The top executives of three major companies are set to appear on Thursday before a Senate panel led by Mr. Sanders, who has made lowering drug costs a signature issue.The chief executives of three major pharmaceutical companies are set to appear in front of the Senate health committee on Thursday to defend how much they charge for drugs in the United States, drawing them further into a confrontation with lawmakers and the Biden administration over the cost of some of the most widely used prescription medications.The three executives scheduled to testify — Joaquin Duato of Johnson & Johnson, Robert M. Davis of Merck and Christopher Boerner of Bristol Myers Squibb — are expected to clash with the health committee’s chairman, Senator Bernie Sanders of Vermont, an independent who has made reining in drug prices a signature cause of his late-career years in Congress.Mr. Sanders plans to focus the hearing on why drug prices are higher in the United States than in other wealthy countries. His staff has singled out several widely used drugs, including Eliquis, a blood thinner made by Bristol Myers Squibb, and Januvia, a diabetes drug from Merck, that can be bought for much less in Canada and Europe than in the United States.The hearing comes as a new federal program authorizing Medicare to negotiate the prices of some costly medications is getting underway. Federal health officials last week made their initial offers to the makers of the first 10 drugs selected for negotiations, a list that includes Eliquis and Januvia.Five of the 10 drugs picked for price talks are made by the companies whose executives will be testifying on Thursday. Drug makers, including all three companies that will be represented at the hearing, have filed a flurry of lawsuits arguing that the negotiation program is unconstitutional.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

President Biden announced that his administration would double its order of Pfizer’s scarce Covid-19 antiviral drug, which has been shown to reduce hospitalizations.WASHINGTON — The United States government doubled its order for Pfizer’s Covid pills on Tuesday, a move that will modestly increase the nation’s very limited supply of the treatment in the short term amid a record-setting surge in coronavirus cases.The new order will eventually provide enough pills for an additional 10 million Americans, bringing the government’s total order of the drug to 20 million treatment courses. But they will not all be available right away. Only 35,000 of the additional courses will be delivered this month, and 50,000 more in February, supplementing 350,000 treatment courses that were already expected over the next two months, according to a senior administration official.The order underscored how urgently health providers need alternatives to vaccines, as roughly 35 million adults remain without a shot and more vulnerable to severe outcomes from Covid-19. Tens of millions more have been vaccinated but have risk factors that also make them especially vulnerable.The new order also suggests that the federal pandemic response will increasingly rely on oral treatments, which are scarce and facing intense demand.“We may need even more,” President Biden said on Tuesday, announcing the move ahead of a Covid-19 briefing he was set to receive from health advisers. “That’s the estimate we need right now.”The government has agreed to pay Pfizer $530 for each treatment course, the same amount it paid for its initial order late last year, the senior official said.Monthly deliveries of the Pfizer treatment, known as Paxlovid, are not expected to ramp up into the millions until April, too late to help with the current surge. The company says it takes six to eight months to produce the drug; the combined order is not due to be completely filled until the end of September.Still, Mr. Biden described the doubled order as a key component of the federal government’s Covid strategy. “They’re a game-changer,” he said, “and have the potential to dramatically alter” the course of the pandemic.Paxlovid was authorized two weeks ago for use in high-risk Covid patients age 12 or older. Pfizer expects to produce 120 million courses of it in 2022 for all global buyers. The treatment has proved in clinical trials to be highly effective in staving off severe illness when taken soon after the start of symptoms.Pfizer’s treatment is meant to be taken as 30 pills over five days, with patients taking three pills at a time: two of Pfizer’s pills and one of a low-dose H.I.V. drug known as ritonavir, which helps Pfizer’s drug remain active in the body longer.But public health experts have warned that without an adequate testing supply — a problem in many parts of the country — it could be difficult to quickly get the pills to those most in need.Mr. Biden on Tuesday said that in addition to more federal test sites opening, the administration’s plan to have insurers reimburse people for at-home tests would go into effect soon, as would a website allowing Americans to order free tests delivered to their homes, from a pool of 500 million being ordered by the federal government. Pfizer’s Covid-19 treatment pill, Paxlovid, in a laboratory in Germany. Health officials urgently need alternatives to vaccines to battle the disease.Agence France-Presse, via Pfizer/Afp Via Getty Images“I know this remains frustrating,” he said. “Believe me, it’s frustrating to me. But we’re making improvements.”The first supplies of Paxlovid have already begun arriving in some parts of the country. The allocations are based on each state’s population, but federal officials are considering shifting that model at some point to one based on case rates and hospitalizations, similar to the system it uses for distributing monoclonal antibody treatments.The Coronavirus Pandemic: Key Things to KnowCard 1 of 3The global surge.

