F.D.A. Cites Failures at Plant Where J.&J. Doses Ruined

Federal regulators on Wednesday issued highly critical findings from their inspection of a Baltimore plant that was forced to throw out up to 15 million doses of Johnson & Johnson’s coronavirus vaccine and ordered to temporarily stop all production.The Food and Drug Administration cited a series of shortcomings at the massive plant, which is operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent workers had contaminated a batch of Johnson & Johnson doses with the harmless virus that is used to deliver AstraZeneca’s vaccine, which is also manufactured at the plant.The violations included failure to properly disinfect the factory and its equipment, as well as failure to institute and follow proper procedures designed to prevent contamination of doses and to ensure the strength and purity of the vaccine manufactured there. “There is no assurance that other batches have not been contaminated,” the inspectors wrote.Their 12-page report cited nine violations, ranging from the design of the building to improperly trained employees. The inspection was finished on Tuesday.In a statement, the F.D.A. noted that it has not authorized Emergent to distribute any doses of Johnson & Johnson vaccine, and that no vaccine manufactured at the plant has been released for use in the United States.AstraZeneca’s vaccine is not yet authorized for use in the United States, and all the Johnson & Johnson doses that have been administered in the country so far were manufactured overseas. At the agency’s request, all production at the factory has been halted.“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the statement from Dr. Janet Woodcock, the F.D.A.’s acting commissioner, and Dr. Peter Marks, the agency’s top vaccine regulator, said.The agency said it was working with Emergent to fix the problems.Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. The company’s Baltimore plant is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” that were supposed to be at the ready in the event of a pandemic.The New York Times reported earlier this month that the Trump administration awarded a $628 million contract to the company about ten months ago despite a history of performance problems. The contract mainly allowed the government to reserve manufacturing space in the plant for vaccine production. On Tuesday, the House Select Subcommittee on the Coronavirus Crisis, announced that it will investigate that contract award and other issues involving Emergent, saying the firm had a track record of failing to meet contract requirements.The inspectors castigated Emergent’s response to the discovery last month that Johnson & Johnson doses had been contaminated with the benign virus used to create AstraZeneca’s vaccine. The incident “has not been fully investigated,” they wrote.They said Emergent did not thoroughly review whether the cross-contamination was caused by one or more workers who move between AstraZeneca’s and Johnson & Johnson’s manufacturing zones or whether it could be related to how raw materials used in the production of both vaccines are handled.The inspectors found that workers frequently moved between the manufacturing zones without documenting that they had showered and changed their gowns as required. In one ten-day period in February, for instance, 13 employees moved from one zone to another on the same day, but only one documented having showered, they said. After the Johnson & Johnson doses were found to be contaminated, the report said, only routine cleaning was performed.Workers also failed to properly handle manufacturing waste, creating risks of contamination in the warehouse where raw materials are stored, the inspectors found. They also cited peeling paint, crowded equipment and other issues with the building. Overall, it “is not maintained in a clean and sanitary condition,” they wrote.Emergent said in a statement on Wednesday that “while we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.”In its own statement, Johnson & Johnson said it had already stepped up its oversight of Emergent, its subcontractor, and that it would “ensure that all of F.D.A.’s observations are addressed promptly and comprehensively.”One major change has already been made: AstraZeneca will no longer be manufactured at the plant, a move that federal officials insisted upon earlier this month to limit the chance of cross-contamination between two vaccines.Dr. Jose Romero, the Arkansas health secretary and chairman of the expert panel advising the Centers for Disease Control and Prevention on the future of the Johnson & Johnson vaccine, said in an interview that he was dismayed by the F.D.A.’s findings. The panel is meeting on Friday on whether to lift, modify or retain a pause in the administration of Johnson & Johnson’s vaccine that was instituted last week for an entirely different issue: the discovery that eight U.S. residents developed a rare but dangerous blood clotting disorder after they got shots.“I’m shocked” Dr. Romero said. “I can’t put it any other way. Inappropriate disinfection, the prevention of contamination — those are significant and serious violations, at least in my mind, and do of course need to be remedied.“I would not have expected that, given the stringency that we have in this country for good manufacturing practices in these vaccine plants,” he said.

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Biden Pushes Mask Mandate as C.D.C. Director Warns of ‘Impending Doom’

