Multiple COVID-19 vaccines may be available at the same time
Multiple COVID-19 vaccines may be available at the same time
MILWAUKEE - As the world waits for a coronavirus vaccine, UW Health is among 80 hospitals nationwide participating in the final phase of the AstraZeneca trial.
Getting rid of this worldwide pandemic is getting the vaccine, said Dr. William Hartman, UW Healths principal investigator of the trial.
In other countries, the AstraZeneca injection has been shown to create COVID-19 neutralizing antibodies. The focus of its two-year study is how long those antibodies last.
Who stays immune and who stays immune the longest, explained Hartman.
If effective in reducing COVID-19 cases by at least 50 percent and approved by the U.S. Food and Drug Administration, the AstraZeneca vaccine could be released before its study is over.
I think we're moving a little more briskly and a bit more efficiently but it's not like corners are being cut, said Dr. Jim Conway of the UW Health Immunization program. Only when the science is clear does the FDA even get a shot at reviewing it.
Conway says we may end up with a dozen different vaccines available at the same time. The first vaccines may be available by the end of 2020.
I think getting it into the general population will take well into 2021, said Conway.
The Wisconsin Department of Health Services (DHS) is making a similar prediction. In its COVID-19 Vaccination Plan, it says multiple vaccines from different manufacturers may be available at the same time.
DHS also says immunity is likely to require two doses, either 21 or 28 days apart.
I think it's pretty clear that health workers are probably that first wave, said Conway.
Also included in Wisconsins first phase of distribution are people over age 65, those living in long-term care facilities, and other essential workers.
Phase two of distribution includes other critical populations -- and eventually the general public in phase three.
To administer the vaccine, hospitals will need enough needles, syringes, and alcohol prep pads. Two of the most promising vaccines, from Pfizer and Moderna, also require ultra-cold storage in minus 80-degree Celsius freezers.
Your average place out in the communities doesn't have access to those kinds of freezers, said Conway.
UW Health is still seeking another 1,000 volunteers for its trial from all racial and ethnic backgrounds. It hopes to eventually be doing 25 injections per day.
It's an awesome experience. This is something that encompasses everyone in the world right now, said Hartman.
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The DHS plan says the vaccine will be procured and distributed by the federal government at no cost to providers or patients.
Conway predicts every person will need to be vaccinated to see a complete return to life as it was pre-COVID-19.
He says that could take until 2023 or longer if people refuse the vaccine or there are supply shortages.
Ninety-percent is fantastic," he said. If you think about the way that vaccines work, you know you can see anywhere between 50 and 85 percent. Eight-five percent is a really, really good vaccine, and that means you get the shot and you develop an immunity to whatever youre getting a shot for.
Pfizer said a clinical trial of its experimental COVID-19 vaccine found it to be more than 90% effective. Mark Lennihan/AP hide caption
Pfizer said a clinical trial of its experimental COVID-19 vaccine found it to be more than 90% effective.
Updated at 3:15 p.m. ET
Pfizer's experimental COVID-19 vaccine appears to be working. The vaccine was found to be more than 90% effective, according to clinical results released by the company Monday.
That news comes from an interim analysis of a study involving 43,538 volunteers, 42% of whom had "diverse backgrounds."
Each participant got two injections spaced 21 days apart. The analysis compared the number of cases of COVID-19 among the volunteers getting the vaccine with an approximately equal sized group of volunteers who got an injection of a liquid that didn't contain the vaccine.
In a news release from Pfizer and its partner BioNTech, the company said results from 94 evaluable cases of COVID-19 among study participants indicated the vaccine is more than 90% effective in preventing COVID-19. The Food and Drug Administration set a minimum effectiveness bar at 50%.
This is the first COVID-19 vaccine in development to have data showing that it exceeded that mark.
"I tend to be an optimist. I've been in vaccine development for over 35 years," said Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer. "But this is extraordinary, and I think it speaks well not only for the potential of this vaccine but potentially other vaccines that are out there in development for COVID-19."
"This result is towards the high end of expectations," said an emailed comment from Shane Crotty, professor at the Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology. "Greater than 90% efficacy at preventing disease, with 94 COVID-19 cases to evaluate, is an excellent outcome! It would be good to see more of the data, but those are very convincing numbers."
While promising, this analysis alone does not provide enough information about the vaccine for Pfizer to ask the FDA for permission to distribute it.
The agency has informed manufacturers that it wants a minimum of two months of follow-up data from at least half of the volunteers. The FDA says the reason for that requirement is that most dangerous side effects from a vaccine occur within two months of getting the final injection. Pfizer says that data won't be available until the third week in November.
The company didn't say how serious the COVID-19 cases were that occurred in the study, or whether any of them required hospitalization.
Natalie Dean, a biostatistician at University of Florida, says she's cautiously optimistic but waiting for more data.
"There remain many open questions, such as how well the vaccine is working across different age groups, how well it is preventing infection and severe disease," Dean wrote in an email to NPR. "But for the pre-specified primary endpoint of laboratory-confirmed symptomatic disease across the trial population, the numbers look very good."
The Pfizer vaccine trial is what's known as an event-driven study. It does not last for a specified period of time. Instead, the study will continue and won't be considered complete until it has recorded a total of 164 cases of COVID-19 among all the volunteers.
As described in its publicly released protocol, the company had planned to conduct four interim analyses, when a proscribed number of COVID-19 cases had occurred. The results released Monday are from the second one, the company having agreed with the FDA to forgo the first analysis.
Heres what you need to know:A researcher with Eli Lilly tests possible coronavirus antibodies in a laboratory in Indianapolis earlier this year.Credit...David Morrison/Eli Lilly, via Associated Press
The Food and Drug Administration has granted emergency authorization of a Covid-19 treatment made by Eli Lilly that was given to Chris Christie, the former New Jersey governor, when he was infected with the coronavirus.
