Search

Covid-19 News: Live Updates on FDA and Pfizer Vaccine - The New York Times

thekflow.blogspot.com
Pfizer said it presented the Food and Drug Administration with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America.
Saul Martinez for The New York Times

The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to move beyond emergency use status in the United States.

The decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations. Defense Secretary Lloyd J. Austin III will be sending guidelines to the country’s 1.4 million active duty service members mandating that they be vaccinated, the Pentagon announced on Monday.

United Airlines recently announced that its employees will be required to show proof of vaccination within five weeks of regulatory approval.

Oregon has adopted a similar requirement for all state workers, as have a host of universities in states from Louisiana to Minnesota. In New York, the F.D.A.’s approval also brought into force a requirement announced in May that all students attending in-person classes at State University of New York and City University of New York schools be vaccinated.

The approval comes as the nation’s fight against the pandemic has intensified again, with the highly infectious Delta variant dramatically slowing the progress that the country had made over the first half of the year. The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans who are eligible for shots to get them.

President Biden addressed the nation on Monday afternoon. “If you’re not vaccinated yet, now is the time,” the president said on Twitter.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Pfizer said it presented the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine was 91 percent effective in preventing infection — a slight drop from the 95 percent efficacy rate that the data showed when the F.D.A. decided to authorize the vaccine for emergency use in December. Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected.

A recent poll by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, found that three of every 10 unvaccinated people said that they would be more likely to get vaccinated with a shot that had been fully approved.

But the pollsters and other experts warned that percentage could be exaggerated. “I think that is a vanishingly small number of people in real life, ” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania and expert on vaccine hesitancy.

More important, Dr. Buttenheim said, would be the effect of requirements. “Mandates simplify things for people,” she said.

The regulatory action gives doctors more leeway to prescribe a third shot of the Pfizer vaccine to patients, but federal officials strongly discouraged people from seeking extra shots until regulators decide they are safe and effective. Pending regulatory clearance, the federal government plans to start offering booster shots for adults next month.

The vaccine will continue to be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval. A decision on whether to authorize the vaccine for children younger than 12 could be at least several months away, and Dr. Woodcock said no child that age should be given any Covid-19 vaccine because regulators lack safety data.

So far, more than 92 million Americans — 54 percent of those fully inoculated — have gotten Pfizer shots. Most of the rest received Moderna’s vaccine.

Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said that the Pfizer vaccine’s licensure followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is produced. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” he said.

He said that federal health agencies would continue to monitor the vaccine’s safety and that the F.D.A. would require Pfizer to continue to study the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including the long-term outcomes for recipients. The F.D.A. in June attached warnings to the Pfizer-BioNTech and Moderna vaccines noting possible increased risk of those conditions after the second dose.

Although Pfizer is now free to market the drug under the name Comirnaty, the company said only the federal government will distribute doses in the United States.

Health experts and state officials welcomed the development. With the Delta variant driving up caseloads across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, president of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention. He called on schools and businesses to require vaccination before allowing people to congregate indoors.

Less than two months after it appeared to have curbed the spread of the virus, United States is now averaging around 150,000 new cases a day and more than 90,000 hospitalized Covid-19 patients. An average of about 1,000 a day are dying of Covid-19 — a toll that federal health experts recently dismissed as highly unlikely, before the Delta variant fully took hold. Many children under 12 are also becoming infected.

Vaccination rates have also rising in recent weeks, in part because of more fear of the virus. Providers were administering about 837,000 shots a day, a substantial jump from earlier this summer.

Some experts have estimated that full approval might convince just five percent of those who are unvaccinated to get shots. Even if that’s so, “that’s still a huge slice of people,” Dr. Thomas Dobbs, the chief health officer for Mississippi, a state that is particularly hard hit by the Delta variant. He said licensure will help “shake loose this false assertion that the vaccines are an ‘experimental’ thing.”

Dr. Marks, the vaccine regulator, cited a series of other myths about the vaccines as a major impediment to fighting the pandemic, including false claims that the shots would cause infertility, foster rather than prevent Covid disease or had led to thousands of deaths. “Let me be clear. These claims are simply not true,” he said.

The F.D.A. is in the midst of a decision-making marathon related to coronavirus vaccines. The next major one looming for regulators is whether or not to authorize booster shots. The Biden administration said last week it plans to offer third shots to adults who got the Pfizer and Moderna vaccines eight months after their second injection, starting Sept. 20. Third shots are already authorized for some people with immune deficiencies, but the risk-benefit calculus is different for the general population.

