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CWA # 381, 6 December 2020

COVID-19
The Vaccine Rush: Expectations vs Realities

  Harini Madhusudan

With major candidates of the big pharma announcing results from their final phases of testing and the upcoming rollout of vaccines, what remains the geopolitical significance of a vaccine success?

A vaccine success takes a backseat in pandemics such as the SARS-COV-2, where the timing, public perception, science, and policy-making are given more prominence. With major candidates of the big pharma announcing results from their final phases of testing and the upcoming rollout of vaccines, what remains the geopolitical significance of a vaccine success? What are the variety of Covid-19 vaccines that are being developed and the measures in place to face the politics of vaccine distribution? What are the expected outcomes of the vaccine rush in the following months?

In August 2020, Russia's Gamaleya National Centre of Epidemiology and Microbiology became the first to register their vaccine announcing that it was 92 per cent effective at preventing the COVID-19. The announcement saw a scutter among the big pharma to announce updates on their respective vaccines at various stages of development. Experts have started warning against the sense of urgency being projected with the vaccine developments and promises of distribution.  As of 2 December, 13 vaccine candidates are in the final stages of testing with a few vaccines being administered to select populations under regulatory approval. The vaccine candidates are being developed, focusing on four particular immunization types- Genetic Code Vaccines, Trojan Horse Vaccines, Protein Vaccines, and "Killed" Vaccines.

COVID-19 and the geopolitical vaccine rush 
The high efficiencies from the vaccine trials have garnered high investments that essentially help build the companies stock values. However, public confidence in the vaccines remains divided. In India, a survey by 'Local Circles,' showed that 59 per cent of the 25,000 people surveyed would not rush to take the vaccine. Misinformation and paranoia among the public who are considerably fatigued by the overwhelming changes would stand as a challenge. 

The hasty results and the pressing need to get approvals, places the quality of data at risk; as with the vaccine candidate by AstraZeneca, who in late November 2020, acknowledged a manufacturing issue with their samples that resulted in half dosages mistakenly administered as a single dose. The vaccine by AstraZeneca had shown 90 per cent efficiency when volunteers were given a half dose followed by a full dose and 62 per cent effective in people who received two doses. Following a test phase conducted by the Serum Institute of India, one volunteer is said to have developed acute neurological symptoms after receiving the shot.

There is an inherent pressure among the pharma companies to show efficiency levels over 90 per cent. These companies have to prepare to face the market urgency to be the best supplier and deal with the demands for billions of doses of vaccines. The vaccine candidate by Pfizer and BioNTech declared a success rate of 95 per cent, however, the data released by the same show that the sample size of the third phase of testing included only 170 COVID-19 infected people, from a sample size of 43,000. Though marketing and PR are essential to persuade the population to take the vaccines, using the same to declare success creates unnecessary competition.  

The scale of the current crisis makes the process challenging. In the past, there have been examples of a rush to develop vaccines going southward. Two examples must be considered of the US' experiences with virus outbreaks, where one time, about 45 million Americans received swine flu vaccines for an H1N1 influenza strain because the vaccination drive moved too fast. Another case was during the Obama administration when a strain of swine flu emerged, and the predictions showed the need for 160 million vaccine doses but later downgraded to 40 million and eventually when it was time to administer the vaccines, 28 million doses were available. Despite the possibility of rectifying such errors, it is important that the present vaccine situation does not- "overpromise and underdeliver."

Vaccine Candidates and Vaccine Alliances 
Two vaccines in Russia Sputnik V and EpiVacCorona have been granted regulatory approval. Globally an estimated 44 candidates are in the works to develop vaccines. The Operation Warp Speed, a trans-Atlantic initiative where three vaccine candidates from the US and Europe have been funded for Phase 3 trials: Moderna's mRNA-1273, University of Oxford, and AstraZeneca's AZD1222, and Pfizer and BioNTech's BNT162. All three candidates have communicated third phase efficiency levels as being above 90 per cent. With four leading candidates, China has administered three of its experimental covid vaccines by Sinopharm and Sinovac Biotech, to almost a million people through its Emergency Use Programme. 

The Global Vaccine Alliance (GAVI) 's COVID-19 Vaccines Advance Market Commitment COVAX AMC initiative, is a public-private global health partnership with a goal to work with vaccine manufacturers and offer low-cost COVID-19 vaccines to increase access to immunization in poor countries. Early catalytic support is aimed towards 92 low- and middle-income economies eligible for participation, and to assist them in planning for delivery of COVID-19 vaccines, including support for technical assistance and strengthening cold chain equipment, according to a decision taken at the Gavi Board in October. In addition to the 92 eligible members, 94 countries have joined as self-funding members of the facility, totaling 186 economies around the world. They are currently working with candidates like Inovio, Moderna, CureVac, Institut Pasteur/Merck/Themis, AstraZeneca/University of Oxford, Novavax, University of Hong Kong, Clover Biopharmaceuticals, and University of Queensland/CSL and there is an expectation of others joining. 

The rush to develop a vaccine is aimed at beating speed records merged with the populist, financial, and political pressures. Vaccine characteristics that are critical for successful rollout globally, like immunization schedule (ideally a single dose), temperature stability (ideally no refrigeration), the potential for rapid scale-up of manufacturing, and low cost, which are key to mass production, are currently not being considered in the competition for license or marketing approval. Of all the candidates available, the vaccine developed by Oxford and AstraZeneca claims to be cheaper, easier to store, and convenient to get to all corners of the world. 

In other development, companies have begun suggesting the acceptable efficacy goals much lower than 50 per cent with a forewarning that the protection may be relatively short-lived. Phil Krause, deputy director for vaccines at the FDA and member of the WHO working group for covid-19 vaccines, warned that a "weakly effective vaccine can do more harm than good." Some experts have also begun to cast doubts toward the reliability of such a competition, for example, Masayuki Miyasaka, a leading immunologist from Osaka University stated, "There's no doubt that their effectiveness is quite high, but their safety is not guaranteed at all," sounding a word of caution about expectations from the vaccines.

Though the vaccine developments have promised high efficiency, there is no clarity on the distribution and availability for the regions across the world. Many laboratories have now begun to take the rights to develop, manufacture, and commercialize it for their own countries' consumption. The WHO has warned of "building a base camp on Mount Everest, not reaching the summit," indicating that the real challenge is the enormous task of global immunization.

The pandemic has been around for almost a year. Though development is a tedious process, the multiple vaccines in the race would help in meeting the global demand. However, they would also bring out the differences between nations that have the means to develop/procure vaccinations and the developing world. The vaccine conundrum brings to the fore the limitations faced during times of crisis despite the heights of technological growth. 


About the author

Harini Madhusudan is a PhD scholar at the Science Diplomacy Programme, in School of Conflict and Security Studies, National Institute of Advanced Studies (NIAS). Her research interests include Outer Space, China and East Asia, US-China, and political economics. Currently, she is pursuing a PhD on, "Militarisation in Outer Space: a case study of India, Japan, and France."

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