FDA authorizes boosters of the Pfizer-BioNTech coronavirus vaccine for older adults and others at high risk from COVID-19

pfizer vaccine distribution UK
A nurse prepares to inject staff with the Pfizer/BioNTech coronavirus vaccine.

  • The FDA authorized boosters of the Pfizer-BioNTech coronavirus vaccine for older adults and people at higher risk.
  • Booster shots are likely to be available in locations like pharmacies and clinics at no cost.
  • The US is still struggling to convince many people to get their first doses of coronavirus vaccines.
  • See more stories on Insider’s business page.

The US coronavirus booster-shot campaign has cleared a crucial hurdle.

The Food and Drug Administration on Wednesday authorized booster doses of the Pfizer-BioNTech coronavirus vaccine for older adults and others at high risk from the pandemic. Boosters can be given starting six months after the first two doses of the shot. The agency said that getting a third shot is safe and can help increase protection against the disease.

The FDA decision caps more than a month of messy debate over the US vaccination drive. In mid-August, a group of President Joe Biden’s top health officials issued an extraordinary joint statement saying that boosters were coming. The statement prompted controversy because it came before reviews by the FDA and the Centers for Disease Control and Prevention, and before much data on the safety or effectiveness of boosters was available.

The US has already greenlit an extra vaccine dose for people with compromised immune systems, and some countries have embarked on booster-shot campaigns focused on vulnerable individuals.

Under the FDA’s emergency-use authorization, four main groups of people are eligible for booster shots:

  • People 65 and older;
  • People 18 to 64 who are at high risk of a severe case of COVID-19 if they get sick;
  • People 18 to 64 who are at higher risk of getting COVID-19 at work, such as healthcare workers and teachers;
  • People 18 to 64 who are at higher risk of getting COVID-19 because of where they live, such as those in prisons and other institutions.

Protecting the most vulnerable amid the pandemic

The hope is that booster shots will help protect those most at risk as the pandemic continues to surge, fueled by the rise of the Delta variant. Delta is more contagious, and appears to be able to partially elude the protection offered by vaccines.

Still, the US is struggling to convince much of its population to get coronavirus vaccines at all. Just over 64% of people 12 and older are fully vaccinated, according to the CDC.

“At this moment, it is clear that the unvaccinated are driving transmission in the United States,” Dr. Amanda Cohn from the CDC said during an FDA meeting on boosters shots on Friday. Cohn said that masks and social distancing are still crucial, because “vaccination will never be perfect” at preventing every case.

The CDC still needs to weigh in formally on who should be prioritized to receive booster doses. The agency’s vaccine advisory committee is set to discuss booster shots on Thursday.

Janet Woodcock
Interim FDA Commissioner Janet Woodcock.

The Biden administration has said that once approved, booster shots will be widely available in locations like pharmacies and clinics. They’ll be offered to individuals for free.

Expanding the reach of boosters

The FDA decision is a setback for Pfizer, which had asked the agency to make boosters available to everyone over age 16, six months after their second dose.

It comes after a panel of doctors and other experts advising the FDA voted against the idea of making booster shots available that widely. The panel instead said that boosters should be given to people 65 and older, and to those most at risk of severe cases of COVID-19.

Experts on the panel said there wasn’t enough evidence showing the benefits of an extra vaccine dose for younger people. They also expressed concern that there wasn’t enough safety data for younger adults, highlighting the risk of myocarditis, or heart inflammation, that has been seen at higher-than-usual levels in teenagers and 20-somethings who have been vaccinated.

“The incremental benefit to the younger population really has not been demonstrated at all,” Dr. Michael Kurilla, an infectious disease expert from the National Institutes of Health, said during the meeting.

“I think we need to target the boosters right now specifically to the people who are likely to be at high risk, and it’s an older population.”

‘A good step to protect yourself’

Infectious-disease experts who aren’t on the FDA’s committee said the group made the right call to limit the initial rollout to more vulnerable people.

“If you fall into the age category, this is a good step to protect yourself,” said Gigi Gronvall, an immunologist and senior scholar at the Johns Hopkins Center for Health Security.