Federal health officials said that both Pfizer-BioNTech’s and Moderna’s vaccines, which rely on similar technology, wane in potency over time. That trend, they said, is converging with the rise of the particularly dangerous Delta variant, making those who completed their vaccinations at the start of the year increasingly vulnerable to infection.

Some health experts have challenged the decision to recommend booster shots as premature, saying the data shows that the vaccines are holding up well against severe disease and hospitalization, including against the Delta variant. Boosters would only be warranted if the vaccines were failing to prevent hospitalizations with Covid-19, some of those experts have said.

Regulators are still reviewing Moderna’s application for full approval of its vaccine. That decision could take several weeks. Johnson & Johnson is expected to apply soon for full approval.

Helene Cooper contributed reporting.

Correction: 

An earlier version of this item misstated the name of the organization led by Dr. Richard Besser. It is the Robert Wood Johnson Foundation, not the Robert Wood Foundation. 

Correction: 

An earlier version of this item misstated the name that the Pfizer-BioNTech coronavirus vaccine is now free to be marketed under. It is Comirnaty, not Comiraty.

New York City will join Washington State, Los Angeles and Chicago, which have all announced full vaccine mandates for teachers in the last few weeks.
Sarah Blesener for The New York Times

New York City will require every employee of the city’s Department of Education — including teachers, principals, custodians and all central office staff — to have received at least one dose of a coronavirus vaccine by Sept. 27, without the option of instead submitting to weekly testing, Mayor Bill de Blasio announced on Monday.

Hours later, Gov. Philip D. Murphy of New Jersey announced that all employees of public, private and parochial schools in his state must be fully inoculated by Oct. 18 or be tested once or twice a week for the coronavirus. He said the rules also apply to all state employees and all substitute teachers, who are already in short supply.

Both announcements came as the Food and Drug Administration approved the Pfizer-BioNTech vaccine for those 16 and older on Monday, a step that is expected to clear the way for many vaccine mandates by public and private employers across the country.

The F.D.A.’s approval also brought into force a requirement announced in May that all students attending in-person classes at State University of New York and City University of New York schools be vaccinated.

New York City’s mandate will affect some 148,000 city employees. It is an escalation of Mr. de Blasio’s effort to slow the spread of the Delta variant by getting more city residents vaccinated. New York is home to by far the largest public school district in the country, with roughly 1 million students.

Education staffers are the first group of city workers to face a full vaccine mandate. The announcement also opens the door to a broader vaccine mandate of city workers, which the mayor said Monday the city was considering. Last month, Mr. de Blasio issued a mandate for city workers that allowed for those unvaccinated to submit for weekly coronavirus testing.

“We know this is going to help ensure that everyone is safe,” Mr. de Blasio said during a news conference on Monday, adding that city schools had extremely low virus transmission last year. The mandate, the mayor said, will help the city “build on that success.”

When it comes to our children and Covid, we have more questions than answers. How will new variants affect them? How will they go back to school safely? Join Dr. Anthony Fauci and Times journalists (who are parents themselves) for a vital Q&A session for parents, educators and students everywhere.

Mr. de Blasio’s push is likely to be unpopular with some D.O.E. employees, but is broadly supported by the city’s powerful teachers’ union. The city is still negotiating with the United Federation of Teachers and other unions representing education staff on what will happen to employees who do not comply with the mandate. The city announced last month that educators who did not comply with the requirement to be vaccinated or submit to testing would be suspended without pay, and a similar consequence is likely for staffers who refuse to be vaccinated under the new mandate.

On Monday, Michael Mulgrew, U.F.T. president, acknowledged that the city had the legal right to create such a mandate, but said key details were still being hashed out.

“While the city is asserting its legal authority to establish this mandate, there are many implementation details, including provisions for medical exceptions, that by law must be negotiated with the U.F.T. and other unions, and if necessary, resolved by arbitration,” Mr. Mulgrew said in a statement.

Mr. de Blasio said that, even if bargaining is stalled or does not succeed, the mandate will still go forward.

The mayor and Meisha Porter, the schools chancellor, said they expect a high level of compliance from schools staff on the new mandate. “I do not expect a staffing shortage,” Ms. Porter said.

In New Jersey, the new rules also apply to employees of public and private preschools, officials said.

The state’s largest teachers’ union, the New Jersey Education Association, a close ally of Mr. Murphy’s, made clear last week that giving teachers the flexibility to be tested in lieu of vaccination was a priority. The union said it did not have an estimate of how many teachers were already vaccinated.