Expert advisers to the Centers for Disease Control and Prevention will meet on Thursday to discuss what federal health officials see as a concerning increase in the rates of a rare but serious blood clotting disorder linked to Johnson & Johnson’s coronavirus vaccine.The Advisory Committee on Immunization Practices will see new data at the meeting that shows elevated risks of the condition in men and women, according to one federal official, setting the stage for the experts to possibly recommend new restrictions on the use of the vaccine.The F.D.A. on Tuesday said that although problems arose in men and women, the highest rate was in about 1 in 100,000 in women aged 30-49.Among the women who were diagnosed with the syndrome, which can impair clotting and cause internal bleeding, about one in seven of them died, the F.D.A. said. The federal official who described the planning for Thursday’s meeting said that updated figures showed roughly nine deaths from the disorder.The panel on Thursday may advise that the vaccine only be given to people who cannot access a different brand or who want it despite the risk, or restrict it to certain groups.The Washington Post first reported the plans for Thursday’s meeting and the new federal data.Jake Sargent, a spokesman for Johnson & Johnson, said the company shares with regulators reports of side effects in people who have received the vaccine and “strongly support raising awareness of the signs and symptoms of this rare event.” About 16 million people in the United States have received a single shot of the Johnson & Johnson vaccine as their primary immunization, compared to 73 million fully immunized with Moderna’s vaccine and 113 million with Pfizer’s. Among the people in the United States who have received a booster shot, just 1.5 percent have gotten the one from Johnson & Johnson.The side effect, known as thrombosis with thrombocytopenia syndrome, can impair clotting and cause internal bleeding. An increased risk for the condition has been linked to the Johnson & Johnson vaccine and the shot from AstraZeneca, which is not authorized in the United States. It has not been linked to the vaccines from Moderna or Pfizer.On Tuesday, the Food and Drug Administration announced that it added a warning to the vaccine’s fact sheets for patients and providers, saying the shot should not be given to anyone who has had a clotting problem after a first dose. The agency said that it “continues to find” that the benefits of the vaccine outweigh its risks.As more cases of the clotting disorder were adjudicated by federal health officials in recent months, F.D.A. and C.D.C. officials grew increasingly alarmed by the numbers presented to them by the C.D.C.’s immunization safety office, which monitors reports in the Vaccine Adverse Event Reporting System, or VAERS, a decades-old system that relies on self-reported cases from patients and health care providers.The reports of the condition grew worrisome enough in recent weeks that federal officials determined they needed to call an emergency meeting of the C.D.C. advisers.The Coronavirus Pandemic: Key Things to KnowCard 1 of 4U.S. surpasses 800,000 deaths.

