It took 28 years to create a safe chickenpox vaccine, 15 years for a Rotavirus vaccine,  we are 30 years into the HIV era, and we still do not have a vaccine for HIV available.  How realistic is it that we will have a safe, effective COVID19 vaccine available soon? 

COVID-19 has infected millions and killed over 60,000 in the US as of today, April 28, 2020. The US is starting to go back to work.  Many states are opening up, and people are heading back to restaurants and the beaches.  Many other people are staying home and will not be heading back out until a vaccine, or a better drug treatment arrives on the scene.  

No one knows precisely what percentage of people with COVID-19 will die from it.  Let’s assume that it is between 0.1-1%.  If 99+% of people are going to survive this, the bar for vaccine safety is super high.  With the rabid anti-vax folks mulling around, any slip-ups will sink a vaccine campaign quickly.  

What ‘s involved in getting a vaccine to market… why is everyone saying 12-18 months?  

Well… first comes the concept.  Luckily we have been trying to devise vaccines for the coronavirus family since the SARS and MERS days.  So we have some idea of how this family of viruses works.  

Over 90 vaccine candidates are currently in development right now.  

Why are the companies pursuing them so sure they will get to market within a year or two?  Why are you hearing them claim they will be ready to start trials by the end of the year?   Because they need funding!  These companies aren’t speaking to you when they say they might have a viable candidate in a few months. They are talking to the investment community.  There are hundreds of billions of dollars on the line here.  

Most vaccine candidates will fail.  Most drug concepts fail. Either they don’t work, or there are side effects. The odds of a vaccine being safe and effective is under 10%.  That’s one reason why having 90 candidates in trial works in our favor— better odds.   

Vaccine-induced enhancement: 

Did you know that some vaccine candidates (that never came to market) made it more likely to get a severe infection?  It’s true.  It’s a side effect known as vaccine-induced enhancement.  If you are going to inject 300 million people in the US with a vaccine, you need to know that it will not cause vaccine-induced enhancement or any other significant side effects.  If a side effect with an incidence of 0.1% is given to everyone, then 300,000 people could have this side effect.   

Another scientific team is working with a unique mRNA vaccine candidate. It’s a neat idea… but we’ve never made one before.  It sounds exciting, but I’m not sure that I will be the first to get in line for it unless it’s been exhaustively tested.  Besides… mRNA is tricky. It likes to degrade fairly quickly. 

There will be extreme pressure on scientists, observers, and ultimately on the FDA to push a vaccine through the pipeline.  While the FDA performs an independent assessment of the data, it has allowed vaccines to hit the market (long ago) that actually caused the disease it was supposed to prevent.  So… it will likely take a long time to get a vaccine candidate through the review process.  And if that process is rushed, many will sit it out and wait for the data to emerge about safety and effectiveness.  

Testing: 

After your vaccine candidate is identified and funding secured, you need to test the vaccine.  Those are referred to as clinical trials.  They need to progress slowly through these trials to be sure they do not allow a vaccine that doesn’t work or doesn’t cause vaccine-induced enhancement through the process.  If vaccine-induced enhancement typically occurs in less than 1% of people who receive a vaccine, then you can imagine how many people they need to test this on to get to an “adequately powered” trial.  

But testing and data collection timelines can be compressed. Researchers need hundreds of thousands of people for testing to find a rare side effect.  That means that they might consider larger trials through early (emergency) use protocols.  They would need to stay vigilant and be on the lookout for side-effects or enhancement issues and act accordingly if issues arise.  As you can see, this starts to get messy.  We are not talking about an orphan drug approval for 5-10,000 people. We are talking about a vaccine for 330 Million people in the US and billions of people worldwide.  

Production: 

Again… we are not talking about a pill for 1000 people. We are talking about producing billions of doses. And these vaccines will likely be injections. So you need billions of vials, billions of packages, machines to fill billions of vials, and a supply chain to push it out for widespread use.  A few companies have said they have that capacity, but they have only one vaccine candidate out of 90+ potential candidates, and there is less than a 10% chance of success with each vaccine candidate.  

And what if the vaccine that proves to be effective isn’t discovered in the US?  Guess what?  You won’t be first in line for it.

Post-production surveillance:

This will be a critical phase of the overall process.  A vaccine will likely be released before all the risks are known.  There will be a ton of pressure on the manufacturers and the FDA to get a vaccine to market quickly.  Prompt identification of side effects will be critical to mitigating the potential for side effects or intensifying effects.     

What’s the bottom line?

Vaccine discovery is hard.  We have been trying to come up with a coronavirus vaccine for livestock for a very long time… with little success. We have tried to come up with other vaccines, such as those for MERS or SARS, and failed.  But we had success with Ebola. So there is hope.  

For now, plan on continuing with your physical distancing… I do not like the social distancing phrase.  We should be social… just not within 6 feet of each other.  Continue to wear masks.  Not below your nose… not because you were told to, but because you are trying to save your life and the lives of people you will never meet.  

And wash your hands, often, as if your life depended on it.  

Don’t hold your breath for a workable vaccine anytime soon.  

 

 

Disclaimer:  this information is for your education and should not be considered medical advice regarding diagnosis or treatment recommendations. Some links on this page may be affiliate links. Read the full disclaimer.

Related Posts

About the author:

Howard J. Luks, MD

Howard J. Luks, MD

A Board Certified Orthopedic Surgeon in Hawthorne, NY. Dr. Howard Luks specializes in the treatment of the shoulder, knee, elbow, and ankle. He has a very "social" patient centric approach and believes that the more you understand about your issue, the more informed your decisions will be. Ultimately your treatments and his recommendations will be based on proper communications, proper understanding, and shared decision-making principles – all geared to improve your quality of life.

Leave a Reply

Your email address will not be published. Required fields are marked *