The booster rollout shouldn’t distract from effort to get more unvaccinated people to get their initial shots, said Bernadette Boden-Albala, director of the University of California, Irvine’s public-health program.

“If you’re not vaccinated, get vaccinated,” Boden-Albala said. “If you are vaccinated, be vigilant. And if you’re vaccinated and eligible for the booster, get it.”

The FDA still has plenty of work ahead on coronavirus vaccines. The agency is reviewing an application from Moderna to give a third shot of its two-dose vaccine. Johnson & Johnson recently put out data showing that its vaccine is more effective after a second dose, and said it’d provided the information to the FDA.

The agency is also being pressed to make vaccines available to younger kids. Pfizer has said it plans to submit data from a study of kids ages 5 to 11 to FDA in early October, and the agency could reach a decision by the end of that month. The drugmaker then plans to submit data from kids between 6 months and 5 years old in November.

Kathrin Jansen, Pfizer head of vaccine research and development
Kathrin Jansen, Pfizer’s head of vaccine research and development

The case for boosters

To make the case for booster shots, Pfizer presented results from at least eight studies showing protection from the vaccine wanes over time and that a booster could help. The company also cited data from Israel that showed big benefits from boosters in older people. That data comes from an observational study and could be skewed by factors that researchers weren’t aware of or couldn’t account for.

The FDA’s own review of the evidence for extra shots avoided taking a firm stance on some of the largest questions surrounding boosters, and noted that Pfizer didn’t formally evaluate the efficacy of boosters.

In a statement on Friday, Pfizer said that it believes booster shots are “a critical tool in the ongoing effort to control the spread of this virus.”

“We continue to believe in the benefits of a booster dose for a broader population,” Kathrin Jansen, Pfizer’s head of vaccine research & development, said in the statement.

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A massive study from Israel suggests older adults were far less likely to develop severe COVID-19 after a booster shot, but the finding carries major limitations

israel vaccine
An Israeli receives a coronavirus vaccine from medical staff at a COVID-19 vaccination center in Tel Aviv, Israel, Wednesday, Jan. 6, 2021.

  • A third dose of Pfizer’s coronavirus vaccine dramatically reduces the risk of infection and severe illness for older adults, a new study found.
  • A team of researchers in Israel published the findings Wednesday in The New England Journal of Medicine.
  • Still, an expert urged caution on interpreting the findings, saying the study has major limitations.
  • See more stories on Insider’s business page.

Older adults in Israel who received a booster shot of Pfizer’s coronavirus vaccine were far less likely to get infected or develop severe illness, a massive study published on Wednesday found.

Including more than 1.1 million people who are 60 and older, the study looked at thousands of infections and hundreds of cases of severe illness, providing some of the most compelling evidence yet on the value of booster shots.

Israel started offering booster doses to its older population on July 30, and a group of researchers analyzed national healthcare records through the month of August.

Israeli study shows boosters cut the risk of infection and severe cases of COVID-19

The main finding was the older population, when boosted, was 11 times less likely to get infected and 19.5 times less likely to get severely ill compared to similar people who had received two doses but not a booster shot.

The study is likely to be influential, because its publication comes just two days before the Food and Drug Administration convenes an independent expert panel to discuss Pfizer’s application to give booster shots in the US. Israeli health officials are scheduled to present findings from their booster campaign at that Friday meeting, and US health officials have pointed to Israel’s experience to bolster their argument for booster shots.

The Biden administration has already said it plans to start offering booster shots to the general public on September 20, depending on OK’s from the FDA and the Centers for Disease Control and Prevention.

In the Israeli study, the group that didn’t get boosters recorded 4,439 infections and 294 severe illnesses. The booster group had 934 infections and 29 severe cases. The risk reduction rates accounted for the fact that the two groups were not even in size, as far more people joined the booster group over time.

The data should be viewed with caution

The result that booster shots reduced the risk of severe illness by nearly 20-fold is surprising, and should be viewed with some skepticism, said Ellie Murray, an epidemiologist at Boston University.

The study has major limitations, she said. Most notably, the researchers observed the real world, rather than testing a booster under more controlled conditions. This means there can be a lot of factors that could skew the results.

