How close are we to a Vaccine?

The traditional route is 10.6 years but with today’s technology, we brought that down to 18 months. In comparison one would agree we’ve come a long way.

Photo by Jakub Gorajek on Unsplash

The traditional vaccine process is a long and complicated process. Only 6% of vaccine candidates are eventually approved for public use and the process takes 10 years with an estimated cost is $1 Billion to $5 Billion dollars.

Thanks to technology and that we don’t live in traditional times anymore, researchers around the world are innovating the vaccine process in real time.

Vaccines prevent disease by boosting a person’s natural immune response against a microbe that they have not encountered before.

There are many different vaccines in development for COVID 19 and they all fall in three categories:

1. Traditional — a vaccine that will kill the virus
2. Protein-based — a modified cold virus that will deliver a protein to stimulate an immune response
3. Gene based vaccines — a virus gene that will stimulate protein for immunity

But regardless of the type, they all must go through the same vetting process before release to the public:

1. Phase 1 — This is the laboratory preclinical trial testing to check whether animals induce immune response and if it causes any medical issues in a small sample of humans.
2. Phase 2 — Once the vaccine is proven safe in animals and with FDA regulations, researchers begin testing in humans on a larger scale to determine the optimal composition, dose and schedule.
3. Phase 3 — This is the final stage before FDA approval for the public. It will collect data on how good the vaccine is at preventing infection and the larger sampling will also show any rare side effects.

The challenge that researchers face is that during any of these phases should any one of them show ineffectiveness or cause harm to people, the researchers must start over with a new candidate.

Once these phases are completed a medical regulatory panel of the FDA looks to see if the vaccine is effective and safe for public use.

How many vaccines are in the pipeline?

There are 94 vaccine candidates in the preclinical phase and eight in trials. Of the eight, there are three in phases 1 and 2:

1) Three that are traditional — which kills the virus

2) Two that are protein based — which will deliver an immune response

3) Three that are gene based — which will contain a COVID 19 gene and when injected a person’s own cells read that gene and make new protein that is part of the virus. By itself it is not dangerous and should trigger an immune response, leading to immunity from the virus.

The United States is developing two of the three gene based DNA vaccines. These two come from U.S. based Inovio Pharmaceuticals and Moderna.

1) Inovio Pharmaceuticals Inc. Pennsylvania-based, Chief Executive Dr. J. Joseph Kim told the U.S. Coronavirus Task Force meeting at the White House on Monday, March 2nd that they have developed a vaccine by the name of INO-4800, which will be ready in April to be tested to the public. Kim said in a statement. “We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people.” https://www.healthline.com/health-news/how-long-will-it-take-to-develop-vaccine-for-coronavirus

i) Inovio is expecting to deliver 1 million doses of vaccine by year-end, using its existing resources, but will need additional resources to scale up to provide further amounts.

ii) The company has finalized the designs for human clinical trials and has developed large-scale manufacturing plans. It is planning to launch trials in the U.S. in 30 healthy volunteers and expects to publish the first results by fall. https://www.healthline.com/health-news/how-long-will-it-take-to-develop-vaccine-for-coronavirus

2) Moderna, Inc. is a Cambridge, Massachusetts-based biotechnology company that is focused on drug discovery and drug development based on messenger RNA (mRNA). The company creates synthetic mRNA that can be injected into patients to help them create their own therapies. It was based on basic science work, whose lab developed a method for modifying mRNA, transfecting into human cells, and dedifferentiating them into stem cells, and then causing them to differentiate into desired cell types. Moderna was founded in 2010 by Derrick Rossi at Harvard who approached fellow Harvard faculty member Tim Springer. They originally named the company “ModeRNA”. https://en.wikipedia.org/wiki/Moderna.

i) In January 2020, Moderna partnered with National Institute of Allergy and Infectious Diseases to develop a vaccine for the SARS-CoV-2 virus. Moderna indicated that they could have a vaccine ready for a phase one clinical trial in people in three months.

ii) On Feb. 24 Moderna said that its coronavirus vaccine mRNA-1273 was ready for human clinical trials. The biotech stated then, that vials of the vaccine had already been shipped to the National Institute of Allergy and Infectious Diseases (NIAID) for use in a U.S. phase 1 clinical study.

The other is from a German company, BioNTech. DNA vaccines are usually used on animals and some were used in the clinical trial for Zika. It has been a struggle to develop DNA vaccines for humans that produce a strong immune response. Should it be fruitful this will be the first time that we will be using a gene based vaccine.

Benefits of Gene-Based Vaccines

These vaccines can be produced much faster and in larger amounts. DNA and RNA will also have longer shelf life over traditional vaccines that use cells and chicken eggs. In additional distribution to rural areas will also be much easier.

Complications

Preclinical trials may not translate well to humans or the level of immunity might be too low. Some people may have an adverse reaction and others could experience “immune enhancement”. This is where the vaccine could make the symptoms worse.

Still a long road but hopeful

Although it is encouraging that the eight vaccine candidates are in Phase 1 and 2 trials, they are not out of the woods yet, and it will be many more months before those challenges are accomplished. Phase 3, on the other hand, typically take between one and four years. However, with today’s technology, if any one of these eight vaccines proved to be effective and safe, though we won’t know for another year, then, we can begin preparation for a wide scale production and distribution.

According to Anthony Fauci, director of the National Institute of Allergy & Infectious Disease we are approximately 12–18 months away.

Depending on what the virus does in the upcoming months, will determine the percentage of population that will need to be vaccinated which could be more than 80% in the United States alone in order for herd immunity.