Last updated on September 9th, 2020 at 10:52 am
Because of the ongoing COVID-19 pandemic, the interest in coronavirus vaccines has been quite high (to say the least). I have been keeping an updated list of vaccine candidates in another article, but it was becoming so cumbersome to update, and I wanted to make information clearer to read, I decided to completely rewrite it.
This article about coronavirus vaccines will also be regularly updated, so stay tuned.
All about COVID-19
Coronaviruses (there are seven that infect humans) are species of virus belonging to the subfamilyCoronavirinae in the family Coronaviridae, in the order Nidovirales. They are an RNA virus that contains around 26-32 thousand nucleobases each.
One of the myths about coronaviruses, stated by Donald Trump and many others, is that it’s related to the flu. No, the influenza viruses aren’t even closely related to coronaviruses – they’re actually in two separate phyla, meaning that they are as closely related to one another as a human is to a lobster. In other words, they aren’t closely related.
This 2019 coronavirus outbreak is known as COVID-19 and is caused by the SARS-CoV-2 virus, which is closely related to other SARS-related viruses. The virus is spread easily by small droplets from infected individuals when they breathe or cough. The time from exposure to the SARS-CoV-2 virus to onset of symptoms is generally between 2 and 14 days.
The CDC and WHO have recommended handwashing, maintaining distance from individuals who are coughing, and not touching one’s face as preventative measures. It is also recommended that individuals cover their nose and mouth with a bent elbow when coughing
The early symptoms of COVID-19 can mimic many other viral diseases – fever, cough, and shortness of breath. However, many cases progress to pneumonia and multi-organ failure. As of now, we don’t know if the disease favors particular groups. For example, smokers, individuals with chronic pulmonary disease, or seniors may be at higher risk of dangerous complications like death.
Early symptoms are often referred to as “flu-like” but that’s a general term that is used for many diseases. Again, that does mean that coronaviruses are related to influenza, just that they can share some symptoms.
As I mentioned above, severe acute respiratory syndrome (SARS) is caused by SARS-associated coronavirus (SARS-CoV), which means that the current coronavirus outbreak is related to SARS. In addition, the disease known as Middle East respiratory syndrome (MERS) is caused by the Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Coronaviruses, like the SARS-CoV-2, MERS-CoV and SARS-CoV species, infect the upper respiratory and gastrointestinal tracts of mammals and birds. Interestingly, coronaviruses may cause a substantial percentage of all common colds in humans.
The SARS coronaviruses have unique pathophysiologies because it causes more severe upper and lower respiratory tract infections.
At this point, we don’t have firm evidence for a particular non-human reservoir for the SARS-CoV-2 virus, the viruses mutation rate, or just about anything important. But we have a lot of myths.
Developing coronavirus vaccines
I wrote previously about how a COVID-19 vaccine is developed. But it bears repeating.
An average vaccine takes anywhere from 2-5 years to develop before a clinical trial can begin. With worldwide collaboration and government money, we have seen coronavirus vaccines ready for clinical trials much sooner than that.
Here are vaccine development steps in order:
- Identifying methods to induce an immune response. There have been two peer-reviewed papers recently published (here and here) that may have identified vaccine targets. Generally, better vaccines are developed to target certain glycoproteins on the virus coat which are stable, that is, don’t mutate frequently. Having this kind of early research helps vaccine scientists produce a better vaccine.
- Pre-clinical studies. This step will help scientists understand SARS-CoV-2 characteristics and pathophysiology in humans. Since it would be unethical to do these studies in actual humans, researchers need to develop an animal model that mimics a human. Also, researchers need to determine if the vaccine is safe and triggers an adaptive immune response in that animal model. For the SARS vaccine, ferrets were used, because their physiology and immune responses are similar to humans, so it might be used for a COVID-19 vaccine.
- IND application. The sponsoring organization (probably a Big Pharma company) must make an Investigational New Drug (IND) application to the FDA’s Center for Biologics Evaluation and Research (CBER) to begin clinical trials. CBER reviews the IND, which will include preclinical data, and the sponsor can proceed with the clinical trial within 30 days if the FDA does not find cause to stop it from moving forward. This is the process in the USA, but it’s much the same in most developed countries.
