Covid-19: F.D.A. Clears Pfizer Vaccine and Millions of Doses Will Be Shipped Right Away

Covid-19: F.D.A. Clears Pfizer Vaccine and Millions of Doses Will Be Shipped Right Away The accelerated timeline comes after President Trump’s chief of staff threatened the F.D.A. head’s job if he didn’t get it done on Friday. The Trump Administration will buy another 100 million doses of Moderna vaccine. This briefing has ended. Follow our latest coverage of the coronavirus pandemic.

With F.D.A. approval, Pfizer will ship millions of vaccine doses immediately. Freezer units at a United Parcel Service center await shipments of Covid-19 vaccines. Credit... UPS/EPA, via Shutterstock The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days. The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks. The F.D.A.’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day. The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures. Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public. Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies. McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol pads, face shields and other supplies to the same sites, where they will meet up with the vaccines that Pfizer is shipping in special boxes, packed with dry ice, designed to keep them at minus 94 degrees Fahrenheit. The Pfizer packaging will include a device that tracks the location of the box, plus a thermal probe that will make sure the deep freeze is maintained throughout the journey from the company’s distribution sites in Michigan and Wisconsin. The decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95 percent effective. The vaccine will be scarce at first. Pfizer had to scale back earlier estimates because of manufacturing setbacks, and has said it will be able to supply up to 25 million doses before the end of the year, and 100 million total vaccines by March. Federal officials are initially holding back half of the supply so that they can give a booster shot to recipients three weeks after their first vaccination. Even though only about three million people will receive a vaccine in the first week, officials have held firm on their estimate that, between the Pfizer and Moderna vaccines, which each require two shots, they hope to give at least 20 million people their first dose of a vaccine by the end of the year. An expert panel advising the F.D.A. on Thursday gave its approval of Pfizer’s vaccine for people 16 and older, and the agency was planning to release the formal authorization on Saturday. That timeline was accelerated by half a day after President Trump attacked Dr. Hahn for failing to authorize a vaccine more quickly. But the accelerated announcement was not expected to speed up the delivery of vaccines around the country. Katie Thomas, Sharon LaFraniere, Noah Weiland, Abby Goodnough and

Trump administration to buy another 100 million doses of Moderna’s Covid-19 vaccine. President Trump at the Operation Warp Speed Vaccine Summit at the White House, Tuesday. On Friday his administration announced a plan to buy more coronavirus vaccine from Moderna. Credit... Doug Mills/The New York Times The federal government announced Friday that it is buying another 100 million doses of Moderna’s Covid-19 vaccine to be delivered between April and June. The Trump administration’s purchase will boost the number of people who can be vaccinated by 50 percent, to 150 million Americans. But that still leaves the question of how and when the roughly 180 million other Americans will be covered. Alex M. Azar II, the secretary of health and human services, did not address shortfalls in announcing the new vaccine purchase late Friday. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021,” he said. Stéphane Bancel, chief executive officer of Moderna, said: “We continue to scale up our manufacturing capability in the U.S. and outside of the U.S.” The government signed deals last summer with Moderna and Pfizer to deliver a total of 200 million doses by next March. Because both vaccines require two doses, those contracts guaranteed enough doses for 100 million people. No supply had been locked in the second quarter of next year, and some federal officials privately voiced concern that the government might run out of doses in March. Officials had recently asked Pfizer to sell it another 100 million doses, but Pfizer had said it could not meet that demand until about June. The new deal indicates that Moderna is able to cover at least some of the gap. At the same time, though, doubts about the ability of other vaccine makers to demonstrate their products are safe and effective have grown, raising questions about whether the United States will be entirely dependent on supplies from Pfizer, Moderna and possibly a third company, Johnson & Johnson. Johnson & Johnson is expected to reveal the results of its clinical trials early next month. The administration’s crash program to develop vaccines, known as Operation Warp Speed, bet heavily on Moderna, along with a handful of other vaccine makers. Its vaccine is similar to Pfizer’s, but it is easier to store and transport. Clinical trials have shown that like Pfizer’s vaccine, it is about 95 percent effective. Unless unexpected problems emerge, the Food and Drug Administration is on track to approve it for emergency use later this month, about one week after Pfizer. The federal government agreed last summer to purchase 100 million doses of Moderna’s vaccine, locking in options to purchase up to another 400 million doses, at a cost of $16.50 a dose. Unlike the options in its contract with Pfizer, the government is allowed to call on Moderna for more doses at the government’s “sole discretion.”

