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Everyone six months and older needs to get the updated COVID vaccine (2023-2024 Covid vaccine). Joining to discuss why and when people should get it, as well as how much it’ll cost, is Sandra Fryhofer, MD, the AMA’s immediate past board chair and liaison to ACIP, the CDC's Advisory Committee on Immunization Practices. AMA Chief Experience Officer Todd Unger hosts.
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Sandra Fryhofer, MD, immediate past chair, AMA Board of Trustees; and AMA liaison, ACIP
Unger: Hello and welcome to the AMA Update video and podcast. Today we're discussing the new COVID vaccines, including who can get them, who most needs them and when. Here with us today is AMA's in-house immunization expert, our AMA ACIP liaison and the AMA's immediate past board chair Dr. Sandra Fryhofer. I'm Todd Unger, AMA's chief experience officer in Chicago.
Dr. Fryhofer, thanks so much for joining us today.
Dr. Fryhofer: Well, thanks for having me.
Unger: This is big news. But before we get into the details, let's get right to the bottom line. Who can get the updated vaccines? Who needs it now? And when will they be available?
Dr. Fryhofer: Well, everyone six months and older needs a dose of this new updated COVID vaccine and should get it as soon as they can. This is a universal recommendation, just like what we have for flu vaccine. The old bivalent BA.4, BA.5 Omicron booster is out. It's no longer authorized.
The official name for this new XBB.1.5 monovalent version is the 2023-2024 COVID vaccine, or just call it the updated COVID vaccine. And, Todd, it's been a whirlwind of a week. Monday, September 11, FDA made the announcement. Tuesday, September 12, ACIP had an all-day meeting and made the universal recommendation.
CDC's new director, Dr. Mandy Cohen, approved it almost immediately. And then just 48 hours later, this new vaccine is available to the public. And I plan to get my dose as soon as possible. The recommendation only applies to Pfizer and Moderna mRNA updated vaccines. The updated protein vaccine by Novavax is still under review by FDA.
Unger: Dr. Fryhofer, I want to make sure I understand and folks out in the audience understand. What if you're already up to date on your vaccines? Do you need to get this new COVID vaccination?
Dr. Fryhofer: Everyone six months and older can and should get a dose. Everyone age five and older needs one shot of the updated vaccine. For those age five and older, a single dose of the updated vaccine is all you need to be up to date, regardless of previous vaccination status and even if you've never had any previous COVID vaccinations.
This is because everyone aged five and older is thought to have at least some immunity to COVID from vaccines, from previous infection or both. Those with immunocompromising conditions need a three-dose prime and at least one updated shot. They can also get additional doses of the new vaccine if their physician recommends it.
Younger children, those six months to four years old, may end up getting more than one updated dose. They need a multi-dose prime with two doses of Moderna or three doses of Pfizer. A dose of the updated vaccine can be part of or in addition to that initial series. The same vaccine brand or product should be used for all vaccine doses for kids, for sure.
Unger: Well, thank you for laying out that framework. That's really helpful. Let's go now to timing. How soon can folks get this new vaccine?
Dr. Fryhofer: The new vaccine can be given at least two months after your last COVID vaccine dose. And if you recently had COVID, you no longer have to wait at least three months after infection to get a dose of the updated vaccine. I asked that specific question at the ACIP meeting.
Unger: And that's important because I think we know so many folks having COVID right now, so really good to know that change. Dr. Fryhofer, you said this vaccine is based on the XBB.1.5 strain. We know the virus keeps mutating. Can it protect against the COVID strains that are out there right now?
Dr. Fryhofer: Vaccine manufacturers say they should, so does FDA. In fact, FDA went on record saying studies suggest the new vaccines are a good match against circulating strains. And remember, it takes time to make vaccine. FDA gave the green light to move forward with the monovalent XBB.1.5 vaccine back in June. Pfizer, Moderna and Novavax have done just that.
But the virus keeps changing. However, CDC says more than 90% of circulating viruses are still XBB lineage viruses but with a few additional substitutions as compared to XBB.1.5. EG.5, also known as Eris, is now the dominant variant. It has mutations to help it evade antibodies produced by previous vaccines and previous infection with earlier variants. FL.1.5.1 is second on the list of dominance.
Another variant to watch is BA.2.86, also called Pirola. It's been detected in at least seven states and has more than 30 substitutions in the spike protein. It's not yet a major player, so it's unlikely to account for the recent increase in cases. Preliminary studies in mice, lab data and also in humans are encouraging and indicate cross-protection. The magnitude of neutralization by the updated vaccine against EG.5 and BA.2.86 seem to be sufficient to provide protection.
Unger: Right. Well, let's talk about another topic that's important because, of course, we're approaching flu season. And we've talked before, and probably we'll talk again, about RSV and vaccinations there. What are the guidelines regarding co-administration with other vaccines? Can you do that?
Dr. Fryhofer: The updated COVID vaccine can be administered at the same time as other vaccines, including flu shots and RSV vaccines for adults. It can also be co-administered with nirsevimab. That's the new monoclonal antibody that's given to babies to prevent RSV in the little babies. There is one exception—COVID vaccines should not be co-administered with mpox vaccines.
Unger: All right. And let's talk a little bit about safety and side effects. One thing in the past that we've talked about is a risk of myocarditis. Talk to us a little bit about that. Is there anything else new?
