Have Coronavirus Vaccines Gone Through Necessary Protocol?
Christy Gray, director of the Division of Immunization at the Virginia Department of Health, recently spoke with WHRV’s Gina Gambony. In this segment of the conversation, they talk about how quickly coronavirus immunizations have been developed.
Gina Gambony Just recently, Dr. Anthony Fauci said that he's concerned about people being wary of receiving a coronavirus vaccine. What do you think scares people? Since you work in the Division of Immunization, I'm sure that you have dealt with this before. What are people afraid of, do you think, about the coronavirus vaccine?
Christy Gray Well, I think the vaccine hesitancy that is out there specific to the COVID vaccine is from several different reasons. And one of them that I've heard very prominently is the concern of how quickly the vaccines are going through the development process of vaccines. And the concern that there might be a few steps that are being skipped in order to get the vaccines to the market faster.
And I, I completely understand that concern, especially for anyone that might not know the development process of vaccines in the U.S.
Because vaccines are given to healthy people to prevent illness, not to treat it, the level of risk-to-benefit must be higher. Because you're giving vaccine to a healthy person, it has to be even less risk associated with it, than something that is being used to treat somebody who may have a very low quality of life or higher level of mortality looming without treatment.
Gina Gambony You have a lot to lose if you're a healthy person. If you get a vaccine that's not up to snuff, you have you have a lot to lose, whereas if you're ill, it's worth the risk to take a medication to try to help you.
Christy Gray Exactly. So the requirements the (Federal Drug Administration) laid out for vaccines are much more rigorous. Not to say that treatments don’t also have to go to those, but because you're giving it to healthy people, there does have to be more benefit there. And the steps that are in place for vaccines to be approved, for the COVID vaccine to be approved, are the same exact steps that any other vaccine has gone through for an FDA approval. They’ve gone through the same human trials first, second, third. And there's also some more exploratory type trials before that, to show proof of concept. But they've gone through the same human trials, same number of people that have to be in those trials before it even gets to the FDA for approval for emergency authorization.
The reason that the vaccines, these vaccines have been able to come to market, if they are approved, as quickly as they have, is because typically the manufacturer is paying the way for these vaccines to go through every step. So, they're paying all the humans that goes through the trials, you know, they're paying for all the work that's involved with all of that, in order for the vaccine to go through each of those steps.
In this scenario, the U.S. government is paying for all of these vaccine steps. And therefore, the manufacturer doesn't have to take time between these steps to secure the funding get to the next step. So, the financial risk to the manufacturer has been removed from the process so that the manufacturer can just focus on making the vaccine.
Another step that’s making this faster is, typically, because of that financial risk, the manufacturer doesn't start building the plant or manufacturing the vaccine in bulk until after the trial. In this scenario, the manufacturer is already doing that. So the vaccine is being manufactured concurrently with the trial. So once the trials end, and the FDA, if they approve it, the vaccine is ready to ship the next day. That is not typical. In a normal, traditional vaccine, the manufacturer gets the okay and then they start mass manufacturing the vaccine.
There are a number of steps, but really the take-home is that the financial risk for manufacturers has been removed because the U.S. government has taken care of all the costs. When going through that process, I also like to remind people about if the vaccine, the government pays for all this, the vaccine get to the FDA, and the FDA says, “No, I'm not approving this,” all that that can get destroyed, it will not go into the market.
Gina Gambony That's interesting, I think this is a big worry.
Christy Gray I completely understand people's concern. And it's really because there's not a lot of communication happening about why it’s come so quickly. And in Virginia, we're definitely going to try to improve that, getting that accurate information out to the public.
Gina Gambony So, no steps have been skipped. They just didn't have the obstacles that would normally be there in the development.
Christy Gray Correct, the financial obstacles.
Gina Gambony Is there any other information about vaccines you think people might not understand?
Christy Gray If you could remind your listeners that if you haven't gotten your flu vaccine, please go out and get it. We really are trying to reduce flu-like illnesses in Virginia to reduce the burden on our health care system, and help protect ourselves, help protect our loved ones. And our health care system to make room for those that are sick from COVID-19. And so definitely go and get your flu shot. It's not too late.
And I also wanted to remind parents that if you if you've delayed your child's Well Child visits, and their routine immunizations, please schedule an appointment today and get them up to date. We are concerned that parents have thought that that's not a reason to go out. You know, we're all doing our part to wear masks and keep up social distancing. But keeping up to date on your routine childhood vaccines is a reason to go to the doctor. It's very important, and many doctors have been making changes to their setup to ensure that getting Well Child visits are safe to the child and the parents. And we don't need an outbreak of a vaccine- preventable disease on top of COVID. So please make your appointment today.