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Los Angeles County could face ‘catastrophic suffering and death,’ a health official warns. Video transcript Back bars 0:00 / 1:03 - 0:00 transcript Los Angeles Health Official Warns Winter Surge Could be ‘Catastrophic’ Barbara Ferrer, Los Angeles County’s public health director, said stress on the county’s already strained healthcare system would rise if winter holidays lead to another spike in coronavirus cases. “This week our average cases per day is about 10,200. If the same proportion of hospitalizations to cases continues to apply, in two weeks we could see over 7,300 current hospitalizations for patients with Covid-19. And over 1,600 of these patients could need care at some point in the I.C.U. This is alarming to all of us, given that there are only around 2,100 I.C.U. adult beds across all our county hospitals. And many of these beds are essential for all the patients that need care for other illnesses, including trauma, cardiac surgeries and cancer treatments. The impact of this Thanksgiving case, these Thanksgiving surges of cases on top of already rising cases is creating extraordinary stress on our health care system. Should this be followed by another surge related to the winter holiday, the numbers of hospitalizations and patients in the I.C.U. could become catastrophic.” Barbara Ferrer, Los Angeles County’s public health director, said stress on the county’s already strained healthcare system would rise if winter holidays lead to another spike in coronavirus cases. Credit Credit... Philip Cheung for The New York Times Los Angeles County could see “catastrophic suffering and death” in the coming weeks, public health officials warn, as the nation’s most populous county reported another record day of new coronavirus cases. The 13,737 cases reported on Friday bring the county’s total to more than 500,000, as the county and California struggle to contain an explosion. California officials reported 37,124 cases on Friday, the highest one-day total of the pandemic. “We’re on a very dangerous track to seeing unprecedented and catastrophic suffering and death here in L.A. County if we can’t stop the surge,” Barbara Ferrer, the county’s public health director, said at a news conference on Friday. “These numbers are overwhelming, and the grief that our community continues to experience can’t be comprehended.” The number of people hospitalized for Covid-19 has sharply risen over the past month. In early November, fewer than 1,000 people were in hospitals for treatment. Today, there are more than 3,600, according to the latest figures from the county. The steep rise in cases in California mirrors a national spike. Officials reported more than 236,000 new cases on Friday, yet another single-day case record. During a news conference on Wednesday, Dr. Ferrer fought through tears as she talked about the state’s rising death toll. “Over 8,000 people who were beloved members of their families are not coming back,” she said. “And their deaths are an incalculable loss to their friends and their families.” Over the past month, the average number of daily deaths has increased more than 250 percent in Los Angeles County. In the past week, 357 people there have died and at least 71,079 people have contracted the virus. “We’re in uncharted territory at this point,” Dr. Ferrer said. “We’re seeing daily numbers of cases and hospitalizations that we’ve not experienced and, frankly, did not anticipate.”

Global roundup Mexico approves Pfizer vaccine for emergency use, and other news around the world. Despite warnings from officials about a surge in coronavirus cases and pleas for them to stay home during the Christmas holiday period, people filled a shopping area in Mexico City on Friday. Credit... Jose Pazos/EPA, via Shutterstock Mexico’s Medical Safety Commission on Friday approved the Pfizer-BioNTech Covid-19 vaccine for emergency use, just before the United States Food and Drug Administration did so as well. Mexico and the United States are now on a growing list of countries — one that includes Britain, Canada, Bahrain, Saudi Arabia and the United Arab Emirates — to have granted full or emergency approval for the Pfizer-BioNTech vaccine. Mexico has arranged to receive a first batch of 250,000 doses, enough for 125,000 people, The Associated Press reported on Friday. Vaccinations are scheduled to begin next week, starting with health care workers. The announcements from regulators in Mexico and the United States capped a flurry of vaccine-related news from around the world. On Thursday, officials in Saudi Arabia said they had approved the Pfizer-BioNTech vaccine as the first to be used in that country. Saudi Arabia did not say how many doses it plans to purchase, or when they would arrive or be distributed. Hong Kong’s chief executive, Carrie Lam, said on Friday that the Chinese territory had struck an agreement to buy 15 million doses of Covid-19 vaccines. Half will come from Sinovac — whose unproven vaccine has already been given to tens of thousands on the Chinese mainland — and the other half from Pfizer-BioNTech. And Japan’s Health Ministry said on Friday that it had formalized a deal to buy 120 million doses of the AstraZeneca vaccine, enough for 60 million people, and that it expected to receive the first quarter of those doses by March. Japan has also agreed to buy 120 million doses of the Pfizer-BioNTech vaccine and 50 million doses of the Moderna vaccine. In other developments across the world: New Zealand said on Saturday that it had chosen the Cook Islands as its first partner for a travel bubble. Travel between the two South Pacific countries is expected to be quarantine-free by the end of March. New Zealand has had just 2,092 confirmed Covid-19 infections during the pandemic, and the Cook Islands have not reported any.

Switzerland ordered shops, bars, restaurants and sports facilities across much of the country to close at 7 p.m. each night. The country had imposed limited measures last month to halt a spike in cases and deaths, but achieved only partial success. Health authorities there reported a sharp rise in the weekly average of new cases on Friday, and warned that hospitals were close to capacity. Establishments in French-speaking areas of the country, which had protested against new restrictions, will be allowed to stay open later if they report case numbers below the national average.

