Report on Global Introduction and Implementation9 john hopkin)
https://www.jhsph.edu/ivac/wp-content/uploads/2020/03/VIEW-hub_Report_Mar2020.pdf
covid vaccine development pipeline- https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/
———————————————————————————————
Fighting the pandemic – vaccine trail stages.
https://www.av.co/covid
——————————————————————————————————-
——————————————————————————————————
milken institude https://milkeninstitute.org/covid-19-trackerhttps:
——————————————————————————————————-
—————————————————————————————————
————–IS OVER DEPANDENCE ON VACCINE_By Dennis Thompson
HealthDay Reporter
MONDAY, April 6, 2020 (HealthDay News) — Public health officials have been warning that a COVID-19
vaccine will not be available to the public for 12 to 18 months, dampening hopes that there will be a
quick end to the global pandemic nightmare.
But Chinese researchers cracked the virus’ genetic code within weeks of its emergence late last year,
and two vaccine candidates are already in early human trials — one in China and the other in the
United States.
What’s the hold up?Essentially, you can speed up the vaccine development process to respond to a
pandemic, but you don’t want to speed it up so much that you allow a bad vaccine to enter the market,
explained Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group.
“The process of developing, testing and licensing a vaccine for widespread population use is designed
to be slow, deliberative, peer-reviewed, reflective, evidence-based, so that we don’t make mistakes,”
Poland said.Going too fast could lead to a vaccine that’s not effective or, worse, can cause serious
health problems, Poland said.Typically, clinical trials take 10 to 15 years and a billion dollars to
complete, Poland said.Vaccine trials come in three phases, said Dr. Wilbur Chen, an adult infectious
disease expert at theUniversity of Maryland’s Center for Vaccine Development and Global Health:
Phase I trials test whether the vaccine is safe, and usually last about six months.
Phase II trials examine how well the vaccine works in creating an immune response within volunteers,
and last up to a year.
Phase III trials track the effectiveness of the vaccine in preventing infection in people who are being
exposed to the pathogen. This phase could take three years or more, and depends on the virus remaining
active long enough for participants to be exposed to it.
The U.S. vaccine candidate now in clinical trials was developed at record speed by scientists at the
U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the biotech company Moderna.
“This was very dramatic that we were able to have the first COVID-19 vaccine into clinical trials
within just a couple of months,” Chen noted.
Researchers combined the virus’ genetic code with existing processes to create the vaccine candidate,
said Dr. Kathleen Neuzil, director of the University of Maryland’s Center for Vaccine Development and
Global Health, in Baltimore.
“The reason we were able to get into trials so quickly is because this vaccine was modeled on other
vaccines for influenza and Zika, using the same manufacturing process and the same technology, but just
substituting the genetic code for this SARS-COV2 virus,” Neuzil said.
This trial has enlisted 45 healthy adults in Seattle, who are being tracked for about six weeks.
The COVID-19 virus infects lung cells using “spike” proteins that line the outside of the virus. These
spikes bump into receptors on the lung cells, tricking the cells into letting the virus enter and
infect them.
The NIAID/Moderna vaccine aims to teach the immune system to recognize these spike proteins and destroy
the virus.
The U.S. Food and Drug Administration has indicated that it is willing to speed up the regulatory
process by allowing clinical trial phases to be combined.
For example, phase I and II trials could be combined by tracking both safety and immune response. Phase
II trial participants could be followed into phase III, and tracked to see if the vaccine prevents
community infection.
“We know we are in the middle of a pandemic right now, so we are very carefully following safety, but
we really can’t forget we’re now at about the million mark for people infected with COVID-19,” Neuzil
said.
But Poland warned there are potential pitfalls that need to be considered in rushing a vaccine to
market.
For example, the vaccine might not provide lasting immunity, either because people’s immunity wanes
quickly or because the virus mutates to get around it.
There already are concerns regarding the ability of people to remain immune to coronaviruses. People
typically lose their immunity to coronavirus strains that cause the common cold within a year, Chen
said.
Poland also is concerned about the focus of the NIAID/Moderna vaccine and other similar candidates on
the “spike” or “S” protein alone.
“That’s one area where there’s been at least one identified mutation,” Poland said of the coronavirus
spike protein. “You put a mutational pressure on an RNA virus and, no surprise, the virus mutates and
changes.”
By comparison, flu vaccines include antigens related to two separate proteins on the influenza virus,
to limit the virus’ ability to mutate away from a person’s established immunity, Poland explained.
Another concern is the potential for unintended safety consequences related to the vaccine.
“Something rushed out too fast that would have some significant side effect later would set back
vaccine acceptance in an already vaccine-skeptical culture for decades,” Poland said.
Neuzil noted that “when we have seen safety signals with vaccines, they ordinarily occur soon after you
give the vaccine.”
