As the Department of Health and Human Services makes sweeping changes to policy under the direction of Robert F. Kennedy Jr., the routine annual vaccine review and approval process has become clouded with doubt and uncertainty.
Colorado hasn’t waited for the air to clear. Colorado lawmakers passed a bill earlier this year along party lines, later signed into law by the governor, which directs the state’s board of health to take into consideration recommendations from other high-profile doctors’ groups, not just the CDC panel — the Advisory Committee on Immunization Practices or ACIP — whose membership was overhauled under RFK.
These changes come after vaccine policy became more controversial during the COVID-19 pandemic.
Childhood immunization rates have fallen in recent years, below where experts would suggest for broad community protection. With back-to-school season here and the respiratory virus season approaching, many questions are swirling about new policies and recommendations, CPR Health Reporter John Daley interviewed a key Colorado decision-maker: Dr. Ned Calonge, the state’s chief medical officer.
This interview has been edited for length and clarity
John Daley: I wonder if you could give folks an update on where things stand with fall vaccines. I would imagine you’re getting a lot of questions?
Dr. Ned Calonge: We’ve been getting questions from vaccine providers, and we expect there will be enough vaccines for everyone who wants one this coming season. The supplies for vaccines are managed nationally, and we know providers across the state have already placed orders to assure availability.
Ed Andrieski/AP
Daley: Is there confusion about the schedule, as it’s normally done, coming from the federal government with the new administration?
Calonge: I think the key area of confusion has been the COVID vaccine recommendation for pregnant persons. We are continuing to recommend a vaccine for that group as protective against COVID during pregnancy. The latest version of the ACIP (Advisory Committee on Immunization Practices) recommendations was just silent on that previous recommendation, and there’s been no new evidence of issues of safety in that population. So, we’re telling providers that our recommendation is to continue to follow the recommendation as it was in place in January of 2025.
Daley: So that would be essentially relying on the guidance from the former vaccine panel?
Calonge: Yes. The one additional issue is that the American Academy of Pediatrics is working on putting forward their authoritative vaccine schedule, so that there’s an updated authoritative schedule for providers and states to base their decision-making on.
Daley: When do you expect that’ll be out?
Calonge: Great question. And I don’t have the answer to that. I know that they’re actively working on it.
Daley: And does that tie in with the state law that the legislature passed this past session that gives the state and the Board of Health the option of following guidance from some of these other high-profile medical groups?
Calonge: That’s correct. So the legislation said we could bring in recommendations from other evidence and science-based authoritative bodies, both nationally and internationally, as we set our schedule and as the Division of insurance sets their funding requirements for insurers in Colorado.
Daley: Let’s talk a little bit about flu and RSV vaccines. Has the CDC signed off on those for this fall yet?
Calonge: The only change in the flu vaccine is the elimination of thimerosal, which is a mercury-containing preservative. The last place that had been used was in multi-dose vials for flu vaccine. What the manufacturers have done is take the thimerosal out and moved all of their production to single-dose prefilled syringes. So there is no thimerosal in any other vaccine in the United States. And so this move will take thimerosal out of all vaccines.
Daley: It seems like the biggest questions are still out there about COVID-19 vaccine recommendations, correct?
Calonge: The schedule continues to have the vaccine recommended but with shared decision-making. So the provider would say, ‘Here’s the vaccine, here’s what we know about benefits, here’s what we know about harms.’
Honestly, that’s the way we think you should do vaccines all the time. That it’s a choice issue for individuals to decide whether or not they wanna be immunized. It has full approval for use in people 65 years and older. That’s the Moderna product, and then 6 months to 64 years, if you have an underlying condition putting you at high risk. And then this issue about the availability or the ability to provide shared decision making. So one of the things that is swirling around is whether or not the FDA will undo Pfizer’s EUA (emergency use authorization) for the pediatric COVID vaccines. That one goes down to four months, and if they don’t have that emergency use authorization, then Moderna will be the vaccine that we have available.
Daley: A lot of people are wondering if they’ll be able to get COVID vaccines this fall. And this would be not just for kids, but also adults that want to get them. What would you say to people who have those questions?
Calonge: We have adequate supply for this coming fall of COVID vaccines.
Daley: Will it be the latest updated COVID vaccine?
Calonge: Yes, it’s the one that we have now, and it’s the one that we would continue to use based on what we’re seeing in terms of COVID infections.
Daley: That’s even if they don’t give approval to Pfizer, there will still be the Moderna version?
Calonge: Correct.
Daley: What’s your main message for Coloradans about all this?
The most effective way to prevent these infections during the upcoming fall — we’re talking about influenza, RSV and COVID-19 — is to be immunized. The shots are safe and effective. There are adverse reactions, but they’re very rare.
Ned Calonge
Calonge: The message remains the same… On the whole, when you look at the trade-off between your risk of getting disease — which is still out there for COVID-19, comes back every year, for flu, and now we have new tools against RSV — the best protection is to be immunized.
Daley: And what would you like Coloradans to understand about this new state law that’s now in effect that gives the state Board of Health the option of following recommendations from these other high-profile medical groups?
Calonge: I think it’s important to know that what Colorado’s done with legislation is to be able to continue our role to share science-based information from a range of these respective public health experts so that Coloradans can make informed health decisions. So that they can make their decisions based on what a range of different experts say. Especially as we’ve seen changes in the federal panel for the ACIP.
Daley: Do you feel like that protects Coloradans and will give them an additional level of safety looking down the road?
Calonge: It’s my strong feeling this gives Coloradans additional choice to protect their health.
Daley: Have you heard of any pushback from the Health and Human Services department on that, or do you anticipate any?
Calonge: We haven’t had any pushback at this point, and I’m always reticent to make predictions, especially about the future.
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