Covid News: F.D.A. Expected to Fully Approve Pfizer Vaccine Next Week – The New York Times

Heres what you need to know:Pfizer vaccines were administered at the St. John Chrysostom Catholic Parish in The Bronx on Sunday.Credit...James Estrin/The New York Times

The Food and Drug Administration is pushing to approve Pfizer-BioNTechs two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agencys 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 countrys 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-BioNTechs and Modernas vaccines to allow third doses for some immunocompromised people, a decision backed by the Centers for Disease Control and Prevention.

Regulators are still reviewing Modernas 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.

Orlando Mayor Buddy Dyer and utility officials asked residents to conserve water Friday to preserve the citys 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 nations 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.

Its 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 states 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.

Rice University, a private institution in Houston, has done its best to build a wall against the Delta variant engulfing the state of Texas by imposing stringent requirements for being on campus.

Unlike the states public universities, which cannot mandate vaccines or masks, Rice requires student and faculty members to wear masks and has testing protocols for all visitors. And while Rice has not risked running afoul of Texas law by requiring vaccines, it has told students they are expected to be vaccinated.

Still, the virus has surged in Houston, and on Thursday, Rice became the second university in the state to shift classes online, dampening hopes for a return to normal college life this fall. Rice delayed the start of school by two days until Aug. 25 and said that classes would remain online through Sept. 3.

It also said that members of the Rice community had tested positive for Covid despite the high vaccination rates 98.5 percent among the student body.

Ill be blunt: the level of breakthrough cases (positive testing among vaccinated persons) is much higher than anticipated, Bridget Gorman, the dean of undergraduates, wrote in a letter to the schools 8,000 graduate and undergraduate students. The university didnt specify how many breakthrough cases there were.

More than 12,000 people are hospitalized with the coronavirus in Texas, where officials have prohibited both masks and vaccine mandates, and where Gov. Greg Abbott recently tested positive.

Were in a hot spot right now, said Rices president, David Leebron, adding that the decision to move temporarily to remote classes was made to give the university time to assess the results of its recent testing.

Having new information of concern, as people worry about breakthrough infections, as people with children are worried around those issues, we wanted to have a little bit of time to gather data and look at it more carefully, he said.

Rice was the second Texas university that has announced a move to remote learning. Last week, the University of Texas at San Antonio said it would begin with mostly remote classes, citing the citys high infection rate.

Face masks will be required in all public indoor spaces in Boston starting Aug. 27, the citys mayor, Kim Janey, announced on Friday. The measure is intended to impede the spread of the coronaviruss extremely transmissible Delta variant.

We know that masks work best when everyone wears one, Ms. Janey said in a statement. Requiring masks indoors is a proactive public health measure to limit transmission of the Delta variant, boost the public confidence in our businesses and venues, and protect the residents of our city who are too young for vaccination.

Bostons Public Health Commission issued the order not long before more than 50,000 college students return to the area and more than 50,000 public school students start class, the city said in a release.

The seven-day average of new reported cases in Suffolk County, which includes Boston, has been above 140 for more than a week, up from fewer than 10 in late June, and hospitalizations have also increased, according to data compiled by The New York Times though both numbers are well below their peaks from last winter.

Boston joins San Francisco, Los Angeles County, Chicago and Washington, D.C., on the list of cities that have instituted similar mandates. However, New York City, which has a strict requirement that patrons and employees of indoor establishments provide proof of at least one vaccine shot, has not imposed a mask rule.

And Republican governors in hard-hit states like Florida and Texas have banned mask mandates, though some districts and municipalities have imposed them anyway.

Massachusetts Governor Charlie Baker, also a Republican, has not taken as strong a stance, but he has so far declined to impose a mask mandate for the commonwealths public schools, despite a strong push to do so from Massachusettss largest teachers union.

In a radio interview earlier this month, Mr. Baker said he thought such decisions were better left to localities.

Im not going to get into making decisions that I believe in many cases ought to be driven, at the end of the day, by the folks at the local level who know those communities best, Mr. Baker said.

The Archdiocese of Philadelphia said earlier this week that it will not sanction religious exemptions to Covid vaccine mandates, joining a growing chorus of other Catholic dioceses that are declining to give their parishioners an excuse for not getting inoculated.

