WASHINGTON — The Centers for Disease Control and Prevention said Wednesday that it had asked the Justice Department to appeal a federal court ruling striking down its requirement for masking on planes, trains, buses and other modes of transportation, after concluding that “an order requiring masking in the indoor transportation corridor remains necessary for the public health.”The announcement came a day after the Biden administration said it intended to appeal the ruling from a Florida judge — but only if the C.D.C. decided that the mask mandate was still necessary.“C.D.C. believes this is a lawful order, well within C.D.C.’s legal authority to protect public health,” the agency said in a statement, adding that it “continues to recommend that people wear masks in all indoor public transportation settings.”The Department of Justice also announced, through its spokesman on Twitter, that it had filed a notice of appeal. But the announcements do not change the status of the mask mandate, which has been lifted by the Transportation Security Administration and cannot legally be enforced unless the administration wins a stay of the lower court order, or wins the appeal.An appeal is potentially risky for the agency. The ruling by a Federal District Court judge, Kathryn Kimball Mizelle, an appointee of former President Donald J. Trump, does not set a legal precedent. But should an appeals court, or the Supreme Court, uphold her decision, it could permanently constrain the C.D.C.’s authority.

After meeting with company representatives, officials said the decision would depend partly on data on infections in vaccinated people that cause serious disease or hospitalization.Representatives of Pfizer met privately with senior U.S. scientists and regulators on Monday to press their case for swift authorization of coronavirus booster vaccines, amid growing public confusion about whether they will be needed and pushback from federal health officials who say the extra doses are not necessary now.The high-level online meeting, which lasted an hour and involved Pfizer’s chief scientific officer briefing virtually every top doctor in the federal government, came on the same day Israel started administering third doses of the Pfizer-BioNTech vaccine to heart transplant patients and others with compromised immune systems. Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.The twin developments underscored the intensifying debate about whether booster shots are needed in the United States, at what point and for whom. Many American experts, including Dr. Anthony S. Fauci, President Biden’s chief medical adviser for the pandemic, have said there is insufficient evidence yet that boosters are necessary. Some, though, say Israel’s move may foreshadow a government decision to at least recommend them for the vulnerable.Pfizer is gathering information on antibody responses in those who receive a third dose, as well as data from Israel, and expects to submit at least some of that to the Food and Drug Administration in the coming weeks in a formal request to broaden the emergency authorization for its coronavirus vaccine.But the final decision on booster shots, several officials said after the meeting, will also depend on real-world information gathered by the Centers for Disease Control and Prevention about breakthrough infections — those occurring in vaccinated people — that cause serious disease or hospitalization.And any recommendations about booster shots are likely to be calibrated, even within age groups, officials said. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait. And then there is the question of what kind of booster: a third dose of the original vaccine, or perhaps a shot tailored to the highly infectious Delta variant, which is surging in the United States.“It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Dr. Fauci said in a brief interview Monday evening, adding, “This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”A spokeswoman for Pfizer said in a statement, “We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data.”With less than half of the United States population fully vaccinated, some experts said Monday that the country needed to remain focused on getting all Americans their first dose. The Food and Drug Administration’s most important task, they said, is to increase public confidence by granting full approval to the coronavirus vaccines in use, which for now are authorized on an emergency basis.