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Thursday, August 4, 2022

Covid has settled into a persistent pattern — and remains damaging

 Our tussle with Covid-19 — after a harrowing introduction and then wave upon wave of infections — seems to have settled into a persistent pattern. It may stay that way for a while.

While Covid is not nearly the threat it once was, transmission of the coronavirus remains at sky-high levels. At the same time, the death rate has dropped thanks to vaccinations and improved treatments, and the overwhelming majority of people in the United States have developed some level of protection, from shots, a previous infection, or some combination of the two.

In some ways, Covid is increasingly looking like other respiratory infections — mild in many people, but sometimes severe in certain high-risk populations.

Ann Falsey, an infectious disease physician at the University of Rochester, is treating Covid patients who are generally elderly, have compromised immune systems, or have serious heart or lung conditions — the same types of people who get hospitalized from the seasonal bugs that most of us shake off.

“It doesn’t remotely look like Covid in someone who’s immunologically naive,” Falsey said, recalling how before vaccines were available people flooded hospitals with cases of widespread pneumonia that are far less common now.

Falsey has studied other respiratory viruses for years, including the four seasonal coronaviruses that cause a decent chunk of common colds. In one 2013 paper focused on two of those viruses, OC43 and 229E, Falsey and colleagues noted that, while they often just caused mild or even asymptomatic infections, they could still occasionally result in hospitalization and death, particularly among the elderly.

In a best-case scenario, perhaps that’s the long-term impact of the SARS-CoV-2 virus.

What remains different for now, however, is that SARS-2 is still killing hundreds of Americans each day.

Average daily deaths have rarely dipped below 300 since last summer. More recently, as the latest Omicron subvariant BA.5 fueled another burst of transmission on top of an elevated plateau of cases, deaths have surpassed 400 a day (though the BA.5 wave appears to have crested). Such levels are far higher than those seen with other respiratory viruses, especially in the summer.

“It’s something that, because we’ve been in this pandemic for so long, we can easily get jaded to,” said Jonathan Abraham, an infectious diseases physician at Brigham and Women’s Hospital in Boston.

Perhaps more worrisome is the fact that many experts don’t foresee much change anytime soon. While there will be ups and downs, some forecasts project 100,000 annual Covid deaths, if not more, for the next several years. Ignoring seasonal variation, that’s some 275 deaths a day.

“It’s hard for me to see, barring any massive change in the way we’re treating the virus right now or trying to manage it, that anything inherent to the virus is really going to change much,” said Stephen Kissler, an epidemiologist at Harvard’s T.H. Chan School of Public Health. “We’re going to continue to see the emergence of variants, we’re going to continue to see spread outside the winter months, we’re probably going to see more spread in winter months in temperate regions — basically any time people are crowding indoors.”

What that means, Kissler said, is that going forward, Covid could generate two to three bad flu seasons’ worth of deaths each year.

That won’t necessarily be the case forever. Many experts see SARS-2 retreating to something more on par with the other human coronaviruses as we keep building up additional layers of immunity. But how long that process takes — three years? five years? 10 years? — remains an open question.

“What are we looking at and how long is this going to go on?” said Vineet Menachery, a coronavirus specialist at the University of Texas Medical Branch. “Is this just how we have to deal with it going forward or is there some relief in sight? I think the honest answer is, we just don’t know. We haven’t seen anything quite like this.”

Beyond deaths, the current level of illness is nothing to shrug off.  Mass infections are both disruptive to society and result in an untold number of cases of long Covid.

Experts note there’s room for improvement with available tools, both by vaccinating those who have not yet rolled up their sleeves and who still account for a sizable chunk of deaths, and by reaching more people with booster shots. U.S. health officials are also still trying to expand access to and uptake of Covid therapies — both those that are given to infected people, like the antiviral Paxlovid that President Biden took during his recent bout, and a treatment called Evusheld, which is given to immunocompromised people who aren’t infected to prevent illness.

But a key reason why the country is still recording several hundred Covid deaths a day is simply because so many infections are occurring. Though there have been regional ebbs and flows, national case counts since mid-May have been greater than 100,000 a day, increasing to 130,000 recently. This is also a massive undercount, given that surveillance efforts have been rolled back and many people either forgo tests or use them at home.

With hundreds of thousands of cases a day, even the small and shrinking percentage of them that result in deaths can add up to hundreds of deaths a day.

So why then, two and a half years into the pandemic, is transmission still so high?

