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New York will require masks indoors for businesses and venues that do not have a  COVID-19 vaccine requirement, Gov. Kathy Hochul (D) announced Friday.  

Driving the news: New York's statewide seven-day average case rate has increased by 43% and hospitalizations have increased by 29% since Thanksgiving, Hochul's office said in announcing the measure. 

Late last month, Hochul declared a state of emergency amid rising COVID-19 cases and the emergence of the Omicron variant.

Details: The mandate will take effect on Monday and last through at least Jan. 15, 2022. 

Violations of the measure can result in a $1,000 fine, Hochul's office said. 

What they're saying: "As Governor, my two top priorities are to protect the health of New Yorkers and to protect the health of our economy. The temporary measures I am taking today will help accomplish this through the holiday season," Hochul said in a statement. 

"We shouldn't have reached the point where we are confronted with a winter surge, especially with the vaccine at our disposal, and I share many New Yorkers' frustration that we are not past this pandemic yet," she added. 

NYC to impose vaccine mandate on private employers

Gov. Hochul will order some NY hospitals to halt elective surgeries

NY to impose indoor mask mandate for businesses without vaccine requirement

The measure is needed to protect the health of New Yorkers through the holiday season, Gov. Kathy Hochul said.

Governor Kathy Hochul at a pres conference. Photo: Lev Radin/Pacific Press/LightRocket via Getty Images

COVID-19

Coronavirus

2024 will be an election year like no other, as President Biden seeks re-election amid economic uncertainty, two wars and questions about his age. His likely foe, former President Trump, faces felony charges and vows revenge on his political enemies. Meanwhile, Americans generally are dissatisfied with those choices and are divided over immigration, race, education and more.

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The U.S. health system faces critical questions about cost, access and equity. Technological advances and new discoveries about diseases like cancer and Alzheimer’s are transforming patient care and reshaping public health.

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If initial data suggesting booster shots are necessary to protect against Omicron bears out, that would mean the world needs more doses — and inequities between high- and low-income countries would almost certainly be exacerbated.

Why it matters: When parts of the world are left without adequate protection to the virus, it leaves everyone vulnerable to dangerous new variants, experts say.

Where it stands: Initial data from Pfizer suggests two doses of the vaccine don't offer much protection against the rapidly-spreading Omicron variant, but three doses do. 

NIAID Director Anthony Fauci told CNN this week that "it's going to be a matter of when, not if" the definition of "fully vaccinated" changes from two shots of Pfizer and Moderna's vaccines

Fauci added he doesn't see the definition "changing tomorrow or next week," but he believes it's "going to be considered literally on a daily basis."

Between the lines: Having enough doses of vaccine to offer everyone three of them is a luxury currently enjoyed almost exclusively by wealthy countries. 

In low-income countries, the vast majority of the population hasn't received any doses. 

The world was already facing a vaccine shortage before Omicron, although it had been narrowing. But if billions more booster doses are suddenly added to the list of new doses needed, that will exacerbate the shortage.

What they're saying: We're currently on track to have enough vaccine supply to vaccinate 70% of the world with two doses by early next year, but changing the standard to three doses would stretch out that timeline, said KFF's Josh Michaud. 

“We’ll need more doses and that’s a real concern," Michaud said.   

"It just ups the complexity of distributing those doses, planning to administer those doses, making sure people are reached and shots go into arms," he added.

Yes, but: Most wealthy countries already bought booster doses, meaning they'd been accounted for in global supply calculations even before Omicron. 

That would shrink the number of new doses needed for boosters as long as there doesn't end up being a variant-specific vaccine — and as long as health officials don't end up recommending a fourth shot, a possibility already raised by Pfizer CEO Albert Bourla. (Pfizer has a lot of money at stake in the booster debate, meaning Bourla's comments should be taken with a grain of salt.)

"One key variable is how well different vaccines hold up. If only some of the available vaccines prove to be effective, or if we need variant-specific vaccine, that supply is likely to be very constrained," said Krishna Udayakumar, founding director of the Duke Global Health Innovation Center.

The big picture: Vaccine production has been steadily ramping up. There will eventually be enough doses for the world, even if everyone needs three shots; the question is when, and how that timeline compares against the spread of Omicron or other variants.

"Increase to three doses would increase demand, but over time," Udayakumar said. "Overall supply could still be adequate so long as countries don’t keep large stocks on hand."

What we're watching: Activists had already been pushing the Biden administration and other wealthy countries to take much stronger action to increase global vaccine supply even before Omicron emerged. 

