POST 261. July 14 2022. CORONAVIRUS. A trifecta of threats could breach hospital capacity again! – BA.5, monkeypox, & drug-resistant infections (Acinetobacter and Candida auris)

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“Well, here we go again. Once more, the ever-changing coronavirus behind COVID-19 is assaulting the United States in a new guise—BA.5, an offshoot of the Omicron variant that devastated the most recent winter. The new variant is spreading quickly, likely because it snakes past some of the immune defenses acquired by vaccinated people, or those infected by earlier variants. Those who have managed to avoid the virus for close to three years will find it a little harder to continue that streak, and some who recently caught COVID are getting it again. “People shouldn’t be surprised if they get infected, and they shouldn’t be surprised if it’s pretty unpleasant,” Stephen Goldstein, a virologist at the University of Utah, told me…

Why, then, does it feel like we’re in a reinfection wave right now, with anecdotal reports being prominent in a way they weren’t seven months ago? It’s because Omicron completely changed our baseline. Before its arrival, only a third of Americans had ever experienced COVID. By the end of February, almost 60 percent had. We’re hearing more about reinfections now in part because the number of people who could possibly be reinfected has doubled…

….The Biden administration, other political leaders, and many media figures have promoted laxer COVID policies, on the grounds that vaccines are still reducing the risk of death and hospitalization. But this stance is foolish for several reasons.

The stakes of that game depend on a very simple question: Should we still care about preventing infections? If the answer is “not so much,” which is the implicit and sometimes explicit posture that America’s leaders have adopted, then BA.5 changes little. But if the answer is “yes,” as I and most of the experts I talk to still believe, then BA.5 is a problem.” (A)

“Fact Sheet: Biden Administration Outlines Strategy to Manage BA.5

Today, the White House COVID-19 Team is announcing its strategy to manage BA.5. The strategy relies on ensuring that Americans continue to have easy and convenient access to the vaccines, treatments, tests, and other tools that protect against and treat COVID-19. These tools – even in the face of BA.5 – work to prevent serious illness, keep people out of the hospital, and save lives – and we can prevent nearly all COVID-19 deaths with them.

To confront BA.5, the Administration will continue mobilizing the full strength and capabilities of the federal government and working with state and local leaders, health care workers, the private sector, and community- and faith-based organizations to ensure that the American people have easy and convenient access to and use vaccines, tests, and treatments.

The Administration’s strategy to manage BA.5 includes:

Making it easy for people to get vaccines and boosters: The Administration will continue working with state and local leaders, doctors and pediatricians, pharmacies, community health centers, long-term care facilities, employers, and community- and faith-based organizations to drive additional uptake of booster shots, particularly among those age 50 and older and other at-risk populations, including long-term care facility staff and residents…

Making it easy to access COVID-19 treatments and boost provider and patient awareness: The Administration will continue working across the federal government, with state and local leaders, health care providers, as well as the public and private sectors, to take additional actions to boost access and awareness of lifesaving treatments, particularly in areas where BA.5 is spreading…

Making free COVID-19 testing, including at-home tests, widely available: Testing continues to be an important tool to help mitigate the spread of COVID-19, including BA.4 and BA.5. In the face of BA.5, the Administration is encouraging Americans to use at-home tests before attending large, indoor gatherings, traveling, or visiting indoors with immunocompromised individuals…

Making free high-quality masks widely available and communicate clear recommendations about when people should consider masking: Experts agree that masking in indoor, public spaces is an important tool to control the spread of COVID-19. The CDC’s COVID-19 Community Levels provide individuals with clear recommendations on when to consider masking in indoor, public spaces…

Prioritizing protections for immunocompromised individuals: As BA.5 cases rise, the Administration will continue to provide support to individuals who are immunocompromised so that they have the support they need to live their lives safely…

Encouraging all building owners to improve indoor ventilation: Improving ventilation can help prevent the spread of BA.4 and BA.5 indoors in buildings. The Administration has provided state and local leaders hundreds of billions of dollars in federal funds that can be used in schools, public buildings, and other settings to improve indoor air quality, and the Administration will continue to advance indoor air quality in buildings…

Empowering people with the latest information on COVID-19 and where to access vaccines, treatments, tests, and masks at COVID.Gov: The Administration will continue to communicate clearly with the American people about COVID-19 and the steps that they can take to protect themselves and their loved ones…” (B)

“President Biden’s coronavirus response team warned Americans on Tuesday that they must do more to protect themselves against Covid-19, as the highly transmissible Omicron subvariant known as BA.5 fuels a new wave of infections, re-infections and hospitalizations across the country.

