Analysis – COVID-19 pills are coming, but no substitute for vaccines, disease experts say

By Julie Steenhuysen

CHICAGO (Reuters) – Oral antiviral pills from Merck & Co and Pfizer Inc/BioNTech SE have been shown to significantly blunt the worst outcomes of COVID-19 if taken early enough, but doctors warn vaccine hesitant people not to confuse the benefit of the treatments with prevention afforded by vaccines.

While 72% of American adults have gotten a first shot of the vaccine, according to a Kaiser Family Foundation poll, the pace of vaccination has slowed, as political partisanship in the United States divides views on the value and safety of vaccines against the coronavirus.

Vaccine mandates by employers, states and the administration of U.S. President Joe Biden have helped increase vaccinations but also fueled that controversy.

Some disease experts fear the arrival of oral COVID-19 treatments may further impede vaccination campaigns. Preliminary results of a survey of 3,000 U.S. citizens by the City University of New York (CUNY) School of Public Health suggest the drugs could “hamper the effort to get people vaccinated,” said Scott Ratzan, an expert in health communication at CUNY, who led the research.

Ratzan said one out of every eight of those surveyed said they would rather get treated with a pill than be vaccinated. “That is a high number,” Ratzan said.

The concern follows news on Friday from Pfizer, maker of a leading COVID-19 vaccine, that its experimental antiviral pill Paxlovid cut the risk of hospitalization and death from the disease by 89% in high-risk adults.

Pfizer’s results followed news from Merck and partner Ridgeback Biotherapeutics on Oct. 1 that their oral antiviral drug cut hospitalization and death by half. That drug, known as molnupiravir, won conditional approval in the UK on Thursday. Both need clearance from U.S. health regulators but could be on the market in December.

“By relying exclusively on an antiviral drug, it’s a bit of a roll of the dice in terms of how you will do. Clearly, it’s going to be better than nothing, but it’s a high-stakes game to play,” said Dr. Peter Hotez, a vaccine expert and professor of molecular virology and microbiology at Baylor College of Medicine.

Six infectious disease experts interviewed by Reuters were equally enthusiastic about the prospect of effective new treatments for COVID-19 and agreed they were no substitute for vaccines.

Even in the face of the highly transmissible Delta variant of the virus, the vaccines from Pfizer/BioNTech remain effective, cutting the risk of hospitalization by a combined 86.8%, according to a government study of U.S. veterans.

They said some unvaccinated people have already relied on monoclonal antibodies – drugs that need to be delivered through intravenous IV infusions or injections – as a backstop in case they become infected. “I think the Pfizer news is terrific news. It goes hand in hand with vaccination. It doesn’t replace it,” said Dr. Leana Wen, an emergency physician and public health professor at George Washington University and Baltimore’s former health commissioner.

Choosing not to get vaccinated “would be a tragic mistake,” said Albert Bourla, chief executive officer of Pfizer Inc. “These are treatments. This is for the unfortunate who will get sick,” Bourla told Reuters in an interview on Friday. “This should not be a reason not to protect yourself and to put yourself, your household and society in danger.”

ANTIVIRAL CHALLENGES

One main reason not to rely on the new pills, the experts said, is that antiviral medications, which stop the virus from replicating in the body, must be given in a narrow window early in the disease because COVID-19 has different phases.

In the first phase, the virus rapidly replicates in the body. A lot of the worst effects of COVID-19, however, occur in the second phase, arising from a defective immune response that gets triggered by the replicating virus, said Dr. Celine Gounder, an infectious disease expert and the CEO and founder of Just Human Productions, a non-profit multimedia organization.

“Once you develop shortness of breath or other symptoms that would lead you to be hospitalized, you are in that dysfunctional immune phase where the antivirals are really not going to provide much benefit,” she said. Hotez agreed. He said getting treated early enough could be challenging because the window when the virus transitions from the replication phase to the inflammatory phase is fluid. “For some people, that will happen earlier; for some, later,” Hotez said. Hotez said many people in the early phase of the illness feel surprisingly well and may be unaware that their oxygen levels are dropping, one of the first signs that the inflammatory phase of the disease has started. “Oftentimes, you’re not going to realize that you’re getting sick until it’s too late,” he said.

(Reporting by Julie Steenhuysen; Additional reporting by Josephine Mason in London, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; editing by Caroline Humer and Grant McCool)

U.S. COVID-19 cases hit six-month high, Florida grapples with surge

By Roshan Abraham and Maria Caspani

(Reuters) -The United States hit a six-month high for new COVID cases with over 100,000 infections reported on Wednesday, according to a Reuters tally, as the Delta variant ravages areas where people did not get vaccinated.

