Table 1.
COVID-19 vaccine candidates approved or in phase III trials as of 22 December 2020
| Vaccine | Developer | Immune features | Clinical Trial Identifier | Exclusion criteria for cancer patients | Demographic data (if available) |
|---|---|---|---|---|---|
| mRNA-1273 (lipid nanoparticle-mRNA) | Moderna/NIAID | Expressing S protein; two repeated i.m. doses |
NCT04470427 Phase III ongoing. Emergency authorization by FDA. |
People who have received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before screening. | No cancer patients enumerated at interim data analysis. |
| Comirnaty BNT162b2 (lipid nanoparticle-mRNA) |
BioNTech, Pfizer, Fosun Pharma | RBD of S protein; two repeated i.m. doses |
NCT04368728 Phase III ongoing. Full approval in Bahrain, Canada, and Saudi Arabia; emergency authorization by FDA and EMA. |
People receiving immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g. for cancer. | No cancer patients enumerated at interim data analysis. |
| Ad5-nCoV/Convidecia (non-replicating adenovirus type 5 vector) | CanSino Biologics | Expressing S protein; single i.m. dose |
NCT04526990 NCT04540419 Phase III ongoing. Limited emergency approval in China. |
People with current diagnosis of or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). | No demographic data published or posted on ClinicalTrials.gov. |
| Gam-Covid-Vac (Sputnik V) adenovirus-based (rAd26-S+rAd5-S) | Gamaleya Research Institute | Single dose and heterologous Ad26 prime; Ad5 boost i.m. doses |
NCT04530396 (RESIST) NCT04564716 Phase 3 ongoing. Emergency approval in Russia and Belarus. |
History of any malignant tumors. | n.a. |
| Ad26.COV2.S/JNJ-78436735 (adenovirus type 26 vector) | Beth Israel Deaconess Medical Center and Johnson & Johnson (Janssen) | Expressing S protein; two repeated i.m. doses |
NCT04505722 (ENSEMBLE) NCT04614948 (ENSEMBLE 2).Phase 3 ongoing. |
Malignancy within 1 year before screening, except squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or other malignancies with minimal risk of recurrence. Patients receiving CT, immune-modulating drugs or RT within 6 months before administration of vaccine and/or during the study. | No demographic data published or posted on ClinicalTrials.gov. |
| ChAdOx1 nCov-19 (AZD-1222) (non-replicating viral vector) |
University of Oxford/AstraZeneca | Expressing S protein; two repeated i.m. doses |
NCT04516746 NCT04540393 (COV002 and COV003) ISRCTN89951424 CTRI/2020/08/027170 Phase III ongoing. |
History of primary malignancy except for malignancy with low potential risk for recurrence after curative treatment or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. | No demographic data published or posted on ClinicalTrials.gov. |
| NVX-CoV2373 (protein subunit) | Novavax | Recombinant S protein; two repeated i.m. doses | (UK) 2020-004123-16/2019nCoV-301 (USA) NCT04611802/2019nCoV-301 Phase III ongoing. |
(UK) Current diagnosis of or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator). (USA) Active malignancy on therapy within 1 year before first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). |
No demographic data published or posted on ClinicalTrials.gov. |
| CoVLP (plant-derived VLP adjuvanted with GSK or Dynavax adjuvants) | Medicago/GSK | Two repeated i.m. doses |
NCT04636697 Phase III ongoing. |
Any confirmed or suspected immunosuppressive condition, including cancer. Investigator discretion is permitted. People receiving cytotoxic, antineoplastic, or immunosuppressants within 36 months before vaccination. |
No demographic data published or posted on ClinicalTrials.gov. |
| COVID-19 vaccine (protein subunit) | Chinese Academy of Medical Sciences/Anhui Zhifei Longcom | Two or three repeated i.m. doses |
