Written by Alex Sperry, Pharmacy Intern, MCW
What is the Importance of a COVID-19 Vaccine?1,2
SARS-CoV-2, better known as COVID-19 was discovered in late 2019 in a Chinese wet market from an unknown patient. Since then the virus has spread to the whole world, resulting in a global pandemic. Currently, as of July 16, 2020, the CDC reports that there have been 3,483,832 cases, and 136,938 deaths in the US. For perspective, that’s is an average of 1062.9 cases for every 100,000 people which means that ~1 person out of 100 people get the virus. Keep in mind, this data is only from January 21st– July 16th.
Some compare the virus to the flu stating that the annual flu is more contagious and more deadly. This is not the case. During the 2018/2019 flu season the US had ~35,000,000 cases (exact numbers are still being confirmed, with only 490,561 patients requiring hospitalization. It is fair to say that the flu is currently more contagious, it is not fair to say it is deadlier. Of those who reported positive, ~34,000 died.
That means that on average, if you contract the flu you have a 0.1% chance of mortality, but COVID-19 has a mortality rate of 3.93%. This has caused many clinicians to scramble to create a vaccine to bring this number down.
This list will explain the top 4 vaccines in development, and what you can expect from them. These 4 vaccines are listed in the order that the purposed completion date is set for. The table below consists of terms to explain what the different phases of vaccine development mean, and other important terms.
Important Terms Related to COVID-19 Vaccine Trials3
|Phase 1||Typically, 20 to 80 people. This stage determines a vaccine’s safety.|
|Phase 2||Typically, 100 to 300 people. This stage determines the effectiveness, and appropriate dose of the vaccine.|
|Phase 3||Typically, several hundred to thousands of people. This study gathers more information on safety and effectiveness for overall public.|
|Placebo||A substance that has no effect related to the disease and is used as a control to compare the tested vaccine’s effectiveness.|
|Booster Shot||An additional dose of a vaccine needed to form a full immunity to a virus or maintain that immunity.|
|Recombinant||Broken down pieces of a virus that makes the virus inactive. These broken pieces are given to help form an immunity.|
|mRNA||Tells the body what proteins to make.|
AstraZeneca/University of Oxford – AZD12224,5
AstraZeneca is conducting a phase 2 & 3 study of their product called AZD1222 sponsored by the University of Oxford. A press release on July 11th, 2020 stated that the AZD1222 vaccine study will end as soon as September and could be released to the public if results are promising.
The vaccine is made from a virus called ChAdOx1. This virus is a weakened version of a cold virus that causes infections in chimpanzees. It has been made to work in humans and simulate the SAR-CoV-2 virus and allow you to build an immunity.
This vaccine will be compared to a placebo of the meningitis vaccine. Previously the vaccine was only tested in patients who were 18-55 years old. However, the phase 3 trial is now being tested in age groups that consist of 56-69, those 70 and up, as well as children age 5-12. Only patients who have not had COVID, are eligible to enter this trial. This vaccine may require a booster shot which would be ~4 months after the initial shot. Researchers are still determining if this would be needed.
Other names of this vaccine are: COV002, COV001 (Original Phase 1 and 2 Study)
Latest Trial Name on Clinicaltrials.gov: NCT04400838, NCT04324606 (original Phase 1& 2 Study)
CanSino/Intitute of Biotechnology, Academy of Military Medical Sciences – CTII-nCoV6
CanSino is conducting a Phase 2 study for their vaccine called CTII-nCoV. This vaccine works similarly to both AstraZeneca’s AZD1222 vaccine, and Moderna’s mRNA-1273 vaccine. This is made or a recombinant strain of coronavirus and will bind to the same area in the body as AZD1222. How it differs, is that instead of your body only forming antibodies to fight off the virus, it also adds an mRNA, similar to how mRNA-1273, to prevent the virus from replicating by causing the virus to make the wrong proteins.
This study is set to complete on January 31st, 2021, to determine if it will be effective to the public. The vaccine will be compared to a placebo to determine its effect. The current data of this trial shows that a booster shot may not be necessary, unlike AZD1222.
Other names of this vaccine are: JSVCT089
Latest Trial Name on Clinicaltrials.gov: NCT04341389
Moderna/National Institute of Allergy and Infectious Disease – mRNA-12737
Moderna is conducting a Phase 1 & 2 study for their vaccine called mRNA1273. This mRNA codes for proteins in the COVID-19 virus that causes the virus to not replicate in the body, making the virus ineffective. The mRNA is placed in an lipid-nanoparticle (LNP) which allows the body to absorb the vaccine more effectively than administering the mRNA alone.
This study, along with their phase 3 study, is expected to be completed on November 22nd, 2021. The developers would then determine if it would be effective to mass produce. The developers have yet to state if they believe a booster will or will not be needed. This trial is currently not being tested again a placebo.
Other names of this vaccine are: 20-0003
Latest Trial Name on Clinicaltrials.gov: NCT04283461
Pfizer/BioNTech SE – BNT162b1, BNT162b2, and BNT162b38
Pfizer is conducting a Phase 1, 2 & 3 study for their vaccine currently called BNT162b. Currently Pfizer is testing 3 different versions of this vaccine in Phase 1, to determine which vaccine(s) should be tested further. This vaccine is a recombinant version of the COVID-19 virus.
This study is predicted to be finished on January 23rd, 2023 and determine if it is suitable for the public. It will be tested against a placebo vaccine to determine its effectiveness. The vaccines are also being tested to determine if a booster shot is required. The trial is testing those from 18-55, and those 56-85 to see if a different vaccine is needed based on your age.
Other names of this vaccine are: C4591001
Latest Trial Name on Clinicaltrials.gov: NCT04380532
- CDC COVID Data Tracker. Centers for Disease Control and Prevention. https://www.cdc.gov/covid-data-tracker/. Accessed July 17, 2020.
- Disease Burden of Influenza. Centers for Disease Control and Prevention. https://www.cdc.gov/flu/about/burden/index.html. Published April 17, 2020. Accessed July 17, 2020.
- Center for Biologics Evaluation and Research. Vaccines. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/vaccines. Accessed July 17, 2020.
- Oxford COVID-19 vaccine to begin phase II/III human trials. University of Oxford. https://www.ox.ac.uk/news/2020-05-22-oxford-covid-19-vaccine-begin-phase-iiiii-human-trials. Accessed July 17, 2020.
- A Study of a Candidate COVID-19 Vaccine (COV001) – Full Text View. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04324606. Accessed July 17, 2020.
- A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) – Full Text View. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04341389. Accessed July 17, 2020.
- Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) – Full Text View. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04283461. Accessed July 17, 2020.
- Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults – Full Text View. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04368728?recrs=d. Accessed July 17, 2020.