When the U.S. made COVID-19 vaccines available for all adults in the spring, Americans, including government officials, hailed the development as a turning point in the pandemic.

President Biden himself echoed the optimism that the U.S. may be turning a corner.

“Today we’re closer than ever to declaring our independence from a deadly virus. That’s not to say the battle against COVID-19 is over. We’ve got a lot more work to do,” he said in July.

“It no longer paralyzes our nation, and it is within our power to make sure it never does again,” he added.

But fast-forward to December, and pandemic history appears to be repeating itself.

In the course of just a few weeks this month, the omicron variant and a steep rise in U.S. cases have triggered COVID-19 restrictions reminiscent of the early part of the outbreak.

Professional sports leagues have begun postponing games, some schools have started transitioning to remote learning and city officials have acknowledged they were reconsidering implementing prior coronavirus protocols such as mask mandates.

The current situation in the U.S. has also promoted concern from health experts.

“You know, I’m extraordinarily worried,” Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law and professor of global health law at Georgetown University Law Center and a contributor to The Hill, said in an interview.

“I’ve always thought that there would be surges and waves but the overall arc would be toward containing the virus and getting back to normal. And now that omicron is here, I’m not sure about that,” Gostin said. “And I think for the foreseeable future, we’re going to have a fairly rough ride with the variant.”

The omicron variant, first detected in South Africa, has spread across the United States since the first case was reported earlier this month.

Scientists are racing to learn more about the new variant, which some health officials say is anticipated to be the dominant strain in the United States in a matter of weeks.

A study, still under peer review, from researchers from the University of Hong Kong’s LKS Faculty of Medicine suggests that while the omicron variant can infect 70 times more quickly in humans than previous strains, “the Omicron infection in the lung is significantly lower than the original SARS-CoV-2, which may be an indicator of lower disease severity.”

Pfizer, BioNTech and Israeli researchers have said that Pfizer’s booster appears to provide good protection against the omicron variant.

Gostin said that “there’s no question” the boosters would be helpful in combating the variant. However, it’s a question of how protective the boosters would be against infections and hospitalizations and how long that protection would last.

“Because a lot of the studies of the boosters have been, you know, in the first few weeks after the booster is given and whether that third shot immunity will wane is an open question,” Gostin said. “But our experience is that it will wane … and we don’t know how long, so we’re just really heading into a concerning unknown here.”

These developments have Americans scratching their heads over whether the U.S. might see a return to the early days of the COVID-19 pandemic.

Already, some families have canceled holiday gatherings, students have transitioned to remote learning, entertainment venues have shut down and city officials are grappling with how to approach mitigation of the new outbreak.

Prince George’s County, Md., public schools announced Friday that they would temporarily return to virtual learning amid a surge of coronavirus cases.

“The increased positivity rates have significantly challenged the ability to … [teach in person], causing anxiety among many school communities and disruption to the school day,” Prince George’s County CEO Monica Goldson said.

Holiday shows have also been canceled amid a surge of the virus.

In New York City, “The Christmas Spectacular Starring the Radio City Rockettes” has canceled all of its upcoming performances due to coronavirus cases among the crew.

Jay Varma, a top public health adviser to Mayor Bill de Blasio (D), said earlier this week that “we’ve never seen this before in #NYC” amid daily cases doubling in just three days.

De Blasio also unveiled a six-pronged approach to combating the spread of the new variant, including investing in K-95 masks and distributing rapid home tests.

Washington, D.C., Mayor Muriel Bowser (D) announced this week that she was considering reinstating an indoor mask mandate just a few weeks after the requirement was lifted in the nation’s capital.

On Friday, the District reported its second day of record-breaking new coronavirus cases.

“I think that we should absolutely try to mitigate the spread as much as we can through indoor masking mandates, vaccination mandates, social distancing and ventilation. But in my view, I think there’s such enormous pandemic fatigue that people are not going to tolerate in America, you know, closures of schools or lockdowns,” Gostin said.

The global health law professor added that the lack of knowledge about the new variant means that Americans should act preemptively, assuming that the threat is serious.

“We really don’t know if it’s less serious. There’s no good data to suggest that it’s less serious, so I think we should act as if it has the same progression to serious disease and hospitalizations as … other former variants did, including delta,” Gostin said. “If it turns out to be significantly less serious, we’ll still see our hospitals filling up to capacity because of the sheer numbers, even if it’s just a smaller rate.”

But some areas of the U.S. have already started to feel the effects.

States in the Midwest have seen a rise in COVID-19 hospitalizations over the past few weeks, with hospital systems’ intensive care units reaching capacity.

Wisconsin last week reported that 96 percent of the ICU beds in the Badger State were occupied. And the state’s governor, Tony Evers (D), called for 100 FEMA workers to assist health care workers. Sixty National Guardsmen have been called up to serve as nursing assistants.

Michigan has also been battered by a wave of COVID-19 infections and on Monday was one of 14 states that reported that their overall inpatient bed capacity had reached 80 percent.

Indiana’s largest hospital system also requested help from the National Guard last week for most of its locations due to COVID-19 hospitalizations.

Gostin said that officials should hesitate before considering reimplementing lockdowns or other harsh measures. He noted that the country should instead focus on getting as many Americans fully boosted as possible and making Pfizer’s antiviral drug, Paxlovid, available.

“Access to testing and to effective monoclonal treatments, while improved over several months, is still quite problematic — and the [U.S. government] and others should be doing all they can to improve access and distribution, including matching supply to needs,” Goodman added in a follow-up email.

