The F.D.A. is aiming to give full approval to Pfizer’s Covid vaccine on Monday. – The New York Times
Coronavirus Updates
Aug. 21, 2021Updated
Aug. 21, 2021, 10:11 p.m. ET
Aug. 21, 2021, 10:11 p.m. ET
The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning.
Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.
An F.D.A. spokeswoman declined to comment.
The agency had recently set an unofficial deadline for approval of around Labor Day.
The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting final regulatory action before putting in effect mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.
Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon this month said it planned to make Covid vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the F.D.A. acts earlier.
Once it obtains the approval, Pfizer-BioNTech is planning to quickly ask the F.D.A. to approve a third dose as a booster shot. The Biden administration on Wednesday announced that fully vaccinated adults should prepare to get booster shots eight months after they received their second doses, beginning Sept. 20. Pfizer is expected to finish submitting data that it says shows a third shot is safe and effective next week.
The F.D.A. last week updated its authorizations of Pfizer-BioNTech’s and Moderna’s vaccines to allow third doses for some immunocompromised people, a decision backed by the Centers for Disease Control and Prevention.
Regulators are still reviewing Moderna’s application for full approval for its coronavirus vaccine, and a decision could come at least several weeks after the one for Pfizer-BioNTech. Moderna is planning to submit its data in support of a booster shot in September.
The Rev. Jesse Jackson and his wife, Jacqueline, have been hospitalized after testing positive for Covid-19, Mr. Jackson’s Rainbow PUSH Coalition said on Saturday in a statement.
Both were being treated at Northwestern Memorial Hospital in Chicago, The Associated Press reported.
“Doctors are currently monitoring the condition of both,” the statement read. No further details were available about their condition. Mr. Jackson is 79, and Jacqueline Jackson is 77.
Mr. Jackson got vaccinated in January. He has been campaigning to convince more Black Americans to get inoculated.
“Vaccination is imperative to save lives, particularly for African Americans, disproportionately the greatest victims of the virus,” he said at the time.
He revealed in 2017 that he had been diagnosed with Parkinson’s disease.
Mr. Jackson has been a civil rights advocate for more than 50 years and sought the Democratic presidential nominations in 1984 and 1988. He was a close associate of the Rev. Dr. Martin Luther King Jr.
Phil Valentine, a prominent conservative radio host in Tennessee who refused to get vaccinated, then urged his followers to get a shot after being hospitalized with Covid-19, has died, his station said on Saturday.
Mr. Valentine scoffed at the need for vaccines, writing on his blog that his chances of dying from the virus, should he become infected, were “way less than one percent.”
He announced his Covid-19 diagnosis on July 11 and pledged to return to his show within a day or two.
“Unfortunately for the haters out there, it looks like I’m going to make it,” he wrote. “Interesting experience. I’ll have to fill you in when I come back on the air. I’m hoping that will be tomorrow, but I may take a day off just as a precaution.”
Less than two weeks later, his radio station, 99.7 WTN, announced that the Nashville host was hospitalized “in very serious condition, suffering from Covid pneumonia.” The statement said Mr. Valentine had had a change of heart and urged others to get a vaccine.
“Phil would like for his listeners to know that while he has never been an ‘anti-vaxer’ he regrets not being more vehemently ‘pro-vaccine,’ and looks forward to being able to more vigorously advocate that position as soon as he is back on the air, which we all hope will be soon,” the station said.
Some people responded to the announcement with words of support for Mr. Valentine, while others said he deserved to get sick.
On Saturday, the station announced on Twitter that Mr. Valentine had died, urging followers to “keep the Valentine family in your thoughts and prayers.”
We are saddened to report that our host and friend Phil Valentine has passed away. Please keep the Valentine family in your thoughts and prayers. pic.twitter.com/vhXpE7x0oX
— SuperTalk 99.7 WTN (@997wtn) August 21, 2021
The British government is starting an antibody surveillance program for adults who test positive for the coronavirus in order to develop a better understanding of its vaccine campaign and the immune response to different virus variants.