The country is reporting over 94,819 cases on a seven-day average, a five-fold increase in less than a month, Reuters data through Wednesday showed. The seven-day average provides the most accurate picture of how fast cases are rising since some states only report infections once a week or only on weekdays.

Seven U.S. states with the lowest COVID-19 vaccination rates – Florida, Texas, Missouri, Arkansas, Louisiana, Alabama and Mississippi – account for half of the country’s new cases and hospitalizations in the last week, White House COVID-19 coordinator Jeff Zients told reporters on Thursday.

In the coming weeks, cases could double to 200,000 per day due to the highly contagious Delta variant, said top U.S. infectious disease expert Dr. Anthony Fauci on Wednesday.

“If another one comes along that has an equally high capability of transmitting but also is much more severe, then we could really be in trouble,” Fauci said in an interview with McClatchy. “People who are not getting vaccinated mistakenly think it’s only about them. But it isn’t. It’s about everybody else, also.”

To combat the Delta surge, the United States plans to give booster shots to Americans with compromised immune systems, top U.S. infectious disease expert Dr. Anthony Fauci said Thursday.

The United States is joining Germany, France and Israel in giving booster shots, ignoring a plea by the World Health Organization to hold off until more people around the world can get their first shot.

FLORIDA SURGE

Southern states, which have some of the nation’s lowest vaccination rates, are reporting the most COVID-19 cases and hospitalizations. Florida, Texas and Louisiana were reporting the highest total number of new cases in the region over the last week, according to a Reuters analysis.

Florida, which has emerged as the nationwide hotbed of new infections, set yet another grim hospitalization record on Thursday with 12,373 confirmed COVID-19 patients in its hospitals, according to data from the U.S. Department of Health and Human Services (HHS).

More children are hospitalized with the virus in Florida than in any other U.S. state, HHS data shows.

“23% of new COVID hospitalizations in the U.S are in Florida, and their hospitals are being overwhelmed again,” White House Press Secretary Jen Psaki said on Wednesday. Psaki urged the state’s governor, Republican Ron DeSantis, to “join us in this fight” after DeSantis accused Biden of singling out his state.

Louisiana and Arkansas are also grappling with record or near-record numbers of coronavirus patients occupying beds, according to a Reuters tally.

President Joe Biden on Tuesday urged Republican leaders in Florida and Texas – home to roughly a third of all new U.S. COVID-19 cases – to follow public health guidelines on the pandemic or “get out of the way.”

To try to halt the spread of the virus, New York City will require proof of vaccination at restaurants, gyms and other businesses.

Some private companies are also mandating vaccines for employees and customers.

As Delta spreads, some companies are delaying plans for workers to return to the office. Amazon.com, which had originally set Sept. 7 as the comeback date, on Thursday said it would not expect U.S. corporate employees to return to the office until next year, according to an internal note seen by Reuters.

(Reporting by Roshan Abraham in Bengaluru and Maria Caspani in New York; Additional reporting by Jeff Mason, Susan Heavey, Carl O’Donnell and Trevor Hunnicutt; Editing by Lisa Shumaker)

Delta variant doubles risk of hospitalization; Novavax vaccine highly effective in large trial

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Delta variant doubles risk of COVID-19 hospitalization

The delta variant of the coronavirus first identified in India may double the risk of hospitalization among COVID-19 patients, compared with the alpha variant first discovered in the UK, a study from Scotland suggests. Researchers looked at 19,543 COVID-19 cases and 377 hospitalizations among 5.4 million people, including 7,723 cases and 134 hospitalizations in patients with the delta variant, who tended to be younger and more affluent. The risk of COVID-19 hospital admission was about double with the delta variant compared to the alpha variant, with the risk particularly increased in those with five or more medical conditions known to contribute to more severe disease, the researchers reported on Monday in The Lancet. They found that two doses of the vaccines from Pfizer and BioNTech and from AstraZeneca still provide strong protection, although not as strong as the protection provided against the alpha variant. Two weeks after the second dose, the Pfizer/BioNTech vaccine was found to provide 79% protection against infection from the delta variant, compared to 92% against the alpha variant. With AstraZeneca’s vaccine, there was 60% protection against delta compared with 73% for alpha. Because this was an observational study, more research is needed to confirm the findings, the research team said.