“This may represent the next phase of vaccine apartheid. Pharmaceutical corporations will funnel hundreds of millions of third doses to rich countries, even as large parts of the world remain unable to access their first," Public Citizen's Zain Rizvi told Axios in an email.

"Governments must rapidly expand global mRNA manufacturing around the world, so everyone has the best tools to face new variants—not just the lucky few," he added. "That is how we end the pandemic.”

Omicron threatens to deepen global vaccine disparities

If the world needs a booster, that widens the supply gap.

The first two boxes have a checkmark made of a syringe, and the third box has a large X in the middle.

COVID-19 vaccines

Supreme Court Chief Justice John Roberts on Thursday dismissed an emergency request to block the federal mask mandate for air travel amid litigation in the lower courts.

Driving the news: Michael Seklecki, a Florida resident, filed a lawsuit against the Transportation Security Administration on behalf of himself and his 4-year-old son, and Lucas Wall, from Washington, joined the suit, all citing medical reasons.

The government argued in an appeal to the U.S. Court of Appeals for the D.C. Circuit that Congress had authorized the policy for safety reasons and noted "the challengers had not pursued an available procedure for obtaining medical exemptions," per the New York Times.

The appeals court has yet to rule on the suit.

Between the lines: Roberts didn't comment on his ruling, nor did he request a response to the emergency relief application or refer it to the full Supreme Court, indicating he "viewed the legal question in the case as insubstantial," the NYT notes.

The big picture: The TSA has on several occasions extended the mask mandate in response to surging COVID-19 cases and the threat of the Delta variant.

The current order for planes, trains, buses and at airports is due to expire March 18.

Chief justice rejects request to block air travel mask mandate

A lower court has yet to rule on the lawsuit.

Chief Justice of the US Supreme Court John Roberts arrives at a joint session of Congress in the House chamber of the U.S. Capitol April 28.

Supreme Court Chief Justice John Roberts in Congress in April. Photo: Michael Reynolds /Pool/Getty Images

Face masks

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After a record economic expansion, the coronavirus pandemic sent the U.S. economy into a recession as unemployment soared to staggering heights. The country now faces urgent questions about how much stimulus is needed for reeling consumers and businesses, and what a recovery might look like.

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The Food and Drug Administration on Thursday expanded its emergency use authorization for Pfizer-BioNTech's COVID-19 vaccine booster shots to include those aged 16 and 17.

Why it matters: The move could expand access to the boosters at a time when there's increasing concern about the Omicron variant.

Pfizer and BioNTech said Wednesday that two doses of their COVID-19 vaccine were significantly less effective at neutralizing Omicron in early lab tests, but a three-dose regimen was more effective.

The big picture: The FDA last month endorsed booster shots of the Pfizer-BioNTech and Moderna COVID-19 vaccines for adults. 

"The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series," Pfizer and BioNTech said in a statement.

"The booster vaccination increases the level of immunity and dramatically improves protection against COVID-19 in all age groups studied so far," BioNTech CEO and co-founder Ugur Sahin added.

What they're saying: “Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” acting FDA Commissioner Janet Woodcock said in a statement. 

“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.” 

What's next: The Centers for Disease Control and Prevention must still sign off on boosters for 16- and 17-year-olds before the shots are available to the age group. 

Go deeper... Fauci: It's "when, not if" definition of "fully vaccinated" changes

FDA authorizes Pfizer COVID booster shots for 16- and 17-year-olds

The move could expand access to third doses at a time when there's increasing concern about the Omicron variant.

 Pharmacy technicians prepare doses of the Pfizer-BioNTech vaccine at a mass COVID-19 vaccination event on January 30, 2021 in Denver, Colorado. 

Change in COVID-19 <span style="background:#432371; padding:0px 5px 3px 5px;color:white;">cases</span> per 100k people in the last two weeks

Data: N.Y. Times; Cartogram: Kavya Beheraj/Axios

COVID-19 cases and deaths are rising all across the U.S. even before the Omicron variant takes hold.

Why it matters: The holidays — and the inevitable spread of Omicron — will only heighten the risks that unvaccinated Americans face from COVID, in all its forms.

Where it stands: The U.S. is now averaging roughly 120,000 new COVID cases per day, a 26% increase over the past two weeks.

Average cases briefly dipped below 100,000 as the summer's Delta wave receded, but the virus has rebounded quickly. New infections were climbing even before Thanksgiving, and holiday travel likely is accelerating the virus' spread even further.

Deaths are also on the rise, after tapering off in the fall.

The virus is now killing about 1,300 Americans per day, on average. That's a 14% increase over the past two weeks. 

At this rate, the U.S. will pass 800,000 total deaths — roughly equivalent to the population of the Charleston, South Carolina, metro area — before Christmas.

