Pfizer’s chief executive said on Friday that the company would not apply for emergency authorization of its coronavirus vaccine before the third week of November, ruling out President Trump’s assertion that a vaccine would be ready before Election Day on Nov. 3.
In a statement posted to the company website, the chief executive, Dr. Albert Bourla, said that although Pfizer could have preliminary numbers by the end of October about whether the vaccine works, it would still need to collect safety and manufacturing data that would stretch the timeline to at least the third week of November.
Close watchers of the vaccine race had already known that Pfizer wouldn’t be able to meet the Food and Drug Administration’s requirements by the end of this month. But Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.
In doing so, the company had aligned its messaging with that of the president, who has made no secret of his desire for an approved vaccine before the election. Mr. Trump even singled out the company by name and said he had spoken with Dr. Bourla, whom he called a “great guy.”
Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego, said that while Pfizer officials had assured him that a vaccine would likely not be authorized before the election, the company’s letter on Friday was “even more solid about their not being part of any political machinations.”
“This is good, really good,” said Dr. Topol, who was one of 60 public health officials and others in the medical community to sign a letter to Pfizer urging it not to rush its vaccine.
Dr. Bourla has pushed back against any suggestion that the company’s vaccine timeline was politically motivated. In September, Pfizer was the driving force behind a pledge by nine vaccine companies to “stand with science” and not put forward anything that had not been properly vetted.
Earlier this month, he published an open letter to employees that said he “would never succumb to political pressure” and expressed disappointment that “we find ourselves in the crucible of the U.S. presidential election.”
Pfizer is one of four companies testing a coronavirus vaccine in late-stage clinical trials in the United States, and it has been the most aggressive in its timeline estimates. Moderna, AstraZeneca and Johnson & Johnson have said that later in the year is more likely, matching the predictions of federal health officials.
As the coronavirus caseload in the United States soars past eight million, epidemiologists warn that nearly half of the states are seeing surges unlike anything they experienced earlier in the pandemic.
Reports of new cases this month have trended upward in all but 11 states, and more than 65,000 cases were announced across the country on Thursday, the most in a single day since July.
Uncontrolled outbreaks in the Midwest and Mountain West are driving the surge, according to a New York Times database. Some of the states with the most extreme growth had relatively few cases until recently, and rural hospitals have been strained.
Per capita, North Dakota and South Dakota are adding more new cases than any states have since the start of the pandemic. Wisconsin has seven of the 10 metropolitan areas in the United States with the highest rates of recent cases.
“What’s happening in the Upper Midwest is just a harbinger of things to come in the rest of the country,” said Michael Osterholm, an infectious-diseases expert at the University of Minnesota.
Further west, Colorado, Montana and New Mexico — fueled in part by a surge in the county that includes Albuquerque — were among the 19 states that were reporting seven-day records as of Thursday night. New infections are also emerging at record levels in Idaho and Wyoming.
New cases per day in the United States
New cases per day in the United States
New cases per day in the U.S.
New cases per day
in the United States
Signs of the uptick are already appearing east of the Mississippi River.
In the Northeast, where cases have been relatively low since a spring surge, the number of new ones is moving upward again. And in the South, where cases spiked this summer, there are worrisome trends in West Virginia and Kentucky.
The number of cases alone is not a full measure of the nation’s outbreak, in part because they come at a time when testing is more widespread than it was a few months ago. Deaths from Covid-19 have also been relatively flat in recent weeks, with an average of about 700 per day.
Still, said Caitlin Rivers, an epidemiologist at Johns Hopkins University, “we are headed in the wrong direction.”
“That’s reflected not only in the number of new cases but also in test positivity and the number of hospitalizations,” she added. “Together, I think these three indicators give a very clear picture that we are seeing increased transmission in communities across the country.”
High levels of infection in colleges and universities, Dr. Osterholm said, are serving as one source of the spread. Transmission also has been prevalent at events such as funerals, family barbecues and birthday parties, he said, adding that the comeback of sporting events and dining has also added to the spread this fall.
“Pandemic fatigue has clearly set in for large segments of the population,” he said.
Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said on Thursday that the current situation was worrying as winter approaches.
But President Trump continued to downplay the resurgence of this virus, saying he did not support the strictest restrictions by local officials to limit its spread.
“We’re not doing any more lockdowns,” he said. “We’re doing fine.”
In one of his final prime-time television events before Election Day, President Trump, who is trailing in national and battleground polls, offered little new to voters who may still be undecided, staking out positions on the coronavirus that are at odds with both the scientific consensus and public opinion.
Simultaneously, on another network, former Vice President Joseph R. Biden Jr. presented a very different vision of the country, promoting a federal response to the pandemic led by health experts.
Mr. Trump arrived at his town-hall event, which took place in Miami and aired on NBC, with a simple pitch: People should vote for him “because we’ve done a great job.” Mr. Biden’s goal for the evening was to both push back on that argument and allow Mr. Trump to keep the focus on himself — something the president appeared happy to do.
With 19 days until Election Day and cases of the virus rising again in much of the country, Mr. Trump said, falsely, “We’re coming around the corner.”
He added, “Vaccines are coming soon and our economy is strong.” In reality, it is not clear when a coronavirus vaccine will be widely available to the public and no medical experts have agreed with him that the country — which recorded at least 65,000 new virus cases on Thursday and has averaged about 700 deaths a day over the past week — is rounding the corner.
Mr. Biden, appearing on ABC from Philadelphia, attacked Mr. Trump for his handling of the pandemic, saying, “He missed enormous opportunities and kept saying things that weren’t true.” Mr. Biden called for a national standard” to combat the outbreak, which has killed over 215,000 people in the United States.
For Prime Minister Boris Johnson of Britain, the pandemic and the looming domestic upheaval it has overshadowed — Brexit — are linked.
The economic turmoil unleashed by the pandemic has raised the pressure on Mr. Johnson to avoid the self-inflicted disruption of ruptured negotiations with the European Union over Britain’s withdrawal.
The prime minister has now reached a moment of truth on the two issues that have dominated Britain this year: the pandemic and the withdrawal talks. But he is still playing for time, a strategy that could put lives or livelihoods at risk if he waits too long.
On Thursday, Mr. Johnson inched closer to imposing more limits on the country. But he stuck to his argument that the best way to curb the coronavirus was through targeted responses, not the two-week nationwide lockdown pushed by the opposition Labour Party and his own scientific advisers.
The prime minister also seemed ready to string out trade talks with Brussels, letting a self-imposed deadline pass on Thursday without a deal. While Mr. Johnson could torpedo the negotiations on Friday, after a two-day summit meeting of European Union leaders, analysts said the British government still appeared eager to strike an agreement by the legal deadline of Dec. 31.
Mr. Johnson’s reluctance to move decisively on either front, the virus or Brexit, risks making both worse, analysts say.
Dragging out the talks with Brussels could put Britain in a bind if the two sides hit an impasse as the clock runs out. Putting off a short lockdown — which experts have dubbed a “circuit breaker” — could necessitate a longer lockdown later, according to medical experts.
“If you’re going to do it, do it early, fast and hard,” said Devi Sridhar, chair of the global public health program at the University of Edinburgh. “The longer they delay, the less likely a two-week circuit breaker will work.”
In other global developments:
Under rules starting Friday in Scotland, couples who marry or enter into civil partnerships will no longer be required to wear face masks during the ceremony. In workplaces, masks will now be mandatory in cafeterias, except for when seated at a table, and, starting Monday, face coverings will be required in communal areas in offices. The country already requires face masks to be worn on public transport, in shops and other indoor public spaces.
President Trump, struggling to gain traction among voters just weeks before the election, called on Thursday for a bigger stimulus package than he had previously offered, and the White House signaled it was willing to make concessions to Democrats. But the proposals were unlikely to win the necessary backing from Senate Republicans who are preparing a far smaller bill of their own.
White House negotiators have proposed a $1.8 trillion relief package. Mr. Trump said that he wanted one that was even bigger and suggested, without explanation, that China would pay for it.
“I would go higher,” Mr. Trump said during an interview with the Fox Business Network. “Go big or go home.”