As one example, the group of people who are first in line to get boosted may be more cautious with other virus-prevention methods, like masking or social distancing. They could be less likely to get infected for those reasons, instead.

Additionally, the study has a very limited follow-up time, and doesn’t show how long protection from boosters may last. That’s an essential question in figuring our whether a booster campaign is worth launching.

The study’s limited duration may skew its findings. Researchers started counting cases for the booster group only when they are 12 days removed from the third dose.

It can take up to a month on average for a person to go from exposed to infected to seriously ill, Murray said. Therefore, the study may not include enough follow-up time to show the true effect of the boosters.

There aren’t any high-quality studies on booster shots

“It’s not clear to me that there’s anywhere near enough follow-up time, even for the earliest boosters,” Murray said.

“All of these problems together make it really hard to know how much we can trust that number that comes out of the study,” Murray added.

The broader challenge is that there’s an absence of high-quality data that provides better answers to these questions. The leading vaccine developers are not running randomized, controlled trials testing booster doses against a placebo and seeing which group fares better in the long run. Instead, drugmakers have run small studies, boosting a few hundred people and finding an elevated immune response, which may suggest but not prove better protection, particularly against severe illness.

The Israeli researchers attempted to account for a number of potential confounding factors, including demographic differences between the boosted and non-boosted populations in Israel. They analyzed the data with several techniques that produced slightly different numbers but the same overall result: a massive reduction in infection risk, lying somewhere between 10-times and 13-times lower for the boosted population, depending on the analysis performed.

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Doctors are speaking out to dispel the ‘groundless’ myth that the COVID-19 vaccine affects fertility in women or men

woman receiving covid vaccine
A woman receives the COVID-19 vaccine in Wales, UK.

  • Rumors that the COVID-19 vaccine affects fertility continue to circulate.
  • No evidence or even theory suggests the shots could impact fertility, but COVID-19 may.
  • Medics have come together on social media to reinforce the message.
  • Visit the Business section of Insider for more stories.

For months, dangerous rumors on social media have claimed that getting vaccinated against the coronavirus could hamper male and female fertility. Celebrities too have perpetuated these false concepts.

But doctors and scientists say there’s no evidence or even theory suggesting the shot affects fertility. On the contrary, COVID-19 may.

“We want to reassure women that there is no evidence to suggest that COVID-19 vaccines will affect fertility. Claims of any effect of COVID-19 vaccination on fertility are speculative and not supported by any data,” Dr. Edward Morris, President at the Royal College of Obstetricians and Gynecologists, said in a January statement.

“There is​ ​no biologically plausible mechanism by which current vaccines would cause any impact on women’s fertility.”

mRNA vaccines cannot enter cells, and tracking systems haven’t raised red flags

It’s thought the rumors began following a now-blocked Facebook post which incorrectly suggested that the vaccine teaches the body to attack a protein involved in placental development.

In reality, the protein the vaccine spurs the body to make and attack bears little resemblance to the one in the placenta.

Plus, based on the way the mRNA vaccines are made, they are “not going to be able to enter the cell of the baby and cause any problem, mechanistically speaking,” Dr. Zaher Merhi, an OB-GYN, reproductive endocrinology and infertility specialist, and the founder of Rejuvenating Fertility Center, previously told Insider.

And, tens of thousands of people have gotten or remained pregnant after vaccination, according to three safety monitoring systems. That data shows that the vaccine isn’t linked to any increase in adverse pregnancy outcomes like miscarriage, preterm birth, or death.

“You’re much more likely to have fertility issues post-COVID than after the vaccine,” Nicola Stonehouse, a virologist at the University of Leeds, told the BBC. One May study even suggested that COVID-19 can damage penile blood vessels, potentially leading to erectile dysfunction and impotence.

Hence more than 20 American medical organizations writing a consensus that people who are or are planning to get pregnant should “feel confident in choosing vaccination to protect themselves, their infants, their families, and their communities.”

Doctors are speaking out against the rumors

On September 9, the CDC tweeted that people who want to become pregnant should get the vaccine.

Other medical professionals, including British general practitioner Dr. Amir Khan, have been reinforcing the message.

