In today’s COVID-19 Update, AMA Director of Science, Medicine and Public Health Andrea Garcia, JD, MPH, walks through the updated CDC COVID-19 Guidance, including what's changed, what hasn't and what it means for kids headed back to school during National Immunization Awareness Month this August. #ivax2Protect
Plus, FDA has authorized a plan for using a partial dose of the Jynneos monkeypox vaccine via intradermal injection to extend supply. This also allows the use of Jynneos to prevent monkeypox in kids under 18. AMA Chief Experience Officer Todd Unger hosts.
Visit AMA's monkeypox resource center.
Learn more at the AMA COVID-19 resource center.
- Andrea Garcia, JD, MPH, director of science, medicine & public health, American Medical Association
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 the AMA's Director of Science, Medicine and Public Health Andrea Garcia in Chicago. I'm Todd Unger, AMA's chief experience officer, also in Chicago. Welcome back, Andrea.
Garcia: Thanks. It's good to be here, as always.
Unger: I think you probably have your hands full because the CDC just announced this past week brand-new guidance. Let's get into that. What, for starters, drove this change?
Garcia: So according to the CDC, we're in a stronger place. We have more tools, we have vaccines, we have treatments to protect ourselves from severe outcomes from COVID-19.
Obviously, we talk about the COVID numbers every week. We know the virus is still very much circulating both here and globally. But overall, we're seeing fewer hospitalizations and deaths compared to earlier in the pandemic.
And given this, the CDC has indicated that they've streamlined the guidance. They're focusing on helping people better understand their risk and how to protect themselves and others. And this includes what actions to take if you're exposed to COVID and what to do if you're sick or test positive.
These new recommendations are really intended to help prevent severe disease. And they also acknowledge that while the pandemic is not over, this helps us move to a point where it is no longer severely disrupting our daily lives. I will say that questions do remain as to how we are protecting persons at high risk for severe illness.
And if there is a winter surge, is there going to be a willingness to put some of these public health measures back in place?
Unger: Well, let's dig in specifically to the changes. What changed the most?
Garcia: So the two biggest changes under the guidance are that people who are exposed to the virus no longer need to quarantine. And that is true regardless of their vaccination status, although they should wear a high-quality mask for 10 days and get tested on day 5. The other big thing here is that routine surveillance and testing of people without symptoms is no longer recommended in most settings.
Unger: And there are many of the other guidelines that we had still in place or are those also changing?
Garcia: Most of them are. So for example, people who test positive for the virus should still isolate at home for at least five days. Wear your mask through day 10.
People are still encouraged to pay attention to their COVID community level for their jurisdiction. Those recommendations still include wearing a mask indoors when the COVID community level is high. And the CDC, of course, is also continuing to promote the importance of being up to date with vaccination to protect people against severe outcomes.
We know that that protection provided by the current vaccines against symptomatic infection and transmission is less than it is against severe disease, and that that protection diminishes over time, especially as we see these emerging variants. And that is why it's important to stay up to date and why if there's a new vaccine that becomes available and you're eligible, it's important to get it.
Unger: Well, there's still some confusion around the day five rule, so to speak, about when people have tested positive for COVID-19, when's it OK to isolate or end isolation? Can you clarify that?
Garcia: Of course. To be clear, the guidance recommends that if you test positive, you should stay home at least five days. And the thinking behind this from the CDC is that you're most infectious during those first five days. The CDC guidance notes that if at 5 days, you are fever free for 24 hours without the use of medication and your symptoms are improving or you never had symptoms, you can end isolation.
But we know based on the data that people can be infectious beyond day five. Some experts have called for a negative test before isolation. The updated guidance from CDC did not recommend a test to end isolation.
They did go on to say if you have moderate or severe illness, you have a weakened immune system, that you should isolate through day 10. If you have confusion, when to end isolation, check with your physician. That's always a good idea.
When ending isolation, you should wear a high-quality mask or avoid being around people who are more likely to get very sick from COVID, those who are older, those who are immunocompromised. And that is until at least day 11.
Unger: And they also provided some guidance on, quote, rebound cases, which happen with and without treatments like Paxlovid. What's the guidance in those situations?