But their new strategy to combat the threat sounded a lot like the old one, couched as advice that they hope more people will follow: Get vaccinated or boosted even if you have already been infected; test if you feel sick; seek out therapeutics if you test positive and wear masks in crowded indoor spaces.

“Variants will continue to emerge if the virus circulates globally and in this country,” Dr. Anthony S. Fauci, Mr. Biden’s chief medical adviser for the pandemic, said at a White House news briefing. “We should not let it disrupt our lives. But we cannot deny that it is a reality that we need to deal with.”..

“The key feature of BA.5, that we know about, is its immune evasiveness — you can be fully vaccinated and boosted and still have a risk of a breakthrough infection,” Dr. Ashish K. Jha, Mr. Biden’s coronavirus response coordinator, said in an interview Monday. “You can be previously infected — even as recent as the last couple of months — and have a very high rate of reinfection.”…

The daily number of reported cases in the United States has remained steady at around 100,000, according to a New York Times database — a figure that many experts say is an undercount because so many people are testing at home. But as of Monday, hospitalizations have risen 17 percent over the past two weeks, according to federal data…

In the interview, Dr. Jha said that figure could reflect those who are hospitalized for medical issues other than Covid, but who test positive for the virus. Many Americans have underlying health conditions, however, and if they get infected with the coronavirus, they are at risk of developing more severe disease. Dr. Jha also suggested Americans test before attending large indoor gatherings or visiting a high-risk immunocompromised person.

During Tuesday’s briefing, Dr. Fauci said the increased hospitalizations — including an uptick in Covid-19 patients who wind up in intensive care units — most likely reflected a big rise in the number of unreported infections. Nationwide as of Monday, the average number of people in I.C.U.s with the virus had increased by 21 percent over the last two weeks, to more than 4,200, according to federal data. The latter figure, which made up about 11 percent of people hospitalized with the virus, was substantially lower than it was in late January during the winter Omicron surge.”  (C)

“The newest offshoot of Omicron, along with a closely related variant, BA.4, are fueling a global surge in cases — 30% over the past fortnight, according to the World Health Organization (WHO)…

“We have been watching this virus evolve rapidly. We’ve been planning and preparing for this moment. And the message that I want to get across to the American people is this: BA.5 is something we’re closely monitoring, and most importantly, we know how to manage it,” said Dr. Ashish Jha, the White House’s Covid-19 response coordinator, in a news briefing on Tuesday.

On the same day, WHO’s Emergency Committee said Covid-19 remained a Public Health Emergency of International Concern — its highest level of alert, first declared on January 20, 2020 — amid rising cases, ongoing viral mutation and increasing pressure on already overstretched health systems. In a statement, the committee, which is made up of independent experts, highlighted challenges to the ongoing global Covid-19 response, including a drop-off in testing and spotty genome sequencing, raising the question of just how accurately any nation might reasonably be able to monitor BA.5…

What makes BA.5 different? Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research, has called BA.5 “the worst version of the virus we’ve seen.” He explained in a recent newsletter: “It takes immune escape, already extensive, to the next level, and, as a function of that, enhanced transmissibility,” well beyond earlier versions of Omicron.

In other words, BA.5 can easily evade immunity from previous infections and vaccines, increasing the risk of reinfection. Though the variant does not appear to lead to more severe illness, in an interview with CNN on Monday, Topol said that given the extent of BA.5’s immune evasion, he expects to see an escalation in hospitalizations, as we’ve seen in Europe and elsewhere that the variant has taken root. “One good thing is it doesn’t appear to be accompanied by the ICU admissions and the deaths as previous variants, but this is definitely concerning,” he added…

“Sub-variants of Omicron, like BA.4 and BA.5, continue to drive waves of cases, hospitalization and death around the world,” WHO Director-General Tedros Adhanom Ghebreyesus said in a media briefing on Tuesday. “Surveillance has reduced significantly — including testing and sequencing — making it increasingly difficult to assess the impact of variants on transmission, disease characteristics, and the effectiveness of counter-measures.”

“New waves of the virus demonstrate again that the Covid-19 [pandemic] is nowhere near over,” he added.” (D)

“America has decided the pandemic is over. The coronavirus has other ideas…

“It’s the Wild West out there,” said Ziyad Al-Aly, an epidemiologist at Washington University in St. Louis. “There are no public health measures at all. We’re in a very peculiar spot, where the risk is vivid and it’s out there, but we’ve let our guard down and we’ve chosen, deliberately, to expose ourselves and make ourselves more vulnerable.”