What we're watching: The Omicron variant is gaining ground worldwide, but Delta remains the dominant strain of COVID-19 within the U.S. — and it's still doing a lot of damage. 

Vaccinated people are highly unlikely to die or get seriously ill from the Delta variant, though they can still contract the virus. 

Some preliminary research suggests that the vaccines may be somewhat less effective against Omicron, at least without a booster dose. 

But no matter how those gradients shake out, the people at the greatest risk of severe illness and death are the unvaccinated.

40% of Americans, and nearly 30% of American adults, are not vaccinated, according to the CDC.

COVID cases and deaths are on the rise

Delta is still doing a lot of damage even before Omicron spreads.

Preliminary studies suggest that two doses of existing coronavirus vaccines are significantly less effective against the Omicron variant, but booster shots confer much stronger immunity.

The big picture: Early South African hospitalization data also indicates that Omicron may cause milder disease than previous variants. If both of those signals continue to hold, an Omicron wave may not be as bad as feared.

Driving the news: Pfizer and BioNTech said yesterday that three doses of their vaccine effectively neutralizes the Omicron variant, at levels comparable to the what two doses offered against earlier variants. 

If that is an indicator of real-world clinical outcomes, that's good news — it would mean the vaccines work incredibly well, especially against severe disease.

And even two doses may still offer strong protection against severe illness, if not from milder infections, the companies wrote in a press release.

The intrigue: Although Omicron is spreading rapidly around the world, there's a chance that it causes less severe disease than other variants — which would be welcome news for both the vaccinated and the unvaccinated.

South African researchers have said that coronavirus patients showing up to the hospital are not as sick as the ones they've treated before, per the NYT, but this data too is still extremely preliminary. 

What we're watching: It's too early to take either of these encouraging signs to the bank. There's still plenty of time for South African hospitalization data to take a dark turn, and researchers are still studying how well the vaccines work against the variant in the real world.

But for now, there's at least hope that we've avoided the worst-case scenarios.

Emerging Omicron data offers glimmers of hope

Booster shots may work against it, and it may cause milder disease.

Illustration of coronaviruses with radiating circles.

The Food and Drug Administration issued an emergency use authorization for an AstraZeneca COVID-19 antibody drug for people with compromised immune systems.

Why it matters: The drug, Evusheld, is the first antibody therapy authorized in the U.S. to prevent coronavirus symptoms before virus exposure.

It provides long-lasting protection with a single dose and is authorized for certain adults and adolescents who are not currently infected with COVID-19 and who haven't recently been exposed.

Currently, it is only authorized for immunocompromised people, including organ transplant recipients, blood cancer patients,  and people taking immunosuppressive drugs for conditions like rheumatoid arthritis.

What they're saying: Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, noted in a statement that vaccines were still the best defense against COVID-19. 

"However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option," Cavazzoni added. 

"Today's action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals."

How it works: The drug is made up of two monoclonal antibodies, laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses — tixagevimab and cilgavimab.

It's administered via two injections — one of each monoclonal antibody — in the same sitting and may provide up to six months of protection.

By the numbers: Under the agreement, AstraZeneca will supply the U.S. government with 700,000 doses of Evusheld, to be proportionally distributed across states at no cost and on a pro rata basis.

FDA approves AstraZeneca COVID drug for people with immune problems

It's the first COVID antibody drug in U.S. to prevent symptoms before virus exposure.

An employee wearing a protective mask collects a lunch delivery from a table outside an AstraZeneca Plc research and development facility in Shanghai, China, on Monday, June 8, 2020. 

Photo: Qilai Shen/Bloomberg via Getty Images

AstraZeneca

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Of the more than 40 known cases of the Omicron variant in the U.S., nearly all are mild, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said Wednesday in an interview with AP.

Why it matters: Concern has ramped up with health experts forecasting a rise in Omicron cases. Over three-quarters of U.S. patients had been vaccinated, and one-third had gotten their booster shots, according to Walensky.

What she's saying: "The disease is mild" in most cases so far, Walensky told AP. Coughing, congestion and fatigue make up the bulk of reported symptoms. 

Though one person was hospitalized, there have been no deaths so far, per AP.

Data remains limited, but the CDC is preparing an analysis on Omicron's likely impact in the U.S., Walensky added.

"What we don't yet know is how transmissible it will be, how well our vaccines will work, whether it will lead to more severe disease," she told ABC's "This Week" on Sunday.

Nearly all U.S. cases of Omicron are mild, CDC director says

Coughing, congestion and fatigue make up the bulk of reported symptoms.