A top White House adviser said monoclonal antibody treatments, sometimes underused, could still be crucial in helping people with Covid-19 avoid getting very sick.WASHINGTON — Facing overcrowded hospitals and an unrelenting surge of Delta variant cases around the country, the Biden administration on Thursday renewed its call for health providers to use monoclonal antibody treatments, which can help Covid-19 patients who are at risk of getting very sick.Dr. Marcella Nunez-Smith, a White House adviser on racial equity in health, said at a news conference that federal “surge teams” deployed to hard-hit states were working to increase uptake of and confidence in the antibody drugs. They have already been administered to more than 600,000 people in the United States during the pandemic, she said, preventing hospitalizations and helping save lives. President Donald J. Trump received one such treatment when he was diagnosed with Covid-19 last year, before it had been authorized for emergency use.In states where vaccination has stalled and cases have soared, the treatments have become a key component of the federal strategy to reduce the toll of the worst outbreaks, underscoring how many Americans remain at risk.Distribution of doses, which are ordered by medical providers, increased fivefold from June to July. About 75 percent of the ordering is from regions of the country with low vaccination rates, according to the Department of Health and Human Services.The administration “continues to stand ready to assist states and territories and jurisdictions across the country to get more people connected” to the treatments, Dr. Nunez-Smith said on Thursday, though she emphasized that vaccination was still the best option for preventing Covid-19.Jeffrey D. Zients, the White House’s Covid-19 response coordinator, said the Biden administration has deployed more than 500 federal workers to help state health departments and hospitals combat the Delta variant, including emergency medical workers in Louisiana and Mississippi and Centers for Disease Control and Prevention teams in Tennessee, Illinois and Missouri.Dr. Nunez-Smith said the administration had conducted virtual trainings on how to administer the drugs for doctors and health system officials in Arizona, Nevada, Utah and Wyoming. In Arizona, federal teams are offering the treatments at two sites, where none of the Covid-19 patients who had received them had subsequently been hospitalized.The treatments, which the federal government pays for and makes free to patients, mimic antibodies that the immune system generates naturally to fight the coronavirus. They have been shown to sharply reduce hospitalizations and deaths when given to patients soon after symptoms appear, typically by intravenous infusion. There is also evidence that they may be able to prevent the disease entirely in certain people exposed to the virus. Unlike coronavirus vaccines, which take as long as six weeks to provide full protection, the antibody treatments can be given to patients who are already sick, with a more immediate effect.The latest data from the Department of Health and Human Services shows that just under half of the distributed supply of the treatments has been used, by more than 6,000 hospitals and other provider sites, dating back to late last year. The federal government relies on providers and state health departments to report their usage numbers and does not track the demographics of the patients who receive the drugs.Dr. Nunez-Smith said that shipments to Florida, which is experiencing a devastating surge in virus cases, had increased eightfold over the past month, and more than 108,000 courses of the treatments were shipped around the country in July.Gov. Ron DeSantis of Florida on Thursday introduced a “rapid response unit” for administering the Regeneron treatment in Jacksonville, saying that the state would set up similar sites in other cities.Interest in the monoclonal antibodies has been spotty throughout the pandemic. When they were authorized last year, the treatments from Regeneron and Eli Lilly were expected to be in high demand and to serve as a bridge in fighting the pandemic before vaccinations ramped up. They were relentlessly promoted by Mr. Trump, who called the Regeneron treatment a “cure,” and top health officials in his administration.Still, they ended up sitting on refrigerator shelves in many places, even during recent surges. Many hospitals and clinics did not make the treatments a priority because of how time consuming and difficult to administer they were at the time, when they had to be given via intravenous infusion. Physicians can now administer the most frequently used treatment, from Regeneron, subcutaneously, or by injection..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}“These are important tools,” said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who has worked with Regeneron on a study that showed that the company’s antibody treatment may be able to prevent Covid-19 when given to people living with someone infected with the coronavirus. “They have shown substantial therapeutic effects.”Dr. Rajesh Gandhi, an infectious disease physician at Massachusetts General Hospital who was an investigator for that study, said evidence of the benefit of the antibody treatments had only grown stronger in recent months. He said more needed to be done to educate physicians and patients on how effective they can be.“Patients need to know to call their physicians” and ask about the treatments, he said. “In 2020, people with mild Covid were told to stay home. That message needs to pivot to a more proactive message.”Regeneron has aired a series of television advertisements for its treatment this year.Virtually all Covid-19 patients receiving monoclonal antibodies during the Delta surge are getting the kind made by Regeneron, one of three that have been authorized by the Food and Drug Administration during the pandemic. The company estimated last week that its treatment was now reaching more than a quarter of eligible patients, up from less than 5 percent earlier in the pandemic.The F.D.A. last month expanded its emergency authorization of the Regeneron treatment so that it could be used to try to prevent Covid-19 in a small number of high-risk patients. They include people with certain health conditions who are not vaccinated or may not mount an adequate immune response, who have been exposed to the virus, or who live in nursing homes or prisons. It had previously been available, like the other monoclonal antibody treatments, only for high-risk patients who had already tested positive for the virus.The federal government in June indefinitely paused shipments of the first authorized monoclonal antibody treatment, from Eli Lilly, because new lab data suggested it would not work well in cases caused by the Beta and Gamma variants.The government has not ordered any doses of a third treatment, from GlaxoSmithKline and Vir, which is being used only minimally so far. Kathleen Quinn, a spokeswoman for GlaxoSmithKline, said the treatment was available at health care facilities in 26 states and U.S. territories.