NCT04466085 (phase II) Phase III ongoing. |
History of any malignant tumors. | n.a. |
| BBIBP-CorV (Vero cell, inactivated) | Wuhan Institute of Biological Products/Sinopharm | Multiple viral antigens; two repeated i.m. doses |
NCT04560881 NCT04612972 Phase III ongoing. Limited emergency approval in China and UAE. |
History of any malignant tumors. | n.a. |
| BBIBP-CorV (Vero cell, Inactivated) | Beijing Institute of Biological Products/Sinopharm | Multiple viral antigens; two repeated i.m. doses |
NCT04560881 NCT04510207 Phase III ongoing. Full approval in UAE and Bahrain. Limited emergency approval in China. |
History of any malignant tumors. | n.a. |
| CoronaVac (inactivated) | Sinovac Biotech | Multiple viral antigens; two repeated i.m. doses |
NCT04456595 (PROFISCOV) 669/UN6.KEP/EC/2020 NCT04582344. NCT04617483 Phase III ongoing. Limited emergency approval in China. |
Use of CT or RT within 6 months before enrollment or planned use within the 2 years following enrollment. History of malignancy or antineoplastic CT, RT, immunosuppressants in the past 6 months. |
No demographic data published or posted on ClinicalTrials.gov. |
| Covaxin (inactivated) | Indian Council of Medical Research/Bharat Biotech | Multiple viral antigens; two repeated i.m. doses | CTRI/2020/11/028976 Phase III ongoing. |
Treatment with immunosuppressive or cytotoxic drugs or use of anticancer CT or RT within the preceding 36 months. | No demographic data published or posted on ClinicalTrials.gov. |
| CVnCoV (lipid nanoparticle-mRNA) | CureVac | Two repeated i.m. doses |
NCT04652102 EudraCT-2020-004066-19 Phase III ongoing. |
Current diagnosis of or treatment of cancer. | No demographic data published or posted on ClinicalTrials.gov. |
| AG0302-COVID19 | AnGes/Osaka University/Takara Bio | Two repeated i.m. doses |
NCT04655625 Phase III ongoing. |
Drugs that affect the immune system such as DMARDs, immunosuppressants, biologics. | No demographic data published or posted on ClinicalTrials.gov. |
| ZF2001 (protein subunits) | Anhui Zhifei Longcom/Chinese Academy of Medical Sciences | Adjuvant + spike protein RBD; two repeated i.m. doses |
NCT04646590 Phase III ongoing. |
Cancer patients (except basal cell carcinoma). | No demographic data published or posted on ClinicalTrials.gov. |
| SCB-2019 | Clover Biopharmaceuticals/The Coalition for Epidemic Preparedness | AS03-adjuvated recombinant trimeric S-protein; two repeated i.m. doses |
NCT04672395 Phase III ongoing. |
Treatment with immunosuppressive therapy (cytotoxic agents, systemic corticosteroids) or planned receipt during the study period; history of malignancy within 1 year before screening. | No demographic data published or posted on ClinicalTrials.gov. |
| Vero cell (inactivated) | Chinese Academy of Medical Sciences | Two repeated i.m. doses |
NCT04659239 Phase III ongoing. |
History of malignant tumors. | No demographic data published or posted on ClinicalTrials.gov. |
| BCG | Murdoch Children's Research Institute | BCG |
NCT04327206 (BRACE) Phase III ongoing. |
History of any malignant tumors. | n.a. |
All Covid-19 vaccine phase III trials ongoing are reported with details about cancer patient eligibility.3
Abs, antibodies; Ad, adenovirus; BCG, Bacillus Calmette-Guérin; COVID, coronavirus disease; CT, chemotherapy; DMARDs, disease-modifying antirheumatic drugs; EMA, European Medical Agency; EU, European Union; FDA, Food and Drug Administration; GSK, GlaxoSmithKline; i.m., intramuscular; mRNA, messenger RNA; n.a., not applicable; NIAID, National Institute of Allergy and Infectious Diseases; RBD, receptor-binding domain; RT, radiotherapy; S protein, spike protein; UAE, United Arab Emirates; VLP, virus-like particles.