Dr. Fryhofer: FDA and CDC are confident in the safety and effectiveness of these updated vaccines, and their continued safety is constantly being monitored. ACIP thoroughly reviewed available safety data. Side effects are similar to previous mRNA vaccines.
Post-authorization studies have shown that myocarditis and anaphylaxis events are rare. In fact, the risk of myocarditis seems to be much lower with the bivalent vaccine doses as compared to earlier primary series doses. So even in young males, the benefits outweigh the risk. And there's another silver lining. At the meeting, data was presented that suggests previous vaccines and boosters can reduce risk of long COVID.
Unger: And that is a huge benefit that maybe might not be top of mind for folks but really, really important. Dr. Fryhofer, let's talk about cost. What about coverage? And are these vaccines still free?
Dr. Fryhofer: Well, yes and no. Understand that the federal government's no longer footing the full bill. COVID vaccines are now being sold commercially.
Unger: What about cost for those out there? Do we know what that actual cost figure will look like?
Dr. Fryhofer: Well, that question was actually asked at ACIP. And amazingly, the manufacturers revealed their list prices at the meeting. And this was a public meeting, so people all around the country could dial in.
And they're all basically in the same ballpark. For Pfizer, $120 a dose. Moderna's a little higher at $129. Novavax says they'll set their retail price at $130 a dose. But the discount price for the CDC would be $72.50 per dose.
Unger: Would insurance cover that cost?
Dr. Fryhofer: It depends on your plan. ACA, the Affordable Care Act, requires insurance companies to cover most ACIP recommended vaccines without cost sharing beginning no longer than a year after ACIP recommends it. So they must be covered by ACA compliant insurance plans. COVID vaccines are already on the ACIP schedules.
What's more, Section 3203 of the CARES Act expedites insurance coverage specifically for COVID vaccines. It mandates coverage without cost sharing as of January 5, 2021, once a COVID vaccine is FDA authorized or approved, and these are. Also, the vaccines are now covered by Medicare.
Unger: And that's good news. Now, what about people who don't have insurance, the uninsured and the underinsured?
Dr. Fryhofer: Well, this is so important. There are anywhere from 25 to 30 million uninsured or underinsured adults aged 18 to 64. The underinsured includes those in grandfathered plans that don't provide ACA coverage protections. The underinsured also includes people in short-term, limited duration insurance plans.
COVID vaccines are part of VFC, which is the Vaccines for Children program, which means uninsured children can get them for free. But there's not a similar program for adults, although it has been proposed in the president's budget. To fill this gap, CDC has put together a bridge access program for COVID vaccines and treatments. And this program will make vaccine available through public health departments and retail pharmacies, including CVS, Walgreens, and also through eTrueNorth. And this is a pharmacy aggregator that subcontracts with smaller pharmacies.
Unger: Now, Dr. Fryhofer, let's circle back to the Novavax protein-based vaccine. You mentioned up front that the approval authorization we were talking about was for the mRNA vaccines. Where does Novavax stand?
Dr. Fryhofer: FDA approved and authorized only the Pfizer and Moderna mRNA versions. So at this time, the application for Novavax is still under review. FDA agrees there's an urgent need for alternatives to the mRNA platform vaccines. And if or when an updated vaccine is authorized or approved by FDA, it would automatically be included in this new ACIP recommendation, and here's why. The specific language in ACIP's universal recommendations for those six months and older would also apply to Novavax if authorized or approved.
Unger: Dr. Fryhofer, I know a lot of people out there want to forget about COVID and they may have booster fatigue. What do physicians say to their patients to convince them to get a dose of this new vaccine?
Dr. Fryhofer: Physicians are a trusted source of information for our patients. We share truth. We give facts. We instill trust. For COVID, things are not as bad as they had been. But still, each week we're seeing thousands of hospitalizations and hundreds of deaths due to COVID. And in recent weeks, rates of hospitalizations are beginning to increase. I'm certainly seeing more cases in my practice.
We know adults 65 and older and those with multiple underlying conditions are at greatest risk of severe outcomes if they get COVID. We know children age 5 to 17 are less likely to suffer severe illness. Still, hundreds of children in this age group died from COVID in 2021 and 2022. And half of the children who died had no underlying conditions.
There is no group that clearly has no risk from COVID. Even children and adults with no underlying conditions can still experience severe illness due to COVID. A CDC analysis presented at ACIP says this universal vaccination recommendation could prevent 400,000 hospitalizations and 40,000 deaths over the next two years.
Unger: Those are pretty convincing figures. Dr. Fryhofer, any final thoughts?
Dr. Fryhofer: New COVID variants have emerged. Vaccine and infection-induced immunity is beginning to wane. This new vaccine will increase our immune response against circulating variants. This new vaccine will help protect us from COVID.
Our challenge now is to get vaccine into arms. Physician recommendation is so powerful and can help make that happen. Talk to your patients and lead by example and get a dose of this new updated vaccine.
Unger: Dr. Fryhofer, thanks so much for being here and for providing that detailed information about the latest update. That wraps up today's episode. We'll be back soon with another AMA Update. In the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this podcast are those of the participants and/or do not necessarily reflect the views and policies of the AMA.