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‘It Won’t Be Politics,’ F.D.A. Chief Says of Vaccine Approval Process
Dr. Stephen M. Hahn, the commissioner of the Food and Drug Administration, told lawmakers he was confident that the development of a coronavirus vaccine would be safe from political interference.
“We have not made a commitment to the timeline per se because we haven’t seen the data, and we don’t know the complexity of the data or the amount of data that will come our way. What I can tell you, sir, is we do feel the urgency of the moment. We do take very much — very seriously our responsibility to protect American lives. We will not delay, but we will not cut corners in our process.” “Dr. Hahn, you said that you have every confidence in the scientists and staff at F.D.A. And I appreciate that and I do too, by the way — is there some kind of deep state that you have seen in the F.D.A. that is any way trying to do anything other than quickly get a vaccine, get therapeutics to the American public?” “Senator, I will answer your question this way. I have 100 percent confidence in the outstanding scientists, doctors, nurses, pharmacists at F.D.A. who have remarkably stood up during this pandemic to help expedite getting medical products to the American people. I have complete confidence in their decisions. And I have complete confidence in the actions that have been taken to date.” “And that confidence is based on following the science not any political pressure, and that’s what we’re expecting with a vaccine approval.” “Yes, sir. And I’ve said that several times today, and I appreciate the opportunity to say it again, our career scientists for any medical products, and particularly vaccines, will follow the science and data and our rigorous standards. And it won’t be politics that make any part of that decision, sir.”
Hahn says F.D.A. decisions are based on science and the agency would ‘not permit any pressure from anyone to change that.’
Four of the Trump administration’s top health officials helping to steer the government’s coronavirus response tried to defend their scientific integrity on Wednesday, amid mounting evidence that President Trump and his administration are trying to interfere with their agencies’ decision making and growing public doubts about whether a Covid-19 vaccine will be safe.
In testimony before the Senate health committee, the officials — Dr. Anthony S. Fauci, the director of the Institutes of Allergy and Infectious Diseases; Dr. Stephen Hahn, the commissioner of food and drugs; Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention and Adm. Brett P. Giroir, the assistant secretary for health — each said they would take a vaccine and recommend their families do the same should the Food and Drug Administration deem it safe and effective.
Their vows carried echoes of an earlier era, when Jonas Salk, the inventor of the polio vaccine, inoculated himself and his children before testing it on the public. In their remarks, just a day after the U.S. surpassed 200,000 virus-related deaths, the doctors all acknowledged — without pointing fingers at the president — that faith in their institutions had been shaken, and said they were committed to restoring it.
“Every one of the decisions we have reached has been made by career F.D.A. scientists based on science and data, not politics,” Dr. Hahn told the panel, adding that he would “not permit any pressure from anyone to change that.”
That is especially the case, he said, regarding whether to grant emergency approval to any Covid-19 vaccine. He said that the agency would seek guidance from a panel of outside experts and that the process would be “transparent and independent.”
Dr. Fauci added that “we have been assured that in fact, the American public will not have to pay for the vaccine. We have been told that at the level of the task force.”
Dr. Redfield said it could take until July to get the entire American public vaccinated. There should be 700 million doses available by April, he said — enough to vaccinate all Americans if two doses are required.
C.D.C. Director Projects 700 Million Covid-19 Doses by April
In his Senate testimony, Dr. Robert R. Redfield said that some Americans will not be able to access a coronavirus vaccine until July 2021.
Ultimately, it’s going to be the vaccines that are going to get us back to the way of life — as we get an effective vaccine. What I was trying to comment, as Senator Kaine alluded to, if the vaccine only induces an immune response in half the people, then it’s exceptional that half the people may not get protection from the vaccine. And what really I was trying to say maybe was just to re-emphasize how important this mask is. And we should have, if projected, about 700 million doses by April, late March, and that should be enough to vaccinate 350 million people because you require two doses. When I was alluding to late second quarter, early third quarter, I was alluding to how long I felt it would take to get those 700 million doses into the American public and complete the vaccine process. And you, know, I can defer to Dr. Fauci for his opinion, but I think that’s going to take us to April, May, June, you know possibly July, to get the entire American public completely vaccinated. But we will have the 700 million doses based on projection by late March, early April.
