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5/2/2020 COVID-19 vaccine - Wikipedia

COVID-19 vaccine
A COVID-19 vaccine is a hypothetical vaccine against coronavirus disease 2019 (COVID‑19). Although no vaccine
has completed clinical trials, there are multiple attempts in progress to develop such a vaccine. In late February
2020, the World Health Organization (WHO) said it did not expect a vaccine against severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), the causative virus, to become available in less than 18 months.[1] The
Coalition for Epidemic Preparedness Innovations (CEPI) – which is organizing a US$2 billion worldwide fund for
rapid investment and development of vaccine candidates[2] – indicated in April that a vaccine may be available under
emergency use protocols in less than 12 months or by early 2021.[3]

In April 2020, 115 vaccine candidates were in development,[3][4] with five having been initiated in Phase I-II safety
and efficacy studies in human subjects, and six in Phase I trials.

Contents
2020 projects
Technology platforms
Vaccine candidates
Clinical trials started in 2020
Preclinical research
Non-specific vaccine
Potential limitations
Controversy of proposed "challenge" studies
Legal status
History
Misinformation
See also
References
External links

2020 projects
COVID-19 was identified in December 2019.[5] A major outbreak spread around the world in 2020, leading to
considerable investment and research activity to develop a vaccine.[5][6] Many organizations are using published
genomes to develop possible vaccines against SARS-CoV-2.[5][7][8][9] In the United States, the Food and Drug
Administration announced its intent "to use all of the regulatory flexibility granted to it by Congress to ensure the
most efficient and timely development of vaccines to fight COVID‑19."[10]

Some 100 organizations or companies are involved in vaccine development.[4] The BioHealth Capital Region, which
is the 4th largest biopharma cluster in the United States,[11] has 8 companies directly contributing to COVID-19
vaccine progress.[12] Five hundred clinical studies worldwide, across all stages of development on vaccine and
therapeutic candidates for COVID‑19, were registered with the World Health Organization Clinical Trial Registry, as
of March 2020.[13]

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In early March 2020, CEPI announced a US$2 billion funding goal in a global partnership between public, private,
philanthropic, and civil society organisations to accelerate development of COVID‑19 vaccines, with commitments to
date by the governments of Denmark, Finland, Germany, Norway, and the UK.[2] In March-April, the Canadian
Government initiated a CA$1.3 billion innovation fund for vaccine research, development, and clinical trials through
2022.[14]

Stated in April, imperatives of the CEPI initiative for vaccine development are speed, manufacturing capacity,
deployment at scale, and global access.[3]

Technology platforms

In April, CEPI scientists reported that 10 different technology platforms were under research and development
during early 2020 to create an effective vaccine against COVID‑19.[3] Major platform targets advanced into Phase I
safety studies include:

nucleic acid (DNA and RNA) (Phase I developer and vaccine candidate: Moderna, mRNA-1273)
viral vector (Phase I developer and vaccine candidate: CanSino Biologics, adenovirus type 5 vector)
virus-like particle involved in DNA replication (Phase I developer and vaccine candidate: Shenzhen Geno-
Immune Medical Institute, LV-SMENP)

According to CEPI, the platforms based on DNA or messenger RNA offer considerable promise to alter COVID‑19
antigen functions for strong immune responses, and can be rapidly assessed, refined for long-term stability, and
prepared for large-scale production capacity.[3] Other platforms being developed in 2020 focus on peptides,
recombinant proteins, live attenuated viruses, and inactivated viruses.[3]

In general, the vaccine technologies being developed for COVID‑19 are not like vaccines already in use to prevent
influenza, but rather are using "next-generation" strategies for precision on the COVID‑19 infection mechanisms,
while hastening development for eventually preventing infection with a new vaccine.[3] Vaccine platforms in
development are also designed to address mechanisms for infection susceptibility to COVID‑19 in specific population
subgroups, such as the elderly, children, pregnant women, or people with existing weakened immune systems.[3]

