Covid-Stricken Alabama Had More Deaths Than Births Last Year
After a first in recorded history, Dr. Scott Harris, the state’s health officer, said, “Our state literally shrunk in 2020.” Here’s the latest on Covid-19.,
F.D.A. Panel Greenlights Pfizer Boosters for High-Risk Individuals
A Food and Drug Administration advisory panel recommended that Pfizer-BioNTech boosters be made available to people 65 and older and those at high risk of severe Covid, but voted against giving blanket boosters to people 16 and older.
“This is the voting question No. 2 that we will ask the committee to consider: Based on the totality of scientific evidence available, including the safety and effectiveness data from Clinical Trial C4591001: Do the known and potential benefits outweigh the known and potential risks of a Pfizer-BioNTech Covid-19 vaccine booster dose administered at least six months after completion of the primary series for use in individual 65 years of age and older, and individuals at high risk of severe Covid-19?” “We do have a unanimous 18 out of 18 who voted ‘yes’ for this question.”
The vote was a blow to President Biden, strengthening criticism of his effort to enhance the immunity of already vaccinated Americans at a time when most residents of poor nations have not even had first doses. The F.D.A. and the Centers for Disease Control and Prevention authorized third shots for some immunocompromised individuals more than a month ago, on the ground that the additional dose would simply lift their protection to the level other people achieve with two shots.
Some F.D.A. experts said that the data from Pfizer and elsewhere still seemed to show that two shots protected against severe disease or hospitalization for months afterward, and that there was not enough evidence that a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
The panel’s final recommendations left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably be deemed eligible for additional shots of the Pfizer vaccine. And a small but growing number of people have stopped waiting for federal authorization and are finding ways to receive booster shots.
Before the panel met on Friday, the Centers for Disease Control and Prevention released data indicating that, for some people, the level of protection against Covid hospitalizations afforded by the Pfizer-BioNTech vaccine dropped significantly four months after full inoculation.
The C.D.C. study supported some others that suggest the Pfizer vaccine may offer less protection from hospitalization over time. The available data is far from unanimous, though so far it suggests that only older adults will need boosters. Participants in the C.D.C. study skewed older and it was unclear if the same waning of vaccine effectiveness happened among younger vaccinated people.
Other studies have shown that Pfizer’s effectiveness against hospitalization has remained above 90 percent, despite the rapid spread of the Delta variant and the passage of time. Pfizer has said that data from Israel suggests a falling effectiveness against severe disease, though it appears that Israel and the United States define “severe disease” differently.
The debate is playing out as the Delta variant continues ravaging less-vaccinated areas of the country. New coronavirus cases and Covid hospitalizations across the United States have started to show signs of decline, although they remain far higher than they were earlier in the summer. And the average number of daily deaths has been increasing since early July, from this year’s low of 175 to nearly 2,000 by the end of this week, according to a New York Times database. About one in every 500 Americans has died from the disease.
The pace of vaccinations remains relatively sluggish. Providers are administering about 775,000 doses per day on average, according to federal data, a fraction of the April peak but still more than 250,000 higher than the low point in July. About 54 percent of Americans are fully vaccinated, according to a New York Times database, the second lowest proportion among the Group of 7 wealthy nations — but Japan’s now aggressive vaccination campaign is likely to leave the United States last among the G-7 shortly.
The F.D.A. has the final word on vaccine approvals, and while it is not obliged to follow the advisory committee’s recommendations, it typically does. The agency will likely issue a decision on boosters by early next week.
— Ron DePasquale
American health experts spoke out on social media and other platforms on Friday and Saturday to applaud the likelihood that federal regulators could soon make Pfizer-BioNTech booster shots available for those 65 and older or at high risk of severe Covid-19, though some argued that the cutoff age should be lower.
The experts were reacting to the actions on Friday of an advisory committee to the Food and Drug Administration. That panel’s recommendation that the boosters be authorized was paired with its rejection of moving toward a blanket authorization for everyone 16 and older.
