AMA Update

New CDC monkeypox guidance, Novavax for kids & Moderna boosters with Andrea Garcia, JD, MPH

Aug 31, 2022

In today’s COVID-19 Update, can kids go to school with monkeypox? Why is Moderna suing Pfizer? Is the government still mailing free COVID tests? AMA's Vice President of Science, Medicine and Public Health Andrea Garcia, JD, MPH, answers these questions and more. AMA Chief Experience Officer Todd Unger hosts.

Visit AMA's monkeypox resource center.

Learn more at the AMA COVID-19 resource center.

Speaker

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

AMA COVID-19 Daily Video Update

AMA’s video collection features experts and physician leaders discussing the latest on the pandemic.

Unger: Hello, this is the American Medical Association's COVID-19 Update video and podcast. Today we have our weekly look at the numbers, trends and latest news about COVID-19 with Andrea Garcia, now vice president of science, medicine and public health in Chicago. Congratulations, Andrea. I'm Todd Unger, AMA's chief experience officer in Chicago.

Well, let's start with the numbers. Nationwide, we're seeing COVID cases decreasing over the past several weeks. What are the numbers? Continue to tell us, Andrea.

Garcia: Well, thanks for having me. And the daily average of new reported COVID cases has continued to fall, which is good news. And, of course, that's a trend that we've been seeing since the beginning of August.

If we look at The New York Times data, they're reporting about 88,000 COVID cases per day. That's down from more than 130,000 per day in mid-July. It's a decrease of about 14% over the past two weeks. And if we look across states, those cases are falling in all but a few states. And some states are seeing pretty dramatic declines, some by about 30% or more over the past two weeks.

Unger: That's fantastic. And in the world of hospitalizations and deaths, are we seeing that continue to fall as well?

Garcia: Well, hospitalizations have continued to fall this week. And that decrease is another one that we've been seeing throughout the month of August. There are about 38,000 people currently in U.S. hospitals with COVID. It's a decrease of about 10% since the start of the month.

The number of deaths reported each day has been fairly flat recently. We're still hovering around just under 500 per day. Obviously, it's far from acceptable. But that number is, of course, much lower than other points throughout the pandemic.

Unger: Well, Labor Day is just around the corner. And, in fact, many parts of the country, kids are already back in school. What are we thinking about in terms of fall boosters?

Garcia: Well, Moderna has asked the FDA for an EUA for its COVID-19 booster shot. And the company's EUA application is based on preclinical data for their bivalent dose that contains the dominant BA.4, BA.5 Omicron subvariant and the original COVID strain. Moderna said its mid to late-stage trial for that vaccine is underway.

If authorized and cleared, they'd be ready to deliver those doses in September. If the vaccine receives authorization and then it's recommended by CDC for use in the population, we would likely see it be available for adults 18 and older. Moderna's application follows Pfizer's. They've applied to the FDA for an EUA for their Omicron COVID booster. And if authorized and recommended, the Pfizer one would be available for those age 12 and up.

Unger: So that could be signed off, I guess, as early as next week. Is that right?

Garcia: Yeah, it's hard to know exact timing. We do know that the CDC's Advisory Committee on Immunization Practices is meeting on September 1 and 2. Once FDA okays and ACIP makes a recommendation, then the CDC director would also sign off and make a final decision, which we know that is the last step in rolling out those new doses. So shipments could begin as early as next week. And that's according to those who are familiar with the plan.

Unger: And we'll have a chance to hear firsthand from the AMA's ACIP liaison, Dr. Sandra Fryhofer, at the conclusion of those meetings. We can share all the details. Moderna and Pfizer also in multiple headlines last week for other reasons, kind of unexpected. Moderna is now suing Pfizer. What's the story here, Andrea? And any impact on fall boosters?

Garcia: So Moderna, on Friday, filed a patent infringement lawsuit against Pfizer and BioNTech for infringing patents central to the mRNA technology platform. And if you look at their press release, Moderna believes that Pfizer and BioNTech's COVID vaccine community infringes patents Moderna filed between 2010 and 2016. And that covers Moderna's foundational mRNA technology, which we know was critical to the development of Moderna's own mRNA COVID vaccine, Spikevax.

In an interview on CNN, Moderna had taken some pains to really narrow the remedy for its grievances in order to limit the impact that this lawsuit could have on public health. They said in a release that they're not aiming to remove Pfizer's vaccine from the market or prevent future sales of that Pfizer vaccine. They've also made it clear that they would not enforce its patent for any COVID vaccine used in the 92 lower and middle-income countries. And I think given all of this, it should not impact fall boosters.

Unger: Well, what may impact fall boosters, however, is a lack of funding. Let's talk about what the latest news is there.

Garcia: So many of the local programs that brought vaccine to places where people in the U.S. gather during our initial COVID vaccine rollout have folded. And we know that there is a lack of additional pandemic response funding for the distribution of these new booster doses. We know the local health departments who are responsible for COVID vaccines are gearing up for flu shots this fall.

They've also been juggling the monkeypox outbreak response. And, of course, with kids going back to school, they're catching kids up on routine immunization. So our public health infrastructure is stretched thin.

Where states can seek money is from FEMA. And that's, for certain, vaccine-related expenses, like setting up site, buying equipment, offering translation or transportation services. But a lot of this rollout is moving to private sites. So states have been promised a really modest amount of $550 million reimbursement and vaccine spending. And for comparison, last year, that figure was about $8.5 billion.

So I think the other consideration when you think about is while these vaccines are supposed to be free for everyone, those with or without insurance, the federal government ran out of money this spring to offer reimbursement for shots for the uninsured. So that's going to make it more difficult for them to access these new boosters.

Unger: And that's quite a reduction in the spending from $8.5 billion down to $550 million. We've also seen that kind of lack of funding affect testing. What do we need to know about that?

Garcia: Well, the federal government announced that they're pausing the program they've set up to send free COVID testing kits. And that pause will start in September. According to their website, they'll be taking orders through Friday, September 2. But due to insufficient funding from Congress, they're not going to replenish the nation's stockpile of tests.

The administration started this program back in January. They've distributed 600 million COVID tests nationwide. I think the hope is that while we are still dealing with a highly contagious Omicron variant, free and accessible testing would help slow the spread of the virus. The good news is many people can still get free tests through private insurance or Medicare or Medicaid.

Unger: Well, in somewhat better news, parents will now have the option of another COVID-19 vaccine to choose from for their children. What can you tell us about that, Andrea?

Garcia: Now, early last week, we saw the CDC director recommend the Novavax vaccine as another COVID-19 vaccine primary series option for adolescents age 12 to 17. That, of course, followed the FDA's EUA for this age group. And we know this vaccine has been available for emergency use for adults 18 and over since July. Again, this is a good option for those who want a more traditional, protein-based vaccine.

Unger: Well, in addition to concerns about COVID for the fall for kids going back to school, there are also concerns, of course, about monkeypox. And the CDC released new guidance for schools. What is the news there?

Garcia: So the guidance for schools, daycares, teachers and parents who are concerned about monkeypox really acknowledges that this is a low risk for children and adolescents in the U.S. right now. Symptoms for children infected with monkeypox are largely similar to those we see in adults. But we do need to acknowledge that the CDC says young children, those under eight years of age, may be at increased risk for severe outcomes from monkeypox disease.

Unger: And if there is an exposure of the children at school daycare, do they need to stay home?

Garcia: According to the guidance, most children who have caregivers with monkeypox should be able to attend school and other programs. The CDC said children, generally, do not need to stay home while they're monitoring for symptoms after they've come into close contact with an infected person, whether it's a parent or caregiver. And they advise that schools and daycares really rely on their everyday operational guidance in hand-washing and cleaning surfaces. And that's going to really help reduce the risk of potential cases from the outbreak.

Of course, kids should stay home when they're sick and if they end up developing symptoms. And you can learn more about that guidance for schools, which is in a Q&A format on the CDC website.

Unger: What's the broader picture look like in terms of monkeypox case numbers?

Garcia: According to the CDC, we're hovering right around 18,000 confirmed cases of monkeypox nationwide. Those case numbers have continued to increase. But the speed of that outbreak does appear to be slowing down.

According to CNBC, the new monkeypox cases are falling in major cities like New York and here in Chicago. And the CDC director said that she is cautiously optimistic that vaccination and harm reduction strategies might be slowing the spread of the virus.

Unger: That is good news. So we'll take it, and we'll end on that particular note. We'll continue, of course, to keep an eye on it. Andrea, thanks so much for joining us today. And we'll be back soon with another episode. You can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us. 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.

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