CEPI classifies development stages for vaccines as either "exploratory" (planning and designing a candidate, with no
evaluation in vivo yet), "preclinical" (in vivo evaluation with preparation for manufacturing a compound to test in
humans), or initiation of Phase I safety studies in healthy people.[3]

Vaccine candidates
As reported by CEPI scientists in April, some 115 total vaccine candidates are in early stages of development as either
confirmed active projects or in "exploratory" or "preclinical" development.[3]

Phase I trials test primarily for safety and preliminary dosing in a few dozen healthy subjects, while Phase II trials –
following success in Phase I – evaluate immunogenicity, dose levels (efficacy based on biomarkers) and adverse
effects of the candidate vaccine, typically in hundreds of people.[15][16] A Phase I-II trial conducts preliminary safety
and immunogenicity testing, is typically randomized, placebo-controlled, and at multiple sites, while determining
more precise, effective doses.[16] Phase III trials typically involve more participants, including a control group, and
test effectiveness of the vaccine to prevent the disease, while monitoring for adverse effects at the optimal dose.[15][16]

Clinical trials started in 2020

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COVID‑19: candidate vaccines in Phase I-II trials

Vaccine candidate Phase of trial References


Technology Location Duration
(developer/sponsor) (participants) and notes

Ad5-nCoV

(CanSino Biologics, March


Institute of recombinant Phase II interventional trial
2020 to [17][18]
adenovirus for dosing and side effects China
Biotechnology of the type 5 vector (500)
December
Academy of Military 2020
Medical Sciences)

Ad5-nCoV

(CanSino Biologics, March


Institute of recombinant [3][19] continuing through 2020
2020 to
adenovirus Phase I (108) China
Biotechnology of the type 5 vector
December during Phase II start[17]
Academy of Military 2020
Medical Sciences)

ChAdOx1 nCoV-19
Phase I-II, randomized, April 2020
adenovirus [20][21]
placebo-controlled, United Kingdom to May
(University of Oxford) vector
multiple sites (510) 2021

BNT162 (a1, b1, b2, c2)


Phase I-II of four vaccines, April 2020
(BioNTech, Fosun RNA dose escalation, parallel Germany to May [22][23]

Pharma, Pfizer) cohorts (196) 2021

unnamed Phase I-II randomized, April 2020


inactivated
double-blinded, single- to [24]
SARS-CoV-2 China
(Sinovac Biotech) virus
center, placebo-controlled December
(744) 2020

INO-4800

(Inovio
Pharmaceuticals, April 2020
DNA plasmid South Korean Phase I-II in
United States, to
CEPI, Korea National delivered by Phase I-II (40) parallel with Phase I in the
South Korea November
Institute of Health, electroporation US[25][26]
2020
International Vaccine
Institute)

mRNA-1273
lipid
March
(Moderna, US nanoparticle
2020 to
dispersion
National Institute of Phase I (45) United States Spring- [3][27][28]
containing
Allergy and Infectious Summer
messenger
2021
Diseases) RNA

lentiviral
Covid-19/aAPC
vector,
pathogen-
(Shenzhen Geno- March
specific [3][29]
Phase I (100) China 2020 to
Immune Medical artificial
2023
Institute) antigen
presenting
dendritic cells
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LV-SMENP-DC
lentiviral
minigene
(Shenzhen Geno- March
vaccine, [3][30]
Phase I (100) China 2020 to
Immune Medical dendritic cells
2023
Institute) modified with
lentiviral vector

bacTRL-Spike

(Symvivo Corporation, April 2020


DNA, bacterial to
University of British Phase I (84) Canada [31]
medium (oral) December
Columbia, Dalhousie 2021
University)

unnamed

(Beijing Institute of inactivated April 2020 has Phase II design registered


COVID-19 to for > 1000 participants,
Biological Products, virus (vero
Phase I (288) China
November including children, not yet
Wuhan Institute of cells) 2021 recruiting[32][33]
Biological Products)