The authorization, announced on Monday, applies only to people newly infected with the virus, and the agency said it should not be used in hospitalized patients. The treatment is approved for people 12 and older, who have tested positive, and who are at risk for developing a severe form of Covid-19 or being hospitalized for the condition. That includes people who are over 65 and obese, the agency said a key group that early studies have shown can benefit the most from the treatment.
Eli Lilly said that its treatment, called bamlanivimab, should be administered as soon as possible after a positive test, and within 10 days of developing symptoms.
Its a great day for science and medicine sort of a feat of whats possible, said Dr. Daniel M. Skovronsky, the chief scientific officer of Eli Lilly. The company and its collaborators, including the National Institutes of Health, he said, were able to create a new drug, manufacture it, test it in clinical trials, and get it authorized for use in just seven months.
In October, the company announced that it had reached a $375 million deal to sell 300,000 doses of the treatment to the U.S. government. Eli Lilly said Monday that it will begin shipping the treatment immediately to AmerisourceBergen, a national distributor, which will then distribute it on behalf of the federal government.
The treatment consists of a single powerful antibody that is believed to keep the infection in check, and has been shown in early studies to reduce emergency room visits and hospitalizations in patients who get the drug early in the course of their disease. It is similar to the treatment that President Trump received, made by the Westchester biotech company Regeneron, which is a cocktail of two antibodies. Regeneron has also applied for emergency authorization.
Mr. Christie disclosed this fall that he had received the Lilly treatment on an emergency basis after he was infected with the virus.
Eli Lillys authorization raised immediate questions about who would get access to the treatments, which must be infused in a clinic or hospital. The company has said it expects to have enough to treat one million people by the end of the year. That means, even in the best case scenario, there wont be nearly enough to curb a virus that is now infecting an average of over 111,000 people a day in the United States.
Its kind of the best times for these therapies to enter, because they can have an impact, said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Its also the worst time because we dont have enough doses, and its going to add to the backlog of testing.
By Monday evening, over 100,000 new U.S. cases had been recorded for the sixth consecutive day and more than 59,000 Covid-19 patients were hospitalized, nearing a record. Seven states and Guam set daily records for new cases.
At least three people who attended an election party at the White House last week, including the housing secretary and President Trumps chief of staff, have tested positive for the coronavirus. Several hundred people gathered at the event in the East Room for several hours, many of them not wearing masks as they mingled and watched election returns.
Ben Carson, the secretary of housing and urban development, tested positive for the coronavirus on Monday, according to a spokesman for the agency. He is the latest in a long list of administration officials, including Mr. Trump, to contract the virus.
He is in good spirits and feels fortunate to have access to effective therapeutics, which aid and markedly speed his recovery, Coalter Baker, the agencys deputy chief of staff, said in an email. Mr. Baker did not specify which treatments Mr. Carson had received or would receive.
Another is David Bossie, an adviser Mr. Trump recently appointed to be the face of his efforts to contest vote tabulations in states like Nevada and Georgia, two people familiar with the diagnosis said on Monday. Mr. Bossie tested positive on Sunday and told campaign officials of the result.
The third person from the election party is Mr. Trumps chief of staff, Mark Meadows, who tested positive for the virus the day after the election, aides said, although Mr. Meadows tried to keep it quiet.
President-elect Joseph R. Biden Jr. made an urgent plea on Monday for Americans to wear masks to slow the spread of the virus, declaring that a mask is not a political statement. He said the pandemic would be his top priority when he replaces Mr. Trump on Jan. 20.
With the world anxiously awaiting any positive news about a pandemic that has killed more than 1.2 million people, the drug maker Pfizer announced on Monday that its coronavirus vaccine appeared to be robustly effective, based on an early analysis of trial results.
Mr. Carson, a neurosurgeon who ran unsuccessfully for the Republican presidential nomination in 2016, has defended Mr. Trumps response to the virus and is a member of the White House virus task force.
At 69, Mr. Carson is at an elevated risk for complications. He is also a cancer survivor, having undergone surgery in 2002 for an aggressive form of prostate cancer.
I really came down with symptoms yesterday. Fever of 101. Chills. Muscle cramps. Respiratory issues and fatigue, Mr. Carson told The Washington Post.
According to Armstrong Williams, a friend and personal adviser to Mr. Carson, the secretary felt ill over the weekend and was examined and tested early Monday at Walter Reed National Military Medical Center.
I was just on the phone with him, Mr. Williams said in an interview at midday on Monday. He said he was feeling pretty bad over the last couple of days, but he was feeling a lot better now. Carsons going to live. Carsons going to be OK.
Some patients who seem to fare well in the first week after diagnosis become seriously ill in the second week.
Mr. Carsons wife, Candy, accompanied him to Walter Reed and was tested, but the results were not back yet, Mr. Williams said. It was not clear which kind of test each had taken.
The secretary was one of several hundred people at the White House party, according people with knowledge of the situation. But Mr. Williams said that Mr. Carson thinks he caught the virus before then, while campaigning for Mr. Trump by bus before Election Day. It was not immediately clear why Mr. Carson thinks so.
Five other White House aides and a Trump campaign adviser also tested positive in the days before and after Election Day, people familiar with the diagnoses told The Times on Friday.
President-elect Joseph R. Biden Jr. named Dr. Rick Bright, a former top vaccine official in the Trump administration who submitted a whistle-blower complaint to Congress, as a member of a Covid-19 panel to advise him during the transition, officials announced Monday.
Dr. Bright, who was ousted as the head of a federal medical research agency, told lawmakers that officials in the government had failed to heed his warnings about acquiring masks and other supplies. He said that Americans died from the virus because of the Trump administrations failure to act.
Lives were endangered, and I believe lives were lost, Dr. Bright, the former director of the Department of Health and Human Servicess Biomedical Advanced Research and Development Authority, told a House subcommittee in May.