That would add a new layer to the vetting process, even as Mr. Trump has insisted a vaccine will be ready as early as next month. The guidelines may be formally released as early as this week if approved by the White House, and would recommend that clinical trial data be vetted by a committee of independent experts before the F.D.A. takes action, according to several people familiar with the draft.
The four officials returned to Capitol Hill after a recent period of turmoil inside the Department of Health and Human Services, the agency that oversees their work.
First, there were revelations that Trump loyalists inside the department, including Michael R. Caputo, its top spokesman, tried to meddle with the C.D.C.’s weekly scientific reports. Then Mr. Caputo took medical leave after a rant on Facebook in which he accused C.D.C. scientists of engaging in “sedition.”
After that came a report in The New York Times that C.D.C. guidance about coronavirus testing, which suggested that certain people exposed to the virus did not need to be screened, had not been written by agency scientists and was posted to its website despite their serious objections. The agency reversed itself last week after widespread criticism.
On Wednesday, Dr. Redfield insisted to the senators that agency scientists were indeed involved, though he conceded that the guidance was the product of the White House coronavirus task force, including Dr. Giroir. Without naming Mr. Caputo, he told senators that remarks from H.H.S. suggesting there was a “deep state” inside the agency were “offensive to me.” And he defended the agency’s scientists, likening them to military people who never disclose their political leanings at work.
Looming over the hearing was the threat of a public scolding by Mr. Trump if he heard testimony he didn’t like. Last week the president rebuked Dr. Redfield after he told a Senate committee that a vaccine would not be widely available until the middle of next year and that masks were so vital in fighting the pandemic that they might be even more important than a vaccine.
Johnson & Johnson begins the final stage of clinical trials for its vaccine, sparking optimism.
The feverish race for a coronavirus vaccine got an infusion of energy on Wednesday as Johnson & Johnson announced that it has begun the final stage of its clinical trials, the fourth company to do so in the United States, which has passed a grim milestone of 200,000 deaths from the pandemic.
Johnson & Johnson is a couple of months behind the leaders, but its vaccine trial will be by far the largest, enrolling 60,000 participants. The company said it could know by the end of this year if its vaccine works.
And its vaccine has potentially big advantages over some competitors. It uses a technology that has a long safety record in vaccines against other diseases. Its vaccine could require just one shot instead of two. And unlike other vaccine candidates, it does not have to be kept frozen as it is delivered to hospitals and other places where it will be given to patients, simplifying the logistics of hundreds of millions of doses.
“Big news,” Mr. Trump tweeted about the trial on Wednesday morning. “@FDA must move quickly!”
The president has repeatedly claimed that a vaccine will be ready before Election Day, and has urged federal regulators to act quickly to approve one, raising fears that they will bow to the pressure and rush their vetting process. The federal government’s Operation Warp Speed program has invested more than $10 billion in private companies’ coronavirus vaccines to date, including about $1.5 billion to Johnson & Johnson.
Facing criticism over secrecy, several companies — including Johnson & Johnson on Wednesday — have taken the rare step of releasing the detailed blueprints of their trials, which are typically considered proprietary. And the F.D.A. is expected this week to release stricter guidelines outlining the criteria it will use to vet clinical trial data.
“We need multiple vaccines to work,” said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center who led the development of the technology used in Johnson & Johnson’s trial. “There are seven billion people in the world, and no single vaccine supplier will be able to manufacture at that scale.”
Johnson & Johnson’s advanced trial, known as a Phase 3 trial, started on Monday. At a news conference, Dr. Paul Stoffels, the company’s chief scientific officer, said the company might be able to determine by the end of the year if the vaccine is safe and effective.