As Germany sees record levels of coronavirus infections and deaths, several states are planning tight lockdowns even before nationwide measures can be announced. On Friday, the Eastern state of Thuringia announced it would close shops and move classes to online lessons by the end of next week. A meeting between Chancellor Angela Merkel and state governors to agree on a countrywide lockdown is expected to take place on Sunday, and the mayor of Berlin told reporters he expected a three-week lockdown starting at the end of next week. German health authorities registered 29,875 new infections on Thursday, beating the previous record, set on Wednesday, by 6,196. Hospitals also recorded a record 598 deaths in one day on Thursday. Derrick Bryson Taylor, Mike Ives, Hisako Ueno, Christopher F. Schuetze and

To build confidence, Fauci says he’ll ‘get vaccinated publicly.’ Dr. Anthony Fauci spoke at a briefing given by the Coronavirus Task Force last month. Credit... Stefani Reynolds for The New York Times As a way to build public confidence in the federal government’s vaccine program, Dr. Anthony S. Fauci, the government’s top infectious disease expert, told The New York Times on Friday that he intends to “get vaccinated publicly, in the public space, so that people can see me getting vaccinated,” as soon as “the vaccine becomes available to me.” Dr. Fauci, 79, added that he is not certain when that will be, and is leaving it up to the health secretary, Alex M. Azar II, to decide. The Food and Drug Administration is expected to issue emergency authorization of the Pfizer vaccine as early as Friday evening. Dr. Fauci also disclosed in an interview with The Times that a healthy 32-year-old who is close to one of his daughters died of Covid-19 — a stark reminder that the disease is deadly in the young as well as the old. The 32-year-old who died was the brother of the boyfriend of one of Dr. Fauci’s daughters. “He’s a perfectly healthy 32-year-old guy who got Covid, got the cardiac complications and died within like a week and a half of getting infected,” Dr. Fauci said, adding, “It is really very devastating to my daughter.” As President Trump and his allies have asserted, incorrectly, that the disease is not a threat to younger people, Dr. Fauci has repeatedly testified on Capitol Hill that there is much to be learned about the novel coronavirus, and that scientists must be humble about what they do not know. Young people are hardly immune; in Florida, for example, more than 100 adults aged 25 to 44 died of Covid in July alone. A study from Harvard released in September “establishes that Covid-19 is a life-threatening disease in people of all ages,” wrote Dr. Mitchell Katz, a deputy editor at JAMA Internal Medicine, in an editorial accompanying the research, adding that “while young adults are much less likely than older persons to become seriously ill, if they reach the point of hospitalization, their risks are substantial.”

Indoor dining in N.Y.C. will shut down again, Cuomo says. Video transcript Back bars 0:00 / 1:31 - 0:00 transcript ‘A Bad Situation’: N.Y.C. Indoor Dining to Close as Virus Spikes As the state grapples with a second wave of coronavirus infections and hospitalizations, Gov. Andrew M. Cuomo said indoor dining would be banned in New York City starting Monday. In New York City, you put the C.D.C. caution on indoor dining together with the rate of transmission, and the density and the crowding — that is a bad situation. The hospitalizations have continued to increase in New York City. We said that we would watch it if the stabilization — if the hospital rate didn’t stabilize — we would close indoor dining. It is not — we’re going to close indoor dining in New York City on Monday. Outdoor dining and takeout continues. Outside of New York City and in the Orange Zones, we’re going to watch the indoor dining data. The numbers are down in the chart, but we’re going to watch over this weekend, and we’ll make any adjustments next week if the data suggests. Federal government must provide relief to these bars and restaurants in this next package. I understand battling Covid. I also understand you’re wiping out businesses — we’ll do what we can in New York. We’re going to extend the commercial eviction moratorium. So if a business can’t pay the rent because of the situation, they won’t be evicted. And gyms and salons, as you also see, they are not the problem that they were. We have restrictions. The restrictions made a difference. We’re going to allow them to operate in Orange Zones with reduced capacity and additional testing. As the state grapples with a second wave of coronavirus infections and hospitalizations, Gov. Andrew M. Cuomo said indoor dining would be banned in New York City starting Monday. Credit Credit... Bryan R. Smith/Agence France-Presse — Getty Images Indoor dining will once again be barred in New York City restaurants starting Monday, Gov. Andrew M. Cuomo announced on Friday, a significant reversal of the city’s reopening that comes as officials try to halt the escalation of a second wave of the coronavirus. The decision, which Mr. Cuomo earlier this week suggested was all but certain, is a crushing blow to the city’s restaurant industry, a vital economic pillar that has been struggling all year in the face of pandemic restrictions and a national recession. For months, New York City’s restaurant owners have warned that their businesses, many of which operate on tight margins in the best of times, are on the edge of financial collapse. Thousands of employees, many of them low-wage workers, have been laid off since March, and their jobs have yet to fully return. Their anxieties only mounted as winter approaches and frigid temperatures threaten to deter customers from dining outdoors. Industry groups have called repeatedly for federal or state financial assistance, with restaurant and bar owners watching nervously as stimulus talks drag on in Washington. “Another forced government closure of New York City restaurants will cause an irreversible harm on even countless more small businesses and the hundreds of thousands of workers they employ, especially if it is not coupled with financial relief,” said Andrew Rigie, the executive director of the New York City Hospitality Alliance, in a statement on Monday. Mr. Cuomo’s announcement came after weeks of shifting messages and changing guidance on indoor dining, which only resumed in New York City at the end of September. The inconsistent approach, which confused residents and business owners alike, came as Mr. Cuomo repeatedly downplayed indoor dining as a source of new infections, focusing much of his attention on parties and other indoor gatherings instead. But on Monday, Mr. Cuomo warned that he would curb indoor dining in regions in the state where hospitalizations did not stabilize, citing guidance from the Centers for Disease Control and Prevention that described eating at indoor restaurants as a “particularly high-risk” activity. On Friday, Mr. Cuomo said that contact tracing data showed that restaurants and bars were the fifth main source of new infections in the state, well behind household and social gatherings. The data is based only on those who give a response to contact tracers and does not capture every infection in the state, officials have said. Of 46,000 cases between September and November, 1.43 percent could be linked to restaurants and bars, compared to 73.84 percent connected with private gatherings. On Friday, Mr. Cuomo said that a state task force, which he convened following concerns that President Trump was expediting the vaccine rollout for political purposes, said that once the Pfizer vaccine was authorized by federal regulators, as was expected Friday evening, New York was ready to distribute. The governor, a third-term Democrat, had previously said no federally-authorized vaccine would be given out in New York until his task force signed off on the distribution. Some of Mr. Cuomo’s conservative critics had described the move as a political ploy that could delay the vaccine’s delivery in New York. Mr. Cuomo, however, said on Friday that the state’s independent review would help build confidence among the public following surveys showing many Americans did not trust the vaccine’s safety. New York State is expected to begin receiving an initial allocation of 170,000 doses of the Pfizer vaccine on Sunday or Monday, Mr. Cuomo said. Those vaccines will be administered to health care workers and residents and staff at long-term care facilities. An additional allocation of vaccines from the drugmaker Moderna, which has also applied for federal for authorization for its vaccine, enough to vaccinate about 346,000 people is expected the week of Dec. 21. In New York City, Mayor Bill de Blasio announced at a news conference on Friday the beginning of a center to coordinate vaccine distribution. The work of the center will involve reporting the number of people getting vaccinated, as well as working with communities to build trust in the vaccine and troubleshoot distribution issues. Michael Gold, Luis Ferré-Sadurní and