The administration is stepping up the pace of vaccinations and expanding access to shots, but it remains in a race against a virus on the upswing.WASHINGTON — President Biden, facing a rise in coronavirus cases around the country, called on Monday for governors and mayors to reinstate mask mandates as the director of the Centers for Disease Control and Prevention warned of “impending doom” from a potential fourth surge of the pandemic.The president’s comments came only hours after the C.D.C. director, Dr. Rochelle Walensky, appeared to fight back tears as she pleaded with Americans to “hold on a little while longer” and continue following public health advice, like wearing masks and social distancing, to curb the virus’ spread.The back-to-back appeals reflected a growing sense of urgency among top White House officials and government scientists that the chance to conquer the pandemic, now in its second year, may slip through its grasp. Coronavirus infections and hospitalizations are on the upswing, including a troubling rise in the Northeast, even as the pace of vaccinations is accelerating.“Please, this is not politics — reinstate the mandate,” Mr. Biden said, adding, “The failure to take this virus seriously is precisely what got us into this mess in the first place.”According to a New York Times database, the seven-day average of new virus cases as of Sunday was about 63,000, a level comparable with late October’s average. That was up from 54,000 a day two weeks earlier, an increase of more than 16 percent. Similar upticks in Europe have led to major surges in the spread of Covid-19, Dr. Walensky said.Public health experts say that the nation is in a race between the vaccination campaign and new, worrisome coronavirus variants. Although more than one in three American adults have received at least one shot and nearly one-fifth are fully vaccinated, the nation is a long way away from reaching so-called herd immunity — the tipping point that comes when spread of a virus begins to slow because so many people, estimated at 70 to 90 percent of the population, are immune to it.But states are rapidly expanding access to more plentiful quantities of the vaccine. On Monday, at least six — Texas, Kansas, Louisiana, North Dakota, Ohio and Oklahoma — made all adults eligible for vaccination. New York said that all adults would be eligible starting April 6.Mr. Biden said on Monday that the administration was taking steps to expand vaccine eligibility and access, including opening a dozen new mass vaccination centers. He directed his coronavirus response team to ensure that 90 percent of Americans would be no farther than five miles from a vaccination site by April 19.The president said doses were plentiful enough now that nine of 10 adults in the nation — or more — would be eligible for a shot by that date. Previously, he had called on states to broaden eligibility to all adults by May 1. He revised that promise because states, buoyed by projected increases in shipments, are opening their vaccination programs more rapidly than expected, a White House official said.But it was Dr. Walensky’s raw display of emotion that seemed to capture the angst of the moment. Barely three months into her new job, the former Harvard Medical School professor and infectious disease specialist acknowledged she was departing from her prepared script during the White House’s regular coronavirus briefing for reporters.She described “a feeling of nausea” she experienced last year when, caring for patients at Massachusetts General Hospital, she saw the corpses of Covid-19 victims piled up, overflowing from the morgue. She recalled how she stood — “gowned, gloved, masked, shielded” — as the last one in a patient’s room before they died alone, without family.Dr. Rochelle Walensky, the director of the C.D.C., said on Monday that the nation had “so much reason for hope,” but she warned of the potential for another virus surge.Anna Moneymaker for The New York Times“I am asking you to just hold on a little longer, to get vaccinated when you can, so that all of those people that we all love will still be here when this pandemic ends,” Dr. Walensky said. The nation has “so much reason for hope,” she added.“But right now,” she said, “I’m scared.”In nine states over the past two weeks, virus cases have risen more than 40 percent, The Times database shows. Michigan led the way with a 133 percent increase, and the Northeast has also seen a marked rise in virus cases. Connecticut reported a 62 percent jump over the past two weeks, and New York and Pennsylvania both reported increases of more than 40 percent.Michigan’s increase has not been traced to any one event, but epidemiologists have noted that cases started to rise after the state eased restrictions for indoor dining on Feb. 1 and lifted other restrictions in January. Other hot spots included North Dakota, where cases rose by nearly 60 percent, and Minnesota, where cases have risen 47 percent. Of those states, North Dakota is the only one currently without a mask mandate.The wave of new cases does come at the same time as some promising news: A C.D.C. report released Monday confirmed the findings of last year’s clinical trials that vaccines developed by Moderna and Pfizer were highly effective against Covid-19. The report documented that the vaccines work to prevent both symptomatic and asymptomatic infections “in real-world conditions.”Researchers followed nearly 4,000 health care employees and essential workers beginning in December. They found 161 infections among the unvaccinated workers, but only three among those who received two doses of vaccine. The study suggested even a single dose was 80 percent effective against infection two weeks after it was administered. Studies are continuing to determine whether vaccinated people can still transmit the virus to others, although many scientists consider that unlikely.A vaccination site on Monday in Houston. A recent drop in cases in Texas may be reversing. Go Nakamura for The New York TimesThe pace of vaccination continues to pick up. The seven-day average of vaccines administered hit 2.76 million on Monday, an increase over the pace the previous week, according to data reported by the C.D.C. On Sunday alone, nearly 3.3. million people were inoculated, said Andy Slavitt, a senior White House pandemic adviser.Broader eligibility pools should bolster that further, with more than three dozen states now allowing all adults to sign up for shots by mid-April.Minnesota will open up to all adults on Tuesday, and Connecticut on Thursday. Florida has lowered the age of eligibility to 40, and Indiana has lowered it to 30.At the same time, Covid surges in some states have health officials increasingly on edge. Similar escalations several weeks ago in Germany, France and Italy have now turned into major outbreaks, Dr. Walensky said.“We know that travel is up, and I just worry that we will see the surges that we saw over the summer and over the winter again,” she said.As his presidency enters its third month, Mr. Biden is still fighting some battles started by his predecessor, who turned the act of mask wearing into a political statement. As soon as he took office, Mr. Biden used his executive authority to impose mask requirements where he could — on federal property. And he urged all Americans to “mask up” for 100 days.But some governors, particularly in more conservative states, ignored him. When the governors of Mississippi and Texas announced this month that they would lift their mask mandates, Mr. Biden denounced the plans as a “big mistake” that reflected “Neanderthal thinking.”Texas’ governor this month allowed all businesses to open at full capacity and lifted the state’s mask mandate.Matthew Busch for The New York TimesIn Texas, a recent drop in cases may be reversing. Although The Times database shows that over the past two weeks coronavirus infections there have declined 17 percent, deaths have declined 34 percent and hospitalizations have declined 25 percent, the seven-day average of newly reported coronavirus infections was up on Sunday to 3,774. Last Wednesday, the average case count was at a low of 3,401.“There is something particularly difficult about this moment,” said Dr. Joshua M. Sharfstein, a former top Food and Drug Administration official who now teaches at the Johns Hopkins Bloomberg School of Public Health. With more and more Americans vaccinated and the potential to bring the pandemic to an end in sight, he said that “it feels like every case is unnecessary.”Dr. Walensky, who has issued several warnings in recent weeks about the need to keep up mask wearing and social distancing, said she planned to talk to governors on Tuesday about the risks of prematurely lifting restrictions.“I know you all so badly want to be done,” she said. “We are just almost there, but not quite yet.”Eileen Sullivan

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