Johnson & Johnson has begun manufacturing the vaccine on an industrial scale to build up a supply that can be released immediately if the vaccine is authorized, Dr. Stoffels said in an interview on Wednesday. He expected to have tens of millions of doses ready by the end of the year. “Then we can ramp up to many more batches,” he said.
Johnson & Johnson’s vaccine uses an adenovirus to carry a gene from the coronavirus into human cells. The cell then produces coronavirus proteins, but not the coronavirus itself. These proteins can potentially prime the immune system to fight off a later infection by the virus.
Adenovirus vaccines must be kept refrigerated but does not need to be frozen, as the two front-runner vaccines, by Moderna and Pfizer, do. The freezing requirement could make the distribution of those vaccines difficult, especially to places without advanced medical facilities.
Moderna and Pfizer’s vaccines also require two jabs given a few weeks apart, a significant logistical hurdle.
For poor children, there was a sharp drop in vaccinations and developmental screenings this spring.
Federal health officials on Wednesday reported a sharp drop in the number of children from low-income families who received dental care, vaccinations and preventive screenings this spring, after the pandemic began, compared with the same period last year.
A data analysis found there were 1.7 million fewer vaccinations given to Medicaid beneficiaries 2 or younger, a drop of 22 percent, and 3.2 million fewer screenings to detect autism or developmental delays, a drop of 44 percent. Dental care dropped by 69 percent, with 7.6 million fewer tooth cleanings and other services.
Most of the decline took place in April, with the rate starting to pick back up, much more in some states than others, in May. “The absence of these vital health care services may have lifelong consequences for these vulnerable children,” Seema Verma, the U.S. administrator of Medicare and Medicaid, said in a statement.
She called on states, pediatricians, families and schools to make sure children catch up on overdue medical appointments, in part to avoid an increase in cases of highly contagious diseases like measles and mumps.
More recent data suggest that the vaccination rate is increasing again, Ms. Verma said, but not fast enough to catch up with last year’s rate. She pointed out that while many children had received medical care via telehealth during the pandemic, vaccinations and tooth cleanings cannot be provided that way. There are about 40 million children on Medicaid, the public health insurance program for the poor, and the Children’s Health Insurance Program, or CHIP.
The analysis also found that about 32,000 Medicaid and CHIP beneficiaries younger than 19 — less than 0.1 percent of all the children in the programs — were treated for Covid-19 through June, while more than 250,000 received a coronavirus test in that time frame. Fewer than 1,000 were hospitalized with Covid through June, according to the federal data.
The Metropolitan Opera cancels its entire 2020-21 season.
The Metropolitan Opera announced Wednesday that the still-untamed pandemic has forced it to cancel its entire 2020-21 season, prolonging one of the gravest crises in the Met’s 137-year history and keeping the nation’s largest performing arts organization dark until next September.
The decision is likely to send ripples of concern through New York and the rest of the country as arts institutions grapple with the question of when it will be safe again to perform indoors. Far from being a gilded outlier, the Met may prove to be a bellwether.
The outbreak has kept the 3,800-seat opera house closed since mid-March, sapping it of more than $150 million in revenue and leaving roughly 1,000 full-time employees, including its world-class orchestra and chorus, furloughed without pay since April.
Now, with the virus still too much of a threat to allow for a reopening on New Year’s Eve, as planned, Peter Gelb, the Met’s general manager, is making plans to adapt to a world transformed by the pandemic, including by trying to curb the company’s labor costs.
“The future of the Met relies upon it being artistically as powerful as ever, if not more so,” Mr. Gelb said in an interview. “The artistic experiences have to be better than ever before to attract audiences back. Where we need to cut back is costs.”
The Met plans to return to its gilded stage next September with Terence Blanchard’s “Fire Shut Up in My Bones,” the first time that it will mount an opera by a Black composer — a long-overdue milestone, and part of a new focus on contemporary works alongside the ornate productions of canonical pieces for which the company is famous.
The Met will also experiment with earlier curtain times, shortening some operas and offering more family fare as it tries to lure back post-pandemic audiences. But one of its most difficult hurdles may play out offstage, as the Met goes to its powerful labor unions to seek concessions it says will be necessary to its survival.
