When will a COVID-19 vaccine be available? How effective will it be? Those are two of the most pressing questions that many ask with the number of COVID-19 cases increasing in much of the U.S.
Unfortunately, the questions cannot yet be answered with a high level of confidence. But there are 23 candidates for the COVID-19 vaccine currently in clinical trials, according to the World Health Organization (WHO). The progress of these candidates can at least provide a clue as to when a COVID-19 vaccine might be available. These are the vaccine candidates and the probability that they will get regulatory approval.
Image source: Getty Images.
In phase 1 testing
The field of early-stage COVID-19 vaccine candidates is crowded. Of the 23 COVID-19 vaccine candidates currently in clinical trials, 18 are in phase 1 studies:
| Organization (s) |
Vaccine candidate |
State |
|---|---|---|
| ANGES / / Takara Bio / Osaka University | DNA vaccine | In phase 1/2 study. |
| BioNTech (NASDAQ: BNTX) / / Pfizer (NYSE: PFE) |
BNT162 (Four candidates) |
In phase 1/2 study. |
| Bharat Biotech | Whole virion inactivated vaccine |
In phase 1/2 study. |
| Cadila Healthcare | ZyCoV-D | In phase 1/2 study. |
| Clover Pharmaceuticals / GlaxoSmithKline / / Dynavax | SCB-2019 | In phase 1/2 study. |
| CSL / Sequirus / University of Queensland | Molecular clamp stabilized spike protein with MF59 adjuvant |
In phase 1/2 study. |
| CureVac | CVnCoV | In phase 1/2 study. |
| Genexin Consortium | GX-19 | In phase 1/2 study. |
| Gamaleya Research Institute | Gam-COVID-Vac | In phase 1/2 study. |
| Imperial College London | RNA vaccine | In phase 1/2 study. |
| Inovio Pharmaceuticals | INO-4800 | In phase 1/2 study. |
| Novavax (NASDAQ: NVAX) | NVX-CoV2373 | In phase 1/2 study. |
| Institute of Medical Biology / Chinese Academy of Medical Sciences |
SARS-CoV-2 Inactivated Vaccine | In phase 1/2 study. |
| Medicago / GlaxoSmithKline / Dynavax | Plant-like virus-like particle | In phase 1/2 study. |
| Sinopharm / Beijing Institute of Biological Products | SARS-CoV-2 Inactivated Vaccine | In phase 1/2 study. |
| Sinopharm / Wuhan Institute of Biological Products | SARS-CoV-2 Inactivated Vaccine | In phase 1/2 study. |
| Vaxine Pty Ltd / Medy-Tox | COVAX-19 | In phase 1/2 study. |
| Walvax Biotechnology / Academy of Military Sciences of the People’s Liberation Army | ARCoV | In phase 1/2 study. |
Data sources: WHO, ClinicalTrials.gov, company press releases.
BioNTech and Pfizer reported positive results on July 1 for BNT162b1, one of four developing candidates. The FDA recently awarded the Fast Track designation to two of those candidates, paving the way for an expedited review process.
Novavax has also attracted a lot of attention for its candidate for the COVID-19 vaccine. Operation Warp Speed, the US government’s program to accelerate the development of the COVID-19 vaccine, selected NVX-CoV2373 to receive $ 1.6 billion in funding.
What are the chances of FDA approval for a vaccine candidate in phase 1 trials? Very low, at least based on historical data. Only 16% of the experimental vaccines in the initial studies between 2006 and 2015 finally obtained FDA approval, according to an analysis by the biopharmaceutical industry trade organization BIO.
In phase 2 testing
Two Chinese drug manufacturers are currently evaluating COVID-19 vaccine candidates in phase 2 clinical studies:
| Organization (s) |
Vaccine candidate |
State |
|---|---|---|
| Cansino Biologics / Beijing Biotechnology Institute | Ad5-nCoV | In phase 2 study |
| Anhui Zhifei Longcom Biopharmaceutical / Institute of Microbiology, Chinese Academy of Sciences | Adjuvant recombinant protein |
In phase 2 study |
Data sources: WHO, ClinicalTrials.gov, Chinese Clinical Trials Registry, company press releases.
The Chinese military is already using Cansino’s experimental Ad5-nCoV vaccine under a one-year special permit issued by the China Central Military Commission. However, the vaccine candidate is not approved for use outside of military personnel at this time.
Neither of these two candidates for the COVID-19 vaccine is being tested in the US at this time. The odds that an experimental vaccine in a phase 2 clinical trial will eventually get FDA approval is low, according to historical BIO data: less than 25%.
In phase 3 testing (or soon it will be)
There are three leaders in the COVID-19 vaccine career based on the clinical progression of their respective candidates. The COVID-19 vaccine candidates from each of these companies are in phase 3 clinical trials or will soon be.
| Organization (s) |
Vaccine candidate |
State |
|---|---|---|
| AstraZeneca (NYSE: AZN) / Oxford University | AZD1222 | In phase 2/3 study |
| Modern (NASDAQ: MRNA) asdf | MRNA-1273 | Phase 3 study scheduled to begin July 27, 2020 |
| Sinovac Biotech | CoronaVac | Phase 3 study scheduled to start in July 2020 |
Data sources: WHO, ClinicalTrials.gov, company press releases.
Moderna’s COVID-19 vaccine program has received the most publicity in the United States. Biotechnology recently announced the publication of the results of a phase 1 study of mRNA-1273 in The New England Journal of Medicine. Those results showed that Moderna’s COVID-19 vaccine candidate produced neutralizing antibodies (which can prevent viral infection) in all 45 study participants.
Not surprisingly, Moderna ranks as a big winner among biotech stocks in 2020. So far this year, Moderna’s shares are up more than 300%.
Chinese drug maker Sinovac reported in June that its vaccine candidate COVID-19 CoronaVac produced neutralizing antibodies in more than 90% of patients in a phase 1/2 clinical study. The results of a phase 1 study of AZD1222, the COVID-19 vaccine candidate developed by AstraZeneca and the University of Oxford, are expected to be published on July 20 in The lancet medical journal.
It is still too early to know whether any of these vaccine candidates will be successful in late-stage testing. However, 74% of the experimental vaccines that reached phase 3 clinical trials between 2006 and 2015 obtained FDA approval, according to BIO.