Television doctor Dr Christian Jessen said she was excited to get the vaccine and not concerned about her fertility.

Dr. Leah Gilliam, a family doctor in Lexington, Tennessee, tweeted that her pregnancy is proof the vaccine doesn’t cause infertility.

And, in reply to Nicki Minaj’s claim that her cousin’s friend became impotent after getting the shot, Dr. Uche Blackstock, an MSNBC medical contributor, said she’d like to talk.

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Qantas says it will ban unvaccinated travelers from international flights

Qantas Airbus A380
A Qantas Airbus A380.

Qantas has confirmed plans to bar unvaccinated passengers from international flights when Australian travel restrictions lift.

“Qantas will have a policy that internationally we’ll only be carrying vaccinated passengers,” CEO Alan Joyce said Wednesday, according to Traveller.com.au.

“Because we think that’s going to be one of the requirements to show that you’re flying safe and getting into those countries. We’re hoping that can happen by Christmas.”

Australia’s borders are currently fully closed, with exemptions given only to Australian citizens and permanent residents, and some other people who can prove their need to travel.

“We think everybody should be protecting themselves, but we also have a requirement to protect our colleagues and our passengers. And then there’s also a requirement to protect the community,” Joyce said.

It was not clear whether Qantas would require passengers on domestic flights to be vaccinated as well. The airline did not immediately respond to Insider’s request for comment.

Qantas announced last month that it would require all its frontline employees, from cabin crew to airport workers, at both Qantas and its budget affiliate Jetstar to be fully vaccinated by November 15, with some medical exemptions given. All other employees will be required to get their vaccinations by March 31, 2022, it said.

The airline currently runs a COVID-19 vaccination scheme in which frequent flyers who are fully vaccinated can either get Australian dollars ($15) taken off their next Qantas or affiliate flight, or extra frequent-flyer points.

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Israel’s coronavirus czar is calling for preparations for a 4th vaccine dose

rabbi israel coronavirus covid vaccine
Rabbi Yisrael Meir Lau receives a COVID-19 coronavirus vaccine in Tel Aviv, Israel.

  • Israel’s coronavirus czar suggested that people may need a fourth shot of COVID-19 vaccine.
  • He said the country needs to “prepare” for that, but didn’t give a timeline.
  • Israel is currently giving most people third vaccine doses as a booster.
  • See more stories on Insider’s business page.

Israel’s coronavirus czar has called for the country to prepare to roll out a fourth coronavirus vaccine dose.

Salman Zarka told Israel’s Kan public radio on Saturday that “given that that the virus is here and will continue to be here, we also need to prepare for a fourth injection,” The Times of Israel reported.

Zarka did not outline a timeline for when those vaccines could be given.

Israel is already rolling out a vaccine booster shot to most people, which would be their third dose.

The country’s health minister last week granted access to a third shot to everyone over the age of 12 who had received their second shot at least five months earlier.

Zarka said on Saturday that the booster could be modified to better target variants of the virus.

He told The Times of Israel in August that people could need to get a shot “every few months – it could be once a year or five or six months.”

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Tyson announces vaccinated workers can get 20 hours of paid sick leave starting next year

Two people wearing white jumpsuits leave a Tyson Foods facility on a sunny day in Indiana
A Tyson Foods pork processing plant in Indiana.

Tyson will give fully vaccinated workers 20 hours of paid sick leave a year to incentivize employees to get the shot.

The meat processor announced the new paid sick leave policy Friday. Tyson will also give all new vaccinated hires one week of paid vacation after six months of employment.

In August, Tyson mandated all employees get the vaccine by November 1 due to the surge of COVID-19 cases stemming from the delta variant.

Tyson worked with unions representing 31,000 workers on the new policy, which will cover workers in all US facilities, per The Wall Street Journal.

Tyson is not the only firm to announce changes in benefits for vaccinated and unvaccinated employees. Delta announced unvaccinated workers would have to pay $200 more for health insurance per month. The charge would cover the financial risk taken on by Delta for having unvaccinated employees, CEO Ed Bastian announced in August.