“At this point, the most important booster we need is to get people vaccinated,” said Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta. The booster doses in Israel, he added, “will help us answer some questions, but at the end of the day I don’t agree with what they’re doing. I think it’s awfully premature.”Within the Biden administration, some fear that if Americans are convinced that coronavirus vaccines provide only short-lived immunity before requiring a booster, they will be less likely to accept a shot. But those concerns could fall by the wayside if new data from Israel, expected in the next several weeks, shows conclusively that immunity wanes after six to eight months, significantly raising the risks for the elderly or other vulnerable populations.Workers unpacking doses of the Pfizer vaccine from cold storage last month. Pfizer is expected to submit a formal request in the coming weeks to broaden the emergency authorization for its vaccine.Bryan Anselm for The New York TimesThe administration convened Monday’s session in response to last week’s announcement by Pfizer and its German partner, BioNTech, that they were developing a version of their vaccine that targets the Delta variant, and reporting promising results from studies of people who received a third dose of the original vaccine six months after the second.The new data is not yet published or peer reviewed, but when the companies announced that they would submit data to the Food and Drug Administration for authorization of booster shots, it caught the Biden White House by surprise.In an unusual joint statement Thursday evening, hours after the Pfizer-BioNTech announcement, the F.D.A. and the C.D.C. pushed back.“Americans who have been fully vaccinated do not need a booster shot at this time,” the statement said, adding, “We are prepared for booster doses if and when the science demonstrates that they are needed.”The move may make good business sense for Pfizer-BioNTech. Since the onset of the pandemic, the partner companies have pursued a “get to market first” strategy in manufacturing and marketing their vaccine.The companies did not take federal money or participate in Operation Warp Speed, former President Donald J. Trump’s fast-track vaccine initiative. They were the not only the first to win Food and Drug Administration authorization for their coronavirus vaccine, the first to use novel mRNA technology, but also the first to gain authorization for their vaccine’s use in adolescents.The strategy has “paid off as handsomely as anyone could ask for,” said Steve Brozak, the president of WBB Securities, a research investment bank focused on biotechnology.Last week, Pfizer and BioNTech said a booster given six months after the second dose of the vaccine increased the potency of antibodies against the original virus and the Beta variant by five- to tenfold. But antibody levels may not be the best biological measurement of the need for booster doses, according to experts, who say it is no surprise that antibodies would increase after taking a third dose.“Antibody response is not the only measure of immune protection,” said Dr. Leana S. Wen, a former health commissioner for Baltimore. “There have been multiple studies that suggest these vaccines also stimulate B cell and T cell immunity, so even if there isn’t as much antibody, that doesn’t mean someone isn’t protected.”In Israel, the government agreed to provide Pfizer with data on its vaccine recipients, and Pfizer has been matching the Israeli data with what its own laboratory tests are showing. Some people familiar with the data say it indicates that immunity is waning among the vaccinated after roughly six to eight months, leading to a growing number of breakthrough infections.The attendees at Monday’s session amounted to a who’s who of government doctors: Dr. Fauci; Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention; Dr. Francis Collins, the director of the National Institutes of Health; Dr. Vivek Murthy, the surgeon general; Dr. Rachel Levine, the assistant secretary for health; Dr. Janet Woodcock, the acting F.D.A. commissioner; Dr. Peter Marks, the director of the F.D.A.’s Center for Biologics Evaluation and Research; and Dr. David Kessler, a former F.D.A. commissioner who is heading the Biden administration’s vaccine distribution effort, among others.Dr. del Rio of Emory University complained about Monday’s meeting being conducted in private instead of Pfizer presenting its data publicly to the C.D.C.’s advisory committee on vaccine practices, which will ultimately recommend whether booster shots are necessary.Slightly more than two-thirds of American adults — 67.7 percent — have had at least one Covid-19 shot, according to the C.D.C. That figure falls short of the Biden administration’s goals; the president had hoped to have 70 percent of adults at least partially vaccinated by July 4.Still, the national vaccination campaign has made clear that the vaccine succeeds at preventing disease, and studies suggest that vaccines remain effective against the Delta variant. Outbreaks are occurring in areas with low rates of vaccination, and the national caseload has ticked up recently; according to a New York Times database.World Health Organization officials emphasized on Monday the importance of prioritizing global vaccine production and distribution over the development of boosters in light of the stark gaps among countries’ vaccination programs.“It’s not to say one or the other; it’s putting things in a crisis in order,” said Dr. Michael Ryan, the executive director of the organization’s health emergencies program, in reference to addressing what the organization calls a two-tier pandemic.Lauren McCarthy