Superspreading Boston biotech conference in February is linked to 1.9 percent of all U.S. cases. The Biogen conference was held at this hotel in February. Credit... Cody O'Loughlin for The New York Times As many as 300,000 coronavirus cases across the United States can be traced to a two-day conference in Boston attended by 175 biotech executives in February, according to a study published Thursday in the journal Science. The conference, convened by the drug company Biogen, was one of the earliest examples in the pandemic of what epidemiologists call “superspreading events,” where a gathering of people leads to a huge number of infections. But new genetic data made publicly available in recent months by many states has allowed researchers for the first time to estimate the national scope of its astonishing ripple effect. “It’s a cautionary tale,” said Bronwyn MacInnis, a genomic epidemiologist at the Broad Institute of Harvard and M.I.T. “When we hear these stories of clusters where 20 or 50 or 100 were affected, that does not account for what happens after.” To track the spread, the researchers took advantage of a kind of genetic fingerprint that they identified in samples of the virus taken from 28 people who had attended the meeting. An earlier version of the paper published online in June suggested that the conference had seeded tens of thousands of cases in the Boston area alone. By March, the researchers had found, viruses bearing the same signature began to appear in the viral genomes taken from coronavirus patients in several other states. But by November, viruses containing the marker could be found in 29 states, linked to some 70,000 in Florida alone. And because the viral genome data linked to U.S. cases has grown by tenfold since June, the researchers are able to make a reliable national estimate. The conference, the study estimates, is responsible for 1.9 percent of all cases in the United States since the start of the pandemic. A vast majority of introductions of the virus into a workplace or home or community fizzle, the researchers noted. But the study highlights how a local event with a mobile population can seed a national outbreak. Because the genetic fingerprint identified in the Biogen attendees existed previously in Europe, it was not possible to reliably estimate how many of the transmissions globally came from the Boston event, the researchers said. Although the Biogen conference occurred at a time when the coronavirus was barely on the radar for most Americans, it might have important implications for the current pandemic moment. The first, eagerly awaited vaccines have been demonstrated to protect from severe Covid-19 symptoms, but it is not known whether they protect people from transmitting the virus. “We risk having folks going around thinking ‘all is good,’” Dr. MacInnis said. “Our data reminds us what can happen when transmission is unchecked.’’