Preclinical research

In April, the WHO issued a statement representing dozens of vaccine scientists around the world, pledging
collaboration to speed development of a vaccine against COVID‑19.[35] The WHO coalition is encouraging
international cooperation between organizations developing vaccine candidates, national regulatory and policy
agencies, financial contributors, public health associations, and governments for eventual manufacturing of a
successful vaccine in quantities sufficient to supply all affected regions, particularly low-resource countries.[3]
Industry analysis of vaccine development historically shows failure rates of 84-90%.[3][36]

Because COVID‑19 is a novel virus target with properties still being discovered and requiring innovative vaccine
technologies and development strategies, the risks associated with developing a successful vaccine across all steps of
preclinical and clinical research are high.[3] To assess potential for vaccine efficacy, unprecedented computer
simulations and new COVID‑19-specific animal models are being developed, but these methods remain untested by
unknown characteristics of the COVID‑19 virus, and are being organized multinationally during 2020.[3] Of the
confirmed active vaccine candidates, about 70% are being developed by private companies, with the remaining
projects under development by academic, government coalitions, and health organizations.[3] Most of the vaccine
developers are small firms or university research teams with little experience in successful vaccine design and limited
capacity for advanced clinical trial costs and manufacturing without partnership by multinational pharmaceutical
companies.[3] The general geographic distribution of COVID‑19 vaccine development involves organizations in the
United States and Canada, together having about 46% of the world's active vaccine research, compared with 36% in
Asian countries, including China, and 18% in Europe.[3]

In early April, CEPI scientists stated that 115 vaccine candidates were in development as either
"exploratory/preclinical" projects or in Phase I safety trials in human participants.[3] The table derives from tracking
public sources for progress on emerging vaccine candidates scheduled for Phase I trial starts in 2020.[4]

Scheduled Phase I trials in 2020

Many vaccine candidates under design or preclinical development for COVID‑19 in 2020, will not gain approval for
human studies due to toxicity, ineffectiveness to induce immune responses or dosing failures in laboratory animals,
or because of underfunding.[37][38] The probability of success for an infectious disease vaccine candidate to pass
preclinical barriers and reach Phase I of human testing is 41-57%.[37]

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Commitment to first-in-human testing of a vaccine candidate COVID-19: candidate vaccines scheduled for Phase I
represents a substantial capital cost for vaccine developers, trials in 2020
Sources:[4][34]
estimated to be about US$14 to US$25 million for a typical
Phase I trial program, but possibly as much as US$70 Vaccine candidate
million.[37][39] For comparison, during the Ebola virus Technology
Start date
epidemic of 2013-16, there were 37 vaccine candidates in urgent (developer) announced
development, but only one eventually succeeded as a licensed
vaccine, involving a total cost to confirm efficacy in Phase II-III NVX-CoV2373
protein
trials of about US$1 billion.[37] subunit, May
(Novavax) nanoparticles

Non-specific vaccine DPX-COVID-19

Some vaccines have heterologous effects, also called non- (IMV, Inc., protein
subunit, lipid-
specific effects. That means they can have benefits beyond the Canadian mid-2020
based
disease they prevent.[40] The anti-tuberculosis vaccine, BCG Immunization delivery
vaccine, is an example that is being tested to determine if it has Research Network)
a protective effect against COVID‑19, pursuant to assertions
that COVID‑19 mortality was lower in countries having routine PittCoVacc
BCG vaccine administration.[41] protein
subunit,
(University of mid-2020
microneedle
In March 2020, a randomized trial of BCG vaccine to reduce Pittsburgh) arrays
COVID‑19 illness began in the Netherlands, seeking to recruit
1,000 healthcare workers.[42] A further randomized trial in unnamed
Australia is seeking to enrol 4,170 healthcare workers.[43][44] A protein
further 700 healthcare workers from Boston and Houston will (University of subunit, S mid-2020
be recruited in another trial,[45] and 900 healthcare workers in Cambridge) protein
Egypt in a trial registered by a university in Cairo.[46] An
additional trial in the Netherlands is testing whether BCG unnamed
vaccine provides protection for older people, recruiting 1,000
people over 65 years and 600 younger adults.[47] A trial of BCG (Imperial College RNA; saRNA mid-2020
in 1,000 healthcare workers in Medellín, Colombia was London)
registered on 24 April 2020.[48] According to the World Health
Organization (WHO) there is no evidence that the Bacille CureVac
Calmette-Guérin vaccine (BCG) protects people against
RNA, mRNA mid-2020
infection with COVID-19 virus.[49] (CEPI)

