After weeks of dangling the possibility of coronavirus vaccine results by October, Pfizer's chief executive said Tuesday that would now be nearly impossible.
The announcement, by Dr. Albert Bourla, came on the same day that Pfizer announced third-quarter earnings, and all but ruled out the possibility of early results before the presidential election Tuesday.
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In a call with investors Tuesday, Wall Street analysts pushed Bourla to be more specific about when the company would have early results that could show the effectiveness of its vaccine, and how much detail the company would provide. Pfizer is one of four companies with large, late-stage clinical trials underway in the United States.
In his remarks, Bourla acknowledged the urgency of developing a vaccine amid a global resurgence in infections. In the United States over the past week, there have been an average of more than 71,000 coronavirus cases per day, and hospitalizations are increasing.
"Let's be very patient -- I know how much the stress levels are growing," Bourla said. "I know how much the vaccine is needed for the world." He also pushed back against any suggestion that politics were motivating the speed of development, saying "this is not a Republican vaccine, or a Democrat vaccine."
Pfizer's clinical trial is testing the vaccine in 44,000 people, half of whom will get a placebo. The trial's protocol, or blueprint, allows for an initial look at results after at least 32 people in either the placebo or vaccinated group have developed covid-19. If more than 26 of those people are in the placebo group, then the vaccine is considered likely to be effective.
Bourla had repeatedly predicted that the initial analysis -- which is conducted by an outside board of scientific experts -- would come by the end of October. But on Tuesday, he said those 32 cases of covid-19 had not yet occurred, a sign that the trial is progressing more slowly than the company had estimated.
He also said the outside panel would need at least a week to analyze any results. Bourla said the company would report results if the outside board found the vaccine was effective or not, but not if there is no definitive conclusion either way.
Even if early results come over the next few weeks, most Americans are not likely to get the vaccine anytime soon. Under guidelines from the Food and Drug Administration, coronavirus vaccine developers must turn in at least two months of safety data after half of the trial's participants have received the second dose of the vaccine, which Pfizer has said will not happen until at least the third week of November.
Bourla said the company has already manufactured "hundreds of thousands" of doses. It expects to have at least 40 million doses by the end of the year, and 100 million doses by March.
PROTESTS IN ITALY
Separately, protesters set trash bins afire and police responded with hydrant sprays in downtown Rome on Tuesday night, part of a day of public outpouring of anger against virus-fighting measures like evening shutdowns for restaurants and bars, and the closures of gyms and theaters.
It was a fifth straight night of violent protest in Italy, following recent local overnight curfews in metropolises including Naples and Rome.
After protests Monday night turned violent in the financial capital of Milan, police arrested 28 people. And in Italy's industrial northern city of Turin, at least 11 were arrested, including two who smashed the window of a Gucci boutique and stripped a mannequin of its trousers.
All of Europe is grappling with how to halt a fall resurgence of the virus before its hospitals become overwhelmed again.
Nightly curfews have been implemented in French cities. Schools must close at 6 p.m. Schools have been closed in Northern Ireland and the Czech Republic. German officials have ordered de facto lockdowns in some areas near the Austrian border, and new mask-wearing requirements are popping up weekly across the continent, including a nationwide requirement in Russia.
"We would all like to live like before, but there are moments where you have to make tough decisions," French Interior Minister Gerald Darmanin said Tuesday as the government held emergency meetings on the pandemic.
Yet in this new round of restrictions, governments are finding a less compliant public, even as the continent has seen more than 250,000 confirmed deaths in the pandemic and last week recorded 46% of the world's new infections, according to the World Health Organization.
Over the weekend, police used pepper spray against protesters angry over new virus restrictions in Poland. Spanish doctors staged their first national walkout in 25 years on Tuesday to protest poor working conditions.
ITALIAN RELIEF BID
Scrambling to ease some of the financial pain caused by the latest restrictions on businesses, Italian Premier Giuseppe Conte's Cabinet approved $5.8 billion in economic relief.
The measures included extending unemployment benefits for unionized workers for up to six weeks, through January; and financial aid for restaurants, cafes, hotels, gyms, ice cream parlors, taxi drivers and other sectors already hit hard by the lockdown earlier this year, and now reeling under the new restrictions with some businesses in danger of folding.
Also allocated were one-time payments of about $1,200 to free-lancers in the entertainment industry, pummeled by the cinema and theater closure, which lasts at least a month.
Conte said the alternative was another national lockdown to avoid overwhelming the national health service.
Aiming to avoid lockdown, "we tried to assemble a series of measures with surgical precision with the awareness they would have had a negative impact," Conte said.
On Tuesday, a dozen restaurant owners protested in front of Milan's City Hall, while many stadium concession stand owners waved banners at the Lombardy regional headquarters.
"No one has thought of us," said Giacomo Errico, the Lombardy president of FIVA Commercio representing 6,000 concession stand owners in the northern region, among 40,000 nationwide, that have been out of work since February.
FRANCE LOCKDOWNS
France has also warned of possible new lockdowns, including extending existing curfews, fully keeping residents at home on weekends or all week and closing nonessential businesses.
Like other leaders in the region, French President Emmanuel Macron is running out of options. As officials from Dublin to Prague grapple with the resurgent pandemic, their efforts to limit the virus' spread with softer measures -- from mandatory mask-wearing to partial curfews -- aren't working.
In Spain, the Canary Islands was seeking to pass a law demanding that visitors arrive at the popular archipelago off northwest Africa with proof of a negative covid-19 test.
Russia, which has the world's fourth-highest tally of 1.5 million confirmed cases, is resisting a second lockdown. But with cases rising at more than 15,000 a day, the health agency ordered all Russians to wear masks in crowded public spaces, including public transport, and in closed spaces like taxis and elevators.
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Dr. Michael Ryan, WHO's emergencies chief, said the European Union's open borders might even need to be shut down again to "take the heat out of this phase of the pandemic."
"There's no question that the European region is an epicenter of disease right now," he said. "Getting ahead is one thing -- and Europe certainly got ahead of this virus in the late spring, early summer. The real question is, how do you stay ahead of this virus."
WHO director-general Tedros Adhanom Ghebreyesus said even more stringent measures should be applied to stop the virus.
MASKLESS POPE
Meanwhile, Pope Francis' decision to forgo wearing a mask has been noticed, with some concern, by the commission of Vatican experts he appointed to help chart the Catholic Church's path through the coronavirus pandemic and the aftermath.
The Rev. Augusto Zampini, one of the key members of the pope's covid-19 commission, acknowledged Tuesday that at age 83 and with part of his lung removed after an illness in his youth, Francis would be at high risk for complications if he were to become infected with covid-19.
"He has started to use the mask now," Zampini said in response to reporters' questions. "And I hope he will use it in the general audiences, when he is close to the people. If you're in an open space, we know that it's different. But well, we are working on that."
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Francis has courted some criticism for declining to wear a mask when indoors, even though Vatican regulations call for masks indoors and out when social distancing cannot be guaranteed. While Francis' lung condition could help explain his decision to forgo the mask, he donned one for more than two hours last week when he presided over an indoor and outdoor interreligious prayer service in downtown Rome.
Yet the following day, Francis went maskless during his indoor general audience in the Vatican auditorium, including when he shook hands with a handful of similarly maskless bishops and leaned in to speak privately to each one. On Saturday, he met with Spanish Prime Minister Pedro Sanchez, who arrived wearing a mask only to take it off for the audience in the pope's library.
Photos of the maskless leaders caused a mild stir in Spain over the weekend, but the prime minister's office dismissed it by saying the delegation was following Vatican protocol rules. Spain last week became the first country in Western Europe with more than 1 million confirmed virus cases.
The Vatican has declined to respond to questions about Francis and masks.
Information for this article was contributed by Katie Thomas of The New York Times; by Colleen Barry, Frances D'Emilio and Nicole Winfield of The Associated Press; and by Marthe Fourcade and Rudy Ruitenberg of Bloomberg News.