U.S. set to face third Covid winter, this time without key tools and treatments – STAT

Biotech & Pharma
Health Tech
Business & Policy
Health & Science
Team
Exclusive analysis of biotech, pharma, and the life sciences
Topics
Columns
Tools
Events
Team
Account
More
Follow Us
By Andrew Joseph and Jason Mast Nov. 10, 2022
The country is heading into its third Covid winter without crucial tools we’ve relied on at previous points in the pandemic, both as governments roll back their responses and as the virus outruns some of our most important medicine-cabinet defenses.
Free at-home tests are no longer showing up at people’s doorsteps. States are reporting outbreak data less frequently, and globally, testing and surveillance programs have been curtailed. Support for community vaccination campaigns has dwindled. And next year at some point, the U.S. government will stop paying for Covid vaccines and treatments, which could widen gaps in access as the products move to being covered by insurance.
Most urgent for some patients, new variants are undercutting the power of the remaining antibody therapies, both bebtelovimab, used as a treatment for high-risk people who are infected, and Evusheld, used as an extra boost of protection for people who have trouble generating their own immune responses after vaccination.
advertisement
Already, some hospitals in New York City are planning to stop giving bebtelovimab, after federal data last week showed resistant variants accounted for more than 50% of local infections, Priya Nori, an infectious disease specialist at Montefiore Medical Center, told STAT. In some cases, they may still give Evusheld, but after warning patients it may not work.
We’re hosting events nationwide (and virtually) to tackle the biggest questions in health and medicine. Browse our upcoming events to see what’s on the horizon.
“It’s going to be challenging times ahead for the immunocompromised,” said Camille Kotton, an infectious disease specialist who treats such patients at Massachusetts General Hospital.
advertisement
Rollbacks in surveillance could be seen as an example of how the country has entered the next phase of its duel with the coronavirus. With just about everyone having some level of protection — from vaccination, infection, and, increasingly, both — we’ve broadly moved out of the emergency phase of the pandemic. Epidemiologists also don’t see the fundamentals of the outbreak changing dramatically in the near future, barring some unexpected curveball. Given all that — and with limited resources, a strained public health network, and a population that’s largely moved on — the reality is we’re moving to track SARS-CoV-2 more like how we track influenza, with less focus on cases while still tracking hospitalizations and deaths.
But experts worried about the rollbacks note that it was a year ago this month that such a curveball arrived in the form of Omicron, which drove an explosion of cases around the world and sent deaths soaring in the United States. Scientists point to the quick discovery of that variant by researchers in southern Africa as an example of what rigorous surveillance systems can do. If we’re paying less attention, and sequencing fewer infections, it might take longer to notice a new variant. World Health Organization officials have lamented reduced testing and sequencing.
“The lesson from that, and from Delta, is that it is very hard to judge too far into the future,” said Tom Inglesby, the director of the Johns Hopkins Center for Health Security. “You can make reasonable estimates, and we have more people who are vaccinated than last year, more people who have been infected and recovered and so have some level of immunity — those things are good. But if we have a variant that emerges and gets around that protective immunity, we could have very substantial rises in case numbers again. And the job of the U.S. government, public health writ large, emergency management, is to be prepared in the event that that happens again.”
The discussion ties into the broader debate about whether, as President Biden said in September, the pandemic is “over.” Even with the president’s remarks, administration health officials have urged people to remember the threat that SARS-2 poses and to keep up with vaccines, and to get treated if they get infected. Covid is still killing more than 300 people a day in the U.S. If more people were vaccinated and boosted, or obtained  treatment when infected, that number could be far lower, health officials say.
Indeed, the administration has upped its booster campaign in recent weeks. Biden received his updated booster on camera, the health department has ads trying to reach older adults and Black, Hispanic, and rural communities, and health secretary Xavier Becerra has held vaccination events in Nevada, Texas, and California. The administration has also been trying to ensure easy access to the oral antiviral Paxlovid.
Health officials have said that even though free at-home tests are no longer available through the U.S. Postal Service, the government is keeping up with other testing programs, including at long-term care facilities, schools, and rural health centers. Insurers are also required to cover tests.
The Biden administration has blamed Congress for not authorizing more funding to offer more tests, while congressional Republicans have said they’ve authorized plenty of money to fight Covid and that the country has moved past the pandemic.
Inglesby, who for a time served as the Biden administration’s testing coordinator, issued a particular warning about lack of access to easy, and free, testing.
“That will be a grave mistake, because it’s in all of our interests to identify Covid cases as quickly as possible so people can get treatment and get isolated, so they stop spreading disease,” Inglesby said.
Further out on the horizon: The Biden administration will at some point stop extending the Covid public health emergency, and it will expire. Such a move will have major implications for telehealth and millions of people on Medicaid, and it will also end the requirement that insurers cover tests free of charge.
For now, the U.S. remains in a comparably quiet period of Covid. Case numbers have been hovering around 40,000 a day, and even though that’s a drastic undercount as more people test at home or don’t bother testing, hospitalizations and deaths have been flat as well. The national plateau belies regional increases and decreases, with some parts of the Southwest and Midwest seeing increased Covid activity.
Experts are watching closely to see if the quiet period can last much longer. Shifting into winter gives the virus a transmission boost, and the latest forms of Omicron to get attention — with barcodes like XBB, BQ.1, and BQ.1.1 — are building. The most recent U.S. data show the BQs are now causing about 1 in 3 infections.