Other companies are offering cash incentives for vaccinated workers. Amazon reportedly instituted a lottery where vaccinated employees have a chance to win cars, vacation packages, and $500,000. Kroger gave employees a one-time $100 payment for getting the vaccine, and Walmart doubled its cash incentive to $150.

“These measures are the latest examples of our ongoing efforts to make Tyson the most sought-after place to work, while reinforcing the importance of team members’ health and safety,” Johanna Söderström, executive vice president and chief human resources officer of Tyson Foods, said in a statement.

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The judge ruling over Elizabeth Holmes’ Theranos trial dismissed 9 people from the jury pool because they were unvaccinated

elizabeth holmes
Elizabeth Holmes, founder of Theranos.

  • US District Judge Edward Davila is presiding over the trial of Theranos founder Elizabeth Holmes.
  • Earlier this week he dismissed nine people as jurors because there weren’t vaccinated.
  • He cited concerns about the health of jurors and their families as the reason for his decision.
  • See more stories on Insider’s business page.

The judge presiding over the Theranos trial has dismissed nine people from the jury pool because they were not vaccinated, Reuters reported Tuesday.

US District Judge Edward Davila took the action on Tuesday, saying his decision was motivated by concern for jurors’ health and those of their families, Reuters reported.

Both the defense and the prosecution supported the decision, the agency reported.

Dismissing jurors on the basis of their not being vaccinated is within the court’s power, and could arise more frequently as courts resume in-person trials, Reuters noted.

But Hadar Aviram, a professor at the University of California Hastings College of the Law, told Reuters that excluding unvaccinated people could lead to a jury that is not representative of the general population.

For example, a July poll from Axios and Ipsos showed that white conservatives are more likely to be resistant to being vaccinated in the US.

Information about the dismissed jurors’ genders, ages, and ethnicities were not made publicly available.

A panel of seven men and five women were sworn in on Thursday for Holmes trial, Bloomberg reported.

The trial’s opening statements are expected next Wednesday.

The Department of Justice has charged Theranos founder Holmes and former chief operating officer Ramesh “Sunny” Balwani with nine counts of wire fraud, and two counts of conspiracy to commit wire fraud in 2018 on allegations that the pair had defrauded investors, medical professionals, and customers. Both have pleaded not guilty.

Holmes could face up to 20 years in prison if convicted, as Insider’s Melkorka Licea has reported.

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A majority of US companies say they’re planning to require employees to get vaccinated by the end of the year

COVID 19 vaccine

More than half of US companies plan to require some or all of their employees to get vaccinated against COVID-19 by the end of the year, according to a survey published by Reuters.

The survey, which polled 961 US companies that employ a total of around 9.7 million people, found that 52% of employers plan to have one or more vaccine mandate requirements.

Among the companies requiring some kind of a vaccine mandate are Google’s parent Alphabet Inc and Goldman Sachs Group.

Willis Towers Watson, which conducted the survey, polled employers between August 18 and 25, Reuters reported.

This is a developing story. Please check back for updates.

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2 top FDA officials resigned over the Biden administration’s booster-shot plan, saying it insisted on the policy before the agency approved it, reports say

Joe Biden
President Joe Biden.

  • The FDA announced the resignations of Marion Gruber and Philip Krause on Tuesday.
  • The pair lead the FDA office in charge of approving vaccines.
  • Politico and Endpoints reported that the pair left in frustration over Biden’s COVID booster plan.
  • See more stories on Insider’s business page.

The US Food and Drug Administration announced the resignations of two top vaccine officials on Tuesday, and reports said the two were leaving the agency in anger over the Biden administration’s plan to roll out COVID-19 booster shots before the officials had a chance to approve it.

Dr. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, plan to leave the FDA in October and November respectively. BioCentury first reported the news on Tuesday.

In a letter announcing the resignations, obtained by the biotech-industry publication Endpoints, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, praised the pair for their work during the COVID-19 pandemic. He didn’t give a reason for their departure.

But sources who spoke to Endpoints and Politico said Gruber and Krause were upset with Biden administration’s booster-shot plan. The Biden administration announced last month that most people will be offered a COVID-19 booster shot about eight months after vaccination.