The program, which the U.K. Health Security Agency said would begin on Tuesday, will allow for up to 8,000 participants each day who book a P.C.R. test through the National Health Service’s “test and trace” program. However, the antibody tests, which will be free, will be sent only to those who test positive for the virus.
The information gathered will help gauge reinfection rates for those who had previously caught the virus, as well as measure breakthrough cases, and also study those who did not mount an immune response.
The British health secretary, Sajid Javid, said in a statement on Sunday that those who take part in the new public program would help “strengthen our understanding of Covid-19 as we cautiously return to a more normal life.”
Previously, antibody tests were mostly available for only clinical or research purposes.
The Health Security Agency said that it hoped that the data collected from the initiative would improve its understanding of the protection provided by antibodies after either infection or vaccination. It said the data could also provide insight about those who do not develop an immune response.
Upon testing positive for the coronavirus, those who have opted into the new program — limited to those 18 and over — will be sent two finger-prick antibody tests. The first must be done as soon as possible after the P.C.R. result, before the body has time to generate antibodies in response to the current infection, and the second 28 days later.
It was supposed to be a glorious celebration of the re-emergence of New York City after more than a year of pandemic hardship — a concert bringing thousands of vaccinated fans on Saturday evening to the Great Lawn of Central Park to hear an all-star lineup.
And for the first couple of hours it was, with messages of New York’s resilience sandwiched between performances by the New York Philharmonic, Jennifer Hudson, Carlos Santana, LL Cool J, and Earth, Wind and Fire, among others.
But shortly after 7:30 p.m., as Barry Manilow was performing “Can’t Smile Without You,” lightning brought the concert to a halt. “Please seek shelter for your safety,” an announcer intoned, stopping the music, as people began filing out of the park.
When the concert was announced by Mr. de Blasio in June, plunging coronavirus case numbers and rising vaccination figures had filled the city with hope.
But circumstances have shifted considerably over the past two months. The spread of the highly contagious Delta variant has led some city businesses to postpone the return to their offices, prompted the city to institute vaccine mandates for indoor dining and entertainment and threatened to destabilize the wider concert business.
Ivermectin, an anti-parasitic drug commonly used for livestock, should not be taken to treat or prevent Covid-19, the Food and Drug Administration said on Saturday.
The warning came a day after the Mississippi State Department of Health issued a similar statement in response to reports that an increasing number of people in Mississippi were using the drug to prevent a Covid infection.
Some studies last year spurred use of the drug against Covid-19, especially in Latin America, and Fox News has promoted some of those studies’ findings on air.
But the National Institutes of Health said in February that most of the studies related to Ivermectin and the coronavirus “had incomplete information and significant methodological limitations,” including small sample sizes and study outcome measures that were often unclear.
In Mississippi, where only 37 percent of the population is fully vaccinated, more than two-thirds of recent calls placed to the state’s poison control center were related to “ingestion of livestock or animal formulations of Ivermectin purchased at livestock supply centers,” the state department of health said in a news release.
Of those who called about ingesting Ivermectin, 85 percent had mild symptoms and one person was told to “seek further evaluation” because of the large amount they were reported to have taken, the state’s health department said.
Ivermectin, which is also formulated for use by people to treat parasitic worms, had been controversially promoted as a potential Covid treatment earlier in the pandemic, but recent studies found that the drug’s efficacy against the coronavirus is thin, and the F.D.A. has not approved the drug for Covid treatment.
On Twitter, the F.D.A. was more declarative in its warning.
“You are not a horse,” the agency said. “You are not a cow. Seriously, y’all. Stop it.”
The F.D.A. said it has received multiple reports, including some in Louisiana, of people who have “required medical support and been hospitalized after self-medicating with ivermectin intended for horses.”
“Taking large doses of this drug is dangerous and can cause serious harm,” the F.D.A. said.
The Mississippi State Department of Health alerted its residents that “animal drugs are highly concentrated for large animals and can be highly toxic in humans.”