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutGuidelines After VaccinationAdvertisementContinue reading the main storySupported byContinue reading the main storyThe U.S. Is Sitting on Tens of Millions of Vaccine Doses the World NeedsDoses from the drug maker AstraZeneca sit in U.S. manufacturing plants, awaiting regulatory authorization as the world goes begging.An Emergent BioSolutions laboratory in Baltimore. The company has already produced tens of millions of doses of the AstraZeneca vaccine, which cannot be used in the United States yet.Credit…Michael Robinson Chavez/The Washington Post, via Getty ImagesNoah Weiland and March 11, 2021, 6:25 p.m. ETWASHINGTON — Tens of millions of doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idly in American manufacturing facilities, awaiting results from its U.S. clinical trial while countries that have authorized its use beg for access.The fate of those doses of AstraZeneca’s vaccine is the subject of an intense debate among White House and federal health officials, with some arguing the administration should let them go abroad where they are desperately needed while others are not ready to relinquish them, according to senior administration officials.AstraZeneca is involved in those conversations.“We understand other governments may have reached out to the U.S. government about donation of AstraZeneca doses, and we’ve asked the U.S. government to give thoughtful consideration to these requests,” said Gonzalo Viña, a spokesman for AstraZeneca.About 30 million doses are currently bottled at AstraZeneca’s facility in West Chester, Ohio, which handles “fill-finish,” the final phase of the manufacturing process during which the vaccine is placed in vials, one official with knowledge of the stockpile said.Emergent BioSolutions, a company in Maryland that AstraZeneca has contracted to manufacture its vaccine in the United States, has also produced enough vaccine in Baltimore for tens of millions more doses once it is filled into vials and packaged, the official said.But although AstraZeneca’s vaccine is already authorized in more than 70 countries, according to a company spokesman, its U.S. clinical trial has not yet reported results, and the company has not applied to the Food and Drug Administration for emergency use authorization. AstraZeneca has asked the Biden administration to let it loan American doses to the European Union, where it has fallen short of its original supply commitments and where the vaccination campaign has stumbled badly.The administration, for now, has denied the request, one official said.Some federal officials have pushed the White House to make a decision in the next few weeks. Officials have discussed sending doses to Brazil, hard hit by a worsening coronavirus crisis.“If those donation actions were to proceed, we would seek guidance from the U.S. government on replacement of doses for use in the U.S.,” Mr. Viña said.The White House did not respond to a request for comment.The administration’s hesitation is at least partly related to uncertainties with vaccine supply before a benchmark of late May laid down by President Biden when he promised enough vaccine doses to cover every adult in the United States. Vaccine production is notoriously complex and delicate, and problems like mold growth can interrupt a plant’s progress.Last May, the Trump administration pledged up to $1.2 billion to AstraZeneca to finance the development and manufacturing of its vaccine, which it developed with the University of Oxford, and to supply the United States with 300 million doses if it proved effective. Federal officials and public health experts last year viewed the vaccine, which is less expensive and easier to store for long periods than some other vaccines, as most likely to be among the first to receive authorization.That never happened, in part because of a pattern of communication blunders by AstraZeneca that weakened the company’s relationship with American regulators and slowed the vaccine’s development. Last fall, AstraZeneca’s trial in the United States — the same one that will soon report results — was grounded for nearly seven weeks because the company was slow to provide the F.D.A. with evidence that the vaccine had not caused serious neurological side effects in two volunteers.The company is now grappling with another safety scare. Acting out of precaution, health authorities in Denmark, Norway and Iceland suspended use of the AstraZeneca’s vaccine on Thursday after several reports across the continent of severe blood clots.European official and the company said there was not evidence of any causal link. In the vast majority of cases, the emergence of such medical conditions has nothing to do with the vaccine. Some percentage of people are expected to fall ill by chance after getting vaccinated, as would happen in any group of people.The Coronavirus Outbreak