Mr. Bidens decision to put Dr. Bright on his advisory panel is intended to send a signal that the incoming administration intends to confront the virus which is surging across the country in a very different way than President Trump, who sought to largely push responsibility onto states.
In a statement on Monday, Mr. Biden said the advisory board will help him shape his approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.
After meeting with the board on Monday, Mr. Biden urged all Americans to wear a mask and vowed to make defeating the pandemic his No. 1 priority when he takes office on Jan. 20.
It doesnt matter your party, your point of view. We can save tens of thousands of lives if everyone would just wear a mask for the next few months, Mr. Biden said.
On Sunday, the nation surpassed 10 million cases and sank deeper into the grip of what could become the worst chapter yet of the pandemic.
The rate of new cases is soaring: The seven-day average of new cases across the United States rose to more than 111,000 a day, as of Sunday. With 29 states setting weekly case records, the virus is surging in more than half the country. Nationwide, hospitalizations have nearly doubled since mid-September, and deaths are slowly increasing again.
The nations worsening outlook comes at an extremely difficult juncture: Mr. Trump, who remains in office until January, is openly at odds with his own coronavirus advisers, and winter, when infections are only expected to spread faster, is coming.
The three co-chairs of Mr. Bidens virus advisory board are: Dr. Vivek H. Murthy, a former surgeon general, who has been a key Biden adviser for months and is expected to take a major public role; Dr. David A. Kessler, a former commissioner of the Food and Drug Administration who worked closely with Dr. Anthony S. Fauci, the nations top epidemiologist, to speed development and approval of HIV drugs; and Dr. Marcella Nunez-Smith, an associate professor of medicine and epidemiology at Yale University.
The 13-member panel will also include Dr. Ezekiel J. Emanuel, an oncologist and the chair of the department of medical ethics and health policy at the University of Pennsylvania. Dr. Emanuel is the brother of Rahm Emanuel, who served as White House chief of staff under former President Barack Obama and as the mayor of Chicago. Dr. Emanuel has been a high-profile advocate of a more aggressive approach to the virus.
The other members of the panel are: Dr. Atul Gawande, a professor of surgery at Brigham and Womens Hospital; Dr. Celine Gounder, a clinical assistant professor at the N.Y.U. Grossman School of Medicine; Dr. Julie Morita, the executive vice president of the Robert Wood Johnson Foundation; Dr. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota; Ms. Loyce Pace, the executive director and president of the Global Health Council; Dr. Luciana Borio, a National Security Council aide under Mr. Trump and acting chief F.D.A. scientist under Mr. Obama; and Dr. Robert Rodriguez and Dr. Eric Goosby of the University of California, San Francisco School of Medicine.
And Dr. Fauci said on Monday that he would stay at his post atop the National Institute of Allergy and Infectious Diseases after Mr. Bidens inauguration, telling CNN that he has no intention of leaving.
Ive been doing it working in public health under six presidents, Dr. Fauci said. Its an important job and my goal is to serve the American public no matter what the administration is.
transcript
transcript
Unfortunately were also dealing with an immense challenge this morning because we see the presence of the coronavirus in the city and its trying to reassert itself. And we have to do everything in our power while were waiting for that help from the federal government to finally come, we need to do everything in our power to stop the coronavirus from reasserting in New York City. We have to stop a second wave from happening here. It is getting dangerously close. Ive been telling you for weeks that we had the ability to stop a second wave. And for weeks, actually, our numbers were higher than we wanted, but they had leveled off. Now, unfortunately, were seeing a real growth in the positivity rate in the city. And that is dangerous. So we have one last chance to stop a second wave. Its as simple as this. This is my message to all New Yorkers today: We can stop a second wave if we act immediately. But we have one last chance. So the more that people wear masks, practice social distancing, all those basics, the more were able to fight back that second wave. So I cant give you a timeline. It will actually depend on how people respond to your reporting and everything else we put out there. If they take decisive action, it can make a huge difference. But it is important, I think, to lay out the danger in terms of new restrictions because I think it will make it very visual, very real to people what were up against. God forbid this continued and we had a full-blown second wave, it means a lot more restrictions. It means, unfortunately, it could mean even having to shut down parts of our economy again, which would be horrible for this city, horrible for the livelihoods of people.
As coronavirus cases have surged to records across the United States, Gov. Philip D. Murphy of New Jersey laid out new restrictions for the state on Monday, calling for restaurants and nightclubs to shut down indoor service at 10 p.m. starting Thursday, and saying that no one may be seated directly at the bar.
High school sports teams are not permitted to participate in out-of-state tournaments, but college athletes may still travel.
Mr. Murphy said he would continue to consider additional targeted restrictions on nonessential businesses.
New Jerseys seven-day average of coronavirus cases now exceeds 2,000 infections a day, or 24 per 100,000 people, the highest rate since May. Last week, the average rate of positive tests, a key indicator of a states control of the virus, reached 6 percent. Hospitalizations have also been rising, though death rates have not spiked.
Mr. Murphy, a Democrat, said in interview on CNBCs Squawk Box on Monday that the new rules would be designed to shave at the edges, without imposing a full lockdown.
The new limits on businesses comes about two weeks after Newark, the states largest city, took similar action on its own to confront a hot spot centered in the Ironbound neighborhood, one of the states most thriving restaurant districts.
And in the New York City area, officials had also hoped to keep the outbreak at bay and press ahead with its slow but steady recovery from the dark days of spring. But now, its forecast is turning more alarming, too.
The number of new cases is swiftly rising, with more than 1,000 cases identified in New York City four days in a row this past week, or 12 per 100,000 people, a level that last occurred in May, according to a New York Times database.