Angela Rasmussen, a virologist at the University of Saskatchewan, would like to see more money for testing and vaccine development, as well as stronger messaging from the Biden administration and top health officials. She was dismayed recently on a trip to Southern California, where she saw few people wearing masks in the airport. “This is what happens when you don’t have politicians and leaders taking a strong stand on this,” she said.

The CDC said it has urged people to monitor community transmission, “stay up to date on vaccines, and take appropriate precautions to protect themselves and others.”

Covid deaths no longer overwhelmingly among the unvaccinated as toll on elderly grows

Nearly one-third of the U.S. population lives in counties rated as having “high” transmission levels by the CDC. Cases are rising especially in the South and West…

But the death rate from covid-19 is still much higher than the mortality from influenza or other contagious diseases. Officials have warned of a possible fall or winter wave — perhaps as many as 100 million infections in the United States — that could flood hospitals with covid patients. Beyond the direct suffering of such a massive outbreak, there could be economic disruptions as tens of millions of people become too sick to work…

Omicron blew through the largely vaccinated population last winter with stunning ease, and since then the subvariants have arrived in rapid succession, starting with BA.2 and BA.2.12.1 in the spring, and now BA.5 and its nearly identical relative BA.4.

Vaccines are based on the original strain of the virus that emerged in Wuhan, China in late 2019. The Food and Drug Administration has asked vaccine makers to come up with new formulas that target BA.5 and BA.4. Those boosters could be ready this fall.

But there is no guarantee that these latest subvariants will still be dominant four or five months from now. The virus is not only evolving; it’s also doing so with remarkable speed. The virus may continually outrace the vaccines.

“I worry that by the time we have a vaccine for BA.5 we’ll have a BA.6 or a BA.7. This virus keeps outsmarting us,” Al-Aly said…

Already there’s another omicron subvariant that has caught the attention of virologists: BA.2.75. First seen last month in India, it has been identified in a smattering of other countries, including the United States. But it’s too soon to know whether it will overtake BA.5 as the dominant variant…

It’s also unclear if these new variants will alter the risk of a person contracting the long-duration symptoms generally known as “long covid.” The percentage of people with severely debilitating symptoms is probably between 1 and 5 percent — amounting to millions of people in this country, according to Harlan Krumholz, a Yale University professor of medicine…

The precocious nature of the virus has made infectious-disease experts wary of predicting the next phase of the pandemic. Topol warns that a new batch of variants could come out of the blue, the same way omicron emerged unexpectedly in November with a stunning collection of mutations already packaged together. Omicron’s precise origin is unknown, but a leading theory is that it evolved in an immunocompromised patient with a persistent infection.

“Inevitably we could see a new Greek letter family like omicron,” Topol said. “There’s still room for this virus to evolve. It has evolved in an accelerated way for months now. So we should count on it.” (E)

“”The only new action from the White House BA.5 briefing was an admonishment to ‘Get your booster!,'” former U.S. Surgeon General Jerome Adams, MD, tweeted July 14. He went on to criticize the administration for not expanding second booster eligibility or changing the definition of “fully vaccinated,” which he said currently “implies you don’t need a booster.”” (L)

“The World Health Organization said Tuesday that it will convene a second emergency meeting next week to decide if monkeypox poses a global health threat as cases rise to 9,200.

The U.N. agency declined last month to declare a global emergency in response to monkeypox. But as infections have risen substantially over the last several weeks, the organization is expected to consider whether to issue its highest alert when the emergency committee reconvenes next week.

“The emergency committee for monkeypox will reconvene next week and look at trends, how effective the countermeasures are, and make recommendations” to countries and communities confronting the outbreak, the WHO’s director-general, Tedros Adhanom Ghebreyesus, said in a virtual press conference.

The WHO did not say which day or days the committee will be meeting in emergency session.

About 9,200 cases of monkeypox have been reported across 63 countries so far this year, up from just over 6,000 as of July 4, the agency said. Three deaths from the virus have been reported this year.

Monkeypox has likely broken out, will be hard to extinguish, says Dr. Scott Gottlieb

Most people during this most recent outbreak are recovering from monkeypox in two to four weeks, according to the U.S. Centers for Disease Control and Prevention. But the virus causes a painful rash that can spread all over the body. People who have caught the virus said the rash, which looks like pimples or blisters, can be very painful.