First off, SARS-2 — especially its Omicron variants — has become an incredibly infectious virus, far more so than some other respiratory viruses. The mitigation measures that people carried well into last year, like masking and distancing, have also broadly been cast aside.

At the same time, prior infections don’t protect us from getting reinfected all that well. Neither do vaccinations, although these continue to provide robust protection against severe disease. This is a result of both waning immunity and the mutations different variants have picked up.

It’s not that recovering from an infection or getting a jab provides no protection against future infection. While some reinfections have been documented after just a few weeks, recent studies from Qatar, Portugal, and Israel have all underscored that, generally, people who had recent infections or shots were less likely to become infected. But that type of immunity doesn’t seem all that durable and doesn’t reduce the risk of infection to zero. Essentially, the virus is still finding plenty of people to infect.

All this can help fuel a nasty cycle, too: The more the virus is spreading, the higher the likelihood that better-spreading variants emerge, which can in turn only accelerate transmission.

Even with a virus as infectious as SARS-2, one that is going to burn through huge numbers of people each year, many experts still see us stabilizing into a better place over time.

Many of us, between infections and vaccines, have had three, perhaps four, maybe even five encounters with the virus or its spike protein. It could be that we need even more exposures to really tame the virus.

“If you get infected over and over again, and it seems like that’s going to be the case — in part because of viral evolution and in part because of waning immunity — that secondary, tertiary, quaternary, those repeated infections are probably not going to be as damaging,” said evolutionary biologist Katia Koelle of Emory University.

Those repeated exposures — especially to different variants — should elicit deeper and broader immunity, with a stronger arsenal of fighters like antibodies and T cells, Koelle said. We might still get infected by SARS-2 dozens of times over our lifetimes — just as with the coronaviruses that cause the common cold — but in most instances, it will cause only a case of the sniffles. (In rare events, subsequent infections may make people sicker than earlier cases.)

The repeated training of the immune system in the form of booster shots is particularly important for older people, who have a harder time building up an immune armamentarium against a novel pathogen and see their defenses wane faster than younger people. But over time, people will scale up their immunity when they are younger and carry that with them as they age. People who are 60 now may not be as vulnerable to Covid when they’re 75 as people who are 75 now.

Perhaps our deeper immunity will even extend to a more durable protection against infection, or make us less likely to further spread the virus. With the four seasonal coronaviruses, it’s thought that protection against infection lasts a year or two, though these viruses haven’t been as well studied as SARS-2.

“Is there a threshold amount of immunity that will protect you” against infection? Menachery said. “If you had asked me that two years ago, I would have thought a vaccine and an infection might have been enough. We’re seeing that that’s not enough at this point,” he said, though he added the reason for that is unclear. Is it that the virus has mutated enough to overcome the immune barriers we’ve been able to erect thus far?

All the experts STAT spoke to for this story stressed that predicting the future with SARS-2 is fraught. There are factors they know they can’t predict, such as how the virus will continue to evolve. Will future variants emerge from the drifting of Omicron like we’ve seen throughout 2022, or will something unexpected, like when Omicron appeared, undercut our immunity?

We, as the virus’s host, could also have a trick up our sleeves. The government is planning on rolling out updated Omicron-targeting booster shots this fall, specifically with a component of the BA.5 subvariant, which now accounts for 85% of U.S. infections. Even if some other Omicron sublineage becomes dominant by then, the shots could be a better match against what’s circulating than the original formulation — and could help bolster protection against infection, and in turn act as a drag on transmission.

The updated shot will combine the BA.5 component with the original vaccines that targeted the virus’s spike protein from early 2020. Training the immune system on two variants can lead to a broader response generally, said Meagan Deming, a virologist and infectious diseases physician at the University of Maryland. 

“Hopefully that breadth of immunity will cover whatever [variant] comes next,” Deming said. “And hopefully we can shut down transmission a little bit this fall. We’ll see.”

https://www.statnews.com/2022/08/04/covid-has-settled-into-a-persistent-pattern-and-remains-damaging-it-may-not-change-anytime-soon/

Red Cross beginning to screen blood donors for monkeypox

 As monkeypox continues its relentless spread around the globe, organizations in the U.S. are taking steps to safeguard the nation’s blood supply.

In addition to temperature checks that are part of standard health screens for prospective donors, the American Red Cross is now checking for the distinctive lesions that are a hallmark of the disease as part of routine arm examinations. And beginning in October, the Red Cross will require individuals who have been diagnosed with monkeypox or exposed to someone with a monkeypox infection to wait at least 21 days before giving blood.

