The COVID-19 vaccine development landscape includes innovative platforms such as DNA, RNA, virus-like particle, peptide, viral vector, recombinant protein, live attenuated virus, an inactivated virus approaches.
On December 11, 2020, the U.S. FDA approved the experimental Pfizer COVID-19 Vaccine, known as Comirnaty, for Emergency Use against the newly identified SARS-CoV-2 coronavirus, which causes COVID-19. On December 21, 2020, Comirnaty received conditional marketing authorization from the European Medicines Agency.
The US Centers for Disease Control and Prevention (CDC) recently issued updated guidance regarding experimental mRNA vaccines on December 30, 2020. And the CDC's Frequently Asked Questions about COVID-19 Vaccination are found at this link.
As of January 15, 2021, the U.S. CDC reported 12,279,180 first-doses vaccines had been administered in the USA. The number of people receiving 2 vaccine doses has reached 1,610,524. And, 1,384,963 vaccinations have occurred in Long-Term Care Facilities.
The state of Texas leads with 2,105,600 vaccines distributed and 1,160,242 administered.
COVID-19 Vaccines: Authorizations (8)
Comirnaty Vaccine - New York-based Pfizer and Germany's BioNTech's Comirnaty COVID-19 Vaccine is an mRNA vaccine that encodes an optimized SARS-CoV-2 full-length spike glycoprotein in a 2-dose (0, 21d) regimen. In a phase 3 study, the vaccine candidate was more than 90% effective in preventing COVID-19. Comiranty was authorized in the USA on December 11, 2020.
Moderna COVID-19 Vaccine - Massachusettes-based Moderna COVID-19 Vaccine is an mRNA vaccine candidate against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form Spike protein. mRNA-1273 is a two-dose (0, 28d) regimen. The U.S. FDA granted an Emergency Use Authorization on December 18, 2020.
Convidicea Vaccine - China-based CanSinoBIO's Convidicea (Ad5-nCoV) vaccine is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform. The Convidicea vaccine candidate is a single-dose regimen authorized in China.
Sputnik V Vaccine - The Russian Sputnik V is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus, which causes COVID019. Sputnik V deploys two different adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting its effect. On August 1, 2020, the Russian Health Minister announced 'clinical trials had been declared completed,' and the Sputnik vaccine was authorized.
COVID-19 Vaccine AstraZeneca - UK-based AstraZeneca and the Oxford University co-developed COVID-19 Vaccine (AZD1222) is made from the ChAdOx1 virus, a weakened version of a common cold virus (adenovirus). Genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein. The vaccine received the UK Medicines and Healthcare products Regulatory Agency authorization for the active immunization of individuals 18 years or older on December 30, 2020.
Covaxin SARS-CoV-2 Vaccine - India-based Bharat Biotech's Covaxin is an inactivated SARS-CoV-2 vaccine candidate. The coronavirus strain was isolated from an asymptomatic COVID-19 patient at NIV, Pune, and is authorized in India.
New Crown COVID-19 Vaccine - China's inactivated 'new crown' vaccine created by Wuhan Institute of Biological Products, under the China National Pharmaceutical Group, Sinopharm, and the Wuhan Institute of Virology. China's National Medical Products Administration issued authorization on December 31, 2020.
CoronaVac Vaccine - China's Sinovac Biotech's CoronaVac Vaccine is based on an inactivated pathogen. The neutralizing antibody seroconversion rate is above 90%, which indicates the vaccine can induce a positive immune response. On January 10, 2021, the Indonesian FDA issued emergency authorization for Sinovac Biotech's CoronaVac vaccine after being found 65.3% effective in a local clinical trial.
COVID-19 Vaccine: Phase 3 Clinical Trials
Johnson and Johnson's Janssen Vaccines & Prevention B.V. investigational SARS-CoV-2 viral vector vaccine is an adenovirus serotype 26 (Ad26) vector-based vaccine. Announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate (Ad26.COV2-S) in a single-dose regimen.
Russia's Vektor State Research Center of Virology and Biotechnology EpiVacCorona vaccine contains fragments extracted from the virus — synthetic peptide antigens. The antigens-based vaccine provokes an immune reaction against COVID-19 and promotes the further development of immunity.
Novavax's NVX-CoV2373 is a prefusion protein subunit coronavirus vaccine candidate created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. This vaccine will require a two-dose (0, 21d) regimen.
CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. CureVac's proprietary technology principle is mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.
AnGes, Inc.'s AG0301 vaccine candidate is a plasmid DNA vaccine that disables the connection between the protein spikes of the coronavirus and receptors in human cells.
COVID-19 Vaccine: Phase 2 Clinical Trials
Sanofi and GSK announced a delay in launching this vaccine candidate. They plan a Phase 2b study with an improved antigen formulation. If data are positive, a global Phase 3 study could start in Q2 2021. This study's positive results would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.
The Israel Institute for Biological Research Indiana vesiculovirus COVID-19 vaccine candidate BriLife's phase 2 study will expand to 960 people, with various dose levels, beginning December 2020.
Valneava SE's VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018. And VLA2001-201 is the first-in-human Phase 1/2 study that will evaluate three dose levels of VLA2001 (low, medium, high) for safety, tolerability, and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart.
COVID-19 Vaccine: Phase 1 Clinical Trials
Inovio's DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. On July 30, 2020, Inovio announced INO-4800 vaccination generated antibodies neutralizing both the earlier strain of the coronavirus and the mutant variant (D614G), which has emerged with greater infectivity and now accounts for about 80% of newly circulating virus.