Novavax vaccine highly effective in North American trial

Novavax Inc on Monday said its COVID-19 vaccine was more than 90% effective, including against a variety of concerning coronavirus variants, in a large, late-stage clinical trial, providing another potential weapon against the disease once approved for use. In the trial involving nearly 30,000 volunteers in the United States and Mexico, the two-shot vaccine was 100% effective in preventing infection by the original version of the coronavirus, the company said. It was more than 93% effective against the predominant variants of the virus that have been of concern among scientists and public health officials. The alpha variant first identified in the UK was the predominant variant in the United States while the trial was being conducted, the company said. The vaccine was 91% effective among volunteers at high risk of severe infection and 100% effective in preventing moderate and severe cases of COVID-19. Novavax said the vaccine was generally well tolerated, with side effects similar to those seen with existing COVID-19 vaccines. The Novavax COVID-19 shot is a more conventional type of vaccine than those currently available. It contains an actual version of the virus’ spike protein that cannot cause disease but can trigger the immune system directly. The company said the results put it on track to file for emergency authorization in the United States and elsewhere in the third quarter of 2021.

Tetanus, diphtheria boosters tied to less severe COVID-19

Older individuals who have gotten a diphtheria or tetanus vaccine booster shot in the last 10 years may be at lower risk for severe COVID-19, a new study suggests. Using a large UK registry, researchers looked back at 10 years of immunization records from 103,409 participants with an average age of 71. They saw a trend toward a lower risk of a positive COVID-19 test in people who had gotten a tetanus or diphtheria booster shot during the study period, although the difference was small and might have been due to chance. There was, however, a statistically significant association between the booster shots and the odds of severe COVID-19. After accounting for age, sex, underlying respiratory diseases, and socioeconomic status, the odds of developing severe COVID-19 were 64% lower in people who had gotten a diphtheria booster and 50% lower in recipients of tetanus booster, according to a report posted on medRxiv on Saturday ahead of peer review. The study does not prove cause and effect. If there is some effect of the boosters, it might be that they protect against severe COVID-19 symptoms by stimulating the immune system, the authors suggest. “The possibility that these vaccinations may influence the severity of COVID-19 warrants follow-up investigations,” they conclude.

(Reporting by Nancy Lapid, Carl O’Donnell and Alistair Smout; Editing by Bill Berkrot)

Delta variant dominant in UK, may increase risk of hospitalization

LONDON (Reuters) -The Delta variant of concern first identified in India is now dominant in Britain and might have an increased risk of hospitalization compared to the Alpha variant, Public Health England said on Thursday.

There were 5,472 new cases of the Delta variant reported in latest weekly figures, taking the total confirmed cases of the variant to 12,431, PHE said, adding it had overtaken Alpha, the variant first identified in England’s Kent, as Britain’s dominant variant.

The Delta variant is also thought to be more transmissible than Alpha, and Prime Minister Boris Johnson has warned that it could derail plans for lockdown restrictions in England to end on June 21.

“With this variant now dominant across the UK, it remains vital that we continue to exercise caution particularly while we learn more about transmission and health impacts,” said Jenny Harries, Chief Executive, UK Health Security Agency.

PHE said that early evidence suggested there may be an increased risk of hospitalization for Delta, also known as B.1.617.2, compared to Alpha, known as B.1.1.7, but more data was needed in order to have more confidence in that finding.

PHE said there continued to be a “substantially increased growth rate for Delta compared to Alpha” but did not update on the transmissibility advantage of the variant.

Officials have previously said that Delta could be from a few percentage points to 50% more transmissible than the Alpha variant, and the extent of that advantage could determine whether restrictions can be lifted on June 21.

(Reporting by Alistair Smout and William James; Editing by Kate Holton)

U.S. to buy at least 100,000 doses of Lilly’s COVID-19 antibody therapy

(Reuters) – Drugmaker Eli Lilly and Co said on Friday the U.S. government has agreed to buy at least 100,000 doses of its newly authorized COVID-19 dual antibody cocktail for $210 million, with doses to be delivered through March-end.

The U.S. government will have the option to purchase up to an additional 1.1 million doses through Nov. 25, the company said.

Lilly said it would begin shipping these doses immediately.

The therapy contains two antibodies bamlanivimab and etesevimab and had got U.S. emergency use authorization earlier this month.

Like rival Regeneron Pharmaceuticals Inc’s dual antibody therapy REGN-COV2, Lilly’s combo has been authorized for the treatment of mild to moderate COVID-19 in patients who are at high risk of progressing to severe disease or hospitalization.