The WHO last issued a global health emergency in January 2020 in response to the Covid-19 outbreak and the following March declared it a pandemic. There’s no official process for the WHO to declare a pandemic under its emergency regulations, which means the term is loosely defined. In 2020, the agency declared Covid a pandemic in an effort to warn complacent governments about the “alarming levels of spread and severity” of the virus.

In contrast to Covid, monkeypox is not a new virus. Scientists first discovered monkeypox in 1958 in captive monkeys used for research and confirmed the first case of a human infected with the virus in 1970 in the nation of Zaire, now called the Democratic Republic of the Congo. Monkeypox is in the same virus family as smallpox, though it causes milder disease. The WHO and national health agencies have decades of experience fighting smallpox, which was declared eradicated in 1980. The successful fight against smallpox could provide health officials with important knowledge to combat monkeypox.

The current monkeypox outbreak is highly unusual because it is spreading widely in North American and European nations where the virus is not usually found. Europe is the global epicenter of the outbreak, reporting more than 80% of confirmed infections worldwide in 2022. The U.S. has reported more than 760 cases across 37 states, Washington, D.C. and Puerto Rico.

Historically, monkeypox has spread at low levels in remote parts of West and Central Africa where rodents and other animals carried the virus. Transmission between people was relatively rare in the past, with the virus normally jumping from animals to humans. The WHO has said the international community did not invest enough resources in fighting monkeypox in Africa before the current outbreak.” (F)

“More than 100 cases of monkeypox have been confirmed in Chicago since the first probable case of the rare disease was discovered locally in early June, according to city health officials.

Chicago Department of Public Health officials announced Monday that 105 Chicagoans have been diagnosed with monkeypox, with the majority – but not all – cases occurring among gay, bisexual and other men who have sex with men.

CDPH Commissioner Dr. Allison Arwady said the spread appears to be through “tight-knit social networks,” but emphasized that anyone can spread the virus.

Monkeypox, which originates in wild animals like rodents and primates, is spread to people via infected animals, with most cases occurring in central and west Africa.

However, person-to-person transmission is possible through close physical contact with monkeypox sores, items that have been contaminated with fluids or sores or through respiratory droplets following prolonged face-to-face contact, according to officials.

Chicagoans can get vaccinated against monkeypox if they’ve been exposed to someone with monkeypox. Gay, bisexual or men who have sex with men can also be vaccinated if they have intimate or sexual contact with other men in a social or sexual setting, or have intimate or sexual contact with multiple or anonymous partners, or have given or received money or other goods/services in exchange for sex, according to officials.

At this time, officials are not recommending vaccination for the general public, including men who have sex with men without other risk factors. Vaccines are being administered to those at the highest risk of exposure in order to interrupt transmission, according to Massimo Pacilli, CDPH’s deputy commissioner for disease control.

“I want folks to know one of the reasons why we can’t give out (vaccine) broadly is (we need) to make sure we have enough for known contacts because that can prevent disease in the highest risk folks,” Arwady said, adding as the city receives additional vaccines, it’ll open up vaccination to a larger population.

City officials have received 5,409 vaccines so far and expect to receive an additional 7,493 in the coming weeks.”  (G)

“The city has struggled to respond to a growing monkeypox outbreak, the first major public health crisis since the Covid pandemic began.

Officials said New York City is the “epicenter” of the nation’s monkeypox outbreak, and announced the opening of a vaccine clinic in Harlem and the reopening of another in Chelsea.CreditCredit…Hiram Durán for The New York Times

Thousands of New Yorkers spent hours refreshing a city government webpage this week, desperately seeking a monkeypox vaccine that, for now, is mostly going to the web-savvy and connected.

The rollout echoed the early days of New York City’s Covid-19 vaccine, when finding an appointment could feel like winning a radio contest. The city decided to assign appointments for the first doses of the highly sought-after monkeypox vaccine via an online system, using Twitter as the main way to notify people. The 2,500 appointments went within minutes.

On top of that, because of a glitch, the initial 600 appointments released Wednesday went only to those who happened to store an older appointment website on their browsers, because the slots appeared there before a link on the main Department of Health website went live…

New York City is the epicenter of the nation’s monkeypox outbreak, its health commissioner, Dr. Ashwin Vasan, said at a news conference on Thursday, with 141 cases recorded so far, more than any other American city. The disease is mostly spreading among men who have sex with men, and experts believe there may be many more cases than have so far been detected.