Though new restrictions would be up to the governor, city health officials and Mayor Bill de Blasios aides have been discussing whether new citywide restrictions should be imposed, including a broader shutdown of nonessential businesses if the citywide seven-day average rate of positive virus test results climbs, and stays, above 3 percent. The figure was 2.21 percent, according to the citys health department.
Hospitalizations and death rates are a small fraction of what they were at the height of the pandemic, and case count comparisons can be tricky, given that much more testing is occurring now. Around the state, the daily average of new cases for the last seven days was 2,757, or 14 per 100,000 people as of Sunday, according to the Times database.
Whats more, the positivity rate in New York City is still well below that in neighboring states.
Mr. de Blasio said on Monday that now, unfortunately, we are seeing a real growth in the positivity rate in the city, and that is dangerous.
He added, This is my message to all New Yorkers: We can stop a second wave if we act immediately, but we have one last chance and everyone has to be a part of it.
The citys contact tracing program has disclosed few details about which trends and patterns are contributing to transmission. But one city health official, who spoke on condition of anonymity to share details from internal discussions, said clusters had been traced to workplaces, including construction sites and offices.
The mayor said that further lockdowns were possible should New York City not regain control of the virus.
God forbid this continued and we had a full-blown second wave, he said. It means a lot more restrictions. Unfortunately, it could mean even having to shut down parts of our economy again.
It could also mean having to close schools, he said.
The mayor has previously said that he favored halting indoor dining if the seven-day positivity rate reached 2 percent a threshold that has already been crossed without his taking any action. On Monday, the mayor would only say that it was time to re-evaluate the wisdom of allowing limited indoor dining.
At his own news conference, Gov. Andrew M. Cuomo said the so-called red zone covering parts of Brooklyn was being downgraded to orange, which allows for less severe restrictions. Parts of Erie, Monroe and Onondaga counties would face greater restrictions, though, he said.
This is going to be the constant for the foreseeable future, Mr. Cuomo said, of his whack-a-mole approach to battling the virus. Every couple of days well say, This place became a microcluster, this place is no longer a microcluster.
The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.
Pfizer, which developed the vaccine with the German drug maker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts.
Pfizer said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said.
Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said.
Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. Still, Pfizer is the first company to announce positive results from a late-stage vaccine trial.
Eleven vaccines are in late-stage trials, including four in the United States. Pfizers progress could bode well for Modernas vaccine, which uses similar technology.
The news comes just days after Joseph R. Biden Jr. clinched a victory over President Trump in the presidential election. Mr. Trump had repeatedly hinted a vaccine would be ready before Election Day, Nov. 3. This fall, Pfizers chief executive, Dr. Albert Bourla, frequently claimed that the company could have a readout by October, something that did not come to pass.
Both President Trump and President-elect Biden hailed the news on Monday.
Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans free of charge.
But in an interview, Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, sought to distance the company from Operation Warp Speed and presidential politics, noting that the company unlike the other vaccine front-runners did not take any federal money to help pay for research and development.
She said she learned of the results from the outside panel of experts shortly after 1 p.m. on Sunday, and that the timing was not influenced by the election. We have always said that science is driving how we conduct ourselves no politics, she said.
The data released by Pfizer Monday was delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.
In the wake of Joseph R. Bidens victory and the latest optimistic reports about the effectiveness of Pfizers vaccine, Gov. Andrew M. Cuomo of New York once again assailed President Trumps vaccine distribution plan, saying, We cant let this vaccination plan go forward the way the Trump administration is designing it.
The Trump administration is rolling out the vaccination plan and I believe its flawed, Mr. Cuomo, a third-term Democrat, said on ABCs Good Morning America on Monday. Theyre basically going to have the private providers do it, and thats going to leave out all sorts of communities that were left out the first time when Covid ravaged them.
Mr. Cuomos comments came even as he acknowledged that Pfizers results were great news, but some conservatives quickly accused the governor of trying to politicize the issue and hamper vaccine distribution efforts.
In a statement, Senator Ben Sasse, Republican of Nebraska, said: After this nasty virus has killed hundreds of thousands of Americans and put millions out of work, it is beyond disgusting that Governor Cuomo would use a glimmer of hope for another worn-out Trump is bad talking point. When we get a vaccine, were going to need all hands on deck distributing it as fast as possible. Shamelessly politicizing this is dangerous and stupid.
For months, Mr. Cuomo has raised concerns about the White Houses vaccination strategy, claiming that the rush to develop a vaccine has become so politicized that people might have serious trepidations about a vaccines safety. As chairman of the National Governors Association, Mr. Cuomo has accused the federal government of not providing states with sufficient answers on how governors should prepare to distribute a vaccine.
Those concerns prompted Mr. Cuomo to announce in September a state task force that is supposed to review any vaccines authorized by the federal government before theyre distributed in New York. Last month, the governor released a draft plan outlining the broad contours of how the vaccine would be distributed in New York, where up to 40 million doses could be needed for the states 19 million residents. Mr. Cuomo said priority would be given to essential workers and those considered most vulnerable.
Mr. Cuomo has also said that relying on the private sector, including pharmacies, could leave out minority communities that have already been disproportionately affected by the virus.
While the plan isnt finalized, a report released by the Department of Health and Human Services says that the most at-risk populations would indeed be prioritized in the initial phases of distribution, which will entail partnerships with local governments and public health sites, in addition to pharmacies, clinics, hospitals and nursing homes.
Ukraines president, Volodymyr Zelensky, said Monday that he has tested positive for the coronavirus, becoming the latest leader to contract the virus despite the extensive protective measures available to a head of state.
Mr. Zelensky, who is 42 and not known to have any of the underlying conditions that could put him at risk of developing severe illness from the virus, said in a post in English on Twitter that he felt good and was taking vitamins, adding, its gonna be fine!
The Ukrainian president said he intended to isolate himself but keep working. It was not clear if he had shown any symptoms. The presidents chief of staff, Andriy Yermak, has also tested positive, according to a statement he posted on Facebook minutes after the presidents tweet.