A randomized placebo-controlled trial to test whether measles- LUNAR-COV19


mumps-rubella (MMR) vaccine can protect healthcare workers
from COVID-19 was scheduled to begin in May 2020, in Cairo, (Arcturus
with the goal of recruiting 200 participants.[50] Therapeutics,
RNA, mRNA mid-2020
Duke University-
National University of
Potential limitations Singapore)
It is possible vaccines in development will not be safe or
unnamed
effective.[51] One study found that between 2006 and 2015, the
protein
success rate of obtaining approval from Phase I to successful (Sanofi Pasteur, subunit, S mid-2020
Phase III trials was 16.2% for vaccines,[36] and CEPI indicates a GlaxoSmithKline) protein
potential success rate of only 10% for vaccine candidates in
2020 development.[3]
unnamed
The rapid development and urgency of producing a vaccine for
(Cobra Biologics, DNA plasmid mid-2020
the COVID‑19 pandemic may increase the risks and failure rate
Karolinska Institute)
of delivering a safe, effective vaccine.[3] Early research to assess
vaccine efficacy using COVID‑19-specific animal models, such
as ACE2-transgenic mice, other laboratory animals, and non- unnamed synthetic mid-2020
viral peptides

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human primates, indicate a need for biosafety-level 3 (Generex Biotech) combined


with Ii-key
containment measures for handling live viruses, and
immune
international coordination to ensure standardized safety activation
procedures.[3] An April 2020 CEPI report stated: "strong
unnamed fragments of
international coordination and cooperation between vaccine
the SARS-
developers, regulators, policymakers, funders, public health mid-2020
(Clover Biopharm) CoV-2 spike
bodies and governments will be needed to ensure that protein
promising late-stage vaccine candidates can be manufactured in
unnamed
sufficient quantities and equitably supplied to all affected areas, plant-derived
July–
particularly low-resource regions."[3] (Medicago, Inc.)
virus-like
August
particle
While the flu vaccine is typically mass-produced by injecting
the virus into the eggs of chickens, this method will not work for unnamed
the COVID‑19 vaccine, as the SARS-CoV-2 virus cannot non-
(Janssen; Beth Israel
replicate inside eggs.[52] replicating September
Deaconess Medical viral vector
Center)
Controversy of proposed
"challenge" studies unnamed