Photo of Rochelle Walensky looking to her right

U.S. Centers for Disease Control and Prevention Director Rochelle Walensky. Photo: Stefani Reynolds/Pool via Getty Images

Omicron variant COVID

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Axios Pro Rata

Former FDA commissioner Stephen Hahn tells Axios that Americans may eventually require annual COVID vaccination boosters, although acknowledges that right now it's just his "best guess."

Why it matters: COVID jabs could become as routine as flu shots.

He says a key factor will be the virus' level of virulence as it mutates. 

"What I find interesting with Omicron is that there are some early and encouraging results of people not getting particularly sick from this variant," Hahn explains. "Viruses often mutate to survive, but become less virulent during that mutation, so that might be what we're seeing ... Instead of getting a booster every six months, it could maybe be once a year."

Post-FDA: Hahn, an oncologist by training, this week was named CEO of Harbinger Health, which is seeking to develop simple blood tests for very early cancer detection. 

Harbinger is a portfolio company of venture capital firm Flagship Pioneering, which is best known for creating and funding Moderna. Hahn joined Flagship over the summer as  head of its preemptive medicine and health security initiative.

He says that his patients would always want to know about the origins of their cancers, and that Harbinger seeks to reverse engineer that question.

Ex-FDA chief: COVID jabs could become as common as flu shots

Hahn, who served under President Trump, says a key factor will be the virus's level of virulence as it mutates.

Stephen Hahn testifying in front of Congress.

At This Hour With Kate Bolduan-11 21 54 Am - 11 23 01 Am-2021-12-08

NIAID director Anthony Fauci told CNN Wednesday that in his personal opinion, "it's going to be a matter of when, not if," the definition of "fully vaccinated" changes.

What he's saying: Fauci said he doesn't see the definition "changing tomorrow or next week," but he believes it's "going to be considered literally on a daily basis." 

"I don't think anybody would argue that optimal protection is going to be with a third shot," he told CNN's Kate Bolduan. "It's a technical, almost semantic definition, and it is the definition for requirements."

The big picture: Pfizer and BioNTech said on Wednesday that two doses of their COVID-19 vaccine were less effective at neutralizing the Omicron variant than a three-dose regimen, according to early lab tests.

The CDC last month said it is "not examining" changing its definition for what it means to be fully vaccinated, according to director Rochelle Walensky. She had previously said the U.S. "may need to update" its definition after the approval of booster shots.

The CDC also last month changed its recommendation for booster shots, saying everyone 18 and older "should" receive a booster dose.

Be smart: The CDC's website says, "Fully vaccinated persons are those who are ≥14 days postcompletion of the primary series of an FDA-authorized COVID-19 vaccine."

Go deeper... Pfizer-BioNTech: Booster doses more effective at blocking Omicron

Fauci: It's "when, not if" definition of "fully vaccinated" changes

"I think that's going to be considered literally on a daily basis, that's always on the table."

Anthony Fauci

Anthony Fauci listens to President Biden speak about the administrations COVID-19 response at the NIH.

Four years after COVID-19 emerged, the U.S. in many ways is far less ready for the next major viral threat, despite the pandemic era's significant scientific advances.

Why it matters: Key weaknesses in the country's COVID response have only become more glaring, including the politicization of public health, an understaffed health care workforce and a growing hostility to science.

The big picture: Experts say it's a matter of when, not if, the world will face another pandemic, and the next one could make the last look mild.

The U.S. was caught flat-footed by the arrival of the coronavirus in early 2020 and was hit much harder than other developed nations.

The intense backlash against the muddled U.S. response contributed to eroded trust in public health, setting back preparedness efforts in important areas.

In a "big picture" way, the U.S. is "less prepared, because so much of this comes down to political will, public trust — public trust in government institutions, public trust in the media, public trust in one another," said Céline Gounder, a senior fellow at health policy nonprofit KFF.

Yes, but: The country's early struggles with tracking the virus, testing and supply chains, along with the rapid development of vaccines through Operation Warp Speed, yielded important lessons that ultimately have left the U.S. better off, said former Biden administration COVID response coordinator Ashish Jha.

"Right now, if we got a novel agent arriving on our shores tomorrow, we could probably pretty rapidly figure out where is it spreading, where is it not," he said, adding that the inability to track COVID was a major reason for harsher measures like stay-at-home orders.

"If you think about medical countermeasures, surveillance, we're clearly in better shape," Jha said.

The rise of nongovernmental data surveillance efforts also represented a monumental change in how public health data is handled, and the ease of at-home testing enabled people to take charge of their own health, said Jennifer Nuzzo, director of the Pandemic Center at Brown University School of Public Health.