Sean M. Spiller, the president-elect of the N.J.E.A. who is also the mayor of Montclair, N.J., said the teachers union supported the governor’s directive and that Mr. Murphy was committed to the “health and safety of N.J.E.A. members and the students we serve.”

Neither New York City nor New Jersey’s new mandates will require vaccination for eligible secondary school students. Mr. de Blasio said such a policy was “not on the table” for the city. Even so, on Friday the city said that about 20,000 high school athletes who participate in high-risk sports like basketball and football would have to be vaccinated by the start of their sport’s season.

New York City joins the states of Oregon and Washington State, and the cities of Los Angeles and Chicago, which have each announced full vaccine mandates for teachers in the last few weeks that have no testing option. California has a mandate similar to New Jersey’s that includes a testing option.

The fact that all teachers and staff in New York City’s 1,800 public schools will now have to be fully vaccinated is likely to reassure many parents who are anxious about sending their children back into classrooms next month.

Mr. de Blasio has been adamant that all students will return to schools in person on Sept. 13. But with three weeks to go until the first day of classes, he has not yet said how the city will handle testing or the quarantining of positive cases, a delay that has deeply frustrated parents and educators. Neither the city nor New Jersey is offering a remote learning option.

The precise percentage of teachers who have been vaccinated is still unknown. City officials have said that more than 63 percent of all Department of Education employees are vaccinated, but they have said that their figures do not include employees who got their shots outside New York City. About 75 percent of teachers who live in New York City have received at least one dose. By contrast, only about 43 percent of Police Department employees have been vaccinated.

Mr. Mulgrew has estimated that 70 or even 80 percent of his members are vaccinated, regardless of where they live, but his union also lacks definitive numbers. The new mandate will end the guessing game.

Mr. de Blasio said the city would announce more details on school safety — including long-awaited information on testing and quarantining — later this week.

The Pentagon announced on Monday that it was moving ahead with plans to require coronavirus vaccinations for all of its active-duty troops now that the vaccine had been fully approved by the Food and Drug Administration for those 16 and older.
Carl Court/Getty Images

Full federal approval for the Pfizer-BioNTech coronavirus vaccine for those 16 and older is opening the way for institutions like the military, corporate employers, hospitals and school districts to announce vaccine mandates for their employees.

National medical groups hailed the step. A joint statement by the American Medical Association, American Hospital Association and American Nurses Association called it “a major step forward in the worldwide effort to end this pandemic.”

“Today’s news marks a critical moment for people who were concerned about getting vaccinated due to the vaccines being authorized for emergency use,” the statement said. “With millions of data points on the vaccine’s safety and efficacy over nearly nine months of vaccinations, every ‘i’ is dotted and every ‘t’ is crossed.”

The groups added, “With the Delta variant surging, there has never been a better time to get vaccinated.”

The F.D.A.’s approval also brought into force a requirement in New York announced in May that all in-person students at State University of New York and City University of New York schools be vaccinated. CUNY’s website said that after federal approval students “have 45 days to get fully vaccinated or will be subject to potential academic withdrawal.”

One of the first and largest is at the Pentagon, which announced on Monday that it was moving ahead with plans to require all active-duty troops to be vaccinated. Defense Secretary Lloyd J. Austin III will soon send specific vaccination guidelines to the country’s 1.4 million active-duty service members, the Pentagon said.

Mr. Austin had already received authorization from President Biden to mandate vaccines for troops once the vaccine was fully approved, and he is moving swiftly to put the plans into action, said John F. Kirby, the Pentagon spokesman.

“These efforts ensure the safety of our service members,” Mr. Kirby said during a news briefing on Monday. He said the deadline date for getting vaccinated was still being determined.

The move is intended to harden the country’s defenses against the highly contagious Delta variant, which has driven new cases and hospitalizations up across the country, especially in areas with low rates of vaccination, where many military bases are located.

Mr. Biden announced last month that all federal employees and on-site contractors must be vaccinated against the coronavirus, or else submit to regular testing and other measures. The requirement applied to the 766,372 civilians working for the Defense Department, but not active-duty service members.

Mr. Austin has previously said that he would not be comfortable imposing a mandate before vaccines were fully approved by the F.D.A. Earlier this year, The New York Times reported that there was an undercurrent of resistance to the vaccine in the armed forces.

The Defense Department’s website said that as of Aug. 18, more than one million service members have been vaccinated, along with more than 300,000 civilian employees.