The only Covid-19 vaccine for which the F.D.A. has enough information to determine a booster shot’s effectiveness is the one made by Pfizer-BioNTech. The timing for the other two vaccines in use in the United States, Moderna’s and Johnson & Johnson’s, is murky.
Dr. Ashish K. Jha, a researcher who is dean of the School of Public Health at Brown University, said on Twitter that authorizing people over 65 for boosters was a “Good result” supported by science. “Clearly consistent with the evidence and this outcome should never have been in doubt,” he wrote.
But Dr. Jha also noted in a separate tweet that boosters would benefit those 60 and above.
Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif., called the F.D.A. panel’s decision “a very good outcome.” The decision, he wrote on Twitter, recognized “the need for high-risk individuals, due to co-existing conditions or occupational exposures, such as the heathcare workforce, essential workers, and teachers.”
However, Dr. Topol also questioned why the cutoff point for third-shot eligibility was set at 65, rather than including people 60 or older. He also said the updated F.D.A. advisory “didn’t address the vulnerability of people who received J&J shots.”
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told The Associated Press that he supported a third dose for older adults but that “I really have trouble” when it comes to getting behind the idea of administering the shot to anyone closer to the age of 16. “The question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Dr. Offit said.
For some Americans outside the medical or scientific fields, the F.D.A. panel’s recommendations seemed opaque, or even contradictory.
For instance, Jen Macy, a wedding and event floral designer in Orange County, Calif., tweeted and also discussed with a Times reporter what she felt was an urgent question: “Can you explain why boosters are being recommended for high risk people but the general population needs to wait for further testing? This makes no sense.”
Michael Knowles, a conservative media figure with a large following on social media and via The Daily Wire, a site that publishes commentary and podcasts, took a comic dig at the F.D.A. panel’s actions. “The vaccines are so effective that you need a booster and so safe that the FDA won’t approve the booster,” he wrote on Twitter. “Do I have that right?”
Last fall, as coronavirus cases climbed and the world hoped for vaccines, health experts feared influenza and Covid-19 would combine for a devastating “twindemic.”
While pandemic measures appeared to keep the flu at bay, this year experts are again concerned, especially as some countries and state authorities roll back lockdown rules. Many officials and experts are urging the public: Do not dismiss the danger of the flu, and seek a flu vaccine.
“This year we are guaranteed to have the flu, and we are going to have some version of a twindemic,” said Dr. William Schaffner, the medical director for the National Foundation for Infectious Diseases. “It could really further strain an already extraordinarily stretched, strained, tired-to-the-bone health care system.”
In the United States, flu activity was significantly lower during the 2020-21 season than during any previous flu season since at least 1997, the first for which data is publicly available.
Scientists said pandemic precautions most likely played a role, as many people adopted masking, social-distancing and hand-washing habits.
But the relative lack of flu cases over the last 18 months could also mean that population-level immunity to the flu is lower this season, said Lynnette Brammer, the leader of the C.D.C.’s domestic influenza surveillance team.
And while it is still uncertain how the season will play out, she added, relaxed pandemic measures in some places will “likely result in the resumption of seasonal flu virus circulation.”
“This all could set us up for a potentially severe flu season,” she added.
The C.D.C. advises that everyone over the age of 6 months old receive a flu shot, with a few exceptions. It takes about two weeks for protection to develop after vaccination, so experts recommend getting vaccinated from September through the end of October, but even after that it is better to get the vaccine than not.
Responding to an escalating crisis inside New York City’s notorious Rikers Island jail complex, Gov. Kathy Hochul on Friday signed a measure that will lead to the release of about 200 detainees, many of them being held for parole violations.
The law, known as the Less is More Act, is intended to ease crowding in the jail at a time when severe staffing shortages at the city’s Department of Correction have led to unsafe and unsanitary conditions for detainees and guards. Ten people have died at Rikers since December, several by suicide.
Even though the law does not go into effect until March, Ms. Hochul said she was directing the board of parole to immediately release 191 people who qualify from Rikers Island. They were expected to be released on Friday.