Lilly’s therapy helped cut the risk of hospitalization and death in COVID-19 patients by 70%, according to early late-stage trial data put out in January.

Despite the government’s efforts to encourage use of the treatments to help keep people out of hospitals, the therapies have seen weak demand.

Healthcare systems have said they have been slow to ramp up use of the antibodies due to extra levels of complexity during the pandemic, including requirements for quick diagnosis times and the need to isolate infectious patients.

United States had already agreed to buy 1.45 million doses of bamlanivimab alone, Lilly said, adding that 1 million of doses have already been delivered and 450,000 additional doses will be delivered by March-end.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta)

Lilly says antibody drug cuts COVID-19 hospitalization, may seek emergency use nod

By Deena Beasley

(Reuters) – Eli Lilly and Co on Wednesday said a single infusion of its experimental antibody treatment reduced the need for hospitalization and emergency room visits for clinical trial patients with moderate COVID-19.

The company said it will discuss the interim results, which have not yet been reviewed by outside experts, with global regulators. The New York Times reported that Lilly Chief Scientific Officer Daniel Skovronsky said the company would talk with the U.S. Food and Drug Administration about the possibility of an emergency use authorization.

The mid-stage study tested three different doses of LY-CoV555, a manufactured copy of a an antibody produced by a patient who recovered from COVID-19. Antibody treatments work by recognizing and locking onto foreign invaders to prevent infection of healthy cells.

Of the total 302 patients treated with the Lilly drug, five or 1.7%, had to be hospitalized or required an emergency room visit. That compared with 6% in the placebo group, Lilly said.

“These data are not a home run but … are among the most encouraging COVID treatment data we’ve seen, particularly given this is in mild-to-moderate outpatients where there has simply been no treatment progress until now,” Raymond James analyst Steven Seedhouse said in a research note.

Oddly, only the middle 2,800-milligram dose achieved the trial’s main goal of reducing the amount of virus detected in patients compared with a placebo 11 days after treatment. Lilly said most trial participants, including those given a placebo, had completely cleared the virus by day 11. Some analysts suggested that future studies may want to use an earlier time point than 11 days.

Most hospitalizations occurred in patients with underlying risk factors such as obesity or advanced age. Lilly said future study would focus on people in these higher-risk groups.

No drug-related serious adverse events or trial deaths were reported.

Lilly said the trial will enroll 800 patients with mild-to-moderate COVID-19, with the next segment testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds to a different area of the coronavirus.

The antibodies, given by intravenous infusion, are also being tested for preventing COVID-19 in nursing home residents and staff and for treating patients already hospitalized with COVID-19.

Several companies including Regeneron Pharmaceuticals Inc and Vir Biotechnology are also testing antibody treatments for COVID-19.

Lilly’s shares were up 1.3% to $152.

(Reporting by Deena Beasley in Los Angeles and Manas Mishra in Bengaluru; Editing by Shinjini Ganguli and Bill Berkrot)

Black Americans hospitalized for COVID-19 at four times the rate of whites, Medicare data shows

(Reuters) – Black Americans enrolled in Medicare were around four times as likely as their white counterparts to be hospitalized for COVID-19, U.S. government data released on Monday showed, highlighting significant racial disparities in health outcomes during the pandemic.

“The disparities in the data reflect longstanding challenges facing minority communities and low income older adults,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), which released the data.

The data showed that more than 325,000 Medicare beneficiaries were diagnosed with COVID-19 between Jan. 1 and May 16. Of those, more than 110,000 were hospitalized.

Black Americans had a hospitalization rate 465 per 100,000 Black Medicare beneficiaries. For other groups measured by CMS, the rates of per capita hospitalizations were 258 for Hispanics, 187 for Asians and 123 for whites.

Hospitalization rates were high for people who qualified for both the senior-focused Medicare program and the low-income-focused Medicaid program, at 473 per 100,000.

“Low socioeconomic status all wrapped up with racial disparities represents a powerful predictor of complications with COVID-19,” Verma said during a briefing about the data.

Medicare beneficiaries with end-stage kidney disease were hospitalized for COVID-19 at a rate of 1,341 per 100,000.

Medicare is a federal health insurance program designed primarily for seniors, as well as some people with disabilities and end-stage kidney disease.

Verma said that CMS’ ongoing push to reimburse providers based on health outcomes rather than paying them fixed fees for their services could help address racial disparities.

“When implemented effectively, (value-based reimbursement) encourages clinicians to care for the whole person and address the social risk factors that are so critical for our beneficiaries’ quality of life,” Verma said.