Cases have been shooting up in Ukraine. The country reported an average of 9,525 cases per day over the past seven days.
Mr. Zelensky has consistently urged Ukrainians to wear masks and to take other coronavirus precautions seriously. He often appears in public wearing a mask or on television conducting business by video conference.
Critics have, however, taken issue with a decision by his political party, which controls Parliament, to allocate more than half of a coronavirus relief fund intended for hospitals to road construction instead.
Mr. Zelensky, a former comedian, was elected president last spring and within months became entangled in an American political scandal when President Trump requested, in a telephone call, that he investigate now President-elect Joseph R. Biden Jr. and Mr. Bidens family.
Mr. Zelenskys wife, Olena Zelenska, had a mild case of Covid-19 in June. At the time, Mr. Zelensky said he isolated for a time but tested negative.
It will be a while before the University of Notre Dame knows whether the boisterous on-field celebration following the football teams double-overtime victory against top-ranked Clemson will cause a surge in students testing positive for the coronavirus.
But the school isnt waiting to react. Faculty members and administrators are already debating stronger measures to prevent the virus from spreading as students take finals and go home for Thanksgiving.
Thousands of students leapt over brick walls, dashed past overwhelmed security guards and stormed the field on Saturday, gleefully mobbing the Notre Dame players and one another for more than 15 minutes and ignoring loudspeaker announcements to retreat.
In a letter to the student body Sunday night, the Rev. John Jenkins, the president of the university, called the widespread disregard of the schools health and safety guidelines over the weekend very disappointing, and said there would be zero tolerance for noncompliance, either on campus or off. (A spokesman for the university said on Monday that Father Jenkins was not referring specifically to the football game, but to other gatherings.)
Any student who does not get tested for the coronavirus, or who leaves South Bend before the results are known, will not be allowed to graduate or register for next semesters classes, he wrote.
But Father Jenkinss credibility on campus is wearing thin. He has twice had to apologize for failing to wear a mask when he should have:posing for photos with returning students in August, and attending a White House reception where many attendees were infected, including him.
In an email Monday to the faculty and staff, Dan Lindley, an associate professor of political science, urged university leaders to lock down the campus for the rest of the semester (classes end Thursday, followed by final exams). His letter was in response to one Sunday night from the schools provost and vice president saying the school would not shut down classes.
BOSTON (CBS) Pharmaceutical company Pfizer announced its coronavirus vaccine is 90% effective. The company announced the development as cases soar nationwide.
The greatest medical advance in the last hundred years, said Pfizer CEO Albert Bourla. Its a very important day for humanity, he said as the company announced its potential coronavirus vaccine has proven to be more than 90% effective in trials.
That really hits the mark, said Dr. Daniel Kuritzkes, the Director of the infectious diseases division at Brigham and Womens Hospital. The FDA had set a minimum benchmark of 50% for even considering the possibility of approving the vaccine. This is 90%, thats really good.
In Bostons Copley Square, people smiled at the news, under their masks. A little glimmer of light at the end of a long tunnel, said Alice Stone. I look forward to this working, and mostly I look forward to having it be free and available for everyone, said Linda Schwabe.
READ: Dr. Mallika Marshall On Coronavirus Vaccine
Bourla said it would be available for free in the United States. First, the drug maker has to collect two more months of safety data. That puts Pfizer at the third week of November before it can apply for emergency use authorization from the federal government.
A couple weeks ago, the Cambridge-based biotech company Moderna announced its on a similar timetable, ready to ship doses by the end of the year if the FDA allows.
Experts say the phased-in roll-out could take a full year, and some public persuasion. A lot of people Ive talked to are not comfortable, said Stephen Campbell, of Jamaica Plain. They dont trust that its going to protect them from the coronavirus, and a lot of people feel like itll end up hurting them for the long term.
We really need a massive education campaign about COVID-19 Vaccination, and why everybody should get a vaccine once the FDA says its OK to do so, said Dr. Kuritzkes.
(Reuters) - Pfizer Inc PFE.N said on Monday its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study, a major victory in the fight against the pandemic.
FILE PHOTO: A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Pfizer logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic
Pfizer and German partner BioNTech SE BNTX.O are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine.
Following are reactions to the news.
Scientists reactions
ALEXANDER GINTSBURG, DIRECTOR OF MOSCOWS GAMALEYA INSTITUTE WHICH DEVELOPED RUSSIAS MAIN VACCINE CANDIDATE, SPUTNIK V
We welcome the progress shown by our foreign colleagues in the development of a vaccine against the new coronavirus. The more vaccines are available in the world, the better people will be protected.
People at high risk of infection - primarily medical workers - are already being actively vaccinated in our country. Production is being scaled up and new production sites are joining the process. In the near future we expect to publish interim results of the post-registration trial of the vaccine Sputnik V, the so-called Phase III trials. I am sure that its effectiveness level will also be high.
CLEMENS WENDTNER, CHIEF PHYSICIAN OF INFECTIOLOGY AND TROPICAL MEDICINE AND HEAD OF THE SPECIAL UNIT FOR HIGHLY CONTAGIOUS LIFE-THREATENING INFECTIONS, MUNICH SCHWABING CLINIC, GERMANY
This is remarkable, as many ongoing vaccination studies on COVID-19 currently only assume a success rate of at least 50%. In addition, it should be emphasized that a sharp end point has been defined - infection yes or no. Alternatively, with less high expectations of a vaccine, already attenuated disease courses, so-called mitigated courses, could be considered a success. In addition, the mRNA vaccination appears to be effective after only four weeks, which means that one does not have to wait long for protection.