A piece of good news is that even as these latest variants have built up in other parts of the world, they have not caused nearly as substantial upticks in hospitalizations and deaths as past waves — an indication that the immunity people have built up is protective for most against the worst outcomes.
But epidemiologists note that the U.S. has suffered worse outcomes than European peers throughout the Omicron era in part because of its comparatively low booster rate. Those extra shots become more important as the virus evolves and immunity wanes, particularly for people at higher risk for severe disease — older people and those with other health conditions.
And it’s not just Covid that health systems will have to contend with this winter. After a break from other viruses the past two winters, the country has seen a resurgence of RSV, which is already filling children’s hospitals, and an early arrival of flu. Even if there’s not a massive Covid wave, the circulation of all the viruses could pressure health systems.
“That’s going to strain many hospitals this winter, the sheer combination of these respiratory viruses, with no particular one responsible more than the others,” said David Rubin, the director of Children’s Hospital of Philadelphia’s PolicyLab, which issues Covid forecasts. “It’s going to keep things high and at capacity for a long period of time.”
Even as Covid has become less of a threat for many, the evolution of the virus means it could be a bigger concern for a significant group of people.
If new variants render bebtelovimab and Evusheld ineffective, the roughly 7 million immunocompromised Americans will be left without two vital defenses. While Evusheld boosted protection, bebtelovimab offered crucial treatment for those — such as transplant patients — who take drugs that interact poorly with Paxlovid, the most effective and most commonly used antiviral.
The loss of those medicines will be  devastating for “immunocompromised patients, who felt safe for a period of time,” said Erin McCreary, an infectious disease specialist at University of Pittsburgh Medical Center. “Now they’re kind of back to square one.”
That pending expiration is already affecting medical care. Nori, the Montefiore infectious disease specialist, said her hospital plans to wind down bebtelovimab and Evusheld administration by the beginning of next week, as there’s now less than a 50% chance it’ll be effective.
“When it’s a flip of a coin whether the medication is working or not, that’s not a medication we want to be giving to patients,” said Nori.
Your daily dose of news in health and medicine.
For immunocompromised patients, alternatives to Evusheld and bebtelovimab are slim. Molnupiravir, Merck’s oral antiviral, is available, but of limited use. Remdesivir is highly effective in preventing hospitalization, but has been rarely used because it has to be given intravenously over three days.
Now, with alternatives dwindling, hospitals are trying to make it work. Roy Gulick, head of infectious diseases at Weill Cornell Medicine in New York, said that antibodies could be ineffective “within weeks,” so the hospital system is trying to figure out how to reserve rooms and staff for remdesivir.
“It’s not trivial at all,” he said. “But, yes, we are trying.”
They’re also advising doctors about ways to manage Paxlovid’s drug interactions to make it more broadly accessible.
McCreary said UPMC is still giving out antibodies, but has started allowing more remdesivir use and sent letters Wednesday to Evusheld patients about resistance. She said the center is also try to enroll patients in studies for next-generation preventative antibodies, when possible.
Various companies are indeed working on new antibodies. Yet none appear close to approval, as the virus has mutated at a faster pace than even pandemic-accelerated drug development can move. But that could change quickly if bebtelovimab and Evusheld are pulled from the market.
An executive at an antibody developer noted that the Food and Drug Administration has tended to act fast when it perceives an emergency, as it did when it authorized bebtelovimab earlier this year after limited human trials, because Omicron rendered other antibodies obsolete.
When there are no antibodies … they’ll be in a mode of working that speeds the development of new antibodies coming forward,” the executive said.
In the meantime, Mass. General’s Kotton said she counsels patients to take extra precaution around exposure. Phil Gouzolie, 67, who’s received a heart transplant, said he would probably stop indoor dining — a liberty he took, for the first time since the pandemic began, this spring, after he got his first Evusheld dose.
“It is what it is,” he said. “I don’t like it, but what am I going to do?”
The country has one new tool heading into this winter: For the first time, vaccine makers updated the shots to better match the circulating variants. But uptake so far of these bivalent boosters — which target both the original virus and a form of Omicron — has been paltry: Just 1 in 10 adults have gotten the shot, and 1 in 4 seniors.
The lethargic booster campaign highlights the limits of interventions if there aren’t successful outreach campaigns and if the public isn’t interested. While the administration is hawking the boosters at events like NASCAR races and state fairs, and trying to ensure they’re accessible, the effort and eagerness is nowhere near what the original vaccination campaign looked like back in early 2021.
Marcus Plescia, the chief medical officer at the Association of State and Territorial Health Officials, said vaccine ambassador programs have fallen back with less funding.
“This use of laypeople or community health workers to speak to people they relate to and who relate to them is a really effective way to deal with vaccine hesitancy, particularly in underserved communities,” he said.
So far, Plescia said, “there doesn’t seem to be the uptake of the bivalent booster that we were hoping for. And that is concerning.”
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
General Assignment Reporter
Andrew covers a range of topics, from addiction to public health to genetics.
General Assignment Reporter
Jason is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients.
Coronavirus
drug development
public health
Vaccines
This name will appear with your comment
There was an error saving your display name. Please check and try again.
advertisement
Reporting from the frontiers of health and medicine
You’ve been selected! Subscribe to STAT+ for less than $2 per day
Unlimited access to essential biotech, medicine, and life sciences journalism
Subscribe to STAT+ for less than $2 per day
Unlimited access to the health care news and insights you need

source

Leave a Comment

%d bloggers like this: