Table 3.
Summary of the Clinical-phase COVID-19 vaccine candidates.
| Platform | target | Vaccine name | Vaccine characteristics | Efficacy/Dose/routes of administration/storage | stage of clinical evaluation/regulatory status | Reference |
|---|---|---|---|---|---|---|
| Inactivated vaccines | Whole virion | WIBP-CorV | Inactivated SARS-CoV-2 Vaccine. Developed by the Wuhan Institute of Biological Products. |
72.51% efficacy |
Phase 1/2 were designed by Wuhan Institute of Biological Products/Sinopharm (ChiCTR2000031809). Phase 3 trials are undergoing in several countries. China approved the Wuhan vaccine for general use. Limited used in the United Arab Emirates. |
[355] |
| BBIBP-CorV | Inactivated SARS-CoV-2 Vaccine. Developed by Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm). An unpublished study showed that the vaccine was only modestly weaker against B.1.351 |
79.34% efficacy/ 2 doses, 3 weeks apart/ Muscle injection/ |
Phases 1/2 by Beijing Institute of Biological Products/Sinopharm (ChiCTR2000032459). Phase 3 trial began in the United Arab Emirates in July, and in Morocco and Peru the following month (ChiCTR2000034780). Approved in China, Bahrain and the United Arab Emirates. Authorized for emergency use in several other countries. Accepted by WHO for Emergency Use Listing (EUL). Entered Phase four Clinical Trial |
[356], [357], [358] |
||
| CoronaVac, known as PiCoVacc | Formalin-inactivated and alum-adjuvanted candidate vaccine. Developed by Sinovac Biotech in china. |
50.65% efficacy in Brazil trial and 91.25% in Turkey trial/ 2 doses, 2 weeks apart/ Muscle injection/ Refrigerated |
Phases 1/2 by Sinovac Biotech (NCT04383574) (NCT04352608). Phase 3 trial (NCT04617483). Phase 3 trial in Turkey (NCT04582344), Indonesia (NCT04508075) and Brazil (NCT04456595). Approved in China and authorized for emergency use in several other countries. Accepted by WHO for Emergency Use Listing (EUL). Entering Phase four Clinical Trial |
[359], [360] | ||
| Covaxin also known as BBV152, BBV154 |
BBV152 is an inactivated SARS-CoV-2 Vaccine. Developed by Indian company Bharat Biotech. BBV154 is a novel adenovirus vectored, intranasal vaccine for COVID-19 |
78% efficacy, Efficacy against Severe COVID-19 disease is 100 % injection into the deltoid muscle/ 2 doses, 4 weeks apart/ Storage at least a week at room temperature |
Phases 1/2 trials induce tolerable safety outcomes and enhanced immune responses (NCT04471519) Authorized for emergency use in India and several other countries. Expression of interest (EOI) data submitted to WHO on 19 April for EUL. |
[361], [362] |
||
|
Live attenuated vaccines |
Whole virion | COVI-VAC | Codon deoptimized live attenuated vaccines that are RNA molecules encoding the rewritten genes of viruses, introducing hundreds of mutations. Developed by Indian company Codagenix |
Single dose/Intranasal | Pre-Clinical by Codagenix/Serum Institute of India and Indian Immunologicals Ltd/Griffith University. Phase 1 trial was launched in the United Kingdom in January (NCT04619628). |
[319] |
|
MV-014–212 (Meissa Vaccine) |
Live attenuated vaccine against respiratory syncytial virus (RSV) that expresses the spike (S) protein of SARS-CoV-2. Developed by Meissa Vaccines company |
single-dose/intranasal | Pre-Clinical by Meissa Vaccines company Phase 1 trial was begun in the United States, Kansas, on April 12, 2021 (NCT04798001). |
[320], [321] | ||
| BCG vaccine | BCG-CORONA | World Health Organization (WHO) reported that the BCG vaccine may be effective in preventing acute respiratory tract infections in elderly patients, other respiratory infections and sepsis. | One dose (0.1 ml) of the licensed BCG vaccine. |
Phase 3 BRACE trial in Australia (NCT04327206) phase 3 BCG-CORONA trial in the US (NTC04632537), Egypt (NCT0350931), Netherlands (NCT04328411), and South Africa (NCT04379336). |
[124], [363], [364], [365] | |
| Recombinant Viral proteins | S protein |
Novavax NVX-CoV2373 |
NVX-CoV2373 is a Subunit Protein vaccine, including a full-length recombinant SARS CoV-2 glycoprotein nanoparticle vaccine adjuvant with Matrix-M1. Developed by Novavax company in the USA. |
96% efficacy against original coronavirus, 86% against B.1.1.7, and 49% against B.1.351 2 doses, 3 weeks apart /Muscle injection /Stable in refrigerator |
Phases 1/2 were generally well-tolerated and elicited robust antibody responses (NCT04533399) Phases 1/2 by the biOTech company (NCT04368988). phase 3 trial in the US and Mexico (NCT04611802) phase 3 trial in the UK (NCT04583995) Accepted by WHO for EUL Entering Phase four Clinical Trial |
[366], [367] |
| EpiVacCorona | Recombinant peptide vaccine for blocking the spike 1 protein receptor-binding domain (S1-RBD) of SARS CoV-2. Developed by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology in Russia. |
2 doses (0.5 ml 2) 3 weeks apart/Muscle injection/Stable in refrigerator for up to two years |
Phases 1/2 trial Being safe and immunogenic vaccine. Containing low reactogenicity. NCT04527575 Approved in Turkmenistan and |
[368] | ||
| ZF2001 | Recombinant peptide vaccine for RBD section of the spike protein of SARS CoV-2 Developed by China's Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Sciences. |
3 doses, 4 weeks apart/ Muscle injection |
Phase 1 (NCT04445194) and Phase 2 (NCT04466085), (NCT04550351), Phase 3 trial (NCT04833101) Phase 4 trial (NCT04833101) trials were designed in China. Emergency used in China and Uzbekistan. |
[369] |
||
| CoVLP | Plant-based COVID-19 vaccine in combination with adjuvants (AS03 or CpG1018) to boost the immune system’s response to the viral proteins. Virus genes delivers into leaves, and the plant cells (called Nicotiana benthamiana,) then create protein shells that mimic viruses. Developed by Medicago in Canada |
2 doses, 3 weeks apart/ Muscle injection/ Stable in refrigerator |
In phase 1 two doses of CoVLP (3.75 μg + AS03), lead to strong humoral and cellular responses (NCT04450004) Phase 2/3 started on November 19, 2020 (NCT04636697) |
[370] | ||
| COVID-19 VLP-based vaccine | Virus-like particle, based on RBD displayed on virus-like particles | Pre-Clinical in Switzerland by Saiba GmbH The vaccine was able to induce high levels of antibodies within a week in test animals |
[371] | |||
| Recombinant viral vectors | S protein |
CanSino, Convidecia also known as Ad5-nCoV |
Non-Replicating Viral Vector (Ad5-nCoV) is based on their adenovirus type 5 vector platform (deletions in the E1 and E3 early genes) expresses the full-length spike glycoprotein. Developed by CanSino Biologics company. |
65.28% efficacy/ Single-dose/ Muscle injection Refrigerated. |
Phase 1 in Wuhan, Hubei, China (NCT04313127) phase II trial (NCT04341389) phase III trial (NCT04540419) Phase 3 by CanSino Biologics in (Tianjin, China), (NCT04526990) Approved in China. Emergency use in other countries. WHO's accepted for EUL Enter Phase four Clinical Trial |
[372], [373], [374] |
|
COVID-19 Vaccine Janssen (JNJ-78436735; Ad26.COV2.S) |
Is based on the human adenovirus Ad26 expresses the full-length spike protein. Developed by Johnson & Johnson in the Netherlands and the US. |
72% in the United States, 68% in Brazil, and 64% in South Africa 1 dose/Muscle injection/ Storage up to two years frozen at –4° F (–20° C), and up to three months refrigerated at 36–46° F (2–8° C). |
phase 1/2 trials in the US (NCT04436276) and Japan (NCT04509947) phase 3 trials (NCT04505722) and (NCT04614948) Authorized for emergency use in the United States, the European Union, Canada, and other countries. WHO's accepted for EUL Enter Phase four Clinical Trial |
[343] | ||
| Sputnik V or Gam-Covid-Vac | Sputnik V is a combination of two different Adenoviruses, Ad26 and Ad5. Developed by Gamaleya Institute, in Russia. The vaccine is early use in Sputnik Light is a one-dose version of the Gamaleya vaccine that is newly authorized in Russia. |
91.6% efficacy 2 doses with 3 weeks apart/ muscle injection/Freezer storage |
phase 1 trial (NCT04436471) phase 2 trial (NCT04437875) Phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia on Sept 7 and Nov 24, 2020. (NCT04530396). It is authorized for emergency use in Russia and dozens of other countries. WHO's Emergency Use Listing (EUL) will be decided after all data are submitted and inspections completed |
[341], [375], [376] |
||
| AstraZeneca (AZD1222) also known as Vaxzevria and Covishield in India | Non-Replicating Recombinant Viral Vector. Developed by Oxford-AstraZeneca in the UK using a chimpanzee adenovirus vaccine vector (ChAdOx1). |