- Clinical trials. Then the sponsoring organization must get Institutional Review Board (IRB) approval to proceed with clinical trials (see this article for more information about the process). The clinical studies must go through three phases like all drugs, although the process could be shortened if the data is very clear and there is a public need (like the COVID-19 pandemic). These clinical trials will be posted to a US government website that tracks all clinical trials worldwide (and must be posted there before a drug can get US FDA approval). Some of the new coronavirus vaccines have entered Phase 1 clinical trials – this phase does not tell us much about the vaccine as it is given to “healthy volunteers”, and it is not randomized or blinded. It usually only includes 50-100 patients. Phase 2 and 3 trials are randomized, double-blind, placebo-controlled clinical trials, with a few hundred and few thousand patients, respectively. No drug (or vaccine) can be approved without Phase 2 and 3 studies successfully completed except in some very rare circumstances.
- Final regulatory approval. After all of the preclinical and clinical is completed, the sponsoring organization must make a Biologics License Application (BLA) to CBER. Although this process is what is done in the USA, it’s similar in most other countries (and some countries accept FDA review for their own country.
- Manufacturing plan. During this research, regulatory agencies must review manufacturing plans for the new vaccine and any pharmaceutical company that intends to produce it must develop a cost-effective and consistent method for production.
I remain convinced that a lot of people, whether they are pro-vaccine or anti-science, think that researchers grab a handful of viruses, a little water, some mercury, an aluminum Diet Coke can, and an aborted fetus, throw it in a Waring blender, put it in a vial, and then inject them into innocent children.
In reality, this process is time-consuming, as is very difficult. Although some of these steps can be speeded up by a few months, it’s not something that can be done in a few weeks, even in an emergency.
Putting the brakes on overpromising
Even though I don’t want to sound like I’m anti-vaccine (wow, that busted my irony meter), I absolutely want to see significant randomized, double-blinded, placebo-controlled clinical trials for any or all of these coronavirus vaccines.
I want to see it published in a peer-reviewed journal. I want to know that the candidate vaccine was vetted for both extraordinary safety and extraordinary effectiveness – as we’ve done for every single vaccine available to humans.
So important to get the details right here. NIH might be able to begin a very small, phase 1 trial in a few months — which is lightning fast — but a larger trial with lots of people won't be ready until at least next year. https://t.co/dLAzt4pCfZ
— Liz Szabo (@LizSzabo) March 2, 2020
Despite what you’re reading on the internet, and what Trump is saying, we are a long way from having a vaccine ready for pivotal clinical trials that will give us an indication of safety and effectiveness.
Paul Offit, MD, who is one of the leading vaccine scientists in the world, and a leading target of the anti-vaccine movement, was interviewed by the Philadelphia Inquirer recently about a potential coronavirus vaccine:
Why is it unrealistic to expect a vaccine for coronavirus in a few months?
Nobody’s ever seen this virus before. Therefore, if you’re interested in making a vaccine, you first had access to that virus only a couple months ago. That’s not long.
[To make a vaccine] you first need to make a decision as to what approach you want to take. Then you have to do extensive animal model testing to make sure that the approach that you’ve taken is safe in animals, and that it induces an immune response which would likely be protective. Then you gradually do studies in people to make sure it’s safe, and then to make sure that it induces an immune response. That takes time, a lot of time, typically years. Then and only then, are you ready to put it into people to see whether or not it works in an outbreak situation.
This cannot be stressed enough – even if everything goes right, it may be years before a vaccine is widely available. I think way too many people believe that once a drug enters clinical trials, it must work and only government regulations prevent it from getting to the market quickly. In fact, around 87% of drugs that enter Phase 1 clinical trials eventually fail to get FDA approval.
Coronavirus vaccines – list of candidates
Below, I am going to provide the complete list (as of this date) of companies or sponsoring institutions that are developing coronavirus vaccines or vaccine candidates. With each vaccine, I am going to attempt to link to the most recent information about that vaccine with some editorial commentary from me.
I am also going to add the following information:
- Vaccine candidate. Until a vaccine is approved for use, most companies use code names for the vaccine candidate.
- Status. “Discovery” means that the vaccine is still being researched, “preclinical” means that it has entered preclinical studies usually in animals, or “Phase 1, 2 or 3” means the actual phase of clinical trials.
- Clinical trial. This will give a link to the clinical trials database which tracks all clinical trials around the world for new drugs or vaccines. In general, a clinical trial needs to be listed in this database to be included in any FDA drug applications.