Some of the symptoms associated with Ivermectin toxicity include rash, nausea, vomiting, abdominal pain, neurological disorders and potentially severe hepatitis that could require hospitalization, Mississippi health officials said.
Mississippi, which has seen a surge in cases recently, reported 5,048 cases on Friday. Hospitalization and death rates have also been rising.
Global Roundup
After a surge in Covid-19 cases and deaths, Sri Lanka issued a 10-day lockdown on Friday night in an effort to prevent the country’s health system from becoming overwhelmed.
The island nation in South Asia has recorded more than 3,600 cases a day since Tuesday, according to government health data.
Keheliya Rambukwella, the country’s health minister, said on Twitter that essential services would still function normally and that vaccination efforts would continue during the lockdown.
“I sincerely request all citizens to adhere to the law and #StayHome,” he said on Twitter, pleading that the public do all they can as the country confronts a surging caseload.
Last week, the World Health Organization provided emergency medical equipment, including beds and oxygen concentrators, to 78 hospitals in Sri Lanka.
Dr. Alaka Singh, the W.H.O. representative to Sri Lanka, said in a statement that the organization would provide a “supply of urgent lifesaving equipment to hospitals across the country.”
The country has already put in place a number of restrictions, such as closing schools and gyms and banning musical shows and weddings.
Sri Lanka has fully vaccinated about a quarter of its population after approving the Pfizer-BioNTech, Moderna and AstraZeneca vaccines, as well as Russia’s Sputnik V shot.
The country has recorded more than 385,000 Covid cases and 7,183 deaths since the start of the pandemic.
In other news from around the world:
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Vietnam recorded 10,654 cases on Friday, one of its highest daily tallies during the pandemic, according to statistics from the W.H.O. Ho Chi Minh, the country’s largest city, issued stay-at-home orders. Just 1.6 percent of the country’s population is fully vaccinated.
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The authorities in China placed hundreds of people in quarantine after infections were detected in cargo workers at the Shanghai airport, according to Reuters.
MELBOURNE, Australia — Protesters in Melbourne demonstrating against Covid restrictions on Saturday clashed with the police, who used pepper spray to disperse them. Several officers were injured and hundreds of people were arrested, the police said.
More than 4,000 people joined the protest, one of a number of anti-lockdown demonstrations that were held on Saturday in Australian cities. Protesters in Melbourne, most of whom appeared not to be wearing masks, charged police lines, threw objects at officers and set off flares, according to news reports and footage posted on social media.
Four officers were treated for concussions, one for a broken thumb and two others for possible broken noses, according to the police in the state of Victoria, which includes Melbourne. Another officer was treated at the scene for a cut on the neck.
The police said it was the first time officers had been forced to use “a range of nonlethal options” to disperse anti-lockdown protesters in Melbourne, which has seen a number of demonstrations against restrictions. Officers fired pellets and used pepper spray.
“While there were some peaceful protesters in attendance, the majority of those who attended came with violence in mind,” the police said in a statement.
Earlier Saturday, Daniel Andrews, the premier of Victoria, extended Melbourne’s lockdown, which has been in place since early August, to the entire state, after 17 new cases were detected in the regional hub of Shepparton.
Restrictions in Melbourne were also tightened. Child care is now only available to essential workers, and the authorities are recommending that children wear masks.
A much smaller protest was held on Saturday in Sydney, the epicenter of Australia’s current Covid outbreak, in which the Delta variant of the virus has been dominant. New South Wales, the state that includes Sydney, reported 825 new cases on Saturday, the most since the pandemic began.
Roughly 250 people attended the Sydney protest, vastly outnumbered by about 1,500 officers patrolling the streets, officials said. Forty-seven people were arrested and 260 tickets were issued for violations of Covid restrictions.
The authorities in Sydney had barred taxis and ride-share services from taking people to the central business district in an attempt to head off the protest. Trains had also been prevented from stopping at stations in the area.
“Anybody who attends the protest tomorrow is going to feel the full force of the N.S.W. police force,” David Elliott, police commissioner of the state of New South Wales, which includes Sydney, said on Friday. “You’ll also be endangering the lives of your loved ones and of course prolonging this lockdown. You’re going to be doing everything you want to stop.”