“This decision is a reasonable response to prevent transmission of the monkeypox virus given scientific uncertainty about whether it is capable of spreading through blood,” Lawrence Gostin, who runs the O’Neill Institute for National and Global Health at Georgetown Law, told STAT via email.

Worldwide, there have been no reports of transmission of the monkeypox virus through blood transfusion. And the risk of being infected through donated blood remains theoretical. Evidence suggests the virus is spread most commonly through direct contact with lesions and respiratory droplets. But there have been a few reports of monkeypox showing up in the blood of patients.

A study in The Lancet, published this week, found that six out of seven patients diagnosed with monkeypox in the U.K. between 2018 and 2021 had detectable virus in blood samples. And last month, a network of doctors across North America, South America, and Europe studying the current outbreak reported in the New England Journal of Medicine that they had found monkeypox virus in a handful of blood samples taken from their patients.

The blood is the body’s superhighway. And the lesion-causing virus uses it to spread from the site of initial infection to other areas of the skin. But because it’s only recently that the virus has started spreading between people, researchers don’t yet have a good handle on how long it lasts in the blood, or if it persists at high enough concentrations to transmit to others who come into contact with blood from someone who is infected.

“There’s a lot of uncertainty right now about the potential for bodily fluids to cause monkeypox infections,” said Peter Chin-Hong, an infectious disease expert at the University of California, San Francisco. “We don’t know what detection in blood means for transmissibility.”

For that reason, he sees the new Red Cross policy as a useful, if somewhat crude, first step. But he worries that it could be missing some cases.

Historically, monkeypox has caused rashes that erupt around the face and oral cavity before spreading to the extremities, accompanied by a flu-like array of symptoms. But as the virus has spread outside of West and Central Africa — where it is endemic — the pattern of disease it causes has begun to shift. In June, the U.S. Centers for Disease Control and Prevention warned doctors to be on the lookout for symptoms that don’t match the typical descriptions of the disease, including single lesions, often near the genitals, instead of the full-blown rash, and the absence of fever, headache, and lymph node swelling.

Conversely, the policy might keep viable donors away, at a time when the nation’s blood supply is the lowest it’s been in more than a decade. In January, the American Red Cross declared a national blood crisis.

“We know that treatments reduce viral load very quickly,” said Chin-Hong. “So this policy might be raising the red flag where there’s probably low risk, particularly at the end of 21 days. What would be even better would be to move to a molecular screening test, particularly if the virus becomes endemic here.”

Blood banks currently screen for known blood-borne pathogens, like hepatitis B and C, West Nile virus, syphilis, and HIV. Building and validating a similar test for monkeypox would take time. A spokesperson for the American Red Cross told STAT the organization has no immediate plans for adding molecular screening for monkeypox.

The organization’s deferral policy is being implemented “out of an abundance of caution,” she added.

The FDA has not yet issued specific requirements for blood donor deferral as it pertains to the monkeypox virus. blood donor eligibility — like temperature checks and health questionnaires — should be sufficient to prevent individuals with symptomatic infections from donating blood. And she noted that at this time there are no blood screening tests available that could test for the presence of monkeypox virus in the general population.

“For these reasons, there is no current recommendation to ask donors specific questions about risk factors for monkeypox virus,” she wrote, adding that the FDA will continue to work with the CDC to monitor cases and “consider recommendations, as appropriate, as additional information becomes available.”

Currently, the majority of monkeypox transmission is occurring in social networks of men who have sex with men — a community that’s already limited in its ability to give blood.

In 1985, during the height of the AIDS epidemic, the FDA banned gay and bisexual men from ever donating blood. That policy was partially lifted 30 years later, when the agency moved from a lifetime ban to a year of abstinence before giving blood. In April 2020, that deferral policy was shortened to three months. The agency is currently reconsidering the policy, after continued backlash over its discriminatory effects on the gay community and the lack of scientific evidence underpinning it.

