Recent Approvals in Vaccination Against SARS-CoV-2 and the Omicron Subvariants - Episode 9
Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FNAP, leads a discussion on monitoring long-term data for the safety and efficacy of the SARS-CoV-2 booster vaccines.
Rodney Rohde, SV, SM, MB (ASCP), FACSc: Let’s switch gears. With all of the boosters and different options we have, what do you think about some of the concern people might have around long-term data relating to the efficacy and safety? Do you guys have any science or experiential learning over a couple of years regarding where you think these are in the realm of safety and efficacy?
Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP: I have 1 quick point. I tell them it’s the best-studied vaccine in the history of the world. People say to me, “I don’t think it’s the best studied.” I say, “I’m here to tell you that the statin you’re taking was studied in 3000 patients for approval. Millions of doses have been given; it’s the best-studied vaccine to roll out in the history of our country and of the world.” I use that as ammunition. I also say, “It isn’t being monitored in only this country. Patients can self-report adverse events. We know that from the VAERS [Vaccine Adverse Event Reporting System] data, and people can report that out. We’ve got v-safe [smartphone-based vaccination health check system] and organizations around the world,including in the United Kingdom and Australia, that are monitoring the safety of these vaccines.
In terms of long-term efficacy and safety issues, it was interesting. I got my first vaccine December 18th, 2020. I just got a v-safe update that said, “How are you doing? Any new health issues to report?” There’s ongoing monitoring, but we can rest assured that the vaccines are safer than the native disease. That’s the point I drive home every day. No matter what study you look at, it remains true. Yes, you don’t feel good, but I’d take that any day. Your best protection against long COVID—30% of the US population is affected by long COVID—is to be vaccinated. The more boosters you get, the less likely you are to develop long COVID. I try to use that information as I’m educating people.
Madeline King, PharmD, BCIDP: We have a lot of data and a lot of patients, but we don’t have long-term data because the disease hasn’t been out long enough. We couldn’t possibly have more than 2 years of data at this point. It’s important to drive home some of the points that Wendy mentioned, that we have so many patients who have been vaccinated, with very minimal reporting of adverse effects. It’s also good to remind people to complete their v-safe text messages. I got mine, too. People don’t realize the importance of them. That information gets used. We know a lot of what we know because of people responding to that. It’s important to push that point as well.
Jacinda Abdul-Mutakabbir, PharmD: I agree. It comes down to driving that home with patients, that any time a drug enters the market, we never stop looking at that drug. After we give it to patients, we don’t say, “We’re going to give this vaccine to 100 million people, and then that’s done. We hope everyone’s doing great afterward.” We continue to have them report any adverse events they have, and we’ll continue to do that with these boosters. As Wendy said, even when we think about those initial COVID-19 studies, it takes 10 years to enroll 20,000 patients.
With HPV [human papillomavirus], there were a little less than 30,000 individuals included in the study that we used for that vaccine. It took 10 years to get those people in that study. It took us less than 1 year to get 30,000 people for Moderna and about 40,000 people for Pfizer. We saw so many people in those initial trials. With these bivalent boosters, at the end of the day, we can say that the FDA and CDC [Centers for Disease Control and Prevention] scientists felt comfortable enough to say, “Let’s have these bivalent boosters, because we have strong data with the original vaccines.” As Wendy said—and Rodney reinforced this—it took them a short time to pivot and add the BA.4 and BA.5 to update that vaccine. We have to draw on the fact that we saw so many of these doses go out with the original series. We saw the protection it afforded, and we saw the safety and efficacy, so we expect that to be the case with the bivalent boosters. But we aren’t going to stop reporting on the adverse effects that they may have.
Technology may be a barrier for certain communities. The VAERS wasn’t super user-friendly for some of the older patients. I fall in that category as well. I’m terrible with QR [quick response] codes. Sometimes that could be a barrier. Communicate with your primary care provider and your pharmacist so that information can be uploaded. They can guide you in making sure that’s submitted. But let’s reinforce the necessity of communication strategies from us as providers at the micro level and then at the macro level, ensuring that we continue to push VAERS as we roll these new vaccines out.
Rodney Rohde, SV, SM, MB (ASCP), FACSc: All excellent points. I just did a v-safe, too. It was several weeks ago, but I remember signing up for that. If you didn’t realize that you can participate in these types of things, ask. Ask when you get a vaccine or when you’re doing something. There’s often a simple app. You can do it on your phone. It might be that you go to a computer where you’re getting the vaccine. There are different ways to do it. You can absolutely sign up and report that you had a rough headache and a sore arm or whatever happened after the vaccine. That’s important information. Those are data that we’re collecting. You can also participate in clinical trials. Some people are willing to do that. That’s how we get efficacy and safety not only in our vaccines but also in our medications and cancer treatments.
Speaking to Wendy’s point, I’d tell patients that it’s the most studied vaccine ever. In the middle of the pandemic, when people were a little hesitant, I’d say, “If you don’t get this vaccine and you end up in the hospital with severe COVID-19, and maybe you’re going to be ventilated, then you’re going to approve an EUA [Emergency Use Authorization] monoclonal therapy? It’s the same thing. What if you were dying from cancer and you had no options, and the physician said, ‘We have an experimental cancer drug that we can get under a special order that’s showing outstanding effectiveness in cell culture in vitro; would you like to try it?’ These things happen all the time in medicine, and you can rest assured that people are going to do it in the safest and most careful way. There are some risks, but it’s better than ending up on a ventilator or mortality happening.”
That was something I’d use. Analogies and examples like that are critical because people sometimes need to be told, “What are you doing? You’re refusing the most studied thing in the world, and it’s relatively safe. It keeps you out of the hospital.”
Transcript Edited for Clarity