Individuals may wish to pursue an exemption from vaccination based on their own reasons of conscience, Kenneth A. Gavin, the chief of communications for the archdiocese, wrote in a statement. In such cases, the burden to support such a request is not one for the local Church or its clergy to validate. Neither the Archdiocese nor its parishes would support exemption requests, he said.

The Philadelphia Inquirer reported the news on Wednesday.

Other dioceses around the country, including those of New York City, San Diego and Honolulu, have made similar statements. Some, like that of El Paso, Texas, have even imposed vaccine requirements for their employees.

The Vatican announced in February a vaccine requirement for its employees in Rome, but quickly reversed the rule after criticism.

The issue has become a matter of contention within the church, as it has within the broader society, with more conservative church leaders supporting people who choose not to get vaccinated while more progressive ones, like Pope Francis, argue in favor of vaccines.

Earlier this week the Pontiff released a public service advertisement in which he called getting vaccinated against Covid-19 an act of love.

But for many Catholics some vaccines are morally questionable, because they can be developed using human cell lines derived from fetuses aborted decades ago, and mandating them is seen by some as an infringement on individual liberties.

Bishops in South Dakota, for instance, have argued in favor of religious exemptions for vaccination.

A Catholic may, after consideration of relevant information and moral principles, discern it to be right or wrong to receive one of the available Covid-19 vaccines, two bishops wrote in a public letter earlier this month. If he or she thus comes to the sure conviction in conscience that they should not receive it, we believe this is a sincere religious belief, as they are bound before God to follow their conscience. We support any Catholic who has come to this conviction in seeking religious exemption from any Covid-19 requirement.

For his part, Francis said getting vaccinated against the virus was a moral act.

Getting the vaccines that are authorized by the respective authorities is an act of love, and helping the majority of people to do so is an act of love, Francis said in the advertisement. Getting vaccinated is a simple yet profound way to care for one another, especially the most vulnerable.

Shefali S. Kulkarni contributed reporting.

An antibody drug developed by AstraZeneca was strongly effective in preventing Covid in a study that mostly enrolled high-risk people, the company announced on Friday.

The findings raise hopes that the drug, which is easier to administer and designed to stay in the body for much longer than the available antibody treatments for Covid, could provide long-lasting protection for people with weakened immune systems who do not respond well to vaccination.

AstraZeneca said it would ask regulators to authorize the therapy, though it is not clear who the company will seek to reach with the drug.

Some people with weakened immune systems became eligible last week to start receiving third doses of the vaccines from Pfizer and Moderna, a decision prompted by data indicating that they were not sufficiently protected by an initial series of shots.

But some immunocompromised people remain ineligible, and even a third shot may not be enough protection for others.

There are tens of thousands of patients for whom a drug like this is really important, said Dr. Myron Cohen, a University of North Carolina researcher who has worked on monoclonal studies but was not involved in AstraZenecas trial. I get emails every day from people who say, I cannot respond to a vaccine. What can I do? Or, Can you help me?

Antibody drugs are becoming an increasingly important tool in the United States as hospitals have been overwhelmed with cases caused by the Delta variant. The treatments, designed to mimic the immune response generated naturally in response to an infection, have almost entirely been used to keep vulnerable people who are already sick with Covid from getting worse.

But AstraZenecas drug is the latest to show that the therapies can also help people before theyre infected.

The antibody drug being predominantly used in the United States, from Regeneron, was recently authorized to prevent Covid-19 in a limited number of high-risk patients, including people with certain health conditions who are not vaccinated or may not mount an adequate immune response. Those people are eligible to get the treatment for prevention if they have been exposed to the virus or live in nursing homes or prisons.

AstraZenecas trial, which enrolled more than 5,000 people in the United States and Europe, found that people who received the treatment had a 77 percent reduced risk of developing Covid within six months compared to people who got a placebo.

Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital, said that he and other physicians would welcome another treatment option. With Delta and other variants, the more tools we have, the better, he said. And so this in my mind, is potentially another tool, especially if it prevents symptomatic Covid in those at most risk.

For weeks in June and July, workers at a Maine factory making one of Americas most popular rapid tests for Covid-19 were given a task that shocked them: take apart millions of the products they had worked so hard to create and stuff them into garbage bags.

Soon afterward, the manufacturer, Abbott Laboratories, announced layoffs, canceled contracts with suppliers and shuttered the only other plant making the test, in Illinois, dismissing a work force of 2,000. This is all about money, Andy Wilkinson, a site manager, told the workers in Maine.

