Covid Vaccine Tracker
In a recent conversation with one person who I would consider knowledgeable, I was led to this site. COVID-19 Live Vaccine Tracker. This is an initial rundown of various Covid vaccines being worked on by international companies and the phase they are in today. I will attempt to update this from time to time.
“A compilation of the active vaccine candidates being studied for coronavirus 2019 (COVID-19) cures. This tracker will update periodically and will have the latest news and information.” The COVID-19 Live Vaccine Tracker, ContagionLive
Phase 3
Vaccine Name: mRNA-1273
Company: Moderna
Moderna’s phase 1 trial, mRNA-1273 vaccine: Results of treating novel coronavirus (COVID-19) were published July 14, 2020 in The New England Journal of Medicine. The NEJM reported on the results of potential vaccine induced protective responses in 45 adult participants receiving doses of 25, 100, or 250 μg (micrograms) throughout March and April 2020. Antibodies did occur and correlated with higher doses of the mRNA-1273 vaccine as by anti–S-2P antibody GMT (geometric mean titer) ; 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group.
With the second vaccination on day 57, the titers had again showed increased antibody GMT when tested; 299,751, 782,719, and 1,192,154 μg. Serum-neutralizing activity (antibody that defends a cell from a pathogen or infectious particle by neutralizing any effect it has biologically) was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum (blood serum containing antibodies from disease or inoculation) specimens.
Adverse effects, includes half of the participants were fatigued, exhibiting chills, headache, myalgia, with pain at the injection site. Systemic adverse effects occurred after the second vaccination particularly with the highest dosage. Three participants (21%) in the 250-μg dose group reported one or more severe adverse events.
The mRNA-1273 vaccine had induced anti–SARS-CoV-2 impact with an immune response in all participants of varying intensity with no trial-limiting safety concerns were identified.
mRNA-1273 vaccine was given a Fast Track designation enrollment for a phase 2 trial at the end of May with an enrollment of 600 in 2 cohorts of those aged 18-55 years and those over 55 years.
A phase 3 trial involving 30,000 volunteers is receiving funding from BARDA and Operation Warp Speed. Participants in the study will receive either an injection of 100 μg mRA-1273 on Days 1 and 29 or a placebo.
Vaccine Name: Inactivated Vaccine
Company: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
The project involving Sinopharm and the Wuhan Institute of Virology are funded by the China Ministry of Science and Technology to achieve a goal of developing a vaccine utilizing inactivated vaccine. Phase 1 and 2 clinical trials with individuals of ages 6 and up are underway. As of June 16th, 1,120 volunteers participated in the phase 1 and 2 trials. The volunteers have received two injections of the vaccine at low, middle, or high dosing strengths or a placebo scheduled 14 days, 21 days or 28 days apart as reported by China National Biotec Group (CNBG). The seroconversion rate (time period during which a specific antibody develops and becomes detectable in the blood) for the 14-day and 21-day schedule of the mid-dose was 97.6%. At 28 days, it was 100%.
The Inactivate Vaccine appears to be working best at the middle strength when given 28 days apart. All participants in middle strength dosing regime developed neutralizing antibodies.
Sinopharm has initiated a phase 3 trial to evaluate their vaccine candidate in the United Arab Emirates. The country has authorized up to 15,000 participants aged 18 to 60 years to enroll.
“China’s Sinopharm touts 100% antibody response for COVID-19 vaccine with workers”
Vaccine Name: CoronaVac
Company: Sinovac
Now known as CoronaVac, PiCoVacc has shown partial and complete protection in macaques against COVID-19, according to a paper published in the journal Science. Investigators said; in mice, rats, and nonhuman primates, the antibodies neutralized 10 representative SARS-CoV-2 strains. The vaccine was administered in 3 doses of 3 or 6 μg per dose.
Investigators moved forward with a phase 1/2 trial which demonstrated no serious adverse events, according to a company press release. The June statement also reported a positive immune response.
A phase 3 trial is underway in Brazil in conjunction with Instituto Butantan. Notaby, there are plans to enroll 9000 patients in the health care industry for that study.
Phase 2/3
Vaccine Name: AZD1222
Company: The University of Oxford; AstraZeneca; IQVIA
Previously known as ChAdOx1, University of Oxford and the Oxford Vaccine Group are introducing a chimpanzee adenovirus vaccine vector known now as AZD1222.
In a phase 1 and 2 trial of 1,090 healthy adult volunteers aged 18-55 years, investigators will administer two treatment arms with a single dose of the vaccine or a meningococcal vaccine. A third cohort will receive AZD1222 plus a booster shot after 4 weeks. A fourth arm will receive either the vaccine or a meningococcal vaccine plus 1 g acetaminophen every 6 hours for 24 hours. One gram of Tylenol administered. I wonder what purpose this serves?
Recent update by commenter Joel: “There were two adverse events (as reported by STAT on September 9) associated with the AstraZenica trial. Both events apparently involved individuals with MS. A recombinant chimp adenovirus vaccine might not be a good idea for people with an autoimmune disorder.
Vaccine Name: BNT162
Company: Pfizer, BioNTech
July 13: Pfizer and BioNTech, In a joint press release in July stated the phase 1/2 trial in Germany resulted in approval by the Paul-Ehrlich-Institute after testing it in 200 healthy adult participants. Pfizer suggested a vaccine could be available in the fall of 2020. Also in the press release, Pfizer stated their most promising candidate is a modified mRNA-based vaccine called BNT162b1.