New York City announced on Monday that every employee of the city’s Department of Education, from principals to janitors, would have to receive at least one dose of a coronavirus vaccine by Sept. 27. Hours later, Gov. Philip D. Murphy of New Jersey announced that all state employees and employees of public, private and parochial schools in his state must be fully inoculated by Oct. 18 or be tested once or twice a week for the virus. And Chevron became the first major American oil producer to require its field workers to get vaccinated.

Before the F.D.A.’s announcement, the three coronavirus vaccines available in the United States, made by Pfizer-BioNTech, Moderna and Johnson & Johnson, were all being administered in the United States under an emergency use authorization. (The Pfizer vaccine remains available on that basis for youths 12 to 15 and for extra doses for some immunocompromised people.)

The F.D.A.’s approval action on Monday could reinforce the legal standing of some mandates and pave the way for some organizations to impose stricter requirements and no longer allow employees the option of frequent testing as an alternative to getting vaccinated.

Officials also hope that full federal approval will quiet some of the vaccine misinformation online and induce more hesitant people to get vaccinated. A recent poll by the Kaiser Family Foundation found that three out of every 10 unvaccinated people said that they would be more likely to get a shot once it was fully approved.

Dr. Ashish K. Jha, dean of Brown University’s School of Public Health, wrote on Twitter on Monday that he thought full approval of the vaccine would make a difference, “mostly by providing confidence to businesses, schools, and yes, our military to mandate vaccines. And it is already starting to happen.”

Dr. Vivek Murthy, the U.S. surgeon general, has issued a formal advisory declaring misinformation an “urgent threat” to public health.
Tom Brenner/Reuters

Dr. Vivek Murthy, President Biden’s surgeon general, renewed the administration’s attack on coronavirus misinformation of Sunday, two days after The New York Times reported that Facebook had shelved a study showing that its most-viewed link during the first three months of the year was to an article that suggested a link between a Covid-19 vaccine and a Florida doctor’s death.

“The speed, scale and sophistication with which it is spreading and impacting our health is really unprecedented,” Dr. Murthy said of coronavirus misinformation during an appearance on CNN on Sunday. “And it’s happening largely, in part, aided and abetted by social media platforms.”

The Biden administration has aggressively and publicly pressured social media companies such as Facebook to share more data about false and misleading information on their sites, and to tamp down its spread. Mr. Biden at one point accused Facebook of “killing people” by allowing false information to circulate widely, before later softening his position.

For his part, Dr. Murthy has issued a formal advisory in which he declared misinformation “an urgent threat” to public health.

Facebook — which has pushed back by publicly accusing the White House of scapegoating it — this week released its first public quarterly report about the most viewed posts in the United States, for the quarter that includes April, May and June.

But only after The Times reported on Friday that the company had prepared a similar report for the first three months of the year did the company produce that initial report.

The report showed that the most viewed link on the platform was a news story with a headline suggesting that a coronavirus vaccine was at fault for the death of a Florida doctor. Misinformation peddlers used the article to question the safety of the Covid-19 vaccines on Facebook. It also revealed that a Facebook page for The Epoch Times, which routinely spreads misinformation, was among the 20 most popular pages on the social network.

Dr. Murthy’s remarks on the issue of misinformation and its spread came after he was asked about reports of people taking an anti-parasite drug to treat Covid-19. “It is costing us in terms of people’s health,” he said.

Asked specifically about Facebook having disclosed the popularity of the news article that was seen to reduce confidence in the coronavirus vaccines, Dr. Murthy said it reinforced the fact that “there is a lot of misinformation circulating on these sites.”

“I will readily say that the sites have recognized that this is a challenge, and they’ve stepped up to do some things to reduce the spread of misinformation. And I credit them for that,” he said. “But it’s not nearly enough.”

“There are people who are superspreaders of misinformation,” he added. “And there are algorithms, still, which continue to serve up more and more misinformation to people who encounter it the first time. These are things that companies can and must change. And I think they have a moral responsibility to do so quickly and transparently.”

Executives at Facebook, including Mark Zuckerberg, its chief executive, have said the platform has been aggressively removing Covid-19 misinformation since the start of the pandemic.

President Tsai Ing-wen of Taiwan, seated, received a dose of the domestically made Medigen Covid-19 vaccine on Monday.
Annabelle Chih/Reuters

Taiwan started administering its first locally developed Covid-19 vaccine on Monday after months of struggles to get sufficient supplies of doses from major foreign vaccine makers.

President Tsai Ing-wen received a shot of the domestically made vaccine at a hospital in the capital, Taipei, giving her personal assurance of its safety.