However, vaccine candidates earlier developed for the coronaviruses behind SARS (severe acute
respiratory syndrome) and MERS (Middle East respiratory syndrome) have raised concerns about creating
lung disease on their own, according to a recent editorial in the New England Journal of Medicine.
The SARS vaccine candidates tended to cause “antibody-enhanced disease” in animal testing, a condition
in which a creature that’s received a vaccine not only gets infected by the target virus but also
suffers worse symptoms than if they’d never been inoculated, Poland explained.
“It protected them from the virus, at the cost of antibody-enhanced disease. These animals developed an
unusual immunopathological picture in their lungs and livers. The vaccines never progressed past that,”
Poland said.
Similar antibody-enhanced disease reactions also occurred in the 1960s with an inactivated measles
vaccine and in 2018 with a vaccine for dengue, Poland said.
Poland foresees a potential future in which a COVID-19 vaccine is rushed out but proves ineffective in
preventing infection, possibly because the virus has mutated around the vaccine. “A second strain
develops next year that, when it infects people who have been immunized, they are not protected because
of the false immunity they have or develop antibody-enhanced disease,” he said.
There are as many as 40 vaccine candidates for COVID-19 in various stages of development, Poland said.
A second U.S. company, Inovio Pharmaceuticals, announced Monday that it is beginning phase I clinical
trials in 40 healthy volunteers in Philadelphia and Kansas City, Mo. This vaccine uses a section of the
virus’ genetic code packaged inside a piece of synthetic DNA.
Having many vaccine candidates will help in the process of speeding a successful vaccine to the public,
Neuzil said.
“You can’t count on a single vaccine,” Neuzil said. “We want a lot of shots on goal right now, hoping
that we’ll score with at least one of these.”
——————————————————————————————————-
———————————————————————————————–
,– CORONA VACCINE PIPE LINE
In the recent weeks, vaccine development for COVID-19 has accelerated with more vaccines are moving
into human trials. With innovation moving at breakneck speed, it is imperative to stay abreast with the
latest ongoings.
To help you make informed business decisions, we would like to share some insights from our recently
released Global Coronavirus Vaccines Pipeline report below. You may download the preview from our
website here!
THE AMERICAS
Protein subunit is the main type of vaccine in development for nearly 50% America-based organizations.
USA holds 37.5% of entities involved in COVID-19 vaccine R&D while 14.6% are from China.
Novavax is the only US biopharma that worked on vaccines for all 3 Coronaviruses: MERS, SARS and COVID-
19.
EMEA
Twice the number of companies developing COVID-19 vaccines compared to MERS & SARS.
In the Nordic region, Denmark has the most biopharmas working on vaccine R&D for COVID-19.
IDT Biologika GmBH is 1st EMEA company to enter Phase 1 for its MERS vaccine candidate, advanced by the
German Center of Infection Research (DZIF).
APAC
RNACure is the only Chinese biopharma with 2 COVID-19 vaccine candidates (out of 44 worldwide) under
pre-clinical stage approved by WHO.
Non-replicating viral vector based coronavirus vaccines are the most common in China.
Around 50% of clinical trials are being conducted in China.
Leading COVID-19 vaccine R&D in India are Bharat Biotech, Serum Institute of India & Zydus Cadila.
I believe this report will give you insights that will help you make informed decisions on your next
steps. So, get your copy of our full report and leverage our pre-order promotion to SAVEAjay, if you
would like to discuss matters pertaining to the report, feel free to drop me a note at ..————–
—————————————————————————————————
——————————————-
——————————————————————————————————-
———————————————————————————————-
5 — According to the World Health Organization, almost 70 coronavirus vaccines are in development
worldwide. Three candidates been already tested in human trials, as drug makers battle to find a remedy
for this novel deadly virus.
The farthest vaccine is in the clinical process and is an experimental vaccine that is developed by
Hong Kong-listed CanSino Biologics Inc. and the Beijing Institute of Biotechnology. It is in phase 2
stage. The other two are being tested in humans and are developed separately by U.S. drugmakers Moderna
Inc. and Inovio Pharmaceuticals Inc., as per a WHO document.
Progress is happening at exceptional speed in developing vaccines as the infectious pathogen cannot be
stamped out only through containment measures. The drug industry is expecting to shorten the time it
usually takes to get a vaccine in the market i.e. about 10 – 15 years to within the next year.
All big and small drug makers are trying to develop a vaccine, which could be the most effective way to
hold the virus. According to the WHO document, pharmaceutical giants like Pfizer Inc. and Sanofi
already have vaccine candidates in the preclinical stages.
Last month CanSino said that it received Chinese regulatory approval to commence human trials of its
vaccine. Cambridge, Massachusetts-based Moderna, also received regulatory approval to move towards
quickly to human trials. They have been asked to skip the years of animal trials, which are the
standard norm in developing vaccines. Last week, Inovio had begun its human trials.