Earlier this week, Mr. Elliott said it was “no coincidence” that a recent spike in the number of daily infections in the state had followed an anti-lockdown protest three weeks ago.
About 5,000 people attended a peaceful protest on Saturday in Brisbane, where no restrictions are in place, according to the local police.
Cyndy O’Brien, an emergency room nurse at Ocean Springs Hospital on the Gulf Coast of Mississippi, could not believe her eyes as she arrived for work. There were people sprawled out in their cars gasping for air as three ambulances with gravely ill patients idled in the parking lot. Just inside the front doors, a crush of anxious people jostled to get the attention of an overwhelmed triage nurse.
“It’s like a war zone,” said Ms. O’Brien, who is the patient care coordinator at Singing River, a small health system near the Alabama border that includes Ocean Springs. “We are just barraged with patients and have nowhere to put them.”
The bottleneck, however, has little to do with a lack of space. Nearly 30 percent of Singing River’s 500 beds are empty. With 169 unfilled nursing positions, administrators must keep the beds empty.
Nursing shortages have long vexed hospitals. But in the year and a half since its ferocious debut in the United States, the coronavirus pandemic has stretched the nation’s nurses as never before, testing their skills and stamina as desperately ill patients with a poorly understood malady flooded emergency rooms. Spurred by a sense of duty, they flocked from across the country, sometimes working as volunteers. More than 1,200 of them have died from the virus.
Now, as the highly contagious Delta variant pummels the United States, bedside nurses are depleted and traumatized, their ranks thinned by early retirements or career shifts that traded the emergency room for less stressful nursing jobs at schools, summer camps and private doctor’s offices.
Across the country, the shortages are complicating efforts to treat hospitalized coronavirus patients, leading to longer emergency room waiting times and rushed or inadequate care as health workers struggle to treat patients who often require exacting, round-the-clock attention, according to interviews with hospital executives, state health officials and medical workers who have spent the past 17 months in the trenches.
This week, the Biden administration strongly recommended booster shots for most vaccinated Americans, and the Centers for Disease Control and Prevention also released three studies that federal officials said provided evidence that booster shots of the Pfizer-BioNTech and Moderna coronavirus vaccines would be needed in the coming months.
Here’s what we know about booster shots — why Americans may need them and when they should get them:
The case for a booster shot
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Taken together, the C.D.C. studies show that although the vaccines remain highly effective against hospitalizations and deaths, the bulwark they provide against infection with the virus has weakened in the past few months.
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The finding accords with early data from seven states, gathered this week by The New York Times, suggesting a rise in breakthrough infections and a smaller increase in hospitalizations among the vaccinated as the Delta variant spread in July.
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The decline in effectiveness against infection may result from waning vaccine immunity, a lapse in precautions like wearing masks or the rise of the highly contagious Delta variant, experts said — or a combination of all three.
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The new studies indicate overall that vaccines have an effectiveness of roughly 55 percent against all infections, 80 percent against symptomatic infection, and 90 percent or higher against hospitalization, noted Ellie Murray, an epidemiologist at Boston University.
Who should get a booster shot and when?
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Americans who received the Pfizer-BioNTech or Moderna coronavirus vaccines should get a booster shot eight months after their second vaccine dose, federal health officials said.
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The boosters will be available beginning Sept. 20, if the Food and Drug Administration agrees to the plan. They will go first to health care workers, nursing home residents and older adults, who were the first to receive the initial round of vaccinations after they were authorized in December.
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At this time, federal health officials are still waiting to see if boosters will be recommended for those who received the Johnson & Johnson vaccine — they most likely will. But less data is available on the Johnson & Johnson vaccine, which was not authorized until the end of February, two months after the mRNA vaccines. (The Johnson & Johnson vaccine uses a modified adenovirus to deliver its instructions to human cells.)