Experts are concerned, however, that the supplies of Paxlovid — which still awaits emergency use approval from the Food and Drug Administration — will not be able to keep up with demand amid high numbers of COVID-19 cases.

In addition, vaccine hesitancy remains among a good portion of the American public, and the Biden administration has battled several legal challenges its vaccine mandates for businesses, federal employees and health care workers.

“Right now, we do need to get a very, you know, much higher percentage of our population vaccinated and boosted because, ultimately, living with the virus — yes — we are going to need to live with the virus,” Gostin acknowledged. “But when we live with the virus, we have to live with it so that it’s not making us sick. That’s the really important part.”

A new pill from Pfizer to treat COVID-19 has been hailed as a game-changer that can drastically cut down the number of hospitalizations and deaths from the disease.

But demand for the treatment, known as Paxlovid, is expected to far outrun supply, blunting its ability to help fight what medical professionals say is an oncoming wave of infections from the omicron variant.

Experts are calling on the Biden administration to take action to help increase manufacturing capacity by enlisting additional companies to help Pfizer make the doses.

“I think we should be doing everything we can,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center. “This requires a full court press.”

He noted that Merck is helping make the Johnson & Johnson vaccine, a model that could be applied to therapeutics like the Pfizer pill as well.

But so far, he said, “I have not seen any aggressive push or attempt to access existing manufacturing capacity in the U.S. or globally to date around therapeutics.”

Pfizer says it expects to have 180,000 courses of the treatment available by the end of 2021, with 30 million available globally in the first half of 2022, rising to 80 million by the end of next year.

But with about 120,000 new COVID-19 cases every day and rising just in the United States, the demand for the antiviral product is spiking sharply.

“It’s kind of a drop in the bucket in the short term,” said David Boulware, an infectious disease expert at the University of Minnesota.

“There’s definitely going to be a shortage,” he added. “People have this expectation of ‘Oh yeah, I’m just going to go get this Paxlovid.’ That’s not going to happen [at least in the next few months].”

Experts said the initial authorization could be restricted to the most high-risk groups, like unvaccinated people and the immunocompromised.

The product from Pfizer has the potential to blunt the damage from the pandemic if it is made widely available. Trial data released by Pfizer earlier this week showed that Paxlovid reduced the risk of hospitalization or death from COVID-19 by 89 percent in high-risk adults.

The treatment must first be authorized by the Food and Drug Administration before it becomes available, but that could happen soon.

President Biden released a statement praising the treatment this week after the trial results were published, though he also appeared to reference the need to ramp up supply.

“If this treatment is indeed authorized — and once the pills are widely available — it will mark a significant step forward in our path out of the pandemic,” Biden said.

The White House did not have additional comment when asked by The Hill about efforts to increase supply of the pills.

When asked about the supply of the drug, Pfizer spokeswoman Sharon Castillo said, “We are in discussions with governments around the world regarding supply agreements for PAXLOVID.”

“Pfizer’s goal is to deliver this oral antiviral therapy to patients in need as soon as possible and at an affordable price, subject to country regulatory authorization,” she added. “It is premature to speculate on the specifics of any future agreements as discussions are ongoing.”

The Biden administration in November announced it was buying 10 million courses of the pills, which are to be delivered starting this year and “throughout 2022,” the Department of Health and Human Services said at the time.

As is still the case with COVID-19 vaccines, supply problems with the Pfizer treatment are likely to be even worse in lower-income countries.

“Demand is going to be significantly outpacing supply for Paxlovid, even in the U.S., much less the rest of the world,” Udayakumar said.

Peter Maybarduk, access to medicines director at the progressive group Public Citizen, put it more starkly: “We are in for a repeat of the medical apartheid that characterized the vaccine rollout, now for treatments,” he said.

Pfizer has entered into an agreement with a United Nations-backed organization called the Medicines Patent Pool to grant licenses to allow its COVID-19 treatment to be supplied to 95 lower-income countries, a move that was praised by experts and advocates as an important step.

But the limitation of that agreement is that it could take several months for production to actually begin, experts said. Udayakumar said he had heard “unofficially” that it could be the second half of 2022 before there is any production from the Medicine Patents Pool agreements.

The expert added that the U.S. could do more to help stand up manufacturing capacity for the treatment in other countries.

The bright side is that pills like Paxlovid are easier to produce than the complex mRNA vaccines, which experts said should make efforts to boost manufacturing more feasible.

A complication, though, is that the Pfizer treatment is intended to be started within five days of the onset of symptoms. That means it will be key to have enough tests and fast turnaround times to allow people to know they have COVID-19 so that they can set up treatment.

Not everyone who gets the virus will need the treatment. Experts say that young, healthy people will likely be able to get by on their own with generally mild cases. But if supply ramps up enough, there could be a large market, experts said, moving beyond the unvaccinated and the immunocompromised to large groups like the elderly.

“To treat with these oral therapeutics requires adequate testing, and that’s a place where we’re really falling down almost everywhere in the world, including the U.S.,” Udayakumar said.

If the treatment becomes widespread, though, it could have a major impact.

“If you have an oral antiviral that can keep people out of the hospital, and keep them from dying, that’s a major path-breaking advance,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “It’s evidence of the fact that we are going to get to a point where this virus becomes tame.”

But for now, he said, “it is going to be something that’s probably going to be supply constrained in the very beginning.”

“And that’s going to blunt the impact that it has early on,” he added. “But hopefully they’ll be able to start to meet demand to be able to have it become ubiquitous.”

==========================================