The data is based on claims filed for reimbursement from Medicare and therefore operates at a delay of several weeks.

(Reporting by Trisha Roy and Carl O’Donnell; Editing by Shinjini Ganguli and Cynthia Osterman)

Fourteen more fall sick from E. coli linked to romaine lettuce: CDC

Romaine lettuce grows near Soledad, California, U.S., May 3, 2017. REUTERS/Michael Fial

(Reuters) – Fourteen more sick people from eight U.S. states were added to an investigation of an E. coli outbreak linked to romaine lettuce, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday.

Three more states – Mississippi, Tennessee and Wisconsin – reported ill people, the CDC said.

Eighty-four people infected with a strain of E. coli have been reported from 19 states, the CDC had said on Wednesday, in an update to its investigation into the outbreak.

The regulator has advised people not to eat or buy romaine lettuce, commonly used in salads, unless they can confirm it is not from the Yuma, Arizona growing region.

Forty-two people had been hospitalized, including nine who had developed a type of kidney failure, the CDC said.

(Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar)

Toxic gases from Indonesian volcano send 30 to hospital

A view of Mount Ijen, an active volcano and popular tourist destination for its sulphur mining, is seen the day after the crater was closed to visitors and many residents living on its slopes were forced to flee to avoid toxic gas near Bondowoso, East Java, Indonesia March 22, 2018 in this photo taken by Antara Foto. Antara Foto/Seno/via REUTERS

JAKARTA (Reuters) – An Indonesian volcano belched thick clouds of sulfuric gas on Wednesday, sending 30 people to hospital and prompting the closure of the popular tourist and mining site.

Nearly 200 people living on the slopes of Mount Ijen in East Java province were forced to evacuate.

“Because of this incident, the public – tourists or miners – are not allowed near the crater until further notice,” said Sutopo Purwo Nugroho, spokesman for the national disaster mitigation agency.

He added that many residents had experienced vomiting and difficulty in breathing.

There was no increase in seismic activity, Nugroho said.

The crater is a popular site for tourists and miners, who dig up hardening yellow sulfur to sell for use in everything from cosmetics to matchsticks.

The volcano regularly puffs out small amounts of noxious gases but the site stays open to the public.

Around five million of Indonesia’s 250 million people live and work near volcanoes, according to authorities, largely because of the fertile farming soil.

(This story has been refiled to correct typo in headline)

(Reporting by Kanupriya Kapoor; Editing by Nick Macfie)

U.S. flu-related hospitalizations highest in nearly a decade: agency

Emergency room nurse Christine Bauer treats Joshua Lagade of Vista, California, for the flu as his girlfriend Mayra Mora looks on in the emergency room at Palomar Medical Center in Escondido, California, U.S., January 18, 2018.

By Deena Beasley

(Reuters) – Flu activity worsened over the past week as more people headed to doctors’ offices and emergency rooms, with hospitalizations at the highest in nearly 10 years, U.S. health officials said on Friday.

Sixteen children died of the flu in the week ended Jan. 27, bringing total pediatric deaths to 53 for the season, according to the Centers for Disease Control and Prevention’s weekly report.

Out of every 100,000 people in the general population, an estimated 51.4 have been hospitalized for the flu, surpassing the rate in the last severe season of 2014/2015, when 710,000 were hospitalized and 148 children died. Adults aged 65 or older had the most hospitalizations, followed by those aged 50 to 64, and children below 5.

The dominant strain during this flu season is an especially nasty type called influenza A (H3N2) that in seasons past had been linked with severe disease and death, especially in the elderly and young.

“So far this year the cumulative rate of hospitalization is the highest since we began tracking in this way,” Dr. Anne Schuchat, acting director of the Centers for Disease Control and Prevention, told reporters on a conference call. The CDC began its current hospital flu surveillance program during the 2009-2010 H1N1 swine flu pandemic.

Schuchat was named acting CDC director earlier this week after Dr. Brenda Fitzgerald resigned from the post because of financial conflicts of interest, including purchases of tobacco and healthcare stocks while in office.

Flu is widespread in 48 states, down from 49 last week, with Oregon reporting less flu activity, the CDC said.

“We are not out of the woods yet,” Schuchat said, noting that sick people should stay home to avoid transmitting the virus to others, frequently wash hands and cover their mouth while coughing or sneezing.

The CDC official also said it was not too late to get a flu vaccine.

(Reporting by Deena Beasley; Editing by Richard Chang)