British and Russian vaccine makers are set to begin clinical trials combining two vaccines. Production of Russia’s Gam-COVID-Vac vaccine against the coronavirus disease, registered under trade name Sputnik V, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in coordination with the Russian Defence Ministry, in Strelna, Russia, outside Saint Petersburg. Credit... Olga Maltseva/Agence France-Presse — Getty Images Scientists developing the AstraZeneca-Oxford vaccine and Russia’s Sputnik V will try a combination of their respective vaccines by the end of the year, Russia’s sovereign wealth fund announced on Friday, in hopes of strengthening the efficacy of both. Vaccination often requires one injection and then a boost, and the process can take two forms: giving the same vaccine multiple times, a technique known as “homologous boosting,” or combining different, yet similar vaccines, called “heterologous boosting.” By combining different but similar vaccines, AstraZeneca and the Russian Investment Fund said they were hoping to boost the immune protection of people who may receive the injections. The Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, which develops the Sputnik V vaccine, uses two different human adenoviruses to develop its product. AstraZenca uses an adenovirus that infects chimpanzees. The AstraZeneca vaccine, which is developed at the University of Oxford, showed encouraging but head-scratching results: two doses of the vaccine provided stronger results (90 percent efficacy) when the first dose was only at half strength, than when two full-dose shots were injected (a 62 percent efficacy). In Russia, the Sputnik V vaccine showed an efficacy rate of 95 percent in preliminary results from a clinical trial, but such results were based on an unspecified small group of volunteers, raising skepticism from experts. The Russian Investment Fund said AstraZeneca and the Gamaleya Research Institute would begin clinical trials by the end of the month. Kirill Dmitriev, the fund’s C.E.O., hailed the partnership as “an important step toward uniting efforts in the fight against the pandemic,” and AstraZeneca said it “could provide an additional approach to help overcome this deadly virus.” The announcement comes days after both Britain and Russia began rolling out of a vaccine, the first two countries in the world to do so. Britain has used the Pfizer/BioNTech vaccine, and Russia has administered the Sputnik V vaccine. A British government official said earlier this week that scientists were reviewing whether it was safe to combine and match vaccines. “What it means is that you give one vaccine to get the immune system triggered up and another one to then boost it further with a different vaccine,” England’s chief scientific adviser, Sir Patrick Vallance, said in an interview with Sky News. “That’s an established way of getting the immune system geed up.” Russia drew widespread criticism when it registered its Sputnik V vaccine for emergency use in August before completing a Phase 3 clinical trial to measure its efficacy, yet President Vladimir V. Putin of Russia has boasted that it was the first vaccine in the world to receive government approval. Elian Peltier and

D.H.S. held an indoor party as the administration told Americans to be cautious during coronavirus surge. From left: Karen S. Evans, the chief information officer at D.H.S.; Chad F. Wolf, the acting secretary of D.H.S.; Troy Edgar, the chief financial officer of D.H.S., in a photo tweeted by Mr. Edgar. Credit... Troy Edgar Officials at the Department of Homeland Security attended an indoor holiday party this week even as the Trump administration urged Americans to double down on pandemic precautions to combat increasing deaths from Covid-19. The political appointees celebrated at the agency’s St. Elizabeth campus in Washington on Thursday, the same day that Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, warned Americans the country would count “more deaths per day than we had at 9/11 or we had at Pearl Harbor” for the next two to three months. Troy Edgar, the chief financial officer for D.H.S., which has played a large role in implementing pandemic-related travel restrictions, posted a photograph at 9:31 p.m. on Thursday of himself alongside Chad F. Wolf, the agency’s acting secretary, and Karen S. Evans, its chief information officer. None of them were wearing masks. “On the stage tonight at the DHS Holiday Party with @DHS_Wolf and Chief Information officer (CIO) Karen Evans,” Mr. Edgar tweeted. “I’m so grateful to serve with the 250,000 dedicated employees of Homeland Security. Merry Christmas.” There were dozens of guests in attendance, according to department officials who asked to speak anonymously because they were not authorized to speak on the record. The latest guidance put forth by Washington mayor Muriel E. Bowser, a Democrat, limits indoor gatherings to no more than 10 people. The White House sent out invitations to at least 20 year-end parties earlier this month. D.H.S. includes the Federal Emergency Management Agency, which has been tasked with supporting state governments with personal protective equipment across the country, and Customs and Border Protection, which has screened travelers for the coronavirus at the nation’s borders. In a statement to The New York Times, Chase Jennings, a spokesman for the Homeland Security Department, described the holiday party as “a meeting yesterday with political staff.” “It is standard procedure for every agency to meet with political staff several times a year across every administration — D.H.S. is no different,” Mr. Jennings said. “The meeting itself was held at one of the largest spaces at D.H.S. headquarters in order to allow for social distancing. C.D.C. guidelines were followed.” But he declined to answer questions inquiring why Mr. Wolf and other top officials were not wearing masks, exactly how many people attended the gathering or why the agency chose to have the party in person rather than virtually. Mr. Wolf is expected to travel internationally this weekend. He and other D.H.S. staff members plan to fly to Panama and El Salvador, in part to discuss accords that have redirected asylum seekers at the southwest border back to Central America, the agency said in a statement on Friday.