“It didn’t hurt,” Ms. Tsai wrote in a Facebook post. “Now, I am in good spirits, and I will continue my daily work.”

The vaccine, which was developed by the Taiwan-based company Medigen, received authorization for emergency use in late July. But critics say they worry that the vaccine, which has completed Phase 2 trials, is being used before its effectiveness and safety have been proved.

Two politicians from the island’s main opposition party, Kuomintang, recently filed a complaint to a local court seeking to suspend the emergency authorization, citing the concerns over the vaccine’s safety. The court dismissed their request last week.

Taiwan, where fewer than 10 locally transmitted cases are reported each day, has favored a less heavy-handed approach to the virus than neighboring mainland China. Since an outbreak that began in May, the government has introduced a series of measures to promote vaccination and received donations of doses from countries including the United States and Japan.

In the past few months, the island’s vaccination rate has increased significantly. As of Monday, around 40 percent of residents had received at least one dose. But only about 3 percent are fully vaccinated. Taiwan has recorded 15,926 total cases of the virus and 828 deaths, according to a New York Times database.

Nearly 600,000 of Taiwan’s 23.5 million residents have registered to get Medigen shots, according to the government data.

Afghans camping outside the gates of the airport in Kabul on Sunday.
Jim Huylebroek for The New York Times

At Hamid Karzai International Airport, where thousands of U.S. troops and NATO allies are trying to evacuate citizens and thousands of Afghans desperate to flee their country after the Taliban took Afghanistan’s capital of Kabul last week, the coronavirus is an afterthought.

The speed, size and scope of the evacuation operation — which came together rapidly as U.S. officials were caught off guard by the Taliban’s swift offensive — has meant few measures, if any, are in place to help prevent the spread of the disease and its newer, more aggressive variants.

There is no testing of the thousands of passengers passing through the base, in what has turned into the final operation of the United States’ nearly 20-year-old war in the country. Social distancing is nonexistent as hundreds of Afghans are ferried in from the airport’s gates and held in crowded parking lots or tents and processed in packed terminals.

The U.S. military cargo aircraft responsible for ferrying a large number of Afghan refugees to bases in the Middle East and Europe are packed with 300 to 400 passengers at a time who sit practically knee-to-back on the floor.

Coronavirus testing usually takes place at American bases outside of Afghanistan, where passengers are tested and isolated if found to be positive. Before the government of Afghanistan collapsed, its ministry of public health had reported a third wave of new coronavirus infections in the country, with a record number of positive cases and deaths.

But coronavirus testing in the country has been unreliable and inconsistent since the start of the pandemic, as testing ability was limited or unavailable in rural areas. The current situation is part of a broader humanitarian and medical issue facing Afghans on top of the security crisis.

Humanitarian and medical aid has been scarce in the past week, with the World Health Organization and other aid agencies unable to fly supplies into the airport while it is overwhelmed by the evacuation effort.

“Conflict, displacement, drought and the Covid-19 pandemic are all contributing to a complex and desperate situation in Afghanistan,” the W.H.O. said in a statement.

According to Dapeng Luo, a representative for the global health body in Afghanistan, the movement and mixing of the newly displaced in Afghanistan, coupled with many now living in often overcrowded and unsanitary conditions, has severely limited infection prevention protocols and increased the risk of transmission of the coronavirus.

Dr. Luo said there were concerns that this, and the nation’s relatively low vaccination rate, could lead to an uptick in the virus.

“This will place an enormous burden on the health system, which is already struggling to cope with escalating trauma and emergency cases and experiencing shortage of supplies due to the current instability, disruptions to governance and shipment of supplies into the country,” Dr. Luo said. “A new wave of Covid-19 could leave some of the most vulnerable without critical health care.”

Rice University now says that it plans to adhere to remote learning until Sept. 3.
Jacqueline Larma/Associated Press

Rice University, where more than 95 percent of students are vaccinated, announced a move to remote classes last week after testing showed an alarmingly high number of community members with breakthrough Covid infections.

Those results, the university now says, were badly distorted by a testing glitch.

Of 4,500 tests administered on the Rice campus, 81 had returned positive results, mostly in vaccinated members of Rice’s community. Even in Houston, where the Delta variant was surging, the results were a surprise. Rice had taken tough efforts to control coronavirus in its community, practically demanding that students, faculty and staff be vaccinated, even as the state of Texas prohibited vaccination mandates. The university also required masks.

Further examination revealed that most of the people who appeared to have tested positive were actually negative for Covid, the university now says.