WALID GELLAD, PROFESSOR OF MEDICINE, UNIVERSITY OF PITTSBURGH, UNITED STATES
This is a hint that these mRNA vaccines are likely to work, and theres at least one other. And theyre likely to be safe, at least from this trial. So thats highly encouraging. The other thing thats highly encouraging is that science can now create a vaccine in a relatively short amount of time and test it, which gives a lot of hope for the future when these things happen again.
ANDREW HILL, SENIOR VISITING RESEARCH FELLOW IN THE DEPARTMENT OF PHARMACOLOGY AT THE UNIVERSITY OF LIVERPOOL, BRITAIN
This vaccine needs to be stored at -80c. This could create major logistical challenges for mass treatment outside major urban areas and in low or middle income countries.
However, overall this is a huge step forwards in the fight against COVID-19. We will need to see whether updated versions of this vaccine are needed to protect people against new strains of the virus which might emerge in future.
RICHARD HATCHETT, CHIEF EXECUTIVE OF THE CEPI COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS
These are hugely positive and encouraging interim results and are testament to the ingenuity and skill of the scientific community in advancing vaccine candidates against COVID-19. We commend Pfizer/BioNTech on this historic interim result and the speed at which they have advanced through clinical development.
We believe these interim results also increase the probability of success of other COVID-19 candidate vaccines which use a similar approach [pre-fusion spike as their immunogen], including all of the vaccines in the CEPI portfolio.
PETER HORBY, PROFESSOR OF EMERGING INFECTIOUS DISEASES AT UNIVERSITY OF OXFORD, BRITAIN
This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general.
Of course we need to see more detail and await the final results, and there is a long, long way to go before vaccines will start to make a real difference, but this feels to me like a watershed moment.
ELEANOR RILEY, PROFESSOR OF IMMUNOLOGY AND INFECTIOUS DISEASE AT THE UNIVERSITY OF EDINBURGH, BRITAIN
At face value, this is exceptionally good news: a vaccine that is 90% effective at preventing symptomatic cases of COVID-19 and with millions of doses available by the end of the year.
However, the full data set on which the claim is based has not yet been released and so we dont know exactly what has been found.
LAWRENCE YOUNG, PROFESSOR OF MOLECULAR ONCOLOGY AT UNIVERSITY OF WARWICK, BRITAIN
Its hard to interpret the interim analysis, but it does appear very encouraging.
In this... preliminary analysis there is a significant reduction in the COVID-19, and I interpret that to mean that ... individuals are not developing disease, but it doesnt tell us anything about whether people are getting infected or not.
JOHN MOORE, PROFESSOR AT WEILL CORNELL MEDICAL COLLEGE, NEW YORK CITY
I can see nothing problematic.
As for what this means for other vaccines, Moore said: Modernas is likely to work as well given the similar design and performance, and Novavax also, as it seems more potent. Its harder to judge about the other candidates.
MICHAEL HEAD, SENIOR RESEARCH FELLOW IN GLOBAL HEALTH, UNIVERSITY OF SOUTHAMPTON, BRITAIN
This cautiously sounds like an excellent result from the phase 3 trials, but we should remain a little cautious. The provisional findings are made available in a press release, and the study is ongoing. However, if the final results show an effectiveness of anywhere near 90% with response in elderly and ethnic minority populations, that is an excellent result for a first generation vaccine.
This has been seen before the rapidly-produced ebola vaccine generated very high levels of effectiveness and exceeded all expectations. Equally, billions of dollars and numerous clinical trials have struggled to produce any form of vaccination against HIV. Science can be unpredictable.
AZRA GHANI, CHAIR IN INFECTIOUS DISEASE EPIDEMIOLOGY, IMPERIAL COLLEGE LONDON
These new results represent the first demonstration of substantial efficacy of a vaccine candidate against COVID-19 disease which is very welcome news. It is important to bear in mind that these are early results based on a relatively small number of cases. In addition, the efficacy estimate is based on seven days of follow-up of participants following the second dose; further data in the coming weeks and months will provide a better picture of longer-term vaccine efficacy.
WILLIAM SCHAFFNER, INFECTIOUS DISEASES EXPERT AT VANDERBILT UNIVERSITY MEDICAL CENTER, NASHVILLE, TENNESSEE, UNITED STATES
The efficacy data are really impressive. This is better than most of us anticipated. I would have been delighted with efficacy of 70% or 75%. 90% is very impressive for any vaccine. The study isnt completed yet, but nonetheless the data look very solid.
IAN JONES, PROFESSOR OF VIROLOGY AT UNIVERSITY OF READING, BRITAIN
Of all the vaccines currently in development the BioNtech product always looked like the most bang-per-buck as it is entirely focused on the part of the virus that binds to the human cell, the receptor binding domain.
The only things we will not know for some time is the longevity of the response in all age groups, but assuming antibody titres are high that should be at least as good as any other vaccine currently in trial.
JOHN BELL, REGIUS PROFESSOR OF MEDICINE AT UNIVERSITY OF OXFORD WHO SITS ON THE UK GOVERNMENTS VACCINE TASKFORCE, TOLD BBC RADIO:
Im really delighted with this result for no other reason than it shows you you can make a vaccine against this little critter. As you know, there are many pathogens where weve tried for decades and never managed to get a vaccine, you know, malaria, HIV.
Distribution of this is going to be challenging, and theres a lot of complexities associated with that. But... thats not the headline here. The headline is, well solve those things if we need to. But... it rolls the pitch for other vaccines because I cant see any reason now why we shouldnt have a handful of good vaccines available to this disease.
Our (Oxfords) first interim analysis is also likely to be available in the very near future, and by that I mean weeks, not months. So, Im pretty optimistic that given this result, well have a reasonably good chance of getting a good result as well.
When you look at the immunological responses you get from the Oxford/AstraZeneca vaccine and the ones from the Pfizer/BioNTech vaccine and indeed even the Moderna vaccine. They all look about the same. So, Im optimistic that that probably reflects similar levels of efficacy.