The comments came after Treasury Secretary Steven Mnuchin said the White House was willing to make additional concessions to Speaker Nancy Pelosi in hopes of rekindling a stimulus deal before the election. But the $1.8 trillion package that he has proposed has already proven to be a non-starter with Senate Republicans who have panned it as too costly, making Mr. Trump’s call for a more expensive bill another complication in the already fraught negotiations.
In the interview on CNBC, Mr. Mnuchin did not directly address the lack of support for a bill by Senator Mitch McConnell, the majority leader, suggesting that he has been briefed on negotiations between the White House and House Democrats while acknowledging that Senate Republicans prefer a more “targeted” relief bill.
But Mr. McConnell downplayed the prospects of a larger bill on Thursday.
“He’s talking about a much larger amount than I can sell to my members,” Mr. McConnell said about the president’s comments.
A city in eastern China has started inoculating some people against the coronavirus with a vaccine that has not finished late-stage clinical trials, ignoring warnings from scientists that the campaign could carry major health risks.
The announcement on Thursday, by health officials in the eastern city of Jiaxing, highlights how China has expanded its mass vaccination campaign for the virus even before rigorous testing concludes. The push to vaccinate so many people has bewildered several scientists, who have pointed out that China’s outbreak has been well under control for months.
The vaccine, developed by the private Chinese company Sinovac Biotech, was being provided on an “emergency use” basis in Jiaxing, the local Center for Disease Control and Prevention said on Thursday. It said the government would prioritize people in relatively high-risk jobs, including medical workers, port inspectors and public service personnel.
After that, ordinary citizens would be allowed to make reservations at community-level vaccination sites, the Jiaxing C.D.C. said. Two shots of the vaccine would be made available to people aged 18 to 59 for around $60, and given at an interval of 14 to 28 days.
Since July, Chinese vaccine makers have vaccinated tens of thousands of state-owned employees, government officials and executives from vaccine companies. The Chinese government has indicated in recent weeks that it would expand the campaign to include more people, including teachers, travelers and supermarket workers.
Zhejiang, the eastern province where Jiaxing lies, “has steadily and orderly promoted the emergency use of the coronavirus vaccine” Chen Guangsheng, a top provincial official in charge of epidemic prevention efforts, said on Friday. He added that Zhejiang had also started “the voluntary vaccination of key recommended subjects.”
Mr. Chen told a news briefing that the government had administered 743,000 doses of flu and coronavirus vaccines, though an official refused to provide a breakdown.
Mr. Chen’s comments prompted several Chinese media outlets to misreport that the figure was referring to the number of people who had taken a vaccine for the coronavirus.
Remdesivir, the only antiviral drug authorized for treatment of Covid-19 in the United States, fails to prevent deaths among patients, according to a study of more than 11,000 people sponsored by the World Health Organization.
“This puts the issue to rest — there is certainly no mortality benefit,” said Dr. Ilan Schwartz, an infectious disease physician at the University of Alberta in Canada.
The drug was granted emergency authorization by the Food and Drug Administration in May after a trial by the National Institutes of Health, which found that remdesivir modestly reduced the time to recovery in patients severely ill with Covid-19.
But that study, too, indicated that remdesivir did not prevent deaths, and Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged that it was not a “knockout” drug.
A final analysis, published this month in The New England Journal of Medicine, suggested “a trend toward reduced mortality” in certain patients receiving remdesivir, according to the drug’s maker, Gilead.
Still, the antiviral has become part of the standard of care for Covid-19 patients in the United States, and has been administered to thousands of patients, including President Trump, since its approval.
The W.H.O.’s study, called the Solidarity trial, enrolled 11,266 adults with Covid-19 in 405 hospitals in 30 countries. The participants were given four drugs singly or in combination: remdesivir, hydroxychloroquine, lopinavir, interferon or interferon plus lopinavir. About 4,100 received no drug treatment.
In the end, no drug or combination reduced mortality, the chances that mechanical ventilation would be needed, or time spent in the hospital, compared with the patients who were not given drug treatment.
Dr. Maricar Malinis, an infectious disease physician at Yale University, said the new remdesivir findings were not terribly surprising, but were “still impactful” in their support of previous findings, especially given the dizzying size of the Solidarity trial.