When Rice began to examine the cases, it found that the results didn’t make sense, according to a note to the university community on Sunday from Kevin E. Kirby, vice president for administration at Rice. Most of the people who tested positive did not have any symptoms. And the cases were scattered, with no clusters.

Rice discovered that the testing provider that reported so many positive results had just switched to using a new test. When 50 of the people who tested positive were retested using different types of tests, all but one of the results came back negative.

All the same, Rice says that it plans to stick with its decision to move to remote learning until Sept. 3. According to a university Covid dashboard, Rice now considers only 27 of the 4,500 tests administered on campus since Aug. 13 to have yielded true positive results, not 81.

A health worker showing a box containing a bottle of Ivermectin, in Cali, Colombia, last year.
Luis Robayo/Agence France-Presse — Getty Images

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.

Employees at Staten Island University Hospital who are opposed to mandatory vaccination and testing protested last week.
Yana Paskova for The New York Times

Outside Staten Island University Hospital this week, as passing cars and fire trucks honked supportively, some employees chanted, “I am not a lab rat!” They were among the nurses, medical technicians, infection control officers and other staff at the hospital who are denouncing efforts to push them to get vaccinated.

Staten Island has the highest rate of Covid-19 infection of any borough in New York City.

The aggressive opposition to the vaccines, and even to regular testing, at a hospital in New York City — the epidemic’s onetime epicenter — shows the challenges of reaching the unvaccinated when some of the very people who could serve as role models refuse vaccination.

Some medical workers at the Staten Island hospital are so fiercely opposed that they call themselves “The Resistance,” after the rebel faction in “Star Wars.” They are defending what they view as their inherent rights, and their leader is gathering hospital workers from other states in an attempt to create a nationwide movement.

Scientists and medical professionals say that those who refuse vaccines are potentially endangering the lives of patients.

As the Delta variant, a highly transmissible version of the coronavirus, drives a surge in cases across the country, public health officials are struggling to boost vaccination rates in frontline medical workers.

Among the nation’s 50 largest hospitals, one in three workers who had direct contact with patients had not received a single dose of a vaccine as of late May, according to an analysis of data collected by the U.S. Department of Health.

The Staten Island protests started last Monday when Northwell Health began requiring unvaccinated staff to get weekly coronavirus tests by nasal swab or risk losing their jobs. On the same day, Gov. Andrew M. Cuomo announced that all health care workers across the state would be required to have at least one dose of the vaccine by Sept. 27, with limited exceptions.

Northwell says that it issued its mandate to protect patients. Before the pandemic, the hospital system encouraged flu vaccinations and required employees who were not vaccinated for flu to wear masks when among patients.

Some protesters, dismissive of scientific data and wary of mandates they say infringe on their civil rights, say they are willing to lose their jobs. Other workers said that they were considering moving out of state, perhaps to Florida, where hospital requirements are looser and the number of deaths and hospitalizations has steadily risen since June.

In Sydney, Australia, last month. All of New South Wales is in lockdown as the delta variant continues to spread.
Mick Tsikas/EPA, via Shutterstock

A rural local government in the state of New South Wales in Australia has put down 15 impounded dogs in a seemingly extreme attempt to keep workers safe from the coronavirus.

The Bourke Shire Council said it could no longer care for the dogs after two had become aggressive and after the person who regularly found new homes for the animals became unavailable, according to a statement it issued to The Sydney Morning Herald.

Emma Hurst, a state lawmaker from the Animal Justice Party, said that the council had killed the dogs instead of letting volunteers from an animal shelter in another town come and collect them.

Among the dogs killed were a mother and her puppies. “It just seems like such a drastic action to take,” Ms. Hurst said.

In its statement, the Bourke Shire Council said: “The town is in a tenuous situation at the moment with Covid. Positive cases are on the increase. Council is being very careful with people entering Bourke.”

All of New South Wales is in lockdown as an outbreak of the Delta variant of the coronavirus continues to spread. Residents have been urged not to travel outside their local government area “if you can avoid it.” However, animal-welfare workers are classified as “authorized workers,” meaning they are exempt from the rules when doing their jobs.

The Office of Local Government, the state government body that oversees local councils, said it was looking into “the circumstances surrounding the incident” and whether the council’s actions complied with animal welfare laws.

Ms. Hurst said she and her office had worked “desperately” to stop the Bourke Shire Council from putting down the dogs after receiving an email from a concerned resident. But, she said, they were told by the council’s general manager that “the dogs were being killed and that was the choice they were making because they had no staff on the ground and no way to care for the dogs.”