FLORIAN KRAMMER, PROFESSOR AT THE DEPARTMENT OF MICROBIOLOGY, ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI, USA
These are fantastic results. The efficacy could be higher than expected, and this probably means that - at least in the U.S. - there will be an application for approval very soon. Of course, it would be better to see age-specific data, but I suspect that these will be published soon. Frankly, this is the best news I have received since Jan. 10.
MARYLYN ADDO, HEAD OF TROPICAL MEDICINE SECTION, UNIVERSITY MEDICAL CENTER EPPENDORF (UKE), HAMBURG, GERMANY
These are interesting first signals, but again they are only communicated in press releases. Primary data are not yet available and a peer-reviewed publication is still pending. We still have to wait for the exact data before we can make a final assessment. At present, there are still few details about the exact data, for example regarding different age groups and in which groups the 94 cases occurred exactly.
BERND SALZBERGER, HEAD OF INFECTIOLOGY, UNIVERSITY HOSPITAL REGENSBURG, GERMANY
In the Pfizer/Biontech press release, the Phase II/III placebo-controlled observer-blinded study with the vaccine BNT162b2 reported a vaccine efficacy of over 90%. Although only a few events - a total of 94 cases - have been observed in the study so far, this is a very good result. No serious side effects have been reported - overall a very positive result, which will probably lead to an early approval.
GERD FAETKENHEUER, HEAD OF INFECTIOLOGY, CLINIC I FOR INTERNAL MEDICINE, UNIVERSITY HOSPITAL COLOGNE, GERMANY
These are great and promising data. It is incredible that in such a short period of time this progress with the development of a vaccine and clinical trials within a few months has been achieved. The results on efficacy and safety so far are excellent.
I think this will have a major impact on our handling of the pandemic and I hope that large quantities of the vaccine will be available quickly. The researchers involved can only be congratulated.
DANNY ALTMANN, PROFESSOR OF IMMUNOLOGY AT IMPERIAL COLLEGE LONDON
In terms of the impact on the COVID-19 pandemic, its good news, but its not overnight success good news.
Altmann cautioned that this and other potentially successful vaccines would still need to be approved and delivered to people across the world, and this will still take many months.
He added, however: I always felt optimistic, and my optimism remains strong.
Government reaction
Todays news about the anti-COVID vaccine is encouraging. But caution is still needed. Scientific research is the real key to overcoming the emergency. In the meantime, we must never forget that the behaviour of each of us is essential to bend the curve.
We welcome every advance made by the global efforts to come up with a COVID-19 vaccine. The federal government is working intensively to as quickly as possible to give the Swiss people access to a safe and effective vaccine. Weve signed two contracts already, with Moderna and AstraZeneca, and were currently in negotiations with additional, promising vaccine makers.
Corporate reaction
LUCIO ROVATI, CEO OF ITALYS ROTTAPHARM BIOTECH, WHICH IS WORKING WITH TAKIS BIOTECH ON A COVID-19 VACCINE
This is important news. Nothing that was not expected. Anyway, great, great. The problem remains that the data is limited in duration, 28 days after the first inoculation. The problem will be to see how long the coverage lasts. But in any case it is already very important to know that there is an effective vaccine, also because it seems a vaccine well tolerated in the medium term. At the end of November data at two months will be available, as required by regulatory agencies, and so at the end of November (the vaccine) could already be approved.
QUENTIN VIVANT, SPOKESMAN FOR FRENCH DRUGMAKER SANOFI SASY.PA
Congratulations to our Pfizer colleagues. We feel energized to move on and bring more vaccines to the world to fight against this pandemic.
Market reaction
RUSSELL SILBERTSON, CO-HEAD OF DEVELOPED MARKET FX & RATES AT ASSET MANAGER NINETY ONE
If the bearish view embedded in markets was that there was no effective vaccine any time soon priced in, clearly that needs significant repricing now.
You couple (this mornings news) with the sheer weight of all the stimulus in markets, and thats a very strong economic upside scenario.
NIKESH PATEL, HEAD OF INVESTMENT STRATEGY, KEMPEN CAPITAL MANAGEMENT, LONDON
This is the first news that allows governments to start planning ahead to when economies can properly start to reopen from lockdowns. That gives them more visibility and concreteness about what fiscal policy they can take.
Monetary policy can only go so far at this point and it needs to be a fiscal response for a real recovery and this kind of news is great as it allows governments to make that fiscal response without fear of endless support.
Whilst we are not there yet, news that this vaccine could be highly effective is the best thing markets could hope for. Public health officials will remind us there is a long road ahead, and many challenges will be faced along the way, but there is an enormous sense of optimism today light at the end of the tunnel. Lets just hope the vaccine deniers wont get in the way, but 2021 just got a lot brighter.
The COVID-19 vaccine news adds to the positive risk tone in stocks and underpins high beta currencies vs the U.S. dollar. Any positive news on a vaccine is good news for the world economy and offers perspective for rebound/normalisation in 2021 growth.
The bigger driver of the economic outlook is from the outside factors. Right now that means the development of a vaccine, which is why we are following news on this front closely.
The base case we have already is that we are likely to get a vaccine by year-end and that it will be rolled out. So we do see news like this as positive. The worrying sign would be if we get negative news say on testing, that would hurt how we view the economic outlook.
Reporting by Kate Kelland, Caroline Copley, Julie Steenhuysen, Josephine Mason, Dhara Ranasinghe, Saikat Chatterjee, Tom Arnold, Tommy Wilkes, Francesco Guarascio, Angelo Amante, Michael Erman, Emilio Parodi, Polina Ivanova, John Miller and Alistair Smout
As COVID-19 continues to rise dramatically in Oregon, Southwest Washington and beyond, get the latest updates here.
