Coronavirus Vaccines

World-class scientists have accelerated the clinical trial process to develop a safe and effective coronavirus preventive vaccine. The SARS-CoV-2 vaccine development landscape includes innovative platforms such as nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus, and inactivated virus approaches.

The goal of these vaccines is to stop SARS-CoV-2, the coronavirus that causes COVID-19, from getting into cells, replicating itself, which then makes a person sick, says the U.S. CDC.

The U.S. FDA has not approved any preventive or therapeutic vaccines for use against either MERS-CoV or SARS-CoV-2 coronaviruses. However, there are various late-stage clinical studies seeking thousands of participants to evaluate experimental coronavirus vaccines.

Coronavirus Vaccines Approved for Limited Use

  • CHINA: Ad5-nCoV COVID-19 vaccine
    • The Ad5-nCoV vaccine candidate 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. On September 21, 2020, the first group of volunteers participating in an international Phase III clinical trial of the Ad5-nCoV vaccine were vaccinated at Moscow medical centers. According to clinical regulations, study participants will be under direct supervision for the first 28-days after vaccination and will have to undergo (4) interim face-to-face examinations at treatment centers.
  • RUSSIA: Sputnik V Vaccine
    • The Russian COVID-19 vaccine Sputnik V is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus. Sputnik V deploys two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine. On August 1, 2020, the Russian Health Minister Mikhail Murashko announced 'clinical trials had been declared completed.' And, Russia stated it is planning a post-authorization vaccination campaign in October 2020.

Phase 3 Clinical Trials

  • Ad26.COV2-S (JNJ-78436735) vaccine
    • Johnson and Johnson's Janssen Vaccines & Prevention B.V. investigational SARS-CoV-2 vaccine, Ad26COV-S, JNJ-78436735, announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.
  • AZD1222 SARS-CoV-2 vaccine
    • AstraZeneca/University of Oxford's Jenner Institute's AZD1222 vaccine uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (ChAdOx1) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. Phase 1/2 study results published in The Lancet confirmed a single dose of AZD1222 resulted in a 4-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants 1-month after injection.  A Phase 3 clinical trial evaluating AZD1222 launched enrolling approximately 30,000 adult volunteers at 80 sites in the USA.
  • New Crown COVID-19 Vaccine
    • An inactivated 'new crown' vaccine created by Wuhan Institute of Biological Products under the China National Pharmaceutical Group, Sinopharm, and the Wuhan Institute of Virology entered clinical trials. On August 13, 2020, JAMA published a study that concluded saying 'In this interim report of phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity.
  • CoronaVac SARS-CoV-2 vaccine
    • Sinovac Biotech's CoronaVac SARS-CoV-2 Vaccine candidate is based on an inactivated pathogen. A phase II clinical trial showed that the vaccine-induced neutralizing antibodies 14 days after the vaccination with a 0 and 14-day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce a positive immune response.
  • BNT162b2 Vaccine
    • Pfizer and BioNTech's BNT162b2 vaccine candidate encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level in a 2-dose regimen. On August 20, 2020, BNT162b2 was found associated with less systemic reactogenicity, particularly in older adults. Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allow for the enrollment of new populations. Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October 2020.
  • mRNA-1273 SARS-CoV-2 vaccine
    • Moderna's mRNA-1273 is an mRNA vaccine candidate against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form of the Spike protein. The Phase 3 COVE study is being conducted in collaboration with the NIH and the BARDA, which began on July 27, 2020, and enrollment of approximately 30,000 participants is on track to complete in September.
  • NVX-CoV2373 vaccine
    • Novavax's NVX-CoV2373 is a prefusion protein coronavirus vaccine candidate created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. On September 24, 2020, a Phase 3 study to evaluate the NVX-CoV2373 COVID-19 vaccine candidate in the United Kingdom was announced and is expected to enroll and immunize up to 10,000 individuals over the next 6-weeks.

Phase 2 Clinical Trial

  • Sanofi and GSK COVID-19 Adjuvanted Vaccine
    • Sanofi and GSK announced the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. Over 400 participants being enrolled in the Phase 1/2 study. If Phase 1/2 data positive, companies aim to move into a Phase 3 trial by end of 2020.

Phase 1 Clinical Trials

  •  INO-4800 DNA vaccine
    • Inovio's DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are 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, as well as the mutant variant (D614G), that has emerged with greater infectivity, and now accounts for about 80% of newly circulating virus.
  • Vaxart COVID-19 Oral Vaccine
    • Vaxart's vaccine candidate is based upon an oral H1 flu tablet which has shown positive results in clinical studies. The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine. Secondary objectives include immunogenicity, duration of an immune response, and occurrence of symptomatic COVID-19.
  • VLA2001 Vaccine

    • Valneava's VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the SARS-COV-2 virus, leveraging the manufacturing technology for Valneva’s Japanese Encephalitis Vaccine. The VLA2001 vaccine candidate is expected to enter initial clinical studies by the end of 2020.