‘For the next 60 to 90 days we’re going to have more deaths per day than we had at 9/11,’ the C.D.C. director warned. Funeral homes are struggling to carry out basic services and keep up with the expanding crisis. Credit... Paul Ratje/Agence France-Presse — Getty Images The next few months are “going to be really tough” in the United States, Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, warned on Thursday. “We are in the time frame now that probably for the next 60 to 90 days we’re going to have more deaths per day than we had at 9/11 or we had at Pearl Harbor,” Dr. Redfield said during an event hosted by the Council on Foreign Relations. In the Sept. 11, 2001, terrorist attack, 2,977 people were killed. The attack on Pearl Harbor on Dec. 7, 1941, killed 2,403 Americans. On Wednesday, at least 3,055 new coronavirus deaths in the U.S. were reported, according to a database maintained by The New York Times. On Thursday, at least 2,923 people died. On Friday, the figure was at least 2,951. Although a vaccine should be available soon, Dr. Redfield said that it is unlikely to reduce the numbers of deaths over the next few months. He urged Americans to “double down” on precautions and protect themselves by wearing masks, maintaining social distancing, avoiding indoor social gatherings and keeping their guard up, even among friends and family members. He also implored Americans not to travel and to reconsider travel plans if they have already made them. “We are turning a corner, but I want to come back to the reality that this is going to be a brutal time for us,” Dr. Redfield said. Health officials across the country share that same grim assessment. “The worst is yet to come in the next week or two or three,” said Catherine Troisi, an infectious-disease epidemiologist at the UTHealth School of Public Health in Houston. “What happens after that is going to depend on our behavior today.” Dr. Troisi said she expected the death toll to accelerate in part because current numbers most likely do not reflect infections from Thanksgiving gatherings. The virus has taken the lives of the young and the old, the healthy and the sick, the prominent and the ordinary people known best by those who loved them. Linda Azani, the assistant manager of Perches Funeral Homes in El Paso, said the toll the virus has taken there is so steep that “there’s not enough of us to go around.” “Not enough directors to see families,” she added. “Not enough facilities to have funerals. Not enough chapels.” Roni Caryn Rabin, Sarah Mervosh, Giulia McDonnell Nieto del Rio and

A state scientist questioned Florida’s virus data. Now her home’s been raided. Body camera footage shows Rebekah Jones outside her home as Florida state agents execute a search warrant earlier this week. Credit... Florida Department of Law Enforcement, via Reuters MIAMI — The complicated story of how a Florida data scientist responsible for managing the state’s coronavirus numbers wound up with state police agents brandishing guns in her house this week began seven long months ago, when the scientist, Rebekah D. Jones, was removed from her post at the Florida Department of Health. Ms. Jones had helped build the statistics dashboard that showed how the virus was rapidly spreading in a state that had been hesitant to mandate broad restrictions. Two months in, Ms. Jones was sidelined and then fired for insubordination, a conflict that she said came to a head when she refused to manipulate data to show that rural counties were ready to reopen from coronavirus lockdowns. The specter of possible censorship by the administration of Gov. Ron DeSantis, a Republican allied with President Trump, exploded into the frenetic pandemic news cycle, and Ms. Jones’s defiance came to symbolize the growing questions over Florida’s handling of the pandemic. The arrival of state agents at her home in Tallahassee on Monday to execute a search warrant in a criminal investigation marked a new, dramatic chapter in Ms. Jones’s saga, which at its core has always returned to the same basic question: Can Floridians, who are in the midst of another alarming rise in coronavirus infections and deaths, trust the state’s data? “This isn’t really unexpected,” she said of this week’s raid. “You take down a governor, he’s going to come for you. Six months ago, I was just a scientist trying to do my job.”

Still divided over a stimulus deal, Congress staved off a shutdown this week. Video transcript Back bars 0:00 / 1:44 - 0:00 transcript Senate Approves Bill to Avoid Shutdown Congress is still divided over a stimulus deal, but on Friday senators voted to stave off a shutdown with a one-week stopgap bill. “Small businesses need saving right now, unemployed people need relief extended right now, vaccine distribution networks need funding right now. None of that should be held hostage over intergovernmental bailouts for states that are currently raking in revenue faster than they can spend it. And yet the speaker and the Democratic leader have persuaded their entire conference that nothing should pass unless the governors of California and New York get to cut the line and jump in front of millions of Americans who are trying to figure out how to pay their bills each and every month.” “As 15 million Americans got sick, and as 292,001 Americans died, the Senate Republican majority, led by the majority leader, made sure the Senate could not do anything of significance to help the American people. May, June, July, August — pause, we don’t need to do anything, said the leader. Let’s wait and see what happens. Democrats didn’t say that, the leader did — waited and waited and waited. Now it’s December, and we still, because of the leader’s intransigence, have nothing of significance to help the American people during the worst economic crisis in 75 years and the greatest public health crisis in a century.” “The question is on passage of the bill. All in favor, say ‘aye.’” “Aye.” “All opposed say ‘no.’ The ‘ayes’ appear to have it. The ‘ayes’ do have it. And the bill is passed.” Congress is still divided over a stimulus deal, but on Friday senators voted to stave off a shutdown with a one-week stopgap bill. Credit Credit... Anna Moneymaker for The New York Times President Trump on Friday signed a one-week stopgap bill to fund the government, buying additional time for negotiators to reach agreement on both a catchall government spending package and a coronavirus aid plan to address the economic toll of the pandemic. The Senate earlier in the day had approved the measure by voice vote, after top congressional leaders corralled the chamber into supporting the one-week extension. While lawmakers and staff on Capitol Hill continue to haggle over an aid plan, the two policy divides that have long impaired a coronavirus relief deal — a Republican insistence on sweeping coronavirus liability protections and Democratic demands for state and local funding — remain sticking points. Senator Mitch McConnell, Republican of Kentucky and the majority leader, has suggested jettisoning both provisions in order to get a swift agreement on a narrower package, but many lawmakers are reluctant to resort to that. Democratic leaders have said the starting point for talks should be a $908 billion bipartisan compromise being drafted by a group of moderates. It would include limited liability protections, $160 billion in state and local funding, $288 billion for the Paycheck Protection Program that extends loans to small businesses, and $300-a-week supplemental federal jobless payments until the spring. The proposal, for now, does not include direct payments from stimulus checks. “These problems don’t go away,” said Senator Lisa Murkowski, Republican of Alaska, who is part of the group that is working on the bipartisan plan. “If anything, they just get bigger. So if we can just stick to it, get a proposal that we can advance that resolves not only goals like unemployment, P.P.P., food security, but also the state and local and tribal and the liability issue — this is what we’ve been working on. This is what we need to keep doing.”