(SK Biosciences,
During the global emergency of the COVID‑19 pandemic, Government of COVID-19
strategies are under consideration to fast-track the timeline for Saskatchewan; antigen September
licensing a vaccine against COVID‑19, especially by Korea Centers for subunits
compressing (to a few months) the usually lengthy duration of Disease Control and
Phase II-III trials (typically, many years).[53][54][55] Following Prevention)
preliminary proof of safety and efficacy of a candidate vaccine
in laboratory animals and healthy humans, controlled CoroFlu
"challenge" studies may be implemented to bypass typical
Phase III research, providing an accelerated path to license a (University of self-limiting
vaccine for widespread prevention against COVID‑19.[53][56] Wisconsin-Madison; influenza late 2020
Challenge studies have been implemented previously for FluGen; Bharat virus
diseases less deadly than COVID‑19 infection, such as common Biotech)
influenza, typhoid fever, cholera, and malaria.[54]
unnamed
The design of a challenge study involves first, simultaneously
testing a vaccine candidate for immunogenicity and safety in (Takis; Applied DNA DNA late 2020
laboratory animals and healthy adult volunteers (100 or fewer) Sciences; Evvivax)
– which is usually a sequential process using animals first – and
second, rapidly advancing its effective dose into a large-scale
AdCOVID
Phase II-III trial in previously-uninfected, low-risk volunteers
(such as young adults), who would then be deliberately infected non-
(Altimmune; replicating
with COVID‑19 for comparison with a placebo control late 2020
University of Alabama viral vector;
group.[53][54][56] Following the challenge, the volunteers would at Birmingham) intranasal
be monitored closely in clinics with life-saving resources, if
needed.[53][54] Volunteering for a vaccine challenge study
unnamed
during the COVID‑19 pandemic is likened to the emergency non-
service of healthcare personnel for COVID‑19-infected people, (Vaxart; Emergent replicating
late 2020
viral vector;
firefighters, or organ donors.[53] BioSolutions) oral

Although challenge studies are ethically questionable due to the


unknown hazards for the volunteers of possible COVID‑19 unnamed
disease enhancement and whether the vaccine received has
(VBI Vaccines; pan-
long-term safety (among other cautions), challenge studies may by year-end
National Research coronavirus
be the only option available as the COVID‑19 pandemic
Council of Canada)
worsens, according to some infectious disease
experts,[53][54][56] to rapidly produce an effective vaccine that
will minimize the projected millions of deaths worldwide from COVID‑19 infection.[53][57]
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Legal status
On February 4, 2020, U.S. Secretary of Health and Human Services Alex Azar published a notice of declaration under
the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID‑19, covering
"any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID‑19, or the transmission of SARS-CoV-2 or a
virus mutating therefrom", and stating that the declaration precludes "liability claims alleging negligence by a
manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent
willful misconduct".[58] The declaration is effective in the United States through October 1, 2024.

History
Vaccines have been produced against several diseases caused by coronaviruses for animal use, including for
infectious bronchitis virus in birds, canine coronavirus and feline coronavirus.[59]

Previous projects to develop vaccines for viruses in the family Coronaviridae that affect humans have been aimed at
severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Vaccines against SARS[60]
and MERS[61] have been tested in non-human animal models. As of 2020, there is no cure or protective vaccine for
SARS that has been shown to be both safe and effective in humans.[62][63] According to research papers published in
2005 and 2006, the identification and development of novel vaccines and medicines to treat SARS was a priority for
governments and public health agencies around the world.[64][65][66]

There is also no proven vaccine against MERS.[67] When MERS became prevalent, it was believed that existing SARS
research may provide a useful template for developing vaccines and therapeutics against a MERS-CoV
infection.[62][68] As of March 2020, there was one (DNA based) MERS vaccine which completed phase I clinical trials
in humans,[69] and three others in progress, all of which are viral-vectored vaccines, two adenoviral-vectored
(ChAdOx1-MERS, BVRS-GamVac), and one MVA-vectored (MVA-MERS-S).[70]

Misinformation
Social media posts have promoted a conspiracy theory claiming the virus behind COVID‑19 was known and that a
vaccine was already available. The patents cited by various social media posts reference existing patents for genetic
sequences and vaccines for other strains of coronavirus such as the SARS coronavirus.[71][72]

See also
2019–20 coronavirus pandemic
Coronavirus disease 2019
Severe acute respiratory syndrome coronavirus 2
2009 swine flu pandemic vaccine
Respiratory disease
COVID-19 drug development
Phases of clinical research

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External links
"COVID-19 Vaccine Tracker" (https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-trac
ker). Regulatory Focus.
Draft landscape of COVID 19 candidate vaccines from WHO (https://www.who.int/who-documents-detail/draft-lan
dscape-of-covid-19-candidate-vaccines)

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