NEW YORK ROUNDUP
Mayor de Blasio announces expanded furloughs for New York City employees.
New York City will furlough more than 9,000 employees this year as it grapples with substantial budget deficits wrought by the pandemic.
Mayor Bill de Blasio made the announcement on Wednesday, a week after he revealed he would furlough much of his City Hall staff, himself included. The action will save the city about $21 million, on top of the roughly $860,000 to be saved with the City Hall furlough. The furloughs will last five workdays, and employees will have to take them between October and March 2021.
These actions will not move the budgetary needle much. This year the city closed its $88 billion budget with an unspecified $1 billion in labor savings. The mayor’s office has since been negotiating with labor unions to find those savings, and the furloughs indicate the kinds of measures the city will have to consider if it wants to avoid 22,000 layoffs.
“No one wants to see layoffs, but unfortunately they’re still on the table,” Mr. de Blasio said Wednesday. “This at least gives us a little more relief while we continue those conversations and try and find a larger solution.”
In other New York City news:
100 teachers in Kenosha, Wis., call in sick to protest in-person classes.
A school district in Wisconsin where schools have reopened over the objections of the local teachers’ union was forced to move seven of its schools to virtual learning this week after more than 100 teachers called in sick to protest the district’s decision to hold in-person classes this fall.
The protests in the Kenosha Unified School District involve only a fraction of the city’s 1,600 teachers, but they underscore the deep worries of many teachers nationally about returning to classrooms during the pandemic. Studies have found that, because of age, obesity or other health factors, as many as a third of teachers may be at risk of severe illness if they become infected with the virus.
“Educators in Kenosha and everywhere want nothing more than to be with our students, but it is utterly unsafe to do so at this time,” Tanya Kitts-Lewinski, the president of the teachers’ union said at a school board meeting on Tuesday night. She said that teachers were tired of being blamed for the difficulty of reopening schools safely.
The school board in Kenosha decided in July to start the year virtually. After parents demanded in-person instruction, the board reversed itself in August, deciding to offer students the choice of full-time classroom learning or full-time remote learning. The teachers’ union criticized that decision, saying it put teachers and students at risk.
Wisconsin is experiencing a spike in cases, with an increase of about 150 percent in the past week compared with the average two weeks earlier. Most of the other urban districts in the state, including Racine, Milwaukee, Green Bay and Madison, started the year with virtual classes. In Kenosha, the state’s third-largest district, at least five students or staff members have tested positive for the virus since school started Sept. 14, according to updates on the district website.
Kenosha, which has been racked by protests over police brutality in recent weeks, is not the first city to experience teacher protests over Covid-19 policies. In two towns in Massachusetts, teachers refused to show up for training at the start of the year, citing concerns about safety.
The Kenosha district said it hoped to return all of its 41 schools to in-person instruction by next week.
In other news around the United States:
For a fourth time, a game that had publicly become the University of Houston’s “season opener” was scratched. The game against the University of North Texas had been set for Saturday. College football schedules have been upended by the virus. In a statement, North Texas said four people associated with its football program had tested positive for the virus. But contact tracing, the university said, “left the football program unable to field a team for a game this week.”
Gov. Mike Parson of Missouri and his wife, Teresa, have both tested positive for the virus, officials said Wednesday. The governor’s office said the first lady had been tested after “displaying minor symptoms.” Kelli Jones, the communications director for the governor, said Mrs. Parson’s symptoms included “a little, tiny cough and a little sniffle.” The governor has no symptoms at this time, officials said. All official events have been canceled until further notice, the governor’s office said, and the governor’s staff has been tested and is awaiting results.
Gov. Eric Holcomb of Indiana announced on Wednesday that the state would gradually enter Phase 5 of reopening, from Sept. 26 to Oct. 17. “The numbers continue to track in the right direction,” Mr. Holcomb said. In the next phase, he said, residents would still be required to wear face coverings and maintain social distancing, but size limits on social gatherings and meetings would be lifted. Restaurants, bars and nightclubs would be allowed to operate at full capacity, he added. Indiana began easing restrictions in May, but by July, because of an increase in cases, Mr. Holcomb paused progress toward reopening.