That vaccine was tested at 10 μg, 30 μg and 100 μg, The investigators noted in a non-peer reviewed paper the highest doses saw adverse events resulting in participants not receiving a second dose. The authors believe that the well-tolerated dose could be between 10 μg and 30 μg.
BNT162b1 has received FDA Fast Track designation as well as another vaccine candidate called BNT162b2—and the CEO told media they may be ready for regulatory approval by the end of the year 2020.
August 5: Pfizer Canada and BioNTech SE signed an agreement with Canada to supply their BNT162 mRNA-based vaccine subject to clinical success and Health Canada approval.
August 20: Pfizer, “Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020. If regulatory authorization or approval is obtained, We plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.” Pfizer, BioNTech May Seek FDA Approval in October
Key safety and immunogenicity data from the US phase 1 trial for the BNT162b2 vaccine candidate. At 30 μg recorded 7 days after the second dose resulted in SARS-CoV-2-neutralizing “geometric mean titers” (GMTs) in younger adults (18-55 years of age) 3.8 times the GMT of a panel of 38 sera (blood serum containing antibodies) of SARS-CoV2 convalescent patients. In older adults (65-85 years of age), the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel. BNT162b2 vaccine demonstrates a strong immunogenicity in younger and older adults.
BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.
September 14: Pfizer and BioNTech are planning to expand the enrollment of a phase 3 COVID-19 vaccine trial from 30,000 to 44,000 participants. Pfizer’s CEO has announced that the firm hopes to have a coronavirus vaccine beginning to roll out by the end of the year.
Phase 2
Vaccine Name: Bacillus Calmette-Guerin (BCG) live-attenuated vaccine
Company: University of Melbourne and Murdoch Children’s Research Institute; Radboud University Medical Center; Faustman Lab at Massachusetts General Hospital
RBD-Dimer vaccine
Vaccine Name: Ad5-nCoV
Company: CanSino Biologics
Adenovirus type 5 vector vaccine candidate
Phase 1/2
Vaccine Name: Ad26.COV2.S
Company: Johnson & Johnson (Janssen)
Adenovirus or messenger RNA based.
Vaccine Name: BBIBP-CorV
Company: Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
Inactivated COVID-19 vaccine
Vaccine Name: GX-19
Company: Genexine
DNA vaccine
Vaccine Name: Gam-COVID-Vac
Company: Gamaleya Research Institute, Acellena Contract Drug Research and Development
Vaccine Name: Self-amplifying RNA vaccine
Company: Imperial College London
Self-amplifying RNA
Vaccine Name: LUNAR-COV19
Company: Arcturus Therapeutics and Duke-NUS Medical School
Self-replicating RNA and nanoparticle non-viral delivery systems,
Vaccine Name: ZyCoV-D
Company: Zydus Cadila
Plasmid DNA
Vaccine Name: NVX-CoV2373
Company: Novavax
Vaccine Name: adjuvanted recombinant protein-based vaccine
Company: Sanofi and GSK
Adjuvanted COVID-19 vaccine
This might be a little to far into the weeds, but I was wondering about the Moderna trial and how it is supposed to work. I posed these questions to an immunologist colleague about the COVID-19 spike protein vaccine strategy:
Q:
Won’t any secreted spike protein that escapes into circulation be rapidly sponged up by the ACE2 on the surface of the vascular endothelium?
Will the secreted spike protein bound by ACE2 be proteolyzed like it is during viral infection?
Will secreted spike protein binding to ACE2 be endocytosed, proteolyzed in the lysosome and peptides presented on the cell surface to trigger a T-cell response?
A:
The answer to all of your questions is, yes. Because of the reasons you listed, there is an expectation that the Moderna vaccine will elicit some level of T cell immunity but how much is still under investigation. The current thinking is that better T cell responses will improve the B cell/antibody response to achieve more complete and durable immunity against the virus.
Joel:
You test the limits of my knowledge. I have to read some more to understand it. I kind of understand your points, I have to read some more to verify my thoughts before I flap my lips.
This coverage reminds me of that gubernatorial race in Califonia after Gray Davis was recalled. I happened to be in Los Angeles and picked up the local newspaper which had an inset describing the nearly hundred candidates running. The first few dozen listed had pictures, statements, contact information and so on, but by last twenty or so were a delightful hodgepodge of “sorry, no picture available”, “no statement at the time of publication” and so on. You could almost hear the typesetter intended too just type “who?”.
I am guessing we will have a useful COVID vaccine or three by sometime early next year, but. as usual, when one throws money at a problem the real payoffs will be the treatments enabled by the effort. The techniques being developed and the surplus capacities will wind up in surprising uses. For all we know, the big wins may be a new class of antibiotics and a new kind of microwave and dishwasher safe wine glass that makes stronger car windshields. If we allow ourselves to learn from our failures, maybe we’ll also improve disease reporting and treatment tracking better and have enough PPE and related manufacturing capacity as well. One can dream.
kaleberg:
Early next year is probably the soonest if they do Phase III Clinical trials. And FDA Commissioner Stephen Hahn got his ass handed to him for the abuse of short-circuiting the approval process before Phase III Clinical trials. I still believe the 21st Century Cures Act allows for some real world testing. How much I am not sure. Read this, I think it will help you understand from where I am coming. http://angrybearblog.com/2020/09/off-roading-with-the-fda.html