Global Roundup

Residents waiting for Covid-19 tests in Yangzhou, China, where a partial lockdown has restricted the movement of millions of citizens for weeks.
Agence France-Presse — Getty Images

China’s zero-tolerance approach to Covid is starting to wear thin in the eastern city of Yangzhou, much of which has been in a lockdown since the beginning of the month.

Over the weekend, one man got into a brawl with a group of volunteers at a roadblock. After video of the altercation was widely shared online, some residents complained that they could not go out to buy their own food and had to rely on volunteers to deliver produce that some people claimed was rotten.

Beijing initially scrambled to stamp out an outbreak that began on July 21 and quickly spread to half of China’s provinces and autonomous regions, exposing some limitations of its approach to pandemic control.

The outbreak, which spread fast and often through asymptomatic cases, posed the biggest challenge yet for Chinese officials since the coronavirus first emerged in Wuhan early last year. At one point some domestic health experts even called for a different Covid approach.

Despite the criticism, China’s National Health Commission on Monday reported zero new cases for the first time since this latest outbreak began.

But the approach has elicited frustration and anger from those who have had to scrap plans as officials turned to the same playbook they used last year — limiting travel, testing and tracing infections, and confining people to their homes. Millions of residents in Zhengzhou were forced to stand in line for virus testing. In Nanjing, where Delta cases first emerged, residents were required to submit to four successive tests.

In Yangzhou, a partial lockdown restricted the movement of millions of residents. Later, officials doubled down, preventing families from leaving their homes.

“After our joint efforts in the previous stage, it is now the time when we most need to grit our teeth to try hardest and fight all in one go,” Xu Lincan, a senior Yangzhou official, was quoted in state media as saying last week.

It was this tough approach that appeared to cause one man to lash out over the weekend after he was stopped at a roadblock near his compound. After volunteers checked his identification and documentation, the man hit one of them on the head, according to a police report.

In the video of the brawl posted online, a group of volunteers in red vests appeared to gang up on the man. One volunteer kicked the man in the head, face and chest. He was later fined and put in detention for 10 days. The other volunteers were also fined, the police said.

In other developments around the world:

  • New Zealand has extended its national lockdown until the end of Friday, with an additional four days’ lockdown for the city of Auckland. The country on Monday announced 35 new cases in the community, bringing the total reported in the current outbreak to 107, mostly in Auckland. All are believed to be the more contagious Delta variant.

Natasha Frost contributed reporting.

Gov. Greg Abbott of Texas said his infection “was brief and mild because of the vaccination I received.”
Tamir Kalifa/Getty Images

Gov. Greg Abbott of Texas announced on Saturday that he had tested negative for the coronavirus, four days after testing positive. He said he would continue to quarantine at the recommendation of doctors.

In a video posted on Twitter, Mr. Abbott, 63, credited vaccines with protecting him from serious illness.

“I’m told my infection was brief and mild because of the vaccination I received,” he said, “So I encourage others who have not received the vaccination to consider getting one.”

He added that Cecilia Abbott, his wife, continues to test negative.

Mr. Abbott, who did not experience symptoms from his infection and who began receiving monoclonal antibody treatment after his positive result, has been a vocal opponent of mask and vaccine mandates. In the days before he announced his test result, the governor attended multiple maskless indoor public events, including a crowded indoor political gathering hosted by a Republican club in Collin County, a hotly contested area of the fast-growing suburbs north of Dallas.

In Saturday’s video, Mr. Abbott said he would continue working from the governor’s mansion, and planned to focus on opening facilities across the state where coronavirus patients could receive monoclonal antibody treatments. Texas health officials are hoping such centers can prevent patients from becoming seriously ill and alleviate pressure on overwhelmed hospitals across the state as infections reach levels not seen since January.

As companies put off bringing employees back to offices, service businesses that cater to office workers have suffered.
Gabriela Bhaskar/The New York Times

New York has lagged behind the rest of the country in its economic recovery, with a 10.5 percent unemployment rate that is nearly twice the national average. Now, rather than seeing the fuller rebound it was counting on, the city is facing fresh challenges.

  • Overall employment remains more than half a million jobs below where it was before the pandemic, with steep losses persisting in the leisure and hospitality industries and in other blue-collar fields.

  • Many companies have scrapped plans to bring employees back to the office shortly. Boston Properties, which owns nearly 12 million square feet of space in the New York region, said about 40 percent of prepandemic occupants had returned to its buildings earlier in the summer, based on lobby badge swipes. In August, that figure had dipped to around 30 percent.