Executives from Emergent, which ruined millions of coronavirus vaccine doses, divulged to Congress the scope of the regulatory review of its troubled Baltimore plant.WASHINGTON — The chief executive of Emergent BioSolutions, whose Baltimore plant ruined millions of coronavirus vaccine doses, disclosed for the first time on Wednesday that more than 100 million doses of Johnson & Johnson’s vaccine are now on hold as regulators check them for possible contamination.In more than three hours of testimony before a House subcommittee, the chief executive, Robert G. Kramer, calmly acknowledged unsanitary conditions, including mold and peeling paint, at the Baltimore plant. He conceded that Johnson & Johnson — not Emergent — had discovered contaminated doses, and he fended off aggressive questions from Democrats about his stock sales and hundreds of thousands of dollars in bonuses for top company executives.Emergent’s Bayview Baltimore plant was forced to halt operations a month ago after contamination spoiled the equivalent of 15 million doses, but Mr. Kramer told lawmakers that he expected the facility to resume production “in a matter of days.” He said he took “very seriously” a report by federal regulators that revealed manufacturing deficiencies and accepted “full responsibility.”“No one is more disappointed than we are that we had to suspend our 24/7 manufacturing of new vaccine,” Mr. Kramer told the panel, adding, “I apologize for the failure of our controls.”Mr. Kramer’s appearance before the House Select Subcommittee on the Coronavirus Crisis, which has opened a broad inquiry into his company, offered the public its first glimpse of the men who run Emergent, a politically connected federal contractor that dominates a niche market in biodefense preparedness, with the U.S. government as its prime customer.Testifying virtually, Mr. Kramer was joined by the firm’s founder and executive chairman, Fuad El-Hibri, who over the past two decades has expanded Emergent from a small biotech outfit into a company with $1.5 billion in annual revenues. Executive compensation documents made public by the subcommittee show that the company’s board praised Mr. El-Hibri, who cashed in stock shares and options worth more than $42 million last year, for “leveraging his critical relationships with key customers, Congress and other stakeholders.”Among those members of Congress is Representative Steve Scalise of Louisiana, the No. 2 House Republican and the top Republican on the House subcommittee. Federal campaign records show that since 2018, Mr. El-Hibri and his wife have donated more than $150,000 to groups affiliated with Mr. Scalise. The company’s political action committee has given about $1.4 million over the past 10 years to members of both parties.Mr. El-Hibri expressed contrition on Wednesday. “The cross-contamination incident is unacceptable,” he said, “period.”Mr. Kramer’s estimate of 100 million doses on hold added 30 million to the number of Johnson & Johnson doses that are effectively quarantined because of regulatory concerns about contamination. Federal officials had previously estimated that the equivalent of about 70 million doses — most of that destined for domestic use — could not be released, pending tests for purity.House Democrats began their inquiry into Emergent after The New York Times documented months of problems at the Baltimore plant, including failure to properly disinfect equipment and to protect against viral and bacterial contamination.Representative Raja Krishnamoorthi asked Mr. Kramer if he would consider turning over his bonus to American taxpayers.Stefani Reynolds for The New York TimesHours before the hearing began, committee staff members released confidential audits, previously reported by The Times, that cited repeated violations of manufacturing standards. A top federal manufacturing expert echoed those concerns in a June 2020 report, warning that Emergent lacked trained staff and adequate quality control.