Public Health

New FDA warning label for Ozempic and Wegovy—plus how and where to get a free COVID vaccine

. 11 MIN READ

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The updated COVID-19 vaccines are covered by insurance and no one should have to pay for them. AMA’s Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, clears up coverage issues with the latest COVID vaccines, provides an update on the rollout, and shares that nearly half of adults plan to get the updated vaccination. Plus, the side effects of Ozempic and the FDA’s new warning on its label. AMA Chief Experience Officer Todd Unger hosts.

Speaker

  • Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association

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Unger: Hello and welcome to the AMA Update video and podcast. Today, we have our weekly look at the headlines with the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia in Chicago. I'm Todd Unger, AMA's chief experience officer, also in Chicago. Hi, Andrea.

Garcia: Hey, Todd. How are you?

Unger: I'm great. Good to see you. And let's get into the headlines. Number one, COVID. Still big in the headlines—it's been a couple of weeks now since the updated COVID vaccines were authorized. Hearing a lot of things about how that's going. Give us the details.

Garcia: Yeah, so we're definitely hearing about a few hiccups, particularly on the distribution side. And I think it's important to keep in mind that this is the first commercial COVID vaccine rollout since the start of the pandemic. So we're now in a new privatized era for these vaccines, and the transition, I think, has been a little challenging.

Part of that has to do with insurance coverage and payment, and we're seeing headlines from the Washington Post and New York Times and others. They're sharing reports of people going to get the vaccine, only to be told that the vaccines are not covered. And they're being asked to pay up to $200 out of pocket for the vaccines.

Because the government is no longer paying for everyone's vaccines, in- and out-of-network coverage is adding to some of the confusion. It's being reported that some pharmacies are out-of-network for certain people. Other times, the vaccines are not showing up on lists of approved medical expenses, and some insurers have even said that they require prior authorization.

This isn't—is not just happening to adults. We're also hearing it from pediatricians and from parents who had been eager to get their children vaccinated immediately. So there are definitely some frustrations.

Unger: Absolutely, a lot of confusion. Let's just kind of get to the bottom line. Are these updated vaccines covered, or will some people have to pay out of pocket for them?

Garcia: So they are covered, and no one should have to pay for them. Last Wednesday, we know, HHS Secretary Becerra explained that anyone with Medicaid, Medicare or private insurance should have the shot covered without a co-payment. Adults who don't have insurance can request that shot from pharmacies participating in the Bridge Access Program. That federal Bridge Access Program provides vaccines for uninsured and underinsured adults.

And then, uninsured and underinsured kids can get that vaccine from the Vaccine for Children's Program. Under federal law, COVID vaccines must be covered by public and private insurance. And we know that Secretary Becerra has said that HHS is working with those pharmacies to make sure that everyone understands how this works.

The Hill is also reporting that HHS met with representatives from the different health insurance industry groups and they've received commitments that these updated COVID vaccines will be covered. The insurance companies told Secretary Becerra that they had technical issues with covering the vaccines, but that's largely, if not been completely, resolved. For people who did end up paying out of pocket, you should definitely contact their insurance company as soon as possible to get that resolved.

Unger: Now, that's good news and, certainly, definitive direction from Secretary Becerra. Thank you for that Update. So that's the coverage side of this. Let's talk about the supply side.

Because we've also heard that there have been some issues on the supply side, even though Pfizer and Moderna say that publicly, there's not a shortage of vaccines. So what's going on?

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Garcia: Yeah, we've definitely heard pharmacies that have had to cancel appointments because the vaccines haven't arrived. Several of the nation's largest pharmacy chains have acknowledged that this has been a challenging rollout. We know CVS, Walgreens and Safeway have had to cancel and reschedule some vaccines appointment, because they're seeing delays in shipments of the vaccine.

I think we're hearing similar challenges on the physician side. We know physician offices have also not received shipments yet. According to Pfizer and Moderna, they've shipped millions of vaccines, but getting them into arms has been challenging. This sounds a bit like deja vu, going back to those early phases of the vaccine rollout during the pandemic.

Overall, we're hearing reassurance that those supply issues should be resolving week over week. And if you haven't been able to get an appointment, that should be changing very soon.

Unger: I've scheduled mine, so hopefully, it will be there when I get there. Andrea, does this mean that there is actually demand right now, that's kind of exceeding the supply? I know we typically see slow uptake with these rollouts, and there's certainly the very real challenge—booster fatigue.

Garcia: Yeah, so there was a Kaiser Family Foundation poll that came out last week, and that showed that nearly half of adults said that the plan to get the new COVID vaccine. I think we're hearing less enthusiasm from parents about getting their children vaccinated. While the updated vaccine is recommended for children six months and up, that poll showed that fewer than 4 in 10 parents say they expect to get the vaccine for their children.

That's not translating to all vaccines, though. I think that latest survey shows some larger shares of eligible people expecting to get their annual flu shot and the newly recommended RSV vaccine. Most adults say that they have already gotten or expect to get their flu shot, and most adults aged 60 and older say they've already gotten or expect to get that RSV vaccine, which is recommended specifically for that age group. So we certainly have some work to do in making sure that people get those updated COVID vaccines.

Unger: Andrea, we do have new data that shows that one group in particular should be getting their COVID vaccine. Tell us more about that.

Garcia: Yeah, so last week, we saw even more data come out from the CDC indicating the benefits for pregnant people in staying up to date with their vaccine, including the COVID vaccine. There were a number of recently released reports that add to that evidence that vaccination during pregnancy helps protect both the patient and the newborn. One study that was published by CDC showed that getting that COVID vaccine during pregnancy can help protect newborns from those serious illnesses and hospitalizations due to COVID.

That study found that getting the COVID vaccine during pregnancy lowered the chance of COVID-19 hospitals for babies under six months old by 35%, and for those under three months old by 54%. And then, another study showed that 75% of the infants hospitalized with COVID were born to unvaccinated women. So overall, we know that vaccination coverage during pregnancy has been low. It's an opportunity for physicians to help improve those vaccination rates among pregnant persons by making a strong vaccine recommendation and, of course, answering any questions that patients may have about the vaccine.

Unger: All right. Well, we're going to switch gears from COVID to another big headline, and something we haven't talked about much here, and that's Ozempic, the weight loss drug that's been gaining in popularity. Andrea, why is it making headlines now?

Garcia: Yeah, so Ozempic is approved for type 2 diabetes, but it's often used for weight loss. It's been gaining in popularity pretty quickly, and it's not just Ozempic. We know that those prescriptions for weight loss drugs have really soared. There was a report released last Wednesday that came from Trillium Health, which is a data analytics firm. And it showed that health care providers were more—wrote more than 9 million prescriptions for Ozempic and similar drugs in the final three months of 2022.

And that number is likely an undercount, because it's based on insurance claims, and many—we know many health plans don't cover these drugs. The reason it's making headlines is because the FDA added a new warning to the Ozempic label. FDA said the medication will now include a warning about potential intestinal blockage. That legal warning was also added to the weight loss drug Wegovy, which is made by the same manufacturer as Ozempic. 

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The label now reads, because these reactions are reported voluntarily from a population of uncertain size, it's not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure. We know that FDA encourages health professionals and patients to report adverse events on these or any medications to FDA's MedWatch adverse event reporting system.

Unger: That's a good thing for people to know as use, of course, increases. Have there been any other reports about potential side effects?

Garcia: So also this past week, we saw Reuters publish an article suggesting that Wegovy and these other weight loss drugs may be scrutinized over reports of suicidal thoughts. And according to that article, FDA has received about 265 reports of suicidal thoughts or behavior in patients who are taking these or similar medications since 2010. According to an examination Reuters did of the adverse event database, 36 of these reports describe a death by suicide or suspected suicide.

Unger: Wow, so what does the FDA typically do in a circumstance like this?

Garcia: Yeah, so FDA definitely monitors these reports to help decide whether or not further investigation of the drug's safety is warranted, and if needed, they take action to protect patients such as requiring a warning label. Accounts of suicidal thoughts linked to this class of drugs is definitely drawing some attention, including an investigation by European regulators that was announced in July. In a statement to Reuters, the FDA did say it's evaluating these reports, and they're going to decide on what, if any, course of action to take after doing a thorough review.

I think it's important to note, and one public health expert did note this in the article, that there are many beneficial drugs that have rare and sometimes dangerous side effects. And those have to be carefully assessed by regulators. There needs to be transparency around those side effects and they also need to be managed by physicians.

Unger: Well, we'll continue to watch that as more develops, Andrea. Thanks so much for joining us today, sharing these updates. That wraps up today's episode. If you enjoyed this discussion, you can support more programming like this by becoming an AMA member at ama-assn.org/join.

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 video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.

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