“The current decision seems to be a more measured response justified by the high ethical duty to keep our blood supply safe,” said Gostin. “Once science is able to exclude the possibility of bloodborne transmission, the policy should quickly change to prevent any stigma.”

https://www.statnews.com/2022/08/03/red-cross-beginning-to-screen-blood-donors-for-monkeypox/

FDA Says Travere's Sparsentan Data Not Sufficient For Accelerated Approval In One Indication

 

  • Travere Therapeutics Inc  completed its planned FDA Type A meeting for a potential submission for accelerated approval of sparsentan for focal segmental glomerulosclerosis (FSGS), a rare disease affecting the kidney filters.
  • FDA indicated that the interim analysis from the ongoing Phase 3 DUPLEX study and the recent limited additional estimated glomerular filtration (eGFR) data-cut do not meet their threshold to support an application for accelerated approval in FSGS.
  • The FDA indicated that the DUPLEX Study maintains the potential for full approval pending completion of the study and recommends that the company pursue traditional approval based on a two-year eGFR slope. 
  • Travere anticipates having topline data from the DUPLEX Study, including full two-year eGFR data, in 1H of 2023 and filing for full approval in 2H of 2023.
  • The company completed a mid-cycle review meeting with the FDA for its marketing application under priority review for accelerated approval of sparsentan for IgA nephropathy.
  • The FDA indicated that no advisory committee meeting is expected, and it remains on track for the PDUFA target action date of November 17.
  • The company and its partner Vifor Pharma are applying for conditional marketing authorization of sparsentan for IgAN in Europe. Review decision expected in 2H of 2023.

Pfizer takes pipeline blow as it abandons cardiomyopathy drug

 Pfizer has stopped development of a drug to treat cardiomyopathy caused by a rare form of heart disease, after it proved ineffective in a phase 3 trial.

PF-07265803 – a p38 mitogen-activated protein kinase (MAPK) antagonist also known as emprumapimod – was being tested as a treatment for symptomatic dilated cardiomyopathy (DCM) due to a mutation in the LMNA gene in the REALM-DCM trial.

LMNA codes for two proteins, lamin A and C, which form structural components in cells. When mutations occur it can lead to a wide range of disease, called laminopathies.

One manifestation can be dilated cardiomyopathy, where the muscles of the heart become thin and stretched, making it harder to pump blood to the rest of the body, which can lead to heart failure. There are no therapies for LMNA-related DCM.

REALM-DCM enrolled adults with LMNA mutations and symptomatic DCM and an implanted defibrillator, with the main efficacy endpoint their ability to complete a six-minute walk test compared to placebo after 24 weeks’ treatment.

The decision to stop development of PF-07265803 comes after of interim futility analysis concluded the study was unlikely to meet its primary endpoint. It was supposed to enrol 200 subjects and generate results in 2014.

“This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in this space,” said Chris Boshoff, Pfizer’s chief development officer for oncology and rare disease therapies.

Patients in REALM-DCM will now stop study medication and complete any necessary follow-up evaluations, under the guidance of study site investigators.

DCM is one of the leading causes of heart failure worldwide, and accounts for about 30% of all heart failure hospitalisations in the US, as well as being the most common reason for needing a heart transplant. One study found that around 7.5% of DCM patients had LMNA mutations.

Pfizer acquired PF-07265803 went it bought Array BioPharma in 2019 for $11.4 billion, a deal focused mainly on Braftovi (encorafenib) and Mektovi (binimetinib) for BRAF-positive colorectal cancer.

If approved, the drug would have slotted into its portfolio alongside Vyndaqel/Vyndamax (tafamidis), used to treat cardiomyopathy caused by another rare disease, transthyretin-mediated amyloidosis (ATTR), which pulled in $1.2 billion in the first six months of 2022.

https://pharmaphorum.com/news/pfizer-takes-pipeline-blow-as-it-abandons-cardiomyopathy-drug/

Wegovy wait continues

 Last year Novo Nordisk looked like it was on the cusp of a strong launch for its new obesity drug Wegovy. Nine months on and, owing to ongoing supply issues, the world is still waiting to see whether this product can really take off.

That wait looks set to continue: the group disclosed yesterday that it would not be able to fully launch Wegovy until the end of the year – having previously guided to the second half of 2022. This – along with the continuation of the Select cardiovascular outcomes trial following its interim analysis – seemed to spook investors, who sent Novo’s stock down 13% yesterday.

The group’s chief executive, Lars Fruergaard Jørgensen, insisted during a second-quarter media call this morning that he was not worried about these setbacks. “Short-term events are not really what determines our ability to build the obesity business," he said. "We’re very encouraged about its medium to long-term prospects.”

Lilly is coming

Still, Lilly is coming for Novo in obesity, and the Danish company will want to make the most of the head start over its rival’s GIP/GLP-1 agonist tirzepatide – particularly as tirzepatide’s weight loss data look better on a cross-trial basis (Lilly takes on Novo in obesity, April 28, 2022).