Garcia: If you experience new symptoms or your symptoms worsen after you've ended isolation, you should restart isolation at day zero and talk to your health care provider.
Unger: There we go. On the heels of this announcement, the CDC followed with new school guidance as well, which is pretty important, given that we're just on the brink of kids going back to school here. What do we need to know there?
Garcia: The updated school guidance is part of this effort by CDC to simplify and streamline their existing guidance. The updates bring school guidance in line with their overall guidance. And they're really designed to help K through 12 schools and early childhood programs remain open and support in-person learning.
The updated guidelines remove prior recommendations for cohorting, for quarantine, and for test-to-stay procedures. And they limit recommendations for screening testing to those high-risk situations when the COVID community level is high or in response to an outbreak. The agency's also added detailed information on when to wear a mask, how to manage cases and exposures, and how to respond to outbreaks.
Unger: Good. I think that'll certainly help in planning for the fall. But another way that we're planning for the fall is with variant-specific vaccines. What's up there in terms of development and rollout of those?
Garcia: It was reported this past week that the Pfizer-BioNTech trial will begin for its updated mRNA vaccine–and that, of course, is the bivalent vaccine that also includes the BA.4, BA.5, the variants–that's starting later this month. The trial announcement was included in BioNTech's financial results for the second quarter of 2022. And the company is saying that they'll be able to roll out these updated shots by October.
That's in time for fall boosters, and that, of course, is pending regulatory approval from FDA and a recommendation for use by CDC. We know that the BA.1 Omicron-focused vaccine was shown to produce higher neutralizing antibodies against the variants and those data have been submitted to regulators for review.
Unger: Excellent. And this news comes during immunization awareness month. What's the CDC want physicians to know about this month in particular and to communicate to patients out there?
Garcia: The National Immunization Awareness Month is an annual observance that's held in August. And it highlights the importance of vaccination for people of all ages. It's that opportunity to highlight the efforts of public health and health care professionals to protect individuals of all ages against vaccine-preventable diseases through on-time vaccination.
And it really serves as that important reminder to catch patients up to date during their routine visits and on vaccinations and to–we know those have been disrupted through the pandemic, so this is really important this year. And for those patients who are eligible for COVID vaccinations, physicians, we know, play a critical role in helping patients understand the importance of vaccination and that COVID vaccines are safe and effective.
Unger: That's so important. And we know from our conversation with L.J. Tan last week we're really behind on those routine immunizations and some of the impact of that is starting to be seen.
We've seen polio pop up in wastewater in New York. Time to get back there and make sure everyone is up to date on their vaccinations. Speaking of vaccine-related news, there's been an update on what we talked about last time concerning stretching doses for the monkeypox vaccine. What can you tell us about that?
Garcia: So we talked last week about how FDA was looking at stretching the doses we have of the JYNNEOS vaccine by allowing intradermal injection. And that approach, 1/5 of the current dose could be used to protect against the virus. We talked about how a public health emergency declaration is not enough to give FDA authority to issue that EUA.
We really needed to see the HHS secretary issue a determination under Section 564 of the Federal Food, Drug, and Cosmetic Act, indicating that those circumstances justify emergency use authorization. So shortly after we filmed last week, Secretary Becerra made that determination. And then we saw FDA authorize a plan to use this approach, citing research that the reduced amount of the vaccine is just about as effective.
And the EUA importantly also allows the use of the vaccine in individuals younger than 18 years of age who are at high risk for monkeypox infection. In those individuals, JYNNEOS is administered by subcutaneous injection. So good news.
And according to CNN, this move could increase the number of vaccine doses in the national stockpile from 441,000 over 2.2 million. I think the one thing that physicians have been asking that needs to be clear is that 564 determination only applied to the JYNNEOS vaccine. It was not for antivirals such as TPOXX.
Unger: Very important. That's a 5X reach improvement there. Really needed. Andrea, we'll continue to talk to you and track information about everything that we're facing to make sure that physicians continue to be informed.
That's it for today's episode. We'll be back soon with another COVID-19 Update video and podcast. You can find resources on COVID-19 and monkeypox on the AMA site. Check that out. 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.