesty

Looking East: Debunking Options for COVID-19 Vaccine Access

BY CHRIS HARDESTY

COVID-19 cases are nearly 50 million and continuing to surge ahead.

At the time of the writing of this article, COVID-19 cases are nearly 50 million and continuing to surge ahead, with countries coming in and out of lockdown interventions so as to walk the delicate balance of social and economic normalcy. All eyes are on a prospective vaccine as the ultimate solution to restore order, with 42 trials already reaching human testing (10 in their final stages of study) and another 150+ following closely behind in preclinical investigation. Hopeful agreements for hundreds of millions of doses are being actively signed by governments, with other utilities such as COVAX in place for widescale distribution.

Perhaps most interesting to me about this “modern pandemic” are the lessons we learn about political stability and international collaboration. The interconnectedness of globalisation is pushed to the brink with nationalistic response plans, border closings, and, frankly, finger pointing. At a time when anyway Western legacies are diminishing and the East is rising, it is the rebirth of the East that has proven greater control over the COVID-19 situation.

One is reminded of the “space race” from a generation past, a form of competition that, while driving an impressive level of focus toward the cause at hand, creates a false sense of “haves and have nots” as it pertains to the scientific progress of vaccine development. We should be reminded as well that the formation of the United Nations, under which the World Health Organization was born just after the Spanish Flu pandemic, was driven in large part by China, Russia (then known as USSR), and the United States, amongst other parties of course.

The purpose of this article is to cast a light on COVID-19 vaccine developments happening outside the West, in particular in Russia, such that ecosystem leaders are fully informed as to the legitimised options available for the health, social, and economic recovery of their peoples.

Astronomical Scientific Discoveries

The term “Sputnik” refers to a traveling companion in Russian, though is more commonly associated with the first artificial satellite launched into orbit. At that point in 1957, the International Geophysical Year was established so as to bring the East and the West together again, for the purposes of scientific research and for the betterment of mankind.

It is no coincidence then that Russia, home to some of the most impressive discoveries over the centuries, is one of the first countries out of the gate with a COVID-19 vaccine, under the trade name of Sputnik V. Spotting the surge in COVID-19, the Gameleya Research Institute of Epidemiology and Microbiology, headquartered in Moscow, activated its two-vector vaccine technology platform that had previously been used in the development of Gam-Evac-Combi, for the Ebola virus, and was in process of studying Middle East Respiratory Syndrome (MERS), another type of coronavirus. The synergies created by the two-vector platform resulted in one of the fastest developments of a COVID-19 vaccine, officially called Gam-COVID-Vac. The vaccine is human adenovirus-based to provide the expected immunity against COVID-19, having completed more than 250 clinical trials and with citations in 75 international papers.

So How Does It Work?
Human adenovirus vector vaccines are not new, having been deployed by militaries around the world for nearly 50 years. This type of vaccine contains a virus that lacks the genes responsible for replication (i.e. a vector), which is then used to transport genetic material that codes the spike protein of, in this case COVID-19, into the human cells. The cells produce the spike proteins, which triggers the immune system to respond, conferring protection against COVID-19. Unlike other human adenovirus vector vaccines for COVID-19, Sputnik V uses two different vectors – human adenovirus type Ad5 and type Ad26 (see Figure 1). These vectors are administered in separate injections at 21 days apart in order to deliver the most effective response, while avoiding the immune system’s launching of defense against the vaccine itself due to the attenuating effects of limiting exposure between the vectors.

The World Health Organization officially lists Sputnik V as one of the investigational COVID-19 vaccines closest to completion of clinical trials. The Phase I/II clinical trials, published in The Lancet in September 2020, were run as two open, non-randomised studies across 76 adult volunteers between the ages of 18-60 years. In Phase I, 18 volunteers received one dose of Ad26 and 18 others received one dose of Ad5, both administered into the deltoid muscle. In Phase II, 40 patients received Ad26 on day 0 and Ad5 on day 21. The vaccine formulations were well-tolerated, with any adverse events considered mild (no severe side effects). The most common adverse events were pain at injection site (58%), hyperthermia (50%), headache (42%), fatigue (28%), and muscle pain (24%).

Importantly, all participants produce antibodies to the COVID-19 glycoprotein. By day 42, Sputnik 5 generated a stable humoral and cellular immune response. The level of virus-neutralising antibodies of volunteers vaccinated with Sputnik 5 was 1.5 times higher than the level of antibodies in convalescent plasma. T-cell immunity (CD4+ as well as CD9+) was formed in all vaccinated volunteers.

The Path Ahead
The Phase III clinical trials of Sputnik V are underway involving over 40,000 volunteers, with first results expected this month and an overall concluding timeframe of May 2021. In addition to Russia, site studies include the likes of Brazil, India, Saudi Arabia, Egypt, United Arab Emirates, and Belarus. The favorable Sputnik V Phase I/II study results have paved the way for emergency use authorisation, thereby expediting deployment timelines, especially to the more vulnerable populations, under a streamlined risk-benefit analysis. Local production in Russia is ramping up with an aim to voluntarily vaccinate 70% of the country in order to bring the pandemic to an end, having already administered the vaccine to frontline healthcare workers and teachers. By December 2020, Russia will have capacity to manufacture seven million Sputnik V doses each month.

Over 50 countries have expressed interest in obtaining Sputnik V based on its currently known safety and efficacy profile, with preliminary applications received for over 1.2 billion doses including from the likes of Brazil and Nepal and with mass production operations planned in India, Korea, and China, amongst others. The purpose of this article is not to advocate for Sputnik V in singularity, but rather to raise awareness that the West versus East rhetoric does not do justice to the legitimised scientific progresses that are happening around all corners of the planet. Bear in mind that it was in fact Russia in 1958 who called on the World Health Organization to initiate Resolution 11.54, which ultimately led to the eradication of smallpox. The COVID-19 pandemic is not the time to raise walls and swords; we must continue to foster a spirit of international collaboration that drives the collective toward restoring order. And country leaders should be aware of the full range of options available to them as it pertains to a COVID-19 vaccine candidate.

The views expressed in this column are the author's own and do not necessarily reflect this publication's view, and this article is not edited by Health Care Asia Magazine. The author was not remunerated for this article.

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Chris Hardesty

Chris Hardesty

Chris is the Director for the Life Sciences Practice at KPMG with a current focus on Asia markets. He is also a member of KPMG's Global Healthcare & Life Sciences practice with experience across a variety of jurisdictions and project types, such as commercial strategy, supply chain, workforce, technology, M&A, and compliance.

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