The coronavirus vaccines are listed in alphabetical order by name of the company or sponsoring institution. It does not imply one is better than another. Study sponsors in red mean that a clinical trial has been registered to begin
AJVaccines
Vaccine candidate: unknown
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Denmark-based AJVaccines have announced they would use modern antigen technology to develop a COVID-19 vaccine candidate. There is no further information or timeline.
Altimmune
Vaccine candidate: Intranasal COVID-19 vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Altimmune produces an intranasal influenza vaccine, NasoVAX and has announced animal testing for a COVID-19 vaccine that would be delivered intranasally in a single dose. They have also stated that they may be ready for clinical trials by August 2020.
Arcturus Therapeutics and Duke-NUS Medical School
Vaccine candidate: unknown
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
US-based Arcturus Therapeutics and Duke-NUS Medical School have announced a partnership to develop a COVID-19 vaccine that uses Arcturus’ self-replicating RNA and nanoparticle non-viral delivery system.
Baylor College of Medicine
Vaccine candidate: Re-purposed SARS vaccine for COVID-19; S1 or RBD protein vaccine candidate
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Dr. Peter Hotez, a Baylor College of Medicine faculty member and one of the leading vaccine scientists in the USA, lead a team that was close to developing a SARS vaccine, which might have been useful for this pandemic. Unfortunately, his team did not get further funding as SARS did not proceed to a full pandemic. He may use this vaccine to be repurposed for COVID-19. They are also developing an S1 or RBD protein vaccine as a targeted vaccine candidate for COVID-19.
BIOCAD
Vaccine candidate: mRNA vaccine candidate
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Russian biotechnology company BIOCAD has announced that it is developing an mRNA COVID-19 vaccine, and it expects to begin preclinical animal testing in April 2020.
Biological Research Institute
Vaccine candidate: unknown
Research status: discovery?
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
This Israeli research center is claiming that it has a vaccine candidate. The institute, which is a part of the Israeli Department of Defense seems to contradict their claims:
Asked about the development, the Defense Ministry said: “There has been no breakthrough in the efforts of the biological institute to find a vaccine for the coronavirus or to develop testing kits. The institute’s work is conducted according to an orderly work plan and it will take time. If and when there will be something to report, it will be done in an orderly fashion.
The biological institute is a world-renowned research and development agency, which relies on experienced researchers and scientists with great knowledge and quality infrastructures. There are now more than 50 experienced scientists working at the institute on researching and developing a medical remedy for the virus.”
CanSinoBiologics
Vaccine candidate: Ad5-nCoV
Research status: Phase 1 clinical trial
Clinical trial identifier: NCT04313127
Clinical trial institution: Tongji Hospital; Wuhan, China
Clinical trial status: A single-center, open-label, dose-escalating phase I clinical trial in healthy 18 to 60 years of age.
CanSino Biologics has developed a recombinant novel coronavirus vaccine that incorporates the adenovirus type 5 vector (Ad5).
Codagenix
Vaccine candidate: Live attenuated COVID-19 vaccine
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
New York-based Codagenix announced in February that it had used the nCoV genome to map out several vaccine candidate genomes for COVID-19. The company said the next step is to grow and test the vaccine viruses in vivo before initiating clinical trials. It has not given any timeline for vaccine clinical trials.
CSL and The University of Queensland
Vaccine candidate: Molecular clamp vaccine for COVID-19
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Australia-based biotech company CSL and The University of Queensland have achieved a proof-of-concept COVID-19 vaccine candidate. CSL is providing vaccine technologies. They are still in the discovery phase and will conduct further testing before preclinical studies commence.
CureVac
Vaccine candidate: unknown
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Similar to Moderna, CureVac, a European company, is developing a synthetic mRNA that stimulates the immune system to produce antibodies. Also like Moderna, they have had no prophylactic vaccines that have been approved by the FDA or any other regulatory authority. Their proposed vaccine is in the pre-clinical stage, so we don’t have a clear timeline for clinical trials, but I would expect that it would be later in 2020.
EpiVax
Vaccine candidate: Ii-Key peptide vaccine
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
EpiVax is developing two Ii-Key peptide vaccine candidates against COVID-19. The company has announced that it could have a vaccine ready for clinical trials within 5-6 months if the company receives the right level of funding.
ExpreS2ion Biotechnologies
Vaccine candidate: unknown
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
ExpreS2ion Biotechnologies has announced that they plan to perform a Phase 1/2a clinical trial and aim to begin clinical testing within 12 months.