The spreading outbreak has not yet caused any deaths in the United States, but it can cause very painful lesions that take weeks to resolve.

With yet another frightening virus spreading in their community, many gay New Yorkers have pinned their hopes on getting the Jynneos vaccine, the safer of two available vaccines that can prevent monkeypox. But distribution missteps have caused anger and frustration. The first 1,000 doses of Jynneos, which arrived two weeks ago, were given out at a single clinic, in Chelsea, with almost no public notice…

Cases of monkeypox have been steadily increasing in the city, even though testing has been limited. New York City’s public health lab, which had been the sole city location running the test for the disease, has been able to test only 10 people per day, city officials said. But testing will now be able to ramp up: As of Wednesday, health providers can now order monkeypox tests through Labcorp, a commercial testing company.

Dr. Vasan said that he picked Chelsea, an upscale Manhattan area, as the location for the first clinic because 75 percent of the city’s known cases so far have been in Manhattan, and one-third of all cases have been in the Chelsea and Hell’s Kitchen neighborhoods, areas with large gay populations.

With the arrival of 6,000 additional doses this week, the city added the second vaccine clinic, which opened Thursday. It is planning a third clinic in Corona, Queens, once vaccine supply increases…

New York City has so far received about 7,000 doses of the Jynneos vaccine. About 4,000 have already been given out or assigned to appointments. An additional several thousand are being held in reserve for distribution through community partners, Dr. Vasan said.

More doses are coming, said Dr. Raj Panjabi, the coordinator of the White House Pandemic Office, who also spoke at the news conference. The federal government will release another 144,000 doses within the next weeks, with some of those coming to New York. In total, four million doses have been ordered for use nationwide, with 1.5 million of those expected to go out to health departments later this summer and fall.

The Jynneos vaccine requires two doses to be fully protective, according to the Food and Drug Administration, but so far, all of the doses coming to the city are being considered as first doses. As more doses arrive, there will be more available for second doses, said Dr. Mary Bassett, the state health commissioner…

At a news conference on Thursday, Mayor Eric Adams said the city was giving out vaccine doses as soon as it received them. “We are not just ignoring it,” he said. “There was a glitch by the third-party vendor that created the website, but we pivot and shifted and we’re getting the vaccines out the door.”  (H)

“Monkeypox has been a developing problem for decades and the current global outbreak was avoidable, but the looming threat was largely ignored, according to a leading expert on the virus.

Dr. Anne Rimoin is a UCLA epidemiology professor and has spent the last two decades in the Democratic Republic of Congo working on monkeypox.

She said it was only when the virus spread beyond rural Africa that it sparked a global response.

“This virus has been spreading in marginalized and vulnerable populations [in Africa] for decades, and we’ve done nothing about it,” Rimoin said. “We have known that monkeypox is a potential problem for decades.”..

So public health experts say the U.S. should have been able to handle the outbreak, and that the missteps right now look a lot like the start of the coronavirus pandemic: not enough tests or vaccines readily available, and an incomplete picture of the spread.

“We have no concept of the scale of the monkeypox outbreak in the U.S.,” biologist Joseph Osmundson at New York University told NPR in June…

“If we do want to get in front of emerging infectious diseases, we are going to have to prioritize dealing with emerging global disease threats at the site where they are spreading early on,” Rimoin said. “We are totally interconnected by trade and travel, population growth, population movement, and we cannot make the mistake again of thinking that an infection that’s happening somewhere in a remote area of the world isn’t going to affect us right at home.”

“We will continue to be chasing behind them, and always be paying the price for not doing what’s needed ahead of time.”

For now, Rimoin said it was a matter of trying to contain a virus that was already spreading.

“It’s much easier to stay out of trouble than it is to get out of trouble,” she said.

“The good news is we have vaccines, we have therapeutics, we know a fair amount about this virus. The bad news is now we have to get the logistics together to be able to confront it head on.” (I)


“The spread of drug-resistant infections surged during the coronavirus pandemic, killing nearly 30,000 people in 2020 and upending much of the recent progress made in containing the spread of so-called superbugs, according to an analysis by the Centers for Disease Control and Prevention.

Deaths caused by infections impervious to antibiotics and antifungal medications rose 15 percent during the first year of the pandemic compared to 2019, federal health officials found. Much of the increase was tied to the chaos wrought by the coronavirus as doctors and nurses struggled to treat waves of grievously sick patients whose illness they did not fully understand, before vaccines and treatments were widely available.