“My teenage son’s room gives your facility a run for its money,” Representative Raja Krishnamoorthi, Democrat of Illinois, told Mr. Kramer.Mr. Kramer initially testified that contamination of the Johnson & Johnson doses “was identified through our quality control procedures and checks and balances.” But under questioning, he acknowledged that a Johnson & Johnson lab in the Netherlands had picked up the problem. Johnson & Johnson hired Emergent to produce its vaccine and, at the insistence of the Biden administration, is now asserting greater control over the plant.The federal government awarded Emergent a $628 million contract last year, mostly to reserve space at the Baltimore plant for vaccine production. Among other things, lawmakers are looking into whether the company leveraged its contacts with a top Trump administration official, Dr. Robert Kadlec, to win that contract and whether federal officials ignored known deficiencies in giving Emergent the work.Mr. El-Hibri told lawmakers that the government and Johnson & Johnson were aware of the risks.“Everyone went into this with their eyes wide open, that this is a facility that had never manufactured a licensed product before,” he said. While the Baltimore plant was “not in perfect condition — far from it,” he argued that the facility “had the highest level of state of readiness” among the plants the government had to choose from.For Republicans, including Mr. Scalise, Wednesday’s session became a vehicle to defend Emergent and the Trump administration, and to raise other virus-related issues: the unproven theory that the coronavirus leaked from a laboratory in China, the “lies of the Communist Party of China,” mask mandates and the Biden administration’s call for a waiver of an international intellectual property agreement.“You are a reputable company that has done yeoman’s work to protect this country in biodefense,” exclaimed Representative Mark E. Green, Republican of Tennessee, adding, “So you gave your folks a bonus for their incredible work.”Emergent is skilled at working Washington. Its board is stocked with former government officials, and Senate lobbying disclosures show that the company has spent an average of $3 million a year on lobbying over the past decade. That is about the same as two pharmaceutical giants, AstraZeneca and Bristol Myers Squibb, whose annual revenues are at least 17 times higher.Democrats pressed Mr. Kramer and Mr. El-Hibri about their contacts with Dr. Kadlec, who previously consulted for Emergent. Documents show that Emergent agreed to pay him $120,000 annually between 2012 and 2015 for his consulting work, and that he recommended that Emergent be given a “priority rating” so that the contract could be approved speedily. Dr. Kadlec has said he did not negotiate the deal but did sign off on it.“Did you or any other Emergent executives speak to or socialize with Dr. Kadlec while these contracts were being issued?” Representative Nydia M. Velázquez, Democrat of New York, asked Mr. Kramer.“Congresswoman,” he replied carefully, “I did not have any conversations with Dr. Kadlec about this.”The government has so far paid Emergent $271 million, even though American regulators have yet to clear a single dose of vaccine produced at the Baltimore plant.Emergent was forced to halt operations a month ago after contamination spoiled the equivalent of 15 million Johnson & Johnson doses.Jim Lo Scalzo/EPA, via ShutterstockA Times investigation found that Emergent has exercised outsize influence over the Strategic National Stockpile, the nation’s emergency medical reserve; in some years, the company’s anthrax vaccine has accounted for as much as half the stockpile’s budget.The investigation found that some federal officials felt the company was gouging taxpayers — an issue that also came up at Wednesday’s hearing when Representative Carolyn B. Maloney, Democrat of New York, demanded to know how much it cost to make the vaccine and what it sold for. Mr. El-Hibri promised to supply the information later.Company executives also view their coronavirus work as one of the “prime drivers” of its 2020 revenues, according to a memorandum released on Wednesday by committee staff members. The executives were rewarded for what the company’s board called “exemplary overall 2020 corporate performance including significantly outperforming revenue and earnings targets.”Mr. Kramer received a $1.2 million cash bonus in 2020, the records show, and also sold about $10 million worth of stock this year, in trades that he said were scheduled in advance and approved by the company. Three of the company’s executive vice presidents received bonuses ranging from $445,000 to $462,000 each.Sean Kirk, the executive responsible for overseeing development and manufacturing operations at all of Emergent’s manufacturing sites, received a special bonus of $100,000 last year, in addition to his regular bonus of $320,611, in part for expanding the company’s contract manufacturing capability to address Covid-19, the documents show. Mr. Kirk is now on personal leave.Emergent officials “appear to have wasted taxpayer dollars while lining their own pockets,” Ms. Maloney charged.Mr. Krishnamoorthi asked Mr. Kramer if he would consider turning over his bonus to the American taxpayers.“I will not make that commitment,” Mr. Kramer replied.“I didn’t think so,” Mr. Krishnamoorthi shot back.Rebecca R. Ruiz