"We have seen how individuals can take action to protect ourselves," Nuzzo told Axios. "It's not just a matter of government."

Still, the public health force is dangerously depleted and burnt out, and growing anti-vaccine sentiment could undercut a key tool for curbing the next pandemic. 

Threat level: Resistance to COVID measures has made it more likely a large segment of the population will ignore public health recommendations. 

It also spurred GOP-led states to curtail public health authorities in a way that could hamstring future responses.

"If you look at some of the revisionist history that's taking hold right now, in a bipartisan way honestly, it seems the new consensus is we did too much to protect the elderly and immunocompromised, and I don't know if we'll have the political will to do that next time around," Gounder said.

Though the pandemic-weary public has long since moved on from COVID, public health experts worry that the country still hasn't fully grappled with why the U.S. response faltered despite its many advantages — and how to prevent that from happening next time.

"There needs to be an accounting, and audit of the response, because some of it is potentially easily fixable," Nuzzo said.

COVID backlash could leave the U.S. less ready for the next pandemic

Despite remarkable scientific advances, key weaknesses in the country's COVID response have only become more glaring.

Illustrated collage of a topographic map of the United States with photographs of COVID tests and a stressed nurse, overlaid with rippling concintric circles. 

Vitals

Axios Vitals

Researchers are getting closer to understanding the underlying causes of long COVID and potential ways to definitively test for it.

Why it matters: That would be a massive step toward unlocking a complex condition that's debilitated millions of Americans, mystified scientists and frustrated patient advocates who feel their struggles have been ignored.

The big picture: The trickiest part of long COVID is the collection of different biological mechanisms believed to be driving a range of lingering symptoms, such as cognitive difficulty, fatigue and breathing problems, among others.

Ultimately, doctors will need multiple ways to diagnose and treat patients.

Between the lines: There are some more established theories of what's causing the condition, including the idea that the coronavirus has found a way to persist in the body by hiding in viral reservoirs. 

Other possibilities: COVID-19 causes some people's immune systems to malfunction, reactivates herpes viruses that linger in most people, or causes inflammation in the lining of the blood vessels, experts said. 

Researchers probing those theories are studying antivirals Paxlovid and Valtrex and the substance use disorder medication naltrexone, which can reduce inflammation.

Where things stand: There still aren't diagnostic tests for long COVID, but they likely aren't too far off, said George Diaz, chief of medicine at Providence Regional Medical Center, who treated the first confirmed U.S. case of COVID.

Some researchers are studying potential biomarkers in long COVID patients that could help better target treatments, including serotonin reduction, iron levels and high levels of a particular protein in blood.

For instance, doctors at Children's National Hospital are using certain lab tests, such as those to determine cortisol levels or detect certain antibodies, to make diagnoses, said Alexandra Yonts, director of the hospital's long COVID program.

"We've learned a tremendous amount if you look at the sheer volume of information that we've gleaned," Yonts said.

"We have strategies for management ... the things you need to do on a day-to-day basis to function, even if that means not being able to do everything that you want to do," Yonts said. "And we have labs that can help us right now at least go in a certain direction towards treatment."

Reality check: Most treatments being studied focus more on managing symptoms rather than curing long COVID. 

The National Institutes of Health's RECOVER Initiative, created to study long COVID, this past week announced the start of mid-stage trials testing three treatments in patients who've experienced symptoms such as fast heart rate, dizziness and fatigue.

Other RECOVER trials have tested therapies for viral persistence and brain fog.

The bottom line: With such a complex condition, researchers warn, it could still be a long road to finding definitive answers, and there likely won't ever be a silver bullet.

But they said important advancements are already being made that could eventually help not only long COVID patients but also those with similar post-viral conditions.

The hunt for long COVID answers zeroes in on causes

Researchers are getting closer to unlocking a complex condition that's debilitated millions of Americans.

Illustration of a researcher looking though a microscope surrounded by wavy shapes and vector-style viruses

Free COVID tests are over, for now. So are guidelines for infected people to isolate. Half of the country thinks the pandemic is finished.

But, in reality, COVID-19 is still with us. Though the official trappings of the crisis keep fading away and it's increasingly being treated like the flu, the virus remains an ever-present threat that's killing hundreds of Americans every week and consuming health care dollars and resources.

The big picture: This split screen effect was apparent this week when the government said it would stop distributing free COVID tests amid lower case rates. That followed the Centers for Disease Control and Prevention easing isolation guidance from five days to 24 hours.

America's split on whether the pandemic is over

The virus remains an ever-present threat that's killing hundreds of Americans every week.

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