As virus cases in the U.S. plummeted this spring, so did Abbotts Covid-testing sales. But now, amid a new surge in infections, steps the company took to eliminate stock and wind down manufacturing are hobbling efforts to expand screening as the highly contagious Delta strain rages across the country. Demand for its 15-minute antigen test, is soaring again as people return to schools and offices.

Yet Abbott has reportedly told thousands of newly interested companies that it cannot equip their testing programs in the near future. CVS, Rite Aid and Walgreens locations have been selling out of the at-home version, and Amazon shows shipping delays of up to three weeks. Abbott is scrambling to hire back hundreds of workers.

America was notoriously slow in rolling out testing in the early days of the pandemic, and the story of the Abbott tests is a microcosm of the larger challenges of ensuring that the private sector can deliver the tools needed to fight public health crises, both before they happen and during the twists and turns of an actual event.

Businesses crave certainty, and pandemics dont lend certainty to demand, said Stephen S. Tang, chief executive of OraSure Technologies, which in the midst of the testing slump in June received emergency F.D.A. authorization for its own rapid test, InteliSwab, long in development. But the company is not yet supplying retail stores.

Meanwhile, Dr. Sean Parsons, chief executive of Ellume, the Australian manufacturer of a competitor rapid test, said this week that demand was 1,000 times greater than forecast and the company was racing to set up a U.S. plant.

Abbotts decisions have ramifications even beyond the United States. Employees in Maine, many of them immigrants from African countries, were upset at having to discard what might have been donated. Other countries probably could have used the materials, according to Dr. Sergio Carmona, chief medical officer of FIND, a nonprofit that promotes access to diagnostics.

This makes me feel sick, he said of the destruction, noting that more than a dozen African nations have no domestic funds to buy Covid tests.

In an interview, Robert B. Ford, Abbotts chief executive, argued that the discarded materials finished test cards should not be viewed as tests. Kits for sale also include swabs, liquid buffer and instructions.

Emily Anthes contributed reporting.

Signature Theater, a prominent Off Broadway nonprofit, has postponed its return to the stage over concerns about the persistent coronavirus pandemic, becoming the first major New York theater to take such a step.

The theaters leadership announced the postponement Friday afternoon, just days before rehearsals were to begin for Infinite Life, a new play by the Pulitzer Prize-winning playwright Annie Baker, who was also planning to direct the work. The production was supposed to run from Oct. 5 to Nov. 7.

Due to ongoing health and safety concerns, Signature Theater and Annie Baker have decided to postpone the upcoming production of Infinite Life, the theater said in a statement. Signature will continue, in discussion with artists, to evaluate on a case-by-case basis how to proceed with other programming planned for this season. The company and artist agree that this is the best choice for this show at this time.

Around the country, there have been a number of cancellations and postponements of pop music tour dates and festivals because of the rise in coronavirus cases caused by the spread of the Delta variant. There have been several theater postponements in California, including at Berkeley Repertory Theater, which recently cited the Delta variant in delaying until next year a Christina Anderson play that had been scheduled to begin in October.

It is unclear whether the postponement of Infinite Life is an outlier or a first indication that the theater industry is getting cold feet about the many reopenings planned this fall, on Broadway and off. Two Broadway shows, Springsteen on Broadway and Pass Over, are already running, and 15 more plan to start next month; there are also some plays already running in commercial and nonprofit venues around the city, and many of the citys larger nonprofits plan to resume presenting shows during the fall.

New York Citys high school student athletes and coaches participating in high-risk sports will have to be vaccinated in order to play, Mayor Bill de Blasio said on Friday. The announcement represents the first student vaccine mandate in New York City, and could set the stage for broader mandates for the citys roughly 1 million public school students later this year.

About 20,000 students and staff about half of the total Public School Athletic League will have to receive at least one vaccine dose by the first day of competitive play. That means students with fall seasons, including football and volleyball players, will have to be at least partially vaccinated by the first few weeks of school.

But students who play winter and spring sports like basketball, ice hockey and lacrosse, along with wrestlers, have several months before they have to start the vaccination process. And more than 20,000 students and staff who participate in sports considered low-risk, including baseball, soccer, tennis, track and gymnastics, will not have to be vaccinated.

Private schools can determine their own mandates for student athletes.