The Baltimore city schools system is planning to lay off around 450 temporary employees and freeze hiring throughout the school system as it seeks to reduce a $21 million budget gap. Across the country, school districts struggling with the additional costs of remote learning and social distancing, combined with funding cuts, have also turned to layoffs. “Nobody’s coming to save us,” said the Baltimore schools chief executive officer, Sonja Santelises.
France raises its Covid-19 alert level in several areas.
France raised its Covid-19 alert level in a number of areas across the country on Wednesday, and the authorities ramped up restrictions on public gatherings in several cities to prevent the health system from buckling under an influx of patients.
The new measures, which will take effect in the coming days, include the total closure of all bars and restaurants in the cities of Aix-en-Provence and Marseille and a ban on public gatherings of more than 10 people in Paris and a handful of other French cities.
Olivier Véran, the health minister, said at a news conference on Wednesday evening that the situation in France was “continuing to deteriorate.” The positivity rate for the virus has passed 6 percent, he said.
Mr. Véran said that the authorities were particularly worried because French hospitals were starting to feel the strain from new Covid-19 patients, who now represent nearly 20 percent of patients in intensive care across the country.
France is still far from the wave of hospitalizations it suffered earlier this year, but Mr. Véran said it was becoming increasingly hard to defer treatments or surgeries to make room for Covid-19 patients, as was widely done during the nation’s lockdown last spring.
Mr. Véran said that the new restrictions would be temporary and re-evaluated on a week-by-week basis and that the government would do all it could to avoid a second nationwide lockdown. He urged citizens to help avoid that.
“You can’t be extremely vigilant on the bus, in the metro, at the office, in shops,” he said, “and then completely let up your vigilance when you are in a bar, at home, or with family and friends.”
In other news around the world:
Young Americans are more likely to believe misinformation about the virus, new research finds.
Every day, New York Times journalists are chronicling and debunking false and misleading information that is going viral online. Today, Adam Satariano, a tech reporter, looks at a new study that found that young people are more likely to believe misinformation about the coronavirus:
As public health officials raise alarms about surging coronavirus cases among young people, new research suggests that Americans under 25 are most likely to believe virus-related misinformation about the severity of the disease and how it originated.
In a survey of 21,196 people in all 50 states and the District of Columbia, researchers identified a clear generational divide. Respondents 18 to 25 had an 18 percent probability of believing a false claim, compared with 9 percent for those over 65, according to the study, conducted by researchers from Harvard University, Rutgers University, Northeastern University and Northwestern University.
The results diverge from past research that said older people were more likely to share false news articles on social media. Last year, a paper published in Science found that people over the age of 65 were seven times as likely as those ages 30 to 44, the youngest group included in that survey, to share articles from websites that spread false information during the 2016 presidential campaign.
In the virus study, people were questioned to gauge their acceptance of 11 false claims. Those included false claims that the virus originated in people who ate bats, that taking antibiotics protects against the disease and that only people 60 or older are at risk of being infected.
“Across the 11 false claims,” the report said, “we find a clear pattern: The older the age group, the lower the average level of belief in false claims.”
Reporting was contributed by Matt Apuzzo, Aurelien Breeden, Michael Cooper, Ben Dooley, Rick Gladstone, Joseph Goldstein, Abby Goodnough, Mike Ives, Corina Knoll, Sharon LaFraniere, Patricia Mazzei, Raphael Minder, Zachary Montague, Aimee Ortiz, Tariq Panja, Campbell Robertson, Dana Rubinstein, Adam Satariano, Anna Schaverien, Christopher F. Schuetze, Sheryl Gay Stolberg, Kate Taylor, Noah Weiland, Billy Witz, Elaine Yu, Mihir Zaveri and Carl Zimmer.