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The F.D.A. has already authorized third doses of Pfizer-BioNTech’s and Moderna’s coronavirus vaccines for some people with weakened immune systems. The authorities decided those individuals, who make up fewer than 3 percent of Americans, merited extra shots because many fail to respond to the standard dosage. Those eligible include people who received solid organ transplants and others with similarly compromised immune systems, the agency said.
More vaccinate mandates are expected as soon as Pfizer-BioNTech’s two-dose Covid-19 vaccine gains full approval from the Food and Drug Administration, which could happen as early as Monday.
Federal and state health officials are hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.
But many Americans might not have much choice as the F.D.A. approval is expected to pave the way for vaccine mandates from public and private employers who had been awaiting the decision.
Others have not waited for the F.D.A.’s final seal of approval.
In the past week, vaccine mandates have been announced for health care workers, teachers and even secondary school students:
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Gov. Kate Brown of Oregon announced on Thursday that all health care workers and school employees in the state will have to be fully vaccinated. This is a tightening of a policy introduced earlier in August, which allowed health care workers and school employees to test frequently for the virus. Now, frequent tests alone are no longer an option.
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Gov. Ned Lamont of Connecticut announced that starting Sept. 27, long-term-care employees and state employees in hospital facilities must have at least one dose of the vaccine, while all other state employees, including teachers, will have to either be vaccinated or regularly tested.
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Gov. Jay Inslee of Washington announced vaccine requirements for all teachers and personnel in public, charter and private schools as a condition of employment.
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Culver City Unified School District, a small school district in Los Angeles county is believed to be the first in the state — and possibly the nation — to require students 12 and older to be inoculated.
And in other news:
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Three vaccinated senators tested positive for the virus this week despite being vaccinated: Roger Wicker, Republican of Mississippi; Angus King, independent of Maine; and John Hickenlooper, Democrat of Colorado. Mr. Wicker was said to only be experiencing mild symptoms. Mr. King said in a statement he was symptomatic but taking recommended precautions. Mr. Hickenlooper said on Twitter that he was experiencing limited symptoms.
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Gov. Greg Abbott of Texas has tested positive for the virus after attending a number of public events where mask requirements were not enforced. The governor has prohibited local governments in the state from mandating masks. Schools in Texas are temporarily allowed to enforce mask mandates because of continuing litigation over the facial coverings.
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Mask mandates for students also continued to be a point of contention in Florida. Some districts in Florida defied Gov. Ron DeSantis’s ban on mask mandates. On Friday, school officials in Broward and Alachua counties were asked by the state to reverse their mask requirements within 48 hours or face losing their salaries.
Orlando Mayor Buddy Dyer and utility officials asked residents to conserve water Friday to preserve the city’s supply of liquid oxygen, which is being used to treat a surging number of Covid-19 patients.
During a Friday afternoon news conference, Linda Ferrone of the Orlando Utilities Commission asked residents to refrain from using excess water and to be prepared to do so for at least several weeks.
A Delta variant-driven surge has made Florida one of the nation’s worst-hit states, with new cases recently topping their winter peak. Hospitalizations in Orange County, where Orlando is, are up 58 percent over the past two weeks, according to a New York Times database. Deaths in the Orlando area have overwhelmed crematoriums, which are running out of room to store bodies, local media reported.
The New York Times has previously reported on supply chain issues and oxygen shortages during the pandemic in India, northern Brazil, Mexico and elsewhere.
“It’s critical that we continue to work together and each one of us do our part, as we have done throughout this pandemic, to mitigate the impacts the virus continues to have on our community,” Mayor Dyer said during the news conference. “While this is another new challenge, I know that as a community, working together, we can overcome it with the help of our residents and businesses.”
The leader of the school board of Orange County has said the district should begin mandating masks in its schools.
That would defy the state’s Republican governor, who has refused to budge on his ban on mask mandates, though several school districts have gone ahead with them.
According to documents obtained by Politico, educators in Broward and Alachua counties have received orders from the state to reverse their mask requirements within 48 hours or face losing their salaries. President Biden stated earlier this week that his Education Department may take legal action to deter states from barring universal masking in classrooms.
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