Executives from Emergent, which ruined millions of coronavirus vaccine doses, divulged to Congress the scope of the regulatory review of its troubled Baltimore plant.WASHINGTON — The chief executive of Emergent BioSolutions, whose Baltimore plant ruined millions of coronavirus vaccine doses, disclosed for the first time on Wednesday that more than 100 million doses of Johnson & Johnson’s vaccine are now on hold as regulators check them for possible contamination.In more than three hours of testimony before a House subcommittee, the chief executive, Robert G. Kramer, calmly acknowledged unsanitary conditions, including mold and peeling paint, at the Baltimore plant. He conceded that Johnson & Johnson — not Emergent — had discovered contaminated doses, and he fended off aggressive questions from Democrats about his stock sales and hundreds of thousands of dollars in bonuses for top company executives.Emergent’s Bayview Baltimore plant was forced to halt operations a month ago after contamination spoiled the equivalent of 15 million doses, but Mr. Kramer told lawmakers that he expected the facility to resume production “in a matter of days.” He said he took “very seriously” a report by federal regulators that revealed manufacturing deficiencies and accepted “full responsibility.”“No one is more disappointed than we are that we had to suspend our 24/7 manufacturing of new vaccine,” Mr. Kramer told the panel, adding, “I apologize for the failure of our controls.”Mr. Kramer’s appearance before the House Select Subcommittee on the Coronavirus Crisis, which has opened a broad inquiry into his company, offered the public its first glimpse of the men who run Emergent, a politically connected federal contractor that dominates a niche market in biodefense preparedness, with the U.S. government as its prime customer.Testifying virtually, Mr. Kramer was joined by the firm’s founder and executive chairman, Fuad El-Hibri, who over the past two decades has expanded Emergent from a small biotech outfit into a company with $1.5 billion in annual revenues. Executive compensation documents made public by the subcommittee show that the company’s board praised Mr. El-Hibri, who cashed in stock shares and options worth more than $42 million last year, for “leveraging his critical relationships with key customers, Congress and other stakeholders.”Among those members of Congress is Representative Steve Scalise of Louisiana, the No. 2 House Republican and the top Republican on the House subcommittee. Federal campaign records show that since 2018, Mr. El-Hibri and his wife have donated more than $150,000 to groups affiliated with Mr. Scalise. The company’s political action committee has given about $1.4 million over the past 10 years to members of both parties.Mr. El-Hibri expressed contrition on Wednesday. “The cross-contamination incident is unacceptable,” he said, “period.”Mr. Kramer’s estimate of 100 million doses on hold added 30 million to the number of Johnson & Johnson doses that are effectively quarantined because of regulatory concerns about contamination. Federal officials had previously estimated that the equivalent of about 70 million doses — most of that destined for domestic use — could not be released, pending tests for purity.House Democrats began their inquiry into Emergent after The New York Times documented months of problems at the Baltimore plant, including failure to properly disinfect equipment and to protect against viral and bacterial contamination.Representative Raja Krishnamoorthi asked Mr. Kramer if he would consider turning over his bonus to American taxpayers.Stefani Reynolds for The New York TimesHours before the hearing began, committee staff members released confidential audits, previously reported by The Times, that cited repeated violations of manufacturing standards. A top federal manufacturing expert echoed those concerns in a June 2020 report, warning that Emergent lacked trained staff and adequate quality control.“My teenage son’s room gives your facility a run for its money,” Representative Raja Krishnamoorthi, Democrat of Illinois, told Mr. Kramer.Mr. Kramer initially testified that contamination of the Johnson & Johnson doses “was identified through our quality control procedures and checks and balances.” But under questioning, he acknowledged that a Johnson & Johnson lab in the Netherlands had picked up the problem. Johnson & Johnson hired Emergent to produce its vaccine and, at the insistence of the Biden administration, is now asserting greater control over the plant.The federal government awarded Emergent a $628 million contract last year, mostly to reserve space at the Baltimore plant for vaccine production. Among other things, lawmakers are looking into whether the company leveraged its contacts with a top Trump administration official, Dr. Robert Kadlec, to win that contract and whether federal officials ignored known deficiencies in giving Emergent the work.Mr. El-Hibri told lawmakers that the government and Johnson & Johnson were aware of the risks.