World Health Organization: Facilitating Covid-19 Vaccines For The World
i1v2e5y5pubs
W21032
WORLD HEALTH ORGANIZATION: FACILITATING COVID-19
VACCINES FOR THE WORLD1
Michelle (Chau Minh) Doan wrote this case under the supervision of Klaus E. Meyer solely to provide material for class discussion.
The authors do not intend to illustrate either effective or ineffective handling of a managerial situation. The authors may have disguised
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Within just a few months of the first confirmed case of COVID-19, the virus had changed lives around the
world. Lockdowns and travel restrictions forced people to work from home, cancel their vacations, and
avoid indoor events. Many people pinned their hopes on a vaccine to combat the disease. Pharmaceutical
companies and research laboratories raced to
ing safe and effective vaccines to market.2 Stakeholders
such as governments, businesses, and non-governmental organizations (NGOs) joined the efforts, but
disagreed on how best to ensure the widespread availability of vaccines.3 The pharmaceutical industry
viewed intellectual property (IP) protection as a means to earn a satisfactory return on their high-risk
investments.4 Others argued that upholding patent laws in times of crisis would make life-saving
medications prohibitively expensive for many people, especially those in developing countries.5
As COVID-19 turned into a global pandemic, the World Health Organization (WHO) initiated a COVID-19
Technology Access Pool (C-TAP) that would help countries around the world access technologies, specifically
vaccines and treatments. This initiative aimed to promote equitable access to, among other related technologies,
coronavirus vaccines.6 However, industry insiders viewed C-TAP as a threat to the patent system for medical
products and, therefore, as a threat to future research and development (R&D). 7 Given the conflict, how should
pharmaceuticals, university medical departments, NGOs, and governments engage in this global effort?
THE GLOBAL PANDEMIC
On December 30, 2019, the Wuhan Municipal Health Commission issued an urgent notice to health care
institutions under its jurisdiction, advising them of cases of pneumonia from unknown causes. The notice
eceived immediate attention on the Internet and from the WHO China Country Office. Medical experts
initially linked the new disease to viral pneumonia due to the disease symptoms, which included fever, dry
cough, shortness of
eath, and, in some cases, invasive lesions in both lungs. Further investigations found
that all infected patients had visited or had been in contact with someone who had visited the Huanan
Seafood Market in Wuhan, a city of 11 million people and the capital of Hubei Province in central China.8
In the early phase of the disease, Hubei authorities downplayed the threat.9 Based on information provided by
local investigators, the WHO reported on January 5, 2020, that it had no evidence of human-to-human
transmission.10 The disease spread, and on January 20, the Chinese authorities changed their position. Central
government authorities took control and announced a far-reaching lockdown of the city of Wuhan, commencing
on January 23rd, with mobility restrictions that confined many people to their residential compounds.11
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WHO withdrew its earlier statement and pointed to rising infections among health care workers as evidence
of human-to-human transmission. Health authorities in Thailand, Japan, South Korea, and the United States
flagged cases of people infected with the virus a
iving from Wuhan. In Fe
uary, Italy reported a major
out
eak, which soon spread to neighbouring countries.12 Within a month, COVID-19 had spread globally
to 18 countries, with 7,818 recorded cases (see Exhibit 1).
The virus swept through the world at an unprecedented pace. Confirmed cases reached 1 million on April
3rd and continued to increase exponentially, with an additional million cases every two weeks (see Exhibit
2). By July 31st, there were 17.3 million cases worldwide. The United States, Brazil, and India were the
hardest-hit countries, reporting more than half of all confirmed cases. The case fatality rate (CFR)—the
proportion of deaths among confirmed cases—was far in excess of other common diseases; early estimates
y WHO suggested a CFR of 3.4 per cent. However, CFR varied across patient demographics, with the
elderly and those with underlying health conditions most at risk.13
Despite warnings from WHO about the severity of the novel coronavirus, initial reactions were mixed.
Some governments, notably those in Asia Pacific, quickly implemented far-reaching lockdowns, while
others followed a more relaxed approach (see Exhibit 3). Locations with low levels of testing, absence of
contact tracing, or mistrust in the government experienced larger and more sustained surges of infection.14
The rapid spread of the out
eak prompted WHO to declare a global pandemic on March 11, XXXXXXXXXX
The pandemic and the lockdowns had a major impact on the economy. Domestically, many businesses
moved to home-based operations, while other businesses, especially those in the hospitality industry, were
forced to close. Internationally, restrictions on travel inhibited international trade and services such as
tourism and education. In June, the World Bank forecasted the deepest global recession since the Second
World War: a contraction of 5.2 per cent in global gross domestic product in 2020, with deeper recessions
in Europe and the Americas (see Exhibit 4). Lower consumption, unemployment, erosion of human capital,
and fragmentation of supply chains were feared to have a long-term impact on the global economy.16
THE QUEST FOR A VACCINE
To combat the public health and economic consequences of the pandemic, the development of vaccines became
a high priority. Pharmaceutical companies and governments around the world joined efforts to develop COVID-
19 vaccines. However, scientists warned against premature release of a new vaccine before the vaccine’s safety
and efficacy had been documented because even rumours of side effects could cause distrust in vaccines.17
The established process for developing new medications involved five stages: discovery research, preclinical tests,
three clinical trial phases, regulatory review and approval, and manufacturing and distribution (see Exhibit 5). In
phase 1 of the three-stage clinical trial process, the safety of the vaccine was assessed on a small number of healthy
volunteers. Phase 2 studied the efficacy of the vaccine on several hundred patients and normally lasted two to three
years. Phase 3 involved thousands of patients and aimed to provide pharmaceutical companies with large-scale
statistical data on the drug’s effectiveness as well as its possible side effects. The data generated in phase 3 would
e presented to the United States Food and Drug Administration (FDA) and its counterparts in other countries to
obtain approval for marketing the drug. Phase 3 trials could take two to four years, depending on the availability of
a suitable patient pool. Altogether, a vaccine development process could take more than 10 years. 18
The urgency of the COVID-19 pandemic, however, did not leave much time for research. Over a period of eight
months (January to August 2021), scientists advanced 36 vaccines to the clinical trials stage, and at least 90
preclinical vaccines were under investigation on animals. Of those vaccines in clinical trials, 23 were in phase
1, 14 were in phase 2, eight were in phase 3, and three had been approved for limited use by August 31st. Most
of these research projects involved international partnerships, especially for the clinical trials.19 Only through
international collaboration could a large and diverse population of patients be found in a short time.
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The eight vaccine candidates leading the race were using three main pharmaceutical platforms: non-
eplicating viral vector, inactivated virus, and ribonucleic acid (RNA) (see Exhibit 6).20 The non-replicating
viral vector platform leveraged research on related coronaviruses such as severe acute respiratory syndrome
(SARS) and Middle East respiratory syndrome (MERS). Of the three non-replicating viral vector candidates
in phase 3, the vaccine developed by the University of Oxford and AstraZeneca plc was regarded as the
most promising. The public–private partnership (PPP) had managed to secure US$1.2 billion21 in funding
from the United States, $85.5 million from the UK government, and $396 million from the European
Commission—all in exchange for supplying early doses.22
The inactivated virus platform was led by Chinese enterprises. Sinovac Biotech Ltd. (Sinovac), a Chinese
iotechnology firm, had made the most notable progress and was successful in acquiring international funding,
including $16 million