  • UQ COVID-19 Vaccine
    • The University of Queensland announced on July 13, 2020, it has dosed the initial participant in phase 1 clinical trial in Brisbane, Australia. CSL and the Australian Government agreed to supply 51 million doses of the UQ COVID-19 vaccine to Australia, with first doses scheduled for release from mid-2021 following successful clinical trials.
  • SCB-2019 SARS-CoV-2 Vaccine
    • The Sichuan 'Clover' Biopharmaceuticals SCB-2019 is a recombinant subunit vaccine candidate for the SARS-CoV-2 virus that causes COVID-19 disease. The vaccine is entering into a phase 1 clinical trial in Australia to test the vaccine with two different boosters provided by GSK and Dynavax. Clover Biopharmaceuticals, Inc.'s S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.
  • Beijing BBIBP-CorV COVID-19 Vaccine Candidate
    • A randomized, double-blind, placebo parallel controlled phase I/II clinical trial to evaluate the safety and immunogenicity of the new inactivated coronavirus vaccine (2019-CoV) (Vero cells) in healthy people aged 3 years and older 
  • Covaxin SARS-CoV-2 Vaccine
    • Covaxin is an inactivated SARS-CoV-2 vaccine candidate. The coronavirus strain was isolated from an asymptomatic COVID-19 patient at NIV, Pune. The vector used in this new vaccine is a deactivated rabies vaccine that is known to produce a strong immune response, and that has been proven safe for all populations including children and pregnant women.
  • CVnCoV SARS-CoV-2 Vaccine

    • CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. This mRNA technology instructs the human body to activate its own defense mechanism.

  • CoVLP Vaccine

    • 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 structure of the virus responsible for COVID-19 disease, allowing them to be recognized by the immune system.

  • CPI-006 Novel Immunotherapy

    • 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 Vaccine

    • Altimmune, Inc.'s AdCOVID is an intranasal COVID-19 vaccine candidate designed to guard the respiratory tract from viral invasion and to provide downstream protection against the viral spread through stimulation of both mucosal and systemic antibodies (IgA and IgG) as well as cell-mediated immunity.

  • EXG-5003 Vaccine

    • 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.

  • GRAd-COV2 Vaccine

    • ReiThera Srl RT-CoV-2 is a Phase I, open-label, dose-escalation multicenter clinical trial to assess the safety and immunogenicity of the candidate vaccine 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 SARS-CoV-2 Vaccine
    • CDX-005 is an intranasal, live-attenuated vaccine candidate that is 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.

Related Vaccine Studies

BCG - Bacille Calmette-Guerin is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. Phase 4 Clinical Trial

  • Texas A&M, Baylor College Medicine, Cedars Sinai Medical Center, and MD Anderson launched a COVID-19 prevention study testing the BCG tuberculosis-approved vaccine. IRB Number 2020-0432F, IRB Approval Date: 06/17/2020. Last update: May 27, 2020.
  • Researchers from the NIAID of the US National Institutes of Health established an association between BCG vaccination and reduced Covid-19 disease mortality rates across the globe on July 9, 2020.
  • An analysis published on July 31, 2020, suggests that mandated BCG vaccination can be effective in the fight against COVID-19.

MMR - M-M-R II vaccine is a live virus vaccine, containing weakened forms of these viruses and works by helping the immune system protect itself from these viruses. Phase 3 Clinical Trial

  • An international research network of physicians and scientists is launching a clinical trial to evaluate whether the MMR vaccine can protect front-line health-care workers against infection from SARS-CoV-2.

  • Washington University School of Medicine in St. Louis is the clinical coordinating center for this international trial.

  • The phase 3 trial aims to enroll up to 30,000 health-care workers globally.

Coronavirus FAQs

Early-stage Coronavirus Vaccine Development News Found here.

     

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    Note: Content sources on this webpage include, but are not limited to, the WHO, the CDC, industry studies, and clinicalTrials.gov. The content was Fact-Checked by Dr. Robert Carlson and other healthcare professionals. Precision Vax takes reasonable steps to verify the accuracy of the information presented in these landscape documents, WHO does not make any (and hereby disclaims all) representations and warranties regarding the accuracy, completeness, fitness for a particular purpose (including any of the aforementioned purposes), quality, safety, efficacy, merchantability and/or non-infringement of any information provided in these landscape documents and/or of any of the products referenced therein.