About 40 percent of the deaths were among hospitalized patients, with the remainder occurring in nursing homes and other health care settings, the C.D.C. report found. Early on, many frontline hospital workers mistakenly administered antibiotics for viral lung infections that did not respond to such drugs, according to the study. Many of the sickest patients spent weeks or months in intensive care units, increasing the chances for drug-resistant bugs to enter their bodies through intravenous lines, catheters and ventilator tubes.

The death toll is likely much higher, federal health officials said, because the public health labs that normally track drug-resistant infections have been swamped during the pandemic, leading to significant gaps in data for many of the most dangerous pathogens.

The C.D.C. said the outbreaks of drug-resistant infections were likely abetted by a nationwide shortage of face masks, gloves and gowns — the vital armor that protects health workers and helps limit the spread of pathogens as they travel from room to room. Because of staff shortages and overwhelmed wards at many hospitals, infection control specialists were often reassigned to provide basic patient care rather than carry out their usual duties of promoting the appropriate use of antibiotics, hand washing and other safety measures, the report said.

These setbacks can and must be temporary,” Dr. Rochelle P. Walensky, the director of the C.D.C., said in a statement accompanying the report. “The Covid-19 pandemic has made it clear — prevention is preparedness. We must prepare our public health systems to fight multiple threats simultaneously.”

Federal officials were especially concerned about the increased spread of some of the most dangerous pathogens. They found a 78 percent spike in infections of Acinetobacter, a bacteria that is resistant to the antibiotic carbapenem and that often spreads among intensive care patients, and a 60 percent rise in Candida auris, a deadly fungus that often stalks nursing homes and long-term care facilities.

The analysis highlights what public health experts have long described as a slow-moving pandemic. More than 700,000 people across the world die each year from infections that no longer respond to antimicrobial drugs, and health experts warn that the death toll could climb to 10 million by 2050 without a concerted effort to reduce the overuse of antibiotics and to develop new medications.

Antimicrobial resistance occurs when bacteria and fungi mutate to outsmart the drugs that have been designed to vanquish them. This evolutionary process is inevitable, but the more these medications are given to people and farm animals, the more likely the resistance will occur.

Nearly a third of all antibiotics are mistakenly prescribed, according to the C.D.C., oftentimes for respiratory ailments like colds that are caused by viruses. The problem appears to have grown during the pandemic: Eighty percent of hospitalized Covid patients received antibiotics between March and October 2020, the agency noted…

“The magnitude of how much worse it’s gotten is really alarming,” said David Hyun, the director of the Antibiotic Resistance Project at the Pew Charitable Trusts, a nongovernmental organization. “It also underscores the urgency that we need to really focus and reinvest in the efforts to address this public health issue.” (J)

“Heavy is the head that wears the COVID-19 crown. Late last week, Pfizer revealed its antiviral Paxlovid fell short in a post-exposure protection trial. Still, in the pill’s quest to reach as many patients as possible, one setback doesn’t spell defeat.

Top-line results from the phase 2/3 EPIC-PEP study showed a five- and 10-day Paxlovid course curbed the risk of infection by 32% and 37%, respectively, versus placebo, in adults exposed to the virus through someone they live with. The readout fell short of statistical significance, the company said late Friday.

Safety looked good in EPIC-PEP whether patients took Paxlovid for five or 10 days, Pfizer said in a release. It’s wrapping up secondary endpoints and subgroup analyses for the study’s full data drop, expected in the “coming months.”

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, Ph.D., Pfizer’s CEO, said in a statement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness, and we are pleased to see the growing global use of Paxlovid in that population.”

Pfizer’s prophylaxis trial weighed data from 2,957 patients who tested negative for the virus and didn’t have any symptoms. For study inclusion, participants had to have been exposed to a symptomatic household contact with COVID-19 within the last four days.

In the study—which started recruitment in September and wrapped up “during the peak of the COVID-19 Omicron wave,” Pfizer said—patients received Paxlovid or placebo twice daily for either five or ten days.

Paxlovid’s post-exposure protection flop “does not change our view that the peak sales potential of [Pfizer’s] COVID-19 franchise (vaccine and oral antiviral) is still under-appreciated,” Cantor Fitzgerald analysts wrote in a note to clients, calling the results a “bump in the road.”

Because Pfizer’s clinical development for Paxlovid is “comprehensive and ambitious,” not “every trial needs to work for the drug to be successful,” the Cantor team said.” (K)


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