Lilly is gunning for an early tirzepatide filing in obesity; the drug was in May approved for type 2 diabetes, where it is branded Mounjaro. Novo’s Mr Jørgensen seemed to welcome the prospect of competition, saying: “We’re encouraged to see that, finally, after 20 years of investment, when we’ve been pretty much on our own, the world is now opening up to obesity treatment.”

But it must be embarrassing for Novo that it has not been able to pull off a smooth launch for Wegovy in a sector in which it already has a presence. Novo had initially been supplying doses of 0.25mg, 0.5mg, 1mg, 1.7mg and 2.4mg, with the lower of these representing “starter” doses, from which patients were titrated up.

But problems began in December, when the group’s contract manufacturer had to stop producing Wegovy after good manufacturing practice issues.

Since then, Novo has only been marketing the two highest doses to patients who had already started on drug. Therefore, the latest quarterly Wegovy sales of DKK1.2bn ($164m) do not include any new patients.

The contract manufacturer got up and running again in the second quarter, and Novo is now building inventory, but Mr Jørgensen admitted that ramp-up had been “a bit below what we had planned”, which has led to the latest delay.

Sellside consensus, compiled by Evaluate Pharma, puts Wegovy revenues at $977m in 2022, a target that now looks out of reach.

Select jitters

Meanwhile, investor jitters were not helped by the continuation of the Select study – which could give Wegovy an important cardiovascular benefit claim – despite Mr Jørgensen stressing that this scenario had always been Novo’s “base case”.

Select is powered to detect a 17% benefit with Wegovy versus placebo on a composite endpoint evaluating cardiovascular death, and non-fatal myocardial infarction or stroke. “One can assume that the trial would only have been stopped if there had been a substantially higher benefit than 17%, which was not the case,” the chief exec said.

Novo still expects a win when the trial reads out in mid-2023, but the fact that it was not stopped early for efficacy has clearly raised questions about the strength of the result.

Lilly touted “early signs of strong demand” for Mounjaro in diabetes today, with second-quarter sales of $16m beating SVB's $10m forecast. The group also appeared to take a swipe at its rival by saying it anticipates "fully supplying" its US launch.

With such a fierce competitor, Novo cannot afford any more slip-ups.

https://www.evaluate.com/vantage/articles/news/corporate-strategy/wegovy-wait-continues

Private takeouts squeezed, and here comes Gilead

 Evidence is mounting that small public developers are finally accepting the new valuation realities – see Amgen’s move on Chemocentryx today – but there are signs that the private world is also feeling the pinch. As SVB pointed out in its latest report on investment trends, venture-backed groups’ static valuations, which are based on their last financing round, could make them less open to low-ball offers than listed developers trading at recently depressed prices. The first half of 2022 was very quiet, with only two private M&A deals, which seems to bear this out. Both happened at lower multiples than the 3x-4x that venture funds like to see, SVB said. There was potentially good news for venture backers today then with Gilead's $405m move on Mirobio, a UK startup that was only founded in 2019. Evaluate Vantage could not dig out Mirobio's post money valuation after its $97m series B in June, but given their quick exit the group's investors cannot be too displeased. Mirobio garnered “considerable interest from several parties”, the company told Vantage, a factor that might have pushed up the price. The developer, which is working on checkpoint agonists for autoimmune conditions, had raised $131m in total. 

Venture-backed buyouts - feeling the pinch? 
Deal Terms Target's last post-money valuationImplied takeout multiple 
GSK-Affinivax$2.1bn up front and $1.2bn milestones $1.1bn (mid 2021) x2
Pfizer-Reviral Up to $525m (includes undisclosed milestones)$203m (mid-2020)x2
Gilead-Mirobio$405m ? ?
Source: SVB Mid-Year 2022 report & Pitchbook.    

https://www.evaluate.com/vantage/articles/news/deals-snippets/private-takeouts-squeezed-and-here-comes-gilead

‘Paxlovid rebound’ raises questions over how long antiviral COVID treatment should last

 President Biden testing positive for COVID-19 again days after completing a course of Paxlovid has raised the question of whether the length of the antiviral treatment should be reconsidered.

Just days after he completed a five-day round of Pfizer’s COVID-19 antiviral treatment, Biden’s physician, Kevin O’Connor, said in a letter on Saturday that the president had tested positive once again. As of Wednesday, Biden is still testing positive for COVID-19.