76% in a U.S. study/ 2 doses/3 weeks interval Muscle injection/ Stable in the refrigerator for at least 6 months |
phase 1/2 clinical trials in South Africa (NCT04324606) phase 2/3 trials in the UK (NCT04400838) Phase III trial in Brazil (NCT04444674) Approved in Brazil and authorized for emergency use in dozens of countries. WHO's accepted for Emergency Use Listing (EUL) Enter Phase four Clinical Trial |
[377], [378] |
||
| LV-SMENP-DC | LV-SMENP-DC is a dendritic cells (DCs) modified with a lentiviral vector expressing synthetic minigene SMENP and immune-modulatory genes to modify DCs and to activate CTLs by LV-DC presenting SARS-CoV-2 specific antigens. | Phases 1 and 2 by Shenzhen Geno-Immune Medical Institute, in China (NCT04276896) |
[379] |
|||
| Covid-19/aAPC vaccine | Pathogen-specific aAPC (artificial antigen-presenting cell), modified with a lentiviral vector expressing synthetic minigene based on multiple viral genes to express the viral proteins and immune-modulatory genes to modify the aAPC and to activate T cells | Phase 1 by Shenzhen Geno-Immune Medical Institute, (NCT04299724) |
[380] |
|||
| Coroflu | Coroflu, a Non-Replicating Influenza A virus Vector based on FluGen’s flu vaccine candidate known as M2SR (lacks the M2 gene), is a self-limiting version of the influenza virus, which is modified by insertion of the SARS-CoV-2 gene sequence of the spike protein. CoroFlu also expresses the influenza virus hemagglutinin protein antigen and gets immune responses to both coronavirus and influenza. |
intra-nasal delivery | Pre-clinical development Developed by University of Wisconsin-Madison | FluGen | Bharat Biotech |
[381] |
||
| nucleic acid vaccines (RNA or DNA Vaccines) | S protein | Comirnaty known as tozinameran or BNT162 mRNA | BNT162 mRNA vaccine, encapsulates the nucleic acid in special 80 nm ionizable, glycol-lipid nanoparticles Developed by BioNTech - Pfizer; Fosun Pharma. |
91.3% efficacy/ 2 doses, Muscle injection/storage at –25 °C to –15 °C |
Phase I/II trials are ongoing in Germany (NCT04380701) and China (NCT04523571) Phase 2/3 by BioNTech (Mainz, Germany) and Pfizer (New York, NY, USA) (NCT04368728) The WHO and FDA authorized Pfizer’s COVID-19 vaccine for emergency use. Enter Phase four Clinical Trial |
[382], [383], [384] |
|
Spikevax, (mRNA-1273, Moderna Biotech) |
mRNA-1273 vaccine is a part of the spike protein genetic code embedded in special lipid-based nanoparticles. Developed by Moderna, BARDA, NIAID in the USA. |
More than 90% efficacy/ 2 doses, through muscle injection/storage 30 days with refrigeration, 6 months at –20 °C |
phase I trial (NCT04283461) Phase 2 trial (NCT04405076) phase 3 trial (NCT04470427) WHO's accepted for Emergency Use Listing (EUL) Enter Phase four Clinical Trial |
[385] | ||
| INO-4800 |
INO-4800 DNA is a plasmid vaccine candidate that contains the plasmid pGX9501, which encodes for the entire length of the Spike glycoprotein of SARS-CoV-2. Developed by Inovio company. In the cells by translating this optimized DNA into proteins, the immune system activates to generate a robust targeted T cell and antibody response. |
2 doses (1.0 mg)/ Administered intradermally by Electroporation/ stable at room temperature for more than a year |
A preclinical study in animals showed induction of functional antibody responses and T-cell responses following immunization. Phase 1 on April 3, 2020 in Center for Pharmaceutical Research, Kansas City. Mo.; University of Pennsylvania, Philadelphia (NCT04336410) Safety, tolerability and immunogenic were 100% (38/38) in vaccinated subjects. Phase 2 trials in the United States as well as China and South Korea Approved in Switzerland and authorized for emergency use in many others |
[338], [386], [387], [388] |
||
| ZyCoV-D | ZyCoV-D is a DNA-based vaccine (plasmid) encoding for the membrane proteins of the virus. |
delivered by a skin patch/three doses at an interval of 28 days/ Stable at room temperature for three months |
Phase 3 trial , developed by Zydus Cadila in Indian CTRI/2021/01/030416 |
[389], [390] |
||
| AG0302-COVID-19 | Is a DNA-based vaccine, developed by Osaka University and Takara Bio in Japan | 2.0 mg twice at 2-week intervals |
Phases 2/3 trial (NCT04655625) |
[391] |