COVID-19 Vaccine Update: When will a COVID-19 vaccine be available?

COVID-19 Vaccine Update: When will a COVID-19 vaccine be available? 

Quick Digest and COVID Vaccine Updates - December 1, 2020: 

• Globally, there are over 155 coronavirus vaccines being tested across national institutes, and 54 are currently in human trials.
• Although vaccines typically take between 10-15 years to create and perfect, scientists and researchers are pushing to get a vaccine out by 2021.
• Both Moderna and Pfizer have preliminary phase 3 results that show that their vaccines are over 90% effective.
• The distribution of a vaccine may begin in early 2021, but we will likely need to wait until the spring until people can easily get vaccinated.
• The cost of a vaccine will likely be under $30 per dose.
• Moderna and Pfizer are both seeking FDA approval for their vaccines.

Dr. William Petri, MD, Ph.D. was interviewed for information on the development of a COVID-19 vaccine. Dr. Petri is the Vice-Chair for Research of the Department of Medicine and The Chief of Division of Infectious Diseases and International Health at The University of Virginia. He is currently working on the development of a COVID-19 vaccine.

How long until the COVID-19 vaccine becomes available?

The development of a vaccine is usually a process that takes anywhere from 10 to 15 years. The development of the coronavirus vaccine is highly expedited and the first vaccine should be approved by early-mid 2021. 

Dr. Fauci predicts that we could have an approved vaccine as early as April 2021. However, having an approved vaccine does not mean that we will all be able to immediately get it. Moderna CEO, Stephane Bancel, believes that everyone in the U.S. will be able to get a vaccine by June 2021. 

How is the COVID-19 vaccine being created so quickly?

The preclinical phase, which includes laboratory and animal studies, typically takes between 3 and 6 years. However, the COVID vaccine timeline is highly expedited. This process is made possible by the increase in government funding, shortened testing timelines, advances in technology, and previous knowledge of other coronaviruses. Additionally, rather than following the aforementioned testing phases in sequential order, researchers have been granted permission to run multiple phases simultaneously.

For example, phase I clinical trials last a full year. However, pharmaceutical companies will be allowed to begin phase II and III before phase I ends. Even once a vaccine is on the market, it will likely be subject to changes and improvements over the next several years in order to increase its efficacy.

What are the most promising COVID-19 vaccines in-development?

The federal government identified 5 vaccine candidates for Operation Warp Speed, an initiative that aims to help get a vaccine to the market as soon as possible. These candidates seemed the most promising in terms of producing a safe and effective vaccine by 2021. In addition to these 5 promising vaccines, several other companies have high hopes of producing effective vaccines within the next year. 

The 5 companies are Moderna, a collaboration between Oxford University and AstraZeneca, Johnson & Johnson, Pfitzer, and Merck. The goal is to have the vaccine ready by early next year. And if one of these companies are able to do so, it would be setting a record as no vaccine has ever been developed so quickly. The current record for vaccine development is currently only 4 years. 

Pfizer and BioNTech

Pfizer is collaborating with BioNTech and Fosun Pharma to work on a messenger RNA (mRNA) based vaccine. This vaccine is currently in Phase III of clinical trials. The vaccine showed to be 95% effective in preventing COVID-19 in a sample of 43,538 participants. Individuals who received this vaccine only experienced mild side effects, such as fatigue in 3.7% of recipients. 

The Pfizer vaccination includes two shots which must be given 3 weeks apart. One drawback of this vaccine is that it must be stored at very cold temperatures, which may make distribution difficult. They expect to produce 50 million doses by the end of 2020 and 1.3 billion doses in 2021. Pfizer may request Emergency Use Authorization from the FDA in the coming months. 

Moderna 

Moderna is currently in phase III of clinical trials, where the vaccine has been tested on 30,000 people. This vaccine is also using messenger RNA (mRNA). The vaccine showed to be almost 95% effective so far. Participants only experienced mild side effects, such as fatigue and headache after injection. 

The Moderna vaccination includes two shots which must be given 4 weeks apart. Moderna's vaccine can be stored at slightly warmer temperatures than Pfizer's vaccine. In a press release, Moderna noted that they expect to have 20 million doses by the end of 2020

Oxford, AstraZeneca 

The vaccine developed by scientists at Oxford is currently in phase III of clinical trials. The vaccine is based on a common cold virus in chimpanzees (ChAdOx1). This virus has been modified to express a spike protein from the COVID-19 virus. 

Oxford temporarily stopped trials to investigate a volunteer who got sick. The Food and Drug Administration (FDA) reviewed that case and deemed it safe to resume. Oxford's current trial includes 50,000 people globally. They expect some results by December 2020. 

Johnson & Johnson

The vaccine being developed by Johnson & Johnson is currently in phase III clinical trials.  Johnson & Johnson is using an adenovirus (Ad26), which is used in the vaccine to prevent Ebola. Johnson & Johnson paused their clinical trials to investigate a volunteer who got sick but found no evidence that the vaccine caused the illness and resumed their trials. 

Johnson & Johnson is currently examining the efficacy of giving two doses rather than one. 

Merck 

Merck is currently working on two coronavirus vaccines. They are working with Themis Bioscience to create a vaccine that uses a weakened measles virus. This vaccine candidate is in phase I trials. 

In addition, Merck is working with IAVI to work on a vaccine that is based on vesicular stomatitis viruses (VSV). This is the same method that was used to produce a vaccine for Ebola. The dose of this vaccine would be taken as a pill rather than an injection. It is currently in phase I trials.