Ms. Hochul also said an additional 200 people serving sentences would be moved from Rikers Island to state prisons over the next five days to ease the burden on the city jail.
But the legislation will still leave Rikers far more crowded than it was last spring, when a wave of releases amid the pandemic dropped the population below 4,000. As of Friday, more than 6,000 people were being held at the jail.
At the same time, coronavirus rates inside the jail appear to be climbing. Correctional health officials first reported an uptick in the prevalence of the virus in mid-August, followed by a spike in cases later that month. After active cases and rates in the jail dropped to near zero in June and July, the seven-day average positive test rate among detainees — 4.36 percent as of this week — is now higher than the city’s 3.92 percent rate at large.
During a City Council hearing this week to address the conditions at Rikers, officials described a two-pronged catastrophe in the making. About 2,700 staff members — roughly a third of the entire work force — are absent or unable to work on any given day for myriad reasons, leading to a lack of supervision that has caused violence among detainees. Crowding in unsanitary conditions is paving the way for a new surge in coronavirus infections. As of this week, the city said there were 65 active virus cases at the jail.
Only 36 percent of detainees at the jail are fully vaccinated, according to city data.
— Chelsia Rose Marcius
Hospital systems across the United States are being strained to their breaking points by the highly contagious Delta coronavirus variant. Nationwide, new cases and hospitalizations have declined slightly in recent weeks, but much of the progress seen in hard-hit Southern states is being offset by growing outbreaks in the Upper Midwest and Mountain West.
One in four hospitals across the country reports that more than 95 percent of its intensive care beds were occupied as of the week ending Sept. 9, up from one in five hospitals last month. Experts say hospitals may have difficulty maintaining standards of care for the sickest patients when all or nearly all I.C.U. beds are occupied.
Struggling to cope with a flood of patients, Idaho officials activated “crisis standards of care” across the state on Thursday, allowing overwhelmed facilities to ration treatment if needed. If the situation worsens, hospital may have to decide which patients will get priority for limited supplies of oxygen or ventilators.
Alaska’s largest hospital announced Tuesday that a relentless outbreak driven has left emergency room patients waiting hours in their vehicles and forced medical teams to ration care. At Providence Alaska Medical Center in Anchorage, the hospital said it was now operating under “crisis standards of care” — procedures put in place to prioritize resources in a way that may leave some patients with substandard care.
State officials in Mississippi tried to outsource “I.C.U.-level-care patients” to Kentucky. And in North Dakota, an executive at the state’s largest health care system said it could use as many as 300 additional nurses to help treat Covid-19 patients. All I.C.U. beds are full in Alabama.
Here’s what else happened this week:
A scientific advisory committee to the Food and Drug Administration on Friday recommended booster shots for recipients of the Pfizer-BioNTech coronavirus vaccine who are 65 or older or are at high risk of severe Covid-19, at least six months after the second shot. The panel also overwhelmingly recommended against approving a Pfizer booster for people 16 and older. The Biden administration had been hoping the F.D.A. and the Centers for Disease Control and Prevention would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.
Both elation and caution were palpable in New York City on Monday when the country’s largest public school system resumed full in-person classes for the first time since March 2020. But with the virus tearing through unvaccinated populations in the city and much of New York’s school-age population still ineligible for vaccination, disruptions are likely.
The longest shutdown in Broadway history is over. Some of the biggest shows in musical theater, including “The Lion King,” “Wicked” and “Hamilton,” resumed performances on Tuesday night, 18 months after the coronavirus pandemic forced them to close.
President Biden met on Wednesday with top executives from Microsoft, the Walt Disney Company, Kaiser Permanente and other companies that have endorsed vaccine mandates, days after he announced a federal effort to require employees of large companies to be vaccinated against the coronavirus or be tested regularly. Vaccinations have divided the work force and many businesses fear the requirements may cause labor shortages.
In the Australian city of Melbourne on Saturday, 235 people were arrested and six police officers were injured during a violent protest against the country’s pandemic lockdown rules, the police said. An additional 193 people at the protest were fined, according to Acting Sergeant Melissa Seach, a spokeswoman for the Victoria Police. One video shared widely on Twitter shows hundreds of protesters running down a street after breaking past a handful of police officers, several of whom were knocked to the ground.
