Omicron could spark ‘viral blizzard’ in coming weeks, top epidemiologist says

Blizzard of '78 remembered in Crawford County

COVID-19 cases are surging across the U.S. ahead of Christmas, sparking the cancellation of sporting events and a growing list of hospitals postponing nonessential surgeries — both a reminder of last year’s holiday surge and a sign that the next several weeks will determine the pandemic’s trajectory for the rest of the winter months. 

Nationwide, the daily average for new cases was more than 133,000 on Dec. 18, a 21 percent jump over the last two weeks, according to data compiled by The New York Times. 

Health officials have warned the omicron variant — which appears to cause less severe illness, though is more transmissible — could exacerbate the ongoing delta-fueled surge and overwhelm the healthcare system. 

“I think we’re really just about to experience a viral blizzard,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN  during a Dec. 17 interview“I think in the next three to eight weeks, we’re going to see millions of Americans are going to be infected with this virus, and that will be overlaid on top of delta, and we’re not yet sure exactly how that’s going to work out.” 

New York — where omicron accounts for at least 13 percent of new cases — for two consecutive days set a record for the daily number of new cases reported. Health officials reported more than 21,000 new cases on Dec.17 and 21,908 on Dec. 18. Three Midwestern states and Vermont also set COVID-19 records last week, including Ohio, which reported nearly 12,000 new cases Dec. 16. 

While early data suggests omicron is tied to less severe illness than the original strain, health officials have warned against underestimating the virus. The outgoing National Institutes of Health director, Francis Collins, MD, PhD, offered a grim projection during a Dec. 19 interview with NPR

“Even if it has somewhat lower risk of severity, we could be having a million cases a day if we’re not really attentive to all of those mitigation strategies,” Dr. Collins said. 

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said areas with low vaccination coverage will likely be especially hard hit across the coming weeks. 

“We are going to see significant stress in some regions of the country on the hospital system, particularly in those areas where you have a low level of vaccination, which is one of the reasons why we continue to stress the importance of getting those unvaccinated people vaccinated,” he told CNN Dec. 19, adding that in some regions of the U.S., omicron accounts for 50 percent of new infections, “which means it’s going to take over.” 

“This virus is extraordinary. It has a doubling time of anywhere from two to three days,” Dr. Fauci said. 

The daily average for U.S. COVID-19 hospitalizations was more than 69,000 as of Dec. 19, marking a 16 percent rise across the last two weeks; and while omicron may be associated with lower disease severity, a significant surge would inevitably lead to more hospitalizations and deaths, health officials say. Connecticut, Washington, D.C., and Rhode Island have seen the highest percent increase in hospitalization rates over the last two weeks. 

As the holidays and planned celebrations near, Dr. Fauci emphasized the importance of booster doses in combating the surge. He urged against holiday gatherings and travel among people who have not been fully vaccinated or received their boosters. Given a rise in breakthrough cases, he also suggested people take a rapid test before attending a gathering. 

“If you do these things … I do believe that you can feel quite comfortable with a family setting, the dinners and the gatherings that you have around the holiday season,” Dr. Fauci told ABC News Dec. 19. “Nothing is 100 percent risk-free, but I think if you do the things that I just mentioned, you’d actually mitigate that risk enough to feel comfortable about being able to enjoy the holiday.” 

Moderna said Dec. 20 that a booster dose of its vaccine increased antibody levels against omicron 37-fold. Laboratory findings from Pfizer also indicate its booster offers significant protection against the strain. 

CDC data showed 61.4 percent of the nation’s population had been fully vaccinated as of Dec. 19. Nearly 30 percent of the fully vaccinated population had received their booster dose.

We’ll Never Be Rid of COVID, Fauci Says

A photo of Anthony Fauci, MD

On the spectrum from active outbreak to eradication, control is the most likely path forward for COVID-19 in the U.S., NIAID Director Anthony Fauci, MD, said during a National Press Club briefing today.

Fauci’s words served as a reality check for those holding out hope that COVID-19 one day might be as rare as measles or polio in America.

“We’re never going to eradicate this,” he said. “We’ve only eradicated one virus, and that’s smallpox. Elimination may be too aspirational, because we’ve only done that with infections for which we’ve had a massive vaccination campaign like polio and measles. Even though we haven’t eradicated [those viruses] from the planet, we have no cases, with few exceptions, in the U.S.”

Fauci said the country should focus on control — a level of infection “that isn’t zero, but that with the combination of the vast majority of the population vaccinated and boosted, together with those who recovered from infection and also are hopefully boosted, that we will get a level of control that will be non-interfering with our lives, our economy, and the kinds of things we would do, namely to get back to some degree of normality.”

“It’s not going to be eradication, and it’s likely not going to be elimination,” he said again later in the briefing. “It’s going to be a low, low, low level of infection that really doesn’t interfere with our way of life, our economy, our ability to move around in society, our ability to do things in closed indoor spaces.”

Fauci said the only way to achieve this will be with vaccinations, boosters, and mitigation strategies such as wearing masks in congregate settings.