Pregnant and breastfeeding women may opt to receive the vaccine Samantha Salinas, a nurse, at an appointment in May in San Antonio, Texas. Credit... Callaghan O'Hare/Reuters In its emergency authorization of the Pfizer-BioNTech vaccine on Friday night, the Food and Drug Administration took an unexpected step, leaving open the possibility that pregnant and breastfeeding women may opt for immunization against the coronavirus. The agency authorized the vaccine for anyone 16 and older, and asked Pfizer to file regular reports on the safety of the vaccine, including its use in pregnant women. There had been no guarantee that the agency would take this route. The vaccine was not tested in pregnant women or in those who were breastfeeding. Regulators in the United Kingdom recommended against these women receiving the shots even while acknowledging that the evidence so far “raises no concerns for safety in pregnancy.” The Centers for Disease Control and Prevention has not yet endorsed the vaccine for pregnant women, but an advisory committee to the agency is expected to meet this weekend to make further recommendations. Some experts said the virus itself poses greater risks to pregnant women than the new vaccine, and noted that vaccines have been given to pregnant women for decades and have been overwhelmingly safe. “This is a really huge step forward in recognizing women’s autonomy to make decisions about their own health care,” said Dr. Emily Miller, an obstetrician at Northwestern University and a member of the Covid-19 task force of the Society for Maternal and Fetal Medicine. With the first doses of the vaccine reserved for health care workers and residents of long-term care facilities, the F.D.A.’s authorization most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States. Some health care workers are at high risk of Covid-19, either because their jobs bring them into intense contact with the virus — for example, cleaning the rooms of sick patients — or because they live in low-income and multigenerational homes, Dr. Faden said.

Most colleges brought back letter grades this fall. A few are returning to pass/fail. Image Lisa Condor, a graduate student at Colorado State, taking classes online from her front yard in Boulder County. Credit... David Zalubowski/Associated Press After a spring semester in which most American universities adopted some form of pass/fail grading system, or even abolished grades entirely, the vast majority planned to bring back normal marks this fall. But as the pandemic has continued to disrupt campuses and uproot student lives, at least some are going back to the more lenient days of spring. After many meetings and much deliberation, Colorado State announced this month that its 25,000 undergraduates could switch to a satisfactory or unsatisfactory grade after final exams if they were unhappy with their marks in a particular class. Kelly Long, the school’s vice provost for undergraduate affairs, said it was clear that many students were struggling in classes, which are mostly online, often because of less-than-ideal home situations. “Perhaps their home environment is not conducive to online learning, or they are having to work or caring for someone who is ill, or they themselves are falling ill,” Dr. Long said. “Those are parts of the generous thinking we’re trying to do.” Dr. Long said Colorado State had consulted with other universities and found that many administrators were also considering whether they had underestimated the impact of the pandemic. “Our peer institutions were starting to revisit the question,” she said. But so far, few have made similar announcements. “We believe that grades have meaning,” said Justin Anderson, a spokesman at Dartmouth, which adopted a pass/fail system in the spring but returned to letter grades this fall. But at M.I.T., one of the most rigorous schools in the country, administrators have continued to be accommodating. Students who receive a letter grade worse than a C in a fall semester course will not have that class appear on their transcript, unless they choose to for credit. In a letter to students on Nov. 30, Rick Danheiser, the faculty chair, said that policy would continue into the spring, and the school might revert to a “pass” system if conditions deteriorate.