——————————————————————————————————-
———————————————————————————————-
——————————————————————————————————
8–Genomics in corona viruse- help in vaccineGenomics (Part 12)
What is known?
There have been no documented cases of SARS-CoV-2 prior to December 2019.
Preliminary genomic analyses indicate that the first human cases of SARS-CoV-2 appeared between
10/19/2019 and 12/17/2019.1-3
The mutation rate of SARS-CoV-2 is estimated to be similar to that of other RNA viruses (such as SARS,
Ebola, Zika), and is currently estimated as 1.04×10-3substitutions per site per year (N = 116
genomes).4
Preliminary phylogenetic analysis identified a very close genetic similarity between SARS-CoV-2 and a
Bat coronavirus (RaTG13) that was isolated from Yunnan Province, China. It has suggested that SARS-
CoV-2 originated from bats.5
Pangolin coronaviruses are also closely related to both SARS-CoV-2 and the closely related Bat
coronavirus (RaTG13). Phylogenetic analysis revealed that SARS-CoV-2 is of bat origin, but is closely
related to pangolin coronavirus.6,7
The Spike protein of SARS-CoV-2, known to mediate entry into host cells, and the major determinant of
host range, is very similar to the Spike protein of SARS-CoV.8 The rest of the genome is more closely
related to two separate bat8and pangolin7 coronavirus.
Analysis of SARS-CoV-2 sequences from Singapore identified a large nucleotide (382 bp) deletion in
ORF-8 that may give rise to an attenuated (less virulent) phenotype.9
What do we need to know?
Are there similar genomic differences in the progression of coronavirus strains from bat to
intermediate species to human?
Are there different strains or clades of circulating virus? If yes, do they differ in virulence?
References
Anderson, K., Estimates of the clock and TMRCA for 2019-nCoV based on 27 genomes.
http://virological.org/t/clock-and-tmrca-based-on-27-genomes/347(accessed 01/26/2020).
Bedford, T.; Neher, R., Genomic epidemiology of novel coronavirus (nCoV) using data from GISAID.
https://nextstrain.org/ncov.
Rambaut, A., Phylodynamic analysis of nCoV-2019 genomes – 27-Jan-2020.
http://virological.org/t/phylodynamic-analysis-of-ncov-2019-genomes-27-jan-2020/353.
Hill, V.; Rambaut, A., Phylodynamic analysis of SARS-CoV-2 | Update 2020-03-06. Virological: 2020.
Paraskevis, D.; Kostaki, E. G.; Magiorkinis, G.; Panayiotakopoulos, G.; Sourvinos, G.; Tsiodras, S.,
Full-genome evolutionary analysis of the novel corona virus (2019-nCoV) rejects the hypothesis of
emergence as a result of a recent recombination event. Infect Genet Evol 2020, 79, 104212.
Liu, P.; Chen, W.; Chen, J.-P., Viral Metagenomics Revealed Sendai Virus and Coronavirus Infection of
Malayan Pangolins (Manis javanica). Viruses 2019, 11 (11), 979.
Liu, P.; Jiang, J.-Z.; Wan, X.-F.; Hua, Y.; Wang, X.; Hou, F.; Chen, J.; Zou, J.; Chen, J., Are
pangolins the intermediate host of the 2019 novel coronavirus (2019-nCoV) ? bioRxiv 2020,
2020.02.18.954628.
Lu, R.; Zhao, X.; Li, J.; Niu, P.; Yang, B.; Wu, H.; Wang, W.; Song, H.; Huang, B.; Zhu, N.; Bi, Y.;
Ma, X.; Zhan, F.; Wang, L.; Hu, T.; Zhou, H.; Hu, Z.; Zhou, W.; Zhao, L.; Chen, J.; Meng, Y.; Wang,
J.; Lin, Y.; Yuan, J.; Xie, Z.; Ma, J.; Liu, W. J.; Wang, D.; Xu, W.; Holmes, E. C.; Gao, G. F.; Wu,
G.; Chen, W.; Shi, W.; Tan, W., Genomic characterisation and epidemiology of 2019 novel coronavirus:
implications for virus origins and receptor binding. The Lancet 2020.
Su, Y. C.; Anderson, D. E.; Young, B. E.; Zhu, F.; Linster, M.; Kalimuddin, S.; Low, J. G.; Yan, Z.;
Jayakumar, J.; Sun, L.; Yan, G. Z.; Mendenhall, I. H.; Leo, Y.-S.; Lye, D. C.; Wang, L.-F.; Smith, G.
J., Discovery of a 382-nt deletion during the early evolution of SARS-CoV-2. bioRxiv 2020,
2020.03.11.987222