Citing the success of Britain’s vaccine rollout, government authorities announced on Friday that coronavirus restrictions on international travel in and out of England would be eased beginning at 4 a.m. local time on Oct. 4.
The current three-tier, traffic-light-inspired system, which was introduced in May, caused confusion among Britons and the travel industry. The system going into place next month replaces that with a single “red” list of countries and territories that present the highest coronavirus risk, and simplified travel measures for arrivals from the rest of the world.
The changes were announced in a statement from Britain’s departments of Transport and Health and Social Care; the health secretary, Sajid Javid; and the transportation secretary, Grant Shapps. Mr. Shapps said it represented a simpler, more straightforward system, “one with less testing and lower costs, allowing more people to travel, see loved ones or conduct business around the world while providing a boost for the travel industry.”
The statement announced other changes as well: Starting on the same day, fully vaccinated passengers will no longer be required to take a coronavirus test before arriving in England from a country that is not on the red list, and that the test they must take on the second day after their return can be a rapid test, which is less expensive than the more accurate PCR test.
However, anyone testing positive will be required to isolate and receive negative results from a PCR test, which will be free to the traveler. The samples will be “genomically sequenced to help identify new variants,” the government’s statement said.
A negative test ahead of arrival will still be required for unvaccinated passengers, and they will also still be required to have PCR tests two and eight days later. Unvaccinated people arriving in England from red list countries will have to quarantine in a government-approved hotel for a mandatory 10 nights at their own cost.
And next week, eight countries will be removed from England’s red list: Turkey, Pakistan, the Maldives, Egypt, Sri Lanka, Oman, Bangladesh and Kenya.
Sixty-six percent of the population of the United Kingdom is fully vaccinated, and an additional 6 percent have received a first dose. But average daily deaths have risen 24 percent over the last two weeks.
And the pandemic is playing out differently across the four U.K. nations — England, Scotland, Wales and Northern Ireland — which operate independently on pandemic travel restrictions, as in many other areas of governance.
On Friday, the BBC reported that the government of Wales, where average daily cases are up 19 percent over the last two weeks, said it would follow England’s lead in adjusting its red list, and that it would “carefully consider” the proposed changes on testing.
Scotland, where average daily cases have fallen by 30 percent over the last two weeks, said that it was also easing travel restrictions, but would maintain the requirements for Day 2 and Day 8 PCR tests for vaccinated arrivals to minimize “the risk of importing variants of concern.”
The government of Northern Ireland website did not offer new guidance on its travel restrictions; cases are flat there. England’s cases are dropping off from a recent spike.
So far, 73 percent of people in Britain have received a single dose of a coronavirus vaccine, while 66 percent have received two doses, according to data collated by The New York Times.
Asking wedding guests to leave their children at home used to be among the thornier requests a couple could make.
Now, Covid precautions are adding more sensitive appeals to wedding invitations.
Tucked inside many embossed envelopes, along with dinner choices and directions to the reception, are politely worded notes telling guests they must be vaccinated, get a Covid test or do both, according to wedding planners.
Couples are not shy about asking guests about their vaccination status, said Jamie Bohlin, a wedding planner and owner of Cape Cod Celebrations in Yarmouth Port, Mass.
“I don’t get an email saying, ‘Should I ask our guests if they’re vaccinated?'” she said. “They just say, ‘We’re asking our guests.'”
In a survey of 1,400 couples last month, 22 percent said they were requiring guests to be vaccinated, according to The Knot, a wedding planning site. That was a jump from the spring, when only 3 percent of couples surveyed said they would make vaccinations a requirement, said Lauren Kay, executive editor at The Knot.
Many couples are taking measures like setting up mobile testing sites the day before their weddings; informing guests that they will need to wear masks throughout the reception; and providing color-coded bracelets that indicate which guests are fine with hugging and which want to keep their distance, according to wedding planners.