  • It is less clear whether some suburban workers will ever return to the city and to their sometimes-arduous commutes. Greenberg Traurig, a global law firm, reduced its planned Manhattan footprint and now plans to open two new offices on Long Island, where many of its lawyers and investor clients relocated to during the pandemic.

  • More than any other American city, New York counts on international tourists. But visitors from Europe continue to be barred. Domestic travelers have returned to New York in rising numbers, but they do not stay as long or spend as much as overseas tourists.

There are signs of hope. But even as the city sponsored an official Homecoming Week, cancellations of trade shows and other big events have mounted. READ THE ARTICLE →

Police officers patrolling in Sydney, Australia, on Saturday, before roughly 250 people in the city protested against the latest lockdowns.
Don Arnold/Getty Images

Australia, which is battling its worst coronavirus outbreak, must cease lockdowns that attempt to stamp out the virus once the country reaches its initial vaccination target of 70 percent of the eligible population, Prime Minister Scott Morrison said on Monday.

“We have to deal with it; otherwise we stay in the cave forever,” Mr. Morrison told reporters in Canberra, the capital. He pushed back on some state leaders who had suggested that they might continue to enforce lockdowns even after the targets were met. He added, “That’s not a sustainable solution.”

Australia, which last year was held up as a blueprint for tackling the pandemic, has for the past several weeks been battling a growing outbreak of the faster-spreading Delta variant. The outbreak, which began in Sydney, has led to lockdowns across the nation.

Last month, state leaders agreed to limit restrictions once 70 percent of eligible Australians were vaccinated. Mr. Morrison has said the goal is to begin to reopen international borders once that number reaches 80 percent. (A trial of a program that would allow vaccinated travelers to quarantine at home, rather than in designated hotels, is beginning this week. The country’s largest airline, Qantas, has also introduced incentives for vaccinated travelers.)

On Monday, New South Wales, of which Sydney is the capital, recorded 818 new cases of the virus, with three additional deaths. In the state of Victoria, 71 new cases were reported on Monday. Melbourne, that state’s capital city, has now been under lockdown for more than 200 days over the course of the pandemic. The latest restrictions there spurred protests over the weekend that turned violent.

“You can’t live with lockdowns forever,” Mr. Morrison said, adding that 30 percent of the eligible population was now fully vaccinated, and that more than half had received one dose. “We must adjust our mind-set.”

A Chevron refinery in Pascagoula, Miss.
Jonathan Bachman/Reuters

The oil and gas giant Chevron will require some of its employees to receive coronavirus vaccinations, becoming the first major U.S. oil producer to announce that it was requiring field workers to be protected against the virus at a time when other large corporations are making similar demands on office workers.

The mandate applies to employees who travel internationally and expatriates, as well as the offshore work force in the Gulf of Mexico and some onshore support personnel, the company said on Monday. Chevron is the second-largest oil and gas producer in the United States after Exxon Mobil.

“As part of our fitness for duty safety standard, workers in certain jobs are required to be vaccinated against Covid-19,” a Chevron spokeswoman said in an email. “We will continue to carefully monitor the medical data and follow the guidance of health authorities in order to protect our work force.”

The news was reported earlier by The Wall Street Journal.

Exxon Mobil does not have a formal mandate on vaccines, but the company is strongly encouraging workers to get vaccinated. A company spokesman, Casey Norton, said in a statement that Exxon was monitoring public health guidance.

“Given the spread of the Delta variant and its impact on unvaccinated individuals, all unvaccinated individuals are expected to wear a face covering in all indoor locations when six feet of social distance cannot be maintained,” he said. That policy went into effect on Aug. 18.

Like Exxon, Royal Dutch Shell encourages vaccination among employees, but it is not mandatory. Employees must comply with local laws requiring vaccination for entering public places or to enter countries. In some workplaces, Shell said, it may help ease vaccinations as a convenience.

Stanley Reed contributed reporting.

Adblock test (Why?)



"may" - Google News
August 23, 2021 at 11:00AM
https://ift.tt/3mq6ycZ

Covid-19 News: Live Updates on FDA and Pfizer Vaccine - The New York Times
"may" - Google News
https://ift.tt/3foH8qu
https://ift.tt/2zNW3tO

Bagikan Berita Ini

0 Response to "Covid-19 News: Live Updates on FDA and Pfizer Vaccine - The New York Times"

Post a Comment


Powered by Blogger.