COVID 19 4 vaccines Updates!

Last month, we made a blog post about what we see being the top four most likely COVID-19 vaccines. In this last month, we have seen many changes to the vaccines we thought were the most likely vaccines, along with other vaccines we had not mentioned. This is a normal thing to happen in the science world, especially with this pandemic. Due to this, we wanted to post an update to let you know what vaccines we believe are making the most progress and will be the most successful.

Important Terms Related to COVID-19 Vaccine Trials1

Term

Meaning

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’s AZD1222 is still one of top picks for COVID-19 vaccines. Since our last post, more study data has been announced, and this trial also has been accelerated to full Phase 3 status. This vaccine called ChAdOx1 works by imitating the SARS-CoV2- but is much weaker than the actual virus allowing us to form antibodies to fight off the infection.

New data provided shows that the vaccine completely prevented infection in rhesus macaque monkeys. These monkeys did not exhibit the normal pneumonia experienced with COVID-19 and that they had a reduced viral load as well. There was also zero evidence for any immune-enhanced diseases for this vaccine meaning that there was no increased risk of another virus from attacking the host.

The vaccine is still anticipated for a review by the FDA as soon as September of 2020.

Other names of this vaccine are: COV002, COV001 (Original Phase 1 and 2 Study)

Latest Trial Name on Clinicaltrials.gov: NCT04516746

Pfizer/BioNTech SE –BNT162b22,3

One vaccine we still have hope for are the three being tested by Pfizer. When we last posted about this vaccine, we knew that Pfizer was conducting tests on three strains of a vaccine called BNT162b. This vaccine works by introducing a type of mRNA that codes for proteins in SARS-CoV-2, but results in the virus’ death.

On July 27th, Pfizer announced new data showing that their BNT162b2 vaccine may be the most effective of the three. Their vaccine is not only being tested in the US, but in 120 different sites across the world in sites with high COVID-19 cases, to determine its efficiency.

Pfizer is optimistic and states they would be able to seek regulatory review by the FDA as soon as October 2020. What is most notable about BNT162B2, is the side effects were minimal compared to all the other strains that were being tested.

Other names of this vaccine are: C4591001, BNT162-01

Latest Trial Name on Clinicaltrials.gov: NCT04368728

CanSino/Intitute of Biotechnology, Academy of Military Medical Sciences – CTII-nCoV6,7

Another previously discussed vaccine is Cansino’s CTII-nCoV vaccine because it has now finished its phase 2 trial and is set to begin its phase 3 trial. This vaccine works by mimicking a chemical group in SARS-CoV-2 and causing the human body to create antibodies against it. This allows for a high level of antibodies to be produced, resulting in reduced odds of contracting COVID-19 as well as shorter infection times if it is contracted.

This new Phase 2 data shows that their vaccine is safe for patients and requires only one injection. The findings showed that a significant antibody level was detected in the participants showing a great level of success. The immune response was found to not only be rapid but had no serious side effects. They are now planning to launch trials in Africa and other countries with high viral infections, because their data also showed high T-cell involvement. T-cells are what produce antibodies and chemicals in the body to fight off infection. They believe that y introducing this vaccine to participants in countries experiencing many viral infections, that they will be able to accurately test the response in the real world. 

The anticipated trial end will be October 2020 and would go on to review based on the results.

Latest Trial Name on Clinicaltrials.gov: NCT04341389

 

Moderna/National Institute of Allergy and Infectious Disease – mRNA-12738

Moderna created one vaccine we had posted about before. It was the first vaccine to be tested in humans and is one of the furthest along so far. This vaccine works by inserting mRNA which then miscodes for a key protein in SARS-CoV-2 resulting in its death.

This vaccine was the first one to enter Phase 3 trials and began its trial on July 14th. This vaccine has shown promise in its ability to fight the virus, and not requiring a booster shot. The only downside is that this vaccine has undesirable side effects. It has been seen to result in chills, fatigue, muscle pain, and fevers. Now that the vaccine enters Phase 3, the company can determine if these adverse events were due to the vaccine or if it was mere coincidence.

It is predicted that the data from this trial would be available at the end of August 2020, or early September 2020. If the data proves that the vaccine is effective, then it could be the first to be reviewed and/or approved by the FDA.

Latest Trial Name on Clinicaltrials.gov: NCT04470427

 

Written by Alexander Sperry,

Medical College of Wisconsin – Doctor of Pharmacy Candidate 2021

  • 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.
  • 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 August 22, 2020.
  • Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-choose-lead-mrna-vaccine-candidate-0. Accessed August 22, 2020.
  • van Doremalen, N., Lambe, T., Spencer, A. et al.ChAdOx1 nCoV-19 vaccine prevents SARS-CoV-2 pneumonia in rhesus macaques. Nature (2020). https://doi.org/10.1038/s41586-020-2608-y
  • Phase III Double Blind, Placebo-Controlled Study of AZD1222 for the Prevention of COVID-19 in adults – Full Text View. ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT04516746?cond=azd1222&draw=2&rank=. Accessed August 22, 2020.
  • Zhu F-C, Guan X-H, Li Y-H, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet. 2020;396(10249):479-488. doi:10.1016/s0140-6736(20)31605-6
  • A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) – Full Text View. 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 August 22, 2020.
  • A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 – Full Text View. Full Text View – ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT04470427. Accessed August 22, 2020.