Generex Biotechnology
Vaccine candidate: Ii-Key peptide COVID-19 vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
The US-based biotechnology company Generex Biotechnology announced that were attempting to produce a vaccine candidate to be tested by Summer 2020.
Geovax and Bravovax
Vaccine candidate: Ankara virus-like particles (MVA-VLP)
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Chinese biotech companies Geovax and Bravovax announced they would collaborate to create a vaccine candidate for COVID-19. Geovax has announced it’s currently in the process of narrowing their vaccine candidates down from three to one. At that point, they can begin clinical trials.
GlaxoSmithKline
Vaccine candidate: COVID-19 S-Trimer
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
GSK is in partnership with a Chinese pharmaceutical company, Clover Biopharmaceuticals. Technically, GSK is providing proprietary adjuvants to help boost the effectiveness of a potential COVID-19 vaccine. Again, since the vaccine is in the preclinical stage, we lack clear knowledge of a potential timeline for the vaccine.
Greffex
Vaccine candidate: Adenovirus-based vector vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
The US-based biotechnology company Greffex is developing an adenovirus-based vector vaccine for COVID-19. The company announced that its vaccine candidate has entered the animal testing stage.
Heat Biologics
Vaccine candidate: gp96-based vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Heat Biologics is collaborating with the University of Miami School of Medicine to use the gp96 heat shock protein backbone to develop at least one COVID-19 vaccine.
Inovio Pharmaceuticals
Vaccine candidate: INO-4800
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Inovio is working on a vaccine candidate called INO-4800, and they also have partnered with a Chinese manufacturer to manufacture the vaccine. Since it is still in preclinical studies, we don’t have a good idea as to when it will enter clinical trials.
Institut Pasteur, Themis Bioscience, University of Pittsburgh
Vaccine candidate: unknown
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
The Coalition for Epidemic Preparedness Innovations (CEPI), an intergovernmental group that invests in vaccines and global health, announced a US$4.9 million investment in a COVID-19 vaccine research consortium involving the Institut Pasteur (Paris, France), Themis Bioscience (Vienna, Austria), and the University of Pittsburgh (Pittsburgh, PA, USA).
Jenner Institute – the University of Oxford
Vaccine candidate: ChAdOx1
Research status: Phase 1/2 clinical trial
Clinical trial identifier: NCT04324606
Clinical trial institution: NA
Clinical trial status: Recruiting approximately 500 healthy adult volunteers, aged 18-55 years, in a single-blinded, randomized, placebo-controlled, multi-center study to determine efficacy, safety, and immunogenicity of the ChAdOx1 vaccine candidate.
The Jenner Institute has developed a vaccine candidate based on a chimp adenovirus vector. They have also signed a manufacturing contract. They have announced plans to start animal trials in March 2020 and to begin Phase 1 clinical trials within a few months.
Johnson & Johnson
Vaccine candidate: unknown
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
JNJ’s Janssen Pharmaceuticals is pursuing several directions in COVID-19 vaccine development. They are developing an oral vaccine in partnership with a biotechnology company, Vaxart. They believe that clinical trials will start in November 2020.
Medicago
Vaccine candidate: plant-based COVID-19 vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
This Canadian company is also claiming it has a vaccine candidate, although there is no published data supporting their claims. However, unlike many other companies, they give a more sobering “at least 18 months” before a vaccine can be available. However, they do have a vaccine production facility in North Carolina, so they have a head start in that respect.
MIGAL Galilee Research Institute
Vaccine candidate: Modified avian coronavirus vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Israel-based MIGAL Galilee Research Institute plans to develop a new COVID-19 vaccine candidate by adapting its research in developing a vaccine for a genetically-similar avian coronavirus. They are planning to develop a vaccine by April to May 2020, and then determine when they might start clinical trials.
Moderna Therapeutics
Vaccine candidate: mRNA-1273
Research status: Phase 1 clinical trial
Clinical trial identifier: NCT04283461
Clinical trial institution: Kaiser-Permanente
Clinical trial status: open-label, dose-ranging clinical trial of 45 healthy participants between 18-55 years old. Recruiting patients currently.
Moderna has recently announced a COVID-19 vaccine candidate, mRNA-1273. This vaccine relies on RNA to kickstart the endogenous production of proteins similar enough to the virus that they trigger the body’s adaptive immune system to produce antibodies effective against the actual target. So far, there is no information available about the preclinical studies (although it may be on the way in a peer-reviewed journal).