This phenomenon has come to be known as “Paxlovid rebound,” when a person tests positive for the coronavirus again even after initially testing negative following a round of treatment with the antiviral. A recent preprint study found that Paxlovid rebound occurred among 3.5 percent and 5.4 percent of coronavirus infections at the seven-day and the 30-day mark after treatment respectively. Biden’s chief medical adviser, Anthony Fauci, also experienced Paxlovid rebound after contracting the virus and started a second round of treatment.

Some experts have called for studies into extending Paxlovid treatments to be prioritized, as early research has suggested that Paxlovid rebound could occur due to insufficient exposure to the drug. Researchers from the University of California, San Diego School of Medicine said last month that the drug may not be reaching enough infected cells in the allotted time.

Paxlovid, under an emergency use authorization issued by the Food and Drug Administration, is administered in two doses taken daily over the course of five days. Physicians are not permitted to prescribe longer rounds of treatment, and clinical data on courses lasting more than five days has yet to be completed.

Earlier this year, Fauci said the National Institutes of Health was in talks with Pfizer about studies looking into longer courses of Paxlovid, though any updates on these possible trials have not been disclosed.

“I’m actually still flabbergasted that we have not set up a clinical trial to figure this out. It’s an easy thing to do,” Robert Wachter, chair of the Department of Medicine at the University of California, San Francisco, told The Hill.

“Wouldn’t cost that much to be able to accumulate enough patients in a week or two and follow them for a few weeks so we could have an answer,” Wachter said, adding that the data needed to potentially extend the length of a round of Paxlovid could have been collected already if trials had been started just a few months ago.

According to Wachter, there aren’t any similar antiviral “analogies” to compare Paxlovid to. Viral rebound isn’t usually tested for, and other antiviral treatments aren’t administered in the same manner.

Eric Toner, a senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, noted that viral rebound has rarely been studied as much as it is now in the context of COVID-19. ​However, Toner said instances of viruses or bacterial infections still lingering after treatment do occur.

Instances of viral rebound of coronavirus are also not unique to Paxlovid. Cases of rebound with molnupiravir, the COVID-19 antiviral created by Merck and Ridgeback, have been observed as well.

People who experience cases of antiviral rebound are still at risk of transmitting COVID-19 to other people. Michael Charness, a researcher from the Veterans Administration Medical Center in Boston, recently told CNN that he and his colleagues had observed at least two instances of people infecting others after their symptoms reoccurred. Both cases involved people who tested positive again after taking Paxlovid.

People tend to have much milder symptoms that resolve fairly easily on their own after testing positive again, Toner said. For this reason, he said a second round of treatment, even in cases of Paxlovid rebound, is probably unneeded. O’Connor, Biden’s physician, has provided regular updates on the president’s health but has not disclosed whether he has started a second course of Paxlovid, like Fauci did.

While the need for and feasibility of longer Paxlovid rounds remains uncertain, the U.S. may find itself relying on antivirals more going forward as new variants of COVID-19, more infectious and better at evading immune protection, continue to crop up.

“If we do see more variants and they’re more evasive and we have more people with infections who are at risk of a serious outcome, then antivirals will become increasingly important,” Wachter said, though he added, “As far as we know, none of that is really true.”

He noted that even with subvariants like BA.5 spreading and causing more infections, the current vaccines are still offering strong protection against severe cases, hospitalizations and deaths.

Researchers have previously said that it would be difficult, but not impossible, for COVID-19 to become resistant to Paxlovid treatment, as the drug targets a part of the virus that does not change easily.

When reached for comment, a Pfizer spokesperson pointed to a health advisory from the Centers for Disease Control and Prevention released earlier this year that stated a brief return of COVID-19 symptoms following the completion of Paxlovid treatment “may be part of the natural history of SARS-CoV-2.”

“While further evaluation is needed, we have not seen any viral resistance emerge to date in patients treated with PAXLOVID, and we continue to monitor data from our ongoing clinical studies and post-authorization safety surveillance,” said the spokesperson. “We remain very confident in PAXLOVID’s clinical effectiveness at preventing severe outcomes from COVID-19 in patients at increased risk.”

The spokesperson for Pfizer did not comment on the possibility of longer Paxlovid courses.

https://thehill.com/policy/healthcare/3587071-paxlovid-rebound-raises-questions-over-how-long-antiviral-covid-treatment-should-last/