PORTLAND, Ore. Cases of COVID-19 began showing up in the United States in January of this year. The first case in Oregon was reported on Feb. 28.
BY THE NUMBERS
REAL-TIME UPDATES
STEUBEN COUNTY, N.Y. (WETM) An 89-year-old resident of Absolut Care Three Rivers in Painted Post has died from COVID-19, according to the Steuben County Public Health Department.
The residents death is the first known COVID-19 death at Absolut Care Three Rivers and the 82nd COVID-19 death in the county.
Our heartfelt condolences go out to the friends and family of the gentleman who has passed, said Public Health Director, Darlene Smith. COVID-19 continues to spread in Steuben County, and we must all take every precaution available to protect our most vulnerable.
Steuben County also reported 36 new positive cases since Saturday, bringing the total number of active cases to 146 and the number of confirmed cases to 1,282.
The individuals are residents of the:
The individuals are isolated and being monitored by the County Health Department. Public Health staff investigated and identified close contacts of the confirmed cases and exposure risks. All those known to have direct contact with the individuals have been notified.
Per CDC and New York State Department of Health guidance, information is collected beginning 48 hours prior to symptom onset or date of test if asymptomatic through the day of the positive test result to identify any potential exposure risks.
The investigations indicate:
In addition to the locations noted above, the individuals reported visiting the following locations that could pose an exposure risk within their investigation timeframes:
Todays age groups for the positives are as follows:
On our call with local hospital systems this morning, it was shared that bed capacity is running low due to COVID-19 admissions in the area, said Public Health Director Smith. We currently have Steuben positives in their 30s to their 90s who are hospitalized. It is so important to limit social gatherings at this time, because these events lend to spread more readily. You could be lucky and not feel too ill with COVID-19, or you could end up in the hospital at any age none of us know which way COVID could impact you specifically. Utilize all prevention strategies so that our hospitals are available for those who need care, COVID-related or otherwise.
All residents should continue to monitor themselves for COVID-19 symptoms of fever, cough, shortness of breath, chills or repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell and contact their healthcare provider for instructions if feeling ill.
There were more than 500 new COVID-19 cases reported in Suffolk County this weekend Riverhead News Review
Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement and relief in the face of the global pandemic.
The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.
The Phase 3 study is ongoing and additional data could affect results.
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In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.
Ive been in vaccine development for 35 years, William Gruber, Pfizers senior vice president of vaccine clinical research and development, told STAT. Ive seen some really good things. This is extraordinary. He later added: This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.
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Although it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.
Nor is there any information yet on whether it prevents people from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms.
Without more information, its too early to start predicting how much of an impact the vaccine could make, said Michael Osterholm, director of the University of Minnesotas Center for Infectious Diseases Research and Policy.
I dont want to dampen any enthusiasm for this vaccine. I just want us to be realistic, Osterholm said. For a vaccine to really have maximal impact, its going to have to also reduce severe illness and death. And we just dont know yet.
Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus. The vaccine does cause side effects, including aches and fevers, according to previously published data. Gruber said that he believed the side effect profile was comparable to standard adult vaccines, but probably worse than Pfizers pneumonia vaccine, Prevnar, or a flu shot.
The results have not been peer-reviewed by outside scientists or published in a medical journal, and even Pfizer and BioNTech have been given no other details about how the vaccine performed by the independent monitors overseeing the study.
Initial supplies of the vaccine, if authorized, will be limited. Pfizer says up to 50 million doses could be available globally. by the end of the year, with 1.3 billion available in 2021. There are also expected to be distribution challenges. The vaccine must be stored at super-cold temperatures, which could make it extremely difficult to deliver to many places. Pfizer has said it is confident those issues can be managed.
Although the estimate of the efficacy of the vaccine could change as the study is completed, it is close to a best-case scenario. That also bodes well for other vaccines in the late stages of testing, including those developed by Moderna, AstraZeneca, and Johnson & Johnson.
If that headline really number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference, said Ashish Jha, the dean of the School of Public Health at Brown University. He cautioned, however, that it is always difficult to evaluate science via press release and that researchers will need to see the full results. He noted that side effects are something to watch, because even if there are no serious long-term complications, people feeling sick for a day or two could lead some to be hesitant to take a vaccine.
This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.
William Gruber, Pfizer senior vice president of vaccine clinical research and development
Both Pfizers vaccine and Modernas use messenger-RNA, or mRNA, technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.
The story of how the data have been analyzed seems to include no small amount of drama. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a Covid-19 vaccine to produce data including its decision to have an independent group of researchers, known as a data safety and monitoring board, take an early look at the data in the 44,000-volunteer study before its completion.
The first analysis was to occur after 32 volunteers both those who received the vaccine and those on placebo had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 individuals with at least one symptom and a positive test result had been reported.
That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.
In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis after a discussion with the FDA. Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. Its not known how many were in the vaccine arm, but it would have to be nine or fewer.
Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
Gruber said that there will not be another interim analysis conducted in the study. He also said that Pfizers estimate that it could file for authorization of the vaccine by the third week of November was based on the assumption that the FDA would be willing to accept two-month safety data on half the volunteers in the study as initially planned, when it was to include 30,000 volunteers, not more than 44,000, as is now the case. Those discussions are ongoing.
But Gruber said he now expects that by the time of the planned meeting of the FDAs vaccine advisory committee in December, the studys efficacy portion could be completed, having reached 164 cases of Covid-19.
He also emphasized that although there will only be a few months of data from this study, results from earlier studies make him optimistic that immunity from the vaccine will not wane rapidly.
The study has enrolled 43,538 volunteers the companies said, and 38,955 have received their second dose. About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
Bourla, Pfizers CEO, said the results mark a great day for science and humanity, in a statement, saying they provide initial evidence of our vaccines ability to prevent Covid-19. He added: We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.
Helen Branswell contributed reporting.