Also, Moderna has several similar vaccines in clinical trials, but none have received FDA approval. Kaiser-Permanente has registered a Phase 1 clinical trial for the mRNA-1273, but we don’t know when it will start. Typically, a Phase 1 clinical trial just tests the vaccine on “healthy adults,” who are either patients or employees of Kaiser-Permanente. Phase 1 trials generally tell us very little about the vaccine’s effectiveness and safety.
At best, pivotal Phase 2 and 3 studies would start in early 2021, with final approval possibly by early 2022. Also, they do not have large vaccine manufacturing facilities, so they will probably need a partnership with a large vaccine manufacturer to produce enough for the world if it works.
Merck
Vaccine candidate: unknown
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Merck has two veterinary coronavirus vaccines (Bovilus for bovine coronavirus and Nobivac for dogs). Although they would not be useful for the SARS-CoV-2 virus, they do indicate that Merck has some experience in producing vaccines for several types of coronavirus. At this time, they have made no indication of whether they are investigating a vaccine for the current disease.
Murdoch Children’s Research Institute
Vaccine candidate: BCG vaccine
Research status: Phase 3 clinical trials
Clinical trial identifier: NCT04327206
Clinical trial institution: Royal Children’s Hospital
Clinical trial status: This is an open-label, two-group, phase III randomized controlled trial in up to 4170 healthcare workers.
This clinical trial is not for a COVID-19 vaccine, but for another vaccine that may prevent or reduce the complications from the disease. The BCG vaccine is one of the oldest vaccines available on the market, first used in 1921 (pdf). With the successful eradication of tuberculosis in many countries, the vaccine isn’t used very much anymore, except in countries with endemic tuberculosis. It is still given to about 100 million children every year.
The BCG vaccine works like most vaccines – it is made from an attenuated, live bovine tuberculosis bacillus, Mycobacterium bovis which induces an adaptive immune response against tuberculosis bacterium. The vaccine is used to treat bladder cancer and may have some usefulness in reversing type 1 diabetes.
Because the BCG vaccine is already on the market, researchers can utilize it in phase 3 clinical trials.
Novavax
Vaccine candidate: unknown
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
There is little information about their vaccine candidate, but Novavax has extensive experience in developing new vaccines using proprietary technologies. They have announced that they will begin preclinical studies now and begin phase 1 clinical trials in July 2020.
Peter Doherty Institute for Infection and Immunity
Vaccine candidate: unknown
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
The Australia-based Peter Doherty Institute for Infection and Immunity is developing COVID-19 vaccines.
Pfizer and BioNTech
Vaccine candidate: BNT162
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Pfizer and German-based BioNTech have announced a partnership to develop a coronavirus vaccine. They are working on another mRNA vaccine candidate, similar to Moderna’s vaccine candidate.
Sanofi
Vaccine candidate: unknown
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Sanofi, a major international vaccine manufacturer, is attempting a novel approach to a vaccine. They want to develop a chimera that combines DNA from the SARS-CoV-2 with a harmless virus that can stimulate the immune system. Sanofi also announced in late March that they were partnering with Translate Bio to create an mRNA vaccine candidate for COVID-19.
Shenzhen Geno-Immune Medical Institute
Vaccine candidate: LV-SMENP-DC
Research status: Phase 1 clinical trial
Clinical trial identifier: NCT04276896
Clinical trial institution: Shenzhen Third People’s Hospital and Shenzhen Second People’s Hospital
Clinical trial status: Phase 1/2 clinical trial of 100 participants
Shenzhen Geno-Immune Medical institute has developed a synthetic minigene that has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease.
Sinovac
Vaccine candidate: Formalin-inactivated and alum-adjuvanted candidate vaccine for COVID-19
Research status: unknown
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
China-based Sinovac is working on a formalin-inactivated and alum-adjuvanted candidate vaccine for COVID-19. However, there is not much information or details about this vaccine.
Sorrento Therapeutics, Inc. and SmartPharm Therapeutics Inc.
Vaccine candidate: Gene-encoded antibody
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
USA-based biotechnology companies Sorrento Therapeutics, Inc. and SmartPharm Therapeutics Inc. announced a joint venture to develop a gene-encoded antibody vaccine. They hope to have a vaccine for preclinical studies within several months.