One former senior FDA leader told Endpoints that Gruber and Krause were leaving the agency because they felt that the Centers for Disease Control and Prevention was making vaccine decisions that should have been left to the FDA, and were upset with Marks, the leader of their division, for not insisting that these decision be made by the FDA.

The source said the final straw was the Biden administration’s announcing plans to start booster shots before the FDA had officially signed off on the plan.

A former FDA official also told Politico that the resignations are tied to anger over the FDA’s lack of autonomy in booster planning, while a current official told the outlet that the pair are leaving over differences with Marks.

When asked about these reports on Tuesday, White House coronavirus czar Jeff Zients said the decision to start booster shots “was made and announced by the nation’s leading public health officials” including the acting FDA commissioner, the CDC director, the surgeon general, the director of the National Institutes of Health, and others.

“Having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” Zients said.

“We have been – also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”

The FDA, Gruber, Krause did not immediately respond to Insider’s request for comment.

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1 in 3 Americans says a COVID-19 vaccine mandate would deter them from dining in a restaurant

Outdoor dining
Vaccine and mask mandates would deter 1 in 3 Americans from dining in restaurants.

  • About a third of Americans would be put off dining in a restaurant if a vaccine mandate was in force.
  • But an equal proportion would be more likely to dine indoors with such a mandate in place, a survey found.
  • New York City and San Francisco are mandating vaccines for indoor dining.
  • See more stories on Insider’s business page.

One in three Americans say they’d be less likely to dine in a restaurant if they were forced to prove they’d been vaccinated, according to a survey by the National Restaurant Association.

The same proportion – 32% – said they’d be deterred from restaurant dining if they had to a wear masks, the survey, published Tuesday, showed.

However, 33% said that a vaccine mandate would actually make them more likely to dine in a restaurant. Meanwhile, 25% said a mask mandate would make them more likely to eat indoors.

New York City, San Francisco, New Orleans, and Los Angeles are among the cities that have already introduced or are considering introducing vaccine mandates for activities like indoor dining.

An analysis published in Nature found that the majority of COVID-19 infections early in the pandemic could be traced to “superspreader” locations, which included restaurants.

According to the National Restaurant Association survey, 35% of Americans say that a vaccine mandate wouldn’t impact their restaurant use either way. The poll of 1,000 adults was conducted in mid-August.

Read more: A startup is attracting entrepreneurs with its automated soft-serve vending machine that requires virtually no labor to operate in America’s malls

Restaurants fear backlash over vaccine and mask mandates

Some restaurant owners are worried that a vaccine mandate could lead to a drop in business from people who either aren’t vaccinated or don’t want to share their vaccination status. Just over a quarter of US adults haven’t received their first vaccine yet, according to the CDC.

Art Depole, the owner of the Mooyah Burgers, Fries, and Shakes restaurant in Times Square, told Insider that New York City’s vaccine mandate was deterring visitors from his restaurant. Business fell by up to 25% the week the city introduced its mandate, he said.

This loss in business could cause his restaurant to raise prices, Depole said. He said that around 20% of his staff planned to resign over the policy, too.

Depole said he understood the reasoning behind the vaccine mandate, but that the restaurant industry was “the easy target” and being “unfairly picked on.”

Restaurants that voluntarily enforced their own vaccine mandates told Insider that some customers had left bad reviews and threatened to spit on and cough at staff over the policy.

Like the vaccine mandate, the mask mandate faced some public backlash when it was introduced, and some retail and hospitality workers said they were subjected to violence and harassment when asking customers to mask up. One 19-year-old McDonald’s worker told Insider she was assaulted after asking a customer to wear a mask.

People’s dining habits are changing as the Delta variant spreads across the US. Sixty percent of adults said they’d changed their restaurant use due to the rise in the Delta variant, with more people choosing to dine outdoors or shun restaurants altogether, per the National Restaurant Association survey.

This comes as restaurants continue to be hit by both labor and supply shortages, causing some to raise prices or slash opening hours. Three in four restaurant owners told the National Restaurant Association that recruiting and retaining employees was their top challenge in July. In January, this was just 8%.

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