A CV va-xx-ine, or several, are likely around the corner. Here is what you need to know.

Emergency Use Authorization


As of the date of publication of this article, two companies have already or are in the process of applying for Emergency use of their product through the FDA. Several more are likely in the near future. This is basically a process to help speed a product to market in times of emergency. 


Given the data made available and the case load around the globe, it is highly likely that the applications will be approved. There is a meeting set for early December, so my best guess is that these will be approved by early to mid-December with distribution starting within 24 hours of approval.  Because of Warp-Speed, the companies have several million products ready to go and are likely to start distributing within hours of approval.


Some of the products need to be shipped frozen so that could pose some distribution issues and delays, but it should not be a major issue as several other vax—ines are normally shipped frozen so most doctors are used to handling this.



What is the data?


So far, the data that has been made public is very limited. What has been released is that the two front running candidates have 90+% efficacy in their clinical trial while another has 70+%.  Basically, that means that in the trial, most of the people that tested positive received the placebo, not the shot. If true, these numbers are of course, very encouraging, but it is important to keep in mind, that these numbers are based on a very small amount of cases. 


As more data emerges over time, those numbers may change. There of course is also no way, at this point, to know for sure if the data was reported accurately, but one would hope that these clinical trials were run ethically and morally and subject to review by outside experts (but with big companies, you really never know so there will certainly be doubt over these results for some time).


No major common side effects have been noted so far that I am aware of. Again, this is another bonus, but the data is unlikely to be able to give any true indication of severe, uncommon side effects until many more people get the product.


What about long-term complications?


This is probably the most common question I get and it has an obvious answer. We have no idea if there could be any long-term issues. You can’t really know about anything long term, until it has been long-term from the time the product is given. 


That does not mean you should or should not get it, it is just a fact. In times of crisis, such as bioterrorism or war, things need to be created faster than usual. Sometimes you have to go on faith that a product will work. You can’t know the consequences until you have lived long enough to see if there are any, so each person will have to decide what risk they are willing to take without having any long-term data.


The lack of long-term data is not really a reason for or against getting this for yourself and your family. It just is what it is. You are going to have to make a decision without this information. There is no way to have long-term data on a new product.



Will you be forced/required/mandated to get it?


Only time will tell. There will certainly be many factors that come into play on this question including the effectiveness of the product over the next year, the amount of disease still in the community, the side effects noted, etc.


My gut is that it will likely be required in many locations. Business, including airlines, may require it, school may require it, some countries may require it. That may not be what you want to hear, but I imagine that things are headed in that direction and I am just giving my honest opinion.


That will not happen for a long time as there won’t be enough doses to require anything on mass for at least 6 months to a year.


What are the side effects we do know of?


Most documented side effects are fairly mild and are the common ones you think of including, pain, swelling, fever, fatigue, headaches, etc.



Isn’t this new technology? Should I be terrified?


Yes, it is new. You should have a healthy skepticism about any new technology. That doesn’t mean you should or should not get the product. That is a personal decision (at least for the foreseeable future) and you have to weigh the risks and benefits for yourself at the time you have to make the decision.


We can only hope that everyone has the best intentions here when creating these new products. It is easy to understand why many people would be nervous about trusting big companies. I certainly have a tough time trusting big corporations. Hopefully the checks and balances in place for the clinical trials have kept them in line and hopefully they want a safe product that works well so that their product is ultimately the one that most people get.



What will happen once the FDA gives the EUA?


Details on distribution are still being worked out but from what I have read, first responders will likely get first dibs (police, fire, healthcare).  Second wave will go to underserved populations, elderly and prisons. Third wave will go to the general public. It is estimated that it will take 4-6 months to start having them available to the general public. 


Children are not likely to receive these until after adults get them as they have not been tested on young children and children tend to have a much lower risk than adults.


Also, keep in mind that for the two front running candidates, you will likely need 2 doses, spaced several months apart so that means it will take longer for everyone to get them.



Will things go back to normal after these are distributed?


Geez, I hope so. If someone has a crystal ball and wants to let me in on the future, I would love to know and would be happy to share what I find out.



Stay Safe,

Dr. Gator


Leave a Reply

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

Post comment