Symvivo Corporation
Vaccine candidate: oral bacTRL-Spike
Research status: Phase 1
Clinical trial identifier: NCT04334980
Clinical trial institution: Vaccine Evaluation Center, BC Children’s Research Institute, University of British Columbia and Canadian Center for Vaccinology Dalhousie University, IWK Health Centre
Clinical trial status: Not yet recruiting
Canada-based Symvivo has developed a genetically-modified, probiotic-based (not one you find on your grocery store shelf) oral vaccine for COVID-19. The study design is a phase 1, randomized, observer-blind, placebo-controlled trial in 84 healthy adults. This trial will last about 12-13 months.
Takis Biotech
Vaccine candidate: DNA-based vaccine
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
This Italian biotech company has announced that they will begin preclinical studies for a new vaccine, and they hope to enter phase 1 clinical trials in the fall.
Tonix Pharmaceuticals and Southern Research
Vaccine candidate: Horsepox vaccine with percutaneous administration
Research status: discovery
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
US-based Tonix Pharmaceuticals and Southern Research have announced a partnership to develop a COVID-19 vaccine candidate based on Tonix’s horsepox vaccine, TNX-1800. The companies have not announced a timeline for development.
United States Army Medical Research and Materiel Command and Walter Reed Army Institute of Research
Vaccine candidate: unknown
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
Yes, the US Army performs vaccine research, mostly for biowarfare. They are developing vaccines for MERS (which is related to COVID-19) and other viruses using some proprietary technology and formulations. They are developing a COVID-19 vaccine candidate, but there’s no information about its status.
VIDO-InterVac
Vaccine candidate: unknown
Research status: preclinical
Clinical trial identifier: none
Clinical trial institution: NA
Clinical trial status: NA
The University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre, also known as VIDO-InterVac, has received funding to develop a COVID-19 vaccine. It is unknown as to what type of vaccine design they will develop.
Summary
But there are several points of caution, that I need to emphasize with all of the voice I can give to this:
- Entering clinical trials means nothing. That doesn’t mean we have a vaccine right around the corner. Most vaccines that enter clinical trials fail, and I have no confidence that any of these vaccine candidates have any better chance of being successful.
- That being said, the only thing that matters is data from pivotal, large phase 2 and 3 clinical trials. We need to know that the vaccine is safe and effective, something we do for every vaccine on the market.
- If we lack solid data that the vaccine is safe and effective, you can predict that the anti-vaccine forces will be out in force whining about “mandatory vaccinations,” making false claims and refusing the vaccine. This could harm the herd effect in stopping the disease.
- We don’t know the rate of mutation for SARS-CoV-2, which could make the vaccine ineffective.
- Other SARS vaccines have failed in clinical trials.
- Because most vaccine research fails, it’s good that there are nearly 40 vaccines under development, so that we have a better chance of getting one that works.
The best thing I can say a lot of companies, governments, and non-governmental entities are focused on developing coronavirus vaccines. This could speed up the timeline for a new vaccine, but clinical trials take time – remember each patient who receives the vaccine or placebo have to be monitored over several months to see the antibody response (or lack thereof).
Thus, we can be cautiously optimistic about a vaccine sometime in 2021. But that’s if everything goes right, and after many years of experience in clinical research and development, I can state with authority that everything rarely goes right.
Notes
As I mentioned at the top, I intend to update this article frequently as new vaccine candidates are announced along with the timelines for preclinical and clinical studies. If anyone has other candidates that I missed, leave a comment, and I’ll look into adding it.
Citations
- EMERGING RESPIRATORY DISEASE – CORONAVIRUSES. Dis Mon. 2017 Sep;63(9):256-262. doi: 10.1016/j.disamonth.2017.03.019. Epub 2017 Sep 12. Review. PubMed PMID: 29737283.
- Ahmed SF, Quadeer AA, McKay MR. Preliminary Identification of Potential Vaccine Targets for the COVID-19 Coronavirus (SARS-CoV-2) Based on SARS-CoV Immunological Studies. Viruses. 2020 Feb 25;12(3). doi: 10.3390/v12030254. PubMed PMID: 32106567.
- Bhattacharya M, Sharma AR, Patra P, Ghosh P, Sharma G, Patra BC, Lee SS, Chakraborty C. Development of epitope-based peptide vaccine against novel coronavirus 2019 (SARS-COV-2): Immunoinformatics approach. J Med Virol. 2020 Feb 28;. doi: 10.1002/jmv.25736. [Epub ahead of print] PubMed PMID: 32108359.
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