The first day of school for all students is Sept. 13, which means eligible students who are still unvaccinated will not be fully protected by the start of school, even if they begin their vaccination process immediately. Just under 60 percent of all eligible New Yorkers ages 12 to 17 have received at least one dose, according to the city, but its not clear how many of those children are public school students.

The mandate follows guidance by the Centers for Disease Control and Prevention that students playing contact sports should be vaccinated to prevent canceled or virtual sports seasons. Last year, some districts across the country saw higher transmission among high-risk sports teams than in classrooms.

The state of Hawaii has already mandated vaccines for its high school student athletes. But vaccine requirements for eligible public school students remain extremely rare. The Culver City school district in California is believed to be the first district in the country to issue a broad vaccine mandate for all its eligible students.

A federal appeals court has allowed the Biden administrations replacement evictions moratorium to stay in place for now, issuing a swift ruling on Friday in a politically charged case that is speeding its way toward the Supreme Court.

In a one-page, unsigned order, a three-judge panel of the United States Court of Appeals for the District of Columbia Circuit declined to block the government from enforcing the emergency public-health policy while a legal challenge to it brought by landlords, including the Alabama Association of Realtors, plays out.

The Justice Department had no immediate comment. But Patrick Newton, a spokesman for the National Association of Realtors, which is not a party to the case but supports the landlords and has been speaking on their behalf, expressed confidence that the Supreme Court would now move quickly to block the policy.

The Centers for Disease Control and Prevention imposed the evictions moratorium on Aug. 3 in counties where Covid-19 is raging, a category that currently covers about 91 percent of counties in the United States. It replaced an earlier nationwide ban on evictions that had been in effect since September and was extended several times.

The ban ultimately expired in July, a month after the Supreme Court allowed the moratorium to continue but strongly suggested that five justices would block the policy if the government extended it past its scheduled expiration.

President Biden, who initially had no intention of reviving the ban, reversed course in early August after coming under intense pressure to act by Speaker Nancy Pelosi and other Democrats. In the interim, the Delta variant sent new coronavirus cases soaring even as it became clear that most of the $46.5 billion that Congress had appropriated for emergency rental assistance funds had yet to reach tenants.

Of the 1.5 million nursing home staff members in the United States, some 540,000 are unvaccinated. Their fate could be directly impacted by a policy announced on Wednesday by President Biden requiring all nursing home employees to be vaccinated, with the rules likely to take effect sometime in September. Facilities that fail to meet that target could face fines or lose eligibility to receive federal reimbursement, a vital source of income for many.

The practical effect is that workers will have to be vaccinated or lose their jobs.

Janet Snipes manages Holly Heights Care Center in Denver. She wants to see all nursing home workers vaccinated, but not at the risk of losing employees who wont comply, in an industry with a high turnover rate and a labor shortage.

Ms. Snipes said several employees had told her that they might leave, including one she described as her best nurse. Getting vaccinated is the safest thing for our residents and our staff, but we feel strongly he needs to mandate for all health care settings, Ms. Snipes said of Mr. Biden. We cant afford to lose staff to hospitals and assisted living facilities.

Several major nursing home chains, and some states, have already imposed vaccine mandates. Industry officials said inoculations were strongly advised, but their position on the new policy echoed that of Ms. Snipes.

We will lose tens of thousands, maybe hundred thousands, of workers, said Mark Parkinson, president and chief executive of the American Health Care Association, a major nursing home trade group.

Dr. Lee A. Fleisher, chief medical officer of the Centers for Medicare & Medicaid Services, said recent data indicated a direct relationship between rising infections at nursing homes and unvaccinated staff.

Of the 625,000 Covid deaths in the United States to date, nearly one-fifth 133,700 have been nursing home residents, according to the Centers for Disease Control and Prevention. The industry is again experiencing rising infection rates and deaths among residents, although none approaching the peak figures of last year.

Global Roundup

The lockdown in Sydney, Australias largest city, has been extended for another month as a Delta outbreak continues to surge.

Sydney has now recorded over 10,000 infections and 65 deaths since the outbreak began in mid-June. This week, daily case numbers jumped from the 400s to the 600s, forcing the state government to extend the lockdown, which began in late June, to Sept. 30. It had previously been scheduled to be lifted later this month.

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Covid News: F.D.A. Expected to Fully Approve Pfizer Vaccine Next Week - The New York Times