Australia scraps a Covid-19 vaccine that produced H.I.V. false positives. Video transcript Back bars 0:00 / 1:16 - 0:00 transcript Australia Scraps Coronavirus Vaccine Prime Minister Scott Morrison of Australia on Friday canceled a large order of a developed coronavirus vaccine after not having the approval from the Therapeutic Goods Administration, the country’s drug regulator. “The advice that we have received, and the National Security Committee of Cabinet met this week and made the final decision yesterday, is that the University of Queensland vaccine will not be able to proceed based on the scientific advice, and that will no longer feature as part of Australia’s vaccine plan. And the decision we’ve taken should give Australians great assurance that we are proceeding carefully. We are moving swiftly, but not with any undue haste here. At the end of the day, the Therapeutic Goods Administration like with any vaccine in Australia, it must have their tick-off — without the tick, there’s no jab when it comes to vaccines in this country. That is true for the Covid-19 vaccine, as it is true for any other vaccine that is administered here in Australia.” “Clearly, the discontinuation of Q vaccine by mutual agreement, it was likely to be a promising vaccine. It was likely to work. But we knew that we didn’t want to have any issues with confidence, and this false positive test may have caused some confusion and lack of confidence. But it was a very, very good technology. It was looking like it was going to make antibodies, and it probably would have worked very well as a vaccine.” Prime Minister Scott Morrison of Australia on Friday canceled a large order of a developed coronavirus vaccine after not having the approval from the Therapeutic Goods Administration, the country’s drug regulator. Credit Credit... James Ross/AAP, via Reuters Australia on Friday canceled a roughly $750 million plan for a large order of a locally developed coronavirus vaccine after the inoculation produced false positive test results for H.I.V. in some volunteers participating in a trial study. Of the dozens of coronavirus vaccines being tested worldwide, the Australian one was the first to be abandoned. While its developers said the experimental vaccine had appeared to be safe and effective, the false positives risked undermining trust in the effort to vaccinate the public. Prime Minister Scott Morrison on Friday said that his government would compensate for the loss of 51 million doses it had planned to buy from the Australian consortium in part by increasing orders of vaccines made by AstraZeneca and Novavax. The government has said it plans to begin inoculating citizens by March. “We can’t have any issues with confidence,” he told reporters, “and we are as a nation now, with a good portfolio of vaccines, able to make these decisions to best protect the Australian people.” Australia’s health minister, Greg Hunt, told reporters that the country still had access to 140 million units of coronavirus vaccines — more than enough to cover its population of about 25 million people. The Australian setback showed the missteps that can inevitably occur when scientists, during a pandemic that has killed more than 1.5 million people, rush to condense the usual yearslong process to develop vaccines into a matter of months. The mistake, said John P. Moore, an immunologist at Weill Cornell Medical College in New York, was an “honest error” that cost money, not human lives. “I’m sure a lot of people are very embarrassed by it,” Professor Moore said. “It’s not great to be associated with a mistake like this. But when you’re running at 90 miles an hour, sometimes you trip.”

Sanofi and GlaxoSmithKline delay plans for a trial after experimental vaccine fails in some older patients. A Sanofi employee works on an experimental Covid-19 vaccine in Frankfurt, Germany, in September. Credit... Martin Joppen/Sanofi, via EPA, via Shutterstock The pharmaceutical companies Sanofi and GlaxoSmithKline said Friday that their experimental Covid-19 vaccine did not appear to work well in older adults, a significant setback to their late-stage clinical trial that was previously expected to begin in the United States in December. Instead, the companies said they planned to test a modified version of their vaccine in a smaller trial beginning in February. Rather than compare their candidate with a placebo, they said, it could be tested against a vaccine expected to be authorized by regulators for emergency use soon. The Sanofi vaccine is one of six that were selected by Operation Warp Speed, the federal government’s effort to quickly bring a vaccine to market. The companies negotiated a $2.1 billion agreement with the United States to provide 100 million doses. A vaccine developed by Pfizer and the German company BioNTech was authorized for emergency use in the United Kingdom and approved in Canada. In the United States, an expert panel voted on Thursday to recommend that the Food and Drug Administration authorize that vaccine. A decision could come as early as Saturday. Another vaccine developed by Moderna could also be authorized within weeks. Sanofi and GSK now face a more difficult path because they may have to show their vaccine is at least as good as one already authorized by regulators. The Pfizer and Moderna vaccines have each shown that they are more than 90 percent effective against Covid-19. The companies said they now expect their vaccine will not be available until the end of next year. “We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data,” said Thomas Triomphe, executive vice president and head of Sanofi Pasteur, the company’s vaccine division. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.” The companies said Friday that interim results of their early-stage clinical trials showed that, among adults 18 to 49 years old, the vaccine stimulated an immune response that was comparable to patients who had recovered from Covid-19. But older adults showed a low immune response, likely because of an insufficient concentration of the antigen, the protein that stimulates the body’s immune reaction. The Sanofi vaccine is based on viral proteins that are produced with engineered viruses that grow inside insect cells. GSK supplements the proteins with adjuvants that stimulate the immune system. The vaccine is based on the same design Sanofi used to create Flublok, an approved vaccine for influenza. If the vaccine does not succeed, or if it takes longer to develop, that could limit the available supply of vaccines, both in the United States and around the world. In addition to the U.S. deal, Sanofi and GlaxoSmithKline also reached a deal in September with the European Union for 300 million doses, and with Canada for up to 72 million doses. Sanofi also agreed to provide 200 million doses to COVAX, an international collaboration to deliver the vaccine equitably across the world. They had previously announced plans to make up to one billion doses in 2021.