Vaxart's VXA-CoV2-1 vaccine candidate is based on an oral H1 flu tablet with positive clinical study results. Phase 1, an open-label, dose-ranging study, will be conducted in healthy adults ages 18 to 55. The study’s primary objective is to examine the safety and reactogenicity of 2-doses of the vaccine.
Merck's V591 SARS-CoV-2 replicating viral vector vaccine candidate uses a measles virus vector platform to deliver the antigens to the immune system to spur antibody production against the SARS-CoV-2 virus. The Phase 1/2 clinical trial is currently recruiting and assessing the Safety, Tolerability, and Immunogenicity of V591 in Healthy Participants.
Aivita Biomedical's AV-COVID-19 AuDendritic cell vaccine candidate consists of autologous dendritic cells loaded with antigens from SARS-CoV-2. In a Phase 1/2 clinical trial "Adaptive Phase IB-II Randomized Clinical Trial Of Preventive Vaccine Consisting Of Autologous Dendritic Cells Loaded With Antigens From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), With Or Without GM-CSF, In Subjects Negative For COVID-19 Infection And Anti-SARS-CoV-2 Antibodies".
The Sichuan 'Clover' Biopharmaceuticals S-Trimer (SCB-2019) recombinant subunit vaccine candidate is targeted for the SARS-CoV-2 virus that causes COVID-19 disease. The vaccine conducts a phase 1 clinical trial in Australia, testing different boosters provided by GSK and Dynavax. Clover's S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.
A randomized, double-blind, placebo parallel controlled phase I/II clinical trial evaluates the new inactivated coronavirus vaccine (2019-CoV) (Vero cells) in healthy people aged 3 years and older.
The GSK and Medicago collaboration intends to develop a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the virus's structure responsible for COVID-19 disease, allowing them to be recognized by the immune system. On November 10, 2020, the companies reported '100 % of subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses.'
Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. To date, over 90 cancer patients have been treated with CPI-006 in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg every three weeks.
AdCOVID is based on Altimmune Inc.'s adenovirus-based intranasal vaccine platform and expresses the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. AdCOVID is designed to guard the respiratory tract from viral invasion and provide downstream protection against the viral spread by stimulating both mucosal and systemic antibodies (IgA and IgG) and cell-mediated immunity.
Elixirgen Therapeutics's EXG-5003 is a temperature-sensitive self-replicating RNA vaccine expressing the receptor-binding domain of the SARS-CoV-2 spike protein. EXG-5003 was optimized for intradermal injection with potential dose-sparing and safety benefits. Human clinical trials are expected to begin at Fujita Health University Hospital in Aichi, Japan, in Q1 2021.
ReiThera Srl RT-CoV-2 is a Phase I, open-label, dose-escalation multicenter clinical trial to assess the candidate vaccine's safety and immunogenicity GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication-defective Gorilla Adenovirus and encodes for SARS-COV-2 full-length prefusion stabilized Spike protein.
CDX-005 is an intranasal, live-attenuated vaccine candidate generated using Codagenix’s proprietary deoptimization technology. CDX-005 is designed to produce immunity against all SARS-CoV-2 proteins, not just the spike surface protein.
ImmunityBio hAd5 COVID-19 vaccine candidate targets the inner nucleocapsid and the outer spike protein, engineered to activate both T cells and antibodies against the SARS-CoV-2 coronavirus. Phase 1 study launched in California during October 2020.
Medicago's Coronavirus Virus-Like Particle vaccine began Phase 1 testing in human volunteers on July 14, 2020. Medicago plans to initiate Phase 2 trials in early November and Phase 3 trials shortly after, in December 2020.
The Phase 1 trial of bacTRL-Spike™ Vaccine for Prevention of COVID-19 is being conducted in partnership with Nucleus Network in Brisbane, Australia. Preliminary data are anticipated in early 2021.
Cadila Healthcare (Zydus Cadila) said it has completed enrolment and dosing of 1,000 volunteers in phase-2 clinical trials of its potential Covid-19 vaccine, ZyCoV-D, and plans to submit the data to the Drug Controller General of India.
OSE Immunotherapeutics's CoVepiT is a prophylactic vaccine based on optimized epitopes selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19.
Arcturus combines its self-replicating mRNA STARR™ Technology with its LUNAR® RNA medicine delivery technology to develop a prophylactic vaccine against COVID-19. Arcturus's LUNAR-COV19 vaccine is developed in collaboration with the Duke-National University of Singapore Medical School is developing an mRNA vaccine to prevent COVID19 coronavirus infection.
ImmunityBio and NantKwest are currently enrolling 35 healthy adults aged 18 to 55 years old in the Phase 1 study for the hAd5-COVID-19 vaccine candidate. This study shows hAd5 S+N COVID-19 vaccine candidate, which delivers two distinct proteins, stimulates T-cell responses of volunteers recovered from SARS-CoV-2 infection, demonstrating that the S and N antigens from the vaccine are recognized by SARS-COV-2 reactive human T cells.
Biological E. Limited, a Hyderabad-based vaccine and pharmaceutical company initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India. The Phase I/II clinical trial will evaluate the vaccine candidate's safety and immunogenicity, consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.
The City of Hope announced it had initiated a phase 1 clinical trial for the investigational vaccine, known as COH04S1, which aims to stimulate the immune system to produce antibodies that can block the SARS-CoV-2 coronavirus from entering cells and also spur abundant T cells that are thought to provide the elusive long-term protection that could protect against future outbreaks.
Vaccination decisions during the COVID-19 pandemic should be discussed between patients and their healthcare providers, says the U.S. CDC. Additionally, Paul Sax, M.D., a Professor of Medicine at Harvard Medical School and an infectious disease specialist, provides concise and engaging answers to clinicians’ questions about Covid-19 vaccination and the questions and concerns patients will raise.
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