“Everyone went into this with their eyes wide open, that this is a facility that had never manufactured a licensed product before,” he said. While the Baltimore plant was “not in perfect condition — far from it,” he argued that the facility “had the highest level of state of readiness” among the plants the government had to choose from.For Republicans, including Mr. Scalise, Wednesday’s session became a vehicle to defend Emergent and the Trump administration, and to raise other virus-related issues: the unproven theory that the coronavirus leaked from a laboratory in China, the “lies of the Communist Party of China,” mask mandates and the Biden administration’s call for a waiver of an international intellectual property agreement.“You are a reputable company that has done yeoman’s work to protect this country in biodefense,” exclaimed Representative Mark E. Green, Republican of Tennessee, adding, “So you gave your folks a bonus for their incredible work.”Emergent is skilled at working Washington. Its board is stocked with former government officials, and Senate lobbying disclosures show that the company has spent an average of $3 million a year on lobbying over the past decade. That is about the same as two pharmaceutical giants, AstraZeneca and Bristol Myers Squibb, whose annual revenues are at least 17 times higher.Democrats pressed Mr. Kramer and Mr. El-Hibri about their contacts with Dr. Kadlec, who previously consulted for Emergent. Documents show that Emergent agreed to pay him $120,000 annually between 2012 and 2015 for his consulting work, and that he recommended that Emergent be given a “priority rating” so that the contract could be approved speedily. Dr. Kadlec has said he did not negotiate the deal but did sign off on it.“Did you or any other Emergent executives speak to or socialize with Dr. Kadlec while these contracts were being issued?” Representative Nydia M. Velázquez, Democrat of New York, asked Mr. Kramer.“Congresswoman,” he replied carefully, “I did not have any conversations with Dr. Kadlec about this.”The government has so far paid Emergent $271 million, even though American regulators have yet to clear a single dose of vaccine produced at the Baltimore plant.Emergent was forced to halt operations a month ago after contamination spoiled the equivalent of 15 million Johnson & Johnson doses.Jim Lo Scalzo/EPA, via ShutterstockA Times investigation found that Emergent has exercised outsize influence over the Strategic National Stockpile, the nation’s emergency medical reserve; in some years, the company’s anthrax vaccine has accounted for as much as half the stockpile’s budget.The investigation found that some federal officials felt the company was gouging taxpayers — an issue that also came up at Wednesday’s hearing when Representative Carolyn B. Maloney, Democrat of New York, demanded to know how much it cost to make the vaccine and what it sold for. Mr. El-Hibri promised to supply the information later.Company executives also view their coronavirus work as one of the “prime drivers” of its 2020 revenues, according to a memorandum released on Wednesday by committee staff members. The executives were rewarded for what the company’s board called “exemplary overall 2020 corporate performance including significantly outperforming revenue and earnings targets.”Mr. Kramer received a $1.2 million cash bonus in 2020, the records show, and also sold about $10 million worth of stock this year, in trades that he said were scheduled in advance and approved by the company. Three of the company’s executive vice presidents received bonuses ranging from $445,000 to $462,000 each.Sean Kirk, the executive responsible for overseeing development and manufacturing operations at all of Emergent’s manufacturing sites, received a special bonus of $100,000 last year, in addition to his regular bonus of $320,611, in part for expanding the company’s contract manufacturing capability to address Covid-19, the documents show. Mr. Kirk is now on personal leave.Emergent officials “appear to have wasted taxpayer dollars while lining their own pockets,” Ms. Maloney charged.Mr. Krishnamoorthi asked Mr. Kramer if he would consider turning over his bonus to the American taxpayers.“I will not make that commitment,” Mr. Kramer replied.“I didn’t think so,” Mr. Krishnamoorthi shot back.Rebecca R. Ruiz