Covid-19 Updates: Full Approval of Pfizer Vaccine in U.S. May Spur Mandates


Credit…Mike Kai Chen for The New York Times

The Food and Drug Administration is poised to give its full approval to the Pfizer-BioNTech Covid-19 vaccine as early as Monday, and health officials are hoping the decision will lead to policy changes, shifts in public sentiment and an increase in the vaccination rate among hesitant Americans.

The approval is expected to pave the way for a series of vaccination requirements by public and private organizations.

For instance, as many schools and universities across the country prepare for students to return to campus, some, like Indiana University, are already requiring vaccines for students. But others, like the University of Memphis, have signaled that they will pursue a vaccine mandate as soon as the vaccines gain full federal approval.

Federal and state health officials are also hoping that full approval will win over those who had been reluctant to roll up their sleeves for a vaccine only authorized for emergency use.

Speaking to CNN on Sunday, Vivek Murthy, the surgeon general, said he thought full F.D.A. approval would have a significant impact on millions of Americans who remain vaccine hesitant.

“This may tip them over toward getting vaccinated,” he said, adding that he expected companies, governors and schools to use the full approval to impose mandates. “We already know that there are many businesses and universities that have moved toward vaccine requirements,” he said.

The Pentagon has said it planned to make Covid vaccinations mandatory for the country’s 1.3 million active-duty troops by the middle of next month, or sooner if the F.D.A. acted earlier.

For the 45 percent of unvaccinated Americans who say they will definitely not get the vaccine, full approval could trigger new restrictions, including limitations on employment and an increase in health insurance premiums.

Some states and municipalities could follow the lead of New York City, which beginning next month will require at least one vaccine dose for those seeking to enter indoor restaurants, gyms or cultural events.

The F.D.A. updated its authorizations of the Pfizer-BioNTech and Moderna vaccines last week 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 vaccine, and a decision could come at least several weeks after the one for Pfizer. Moderna is planning to submit its data in support of a booster shot in September.

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

A health worker showing a box containing a bottle of Ivermectin, in Cali, Colombia, last year.
Credit…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.
Credit…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.
Credit…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.
Credit…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.”
Credit…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.

Police officers patrolling in Sydney, Australia, on Saturday, before roughly 250 people in the city protested against the latest lockdowns.
Credit…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.”





Source link

Leave a Reply

Your email address will not be published. Required fields are marked *