“Over time, we feel confident we will get this under control,” he said. While he said he “hopes” this comes in the “next several months,” he cautioned that he “never predict[s], because you never get it right. Sure enough, someone will come back and say, ‘You said this in December and you were wrong.'”

In terms of boosters, Fauci said it’s possible that a third shot — “and maybe an additional one” — will be enough to provide durable immunity, but that “we’ll just have to wait and see. We don’t know yet.”

Kids under age 5 who have yet to be vaccinated will have to wait a few more months to get their shots, he added. While the lower, 3 μg dose of the Pfizer vaccine looked sufficient for children ages 6 months up to 2 years, that dose was not sufficient for those ages 2 to 5, he said.

“The company decided that they believe this is really a three-dose vaccine, and there’s no doubt if you give three doses you’re going to get an effective and safe vaccine,” he said. “But they haven’t proven it yet, so that’s the delay.”

“I can guarantee you it’s going to be effective,” Fauci added.

Data aren’t expected until the end of the first quarter of 2022, he said, meaning vaccines for this pediatric population likely won’t be available until “a few months into 2022.”

Health officials say omicron variant likely to cause record-high coronavirus cases, hospitalizations in U.S.

Top government health officials on Sunday warned that the United States will probably see record numbers of coronavirus cases and hospitalizations as the omicron variant spreads rapidly and forces Americans to again grapple with the dangers of a pandemic that has upended life around the globe.

“Unfortunately, I think that that is going to happen. We are going to see a significant stress in some regions of the country on the hospital system, particularly in those areas where you have a low level of vaccination,” Anthony S. Fauci, the nation’s leading infectious-disease specialist, said on CNN’s “State of the Union” when asked whether the United States could see record numbers of cases, hospitalizations and deaths.

Fauci described the variant as “extraordinary” in its transmissibility, with a doubling time of two to three days. It accounts for 50 percent of coronavirus cases in parts of the country, which meant it would almost certainly take over as the dominant variant in the United States, he added.

“It is going to be a tough few weeks, months, as we get deeper into the winter,” Fauci said.

On CBS News’s “Face the Nation,” Francis Collins, director of the National Institutes of Health, said that cases will rise steeply over the next couple of weeks and that the country could soon see 1 million new cases a day tied to the omicron variant, dramatically exceeding the record of about 250,000 new cases per day set in January.

“The big question is, are those million cases going to be sick enough to need health care and especially hospitalization?” Collins said. “We’re just holding our breath to see how severe this will be.”

Fauci and Collins painted a stark but realistic picture of the winter ahead, on the heels of a week of coronavirus-related setbacks. Coronavirus cases, hospitalizations and deaths rose across much of the country last week, with officials warning of a surge just as millions of Americans — already weary after nearly two years of the pandemic — are expected to travel for Christmas and New Year’s. On Friday, Pfizer and BioNTech announced that coronavirus vaccines for children younger than 5 would be pushed back further into 2022, as the companies modified their trials to include a third dose. On Sunday, New York, one of the country’s early epicenters in the pandemic, reported 22,478 cases.

Health officials have continued to urge the unvaccinated to get their shots and those who have received only two doses of either the Pfizer or Moderna mRNA vaccines to get booster doses. Vaccines cannot be the only layer of protection against the omicron variant, Fauci said, but defeating the pandemic would not be possible without them.

There are still safe ways for vaccinated people to get together for the holidays, including wearing a mask while traveling, testing beforehand and knowing the vaccination status of everyone present at indoor celebrations, Fauci said on “Face the Nation.”

“If you do these things, I do believe that you can feel quite comfortable with a family setting,” he said. “Nothing is 100 percent risk-free, but I think if you do the things that I just mentioned, you’d actually mitigate that risk enough to feel comfortable about being able to enjoy the holiday.”

Collins stopped short of urging people to cancel holiday plans but said travel will be risky even for vaccinated people.

“This virus is going to be all around us,” he said. “I’m not going to say you shouldn’t travel, but you should do so very carefully. … People are going, ‘I’m so sick of hearing this,’ and I am, too. But the virus is not sick of us, and it is still out there looking for us, and we’ve got to double down on these things if we’re going to get through the next few months.”

Doctors, nurses and others are warning that the nation’s health system continues to be strained by an unending stream of coronavirus cases. Confirmed U.S. coronavirus infections have surpassed more than 128,000 per day and confirmed virus deaths are near 1,300 per day, according to The Washington Post’s rolling seven-day average.

“For people trained to save lives, this moment is frustrating, exhausting and heartbreaking,” the American Hospital Association, the American Medical Association and the American Nurses Association said in a joint statement on Friday, urging more Americans to get booster shots.

Public health experts are bracing for a winter surge of cases driven by the omicron variant, which can evade some protection conferred by vaccinations and prior infections, as well as cases linked to the delta variant. Officials caution that they are still relying on preliminary data about the omicron variant’s severity compared with earlier forms of the virus.

President Biden plans to address the nation Tuesday on the status of the country’s fight against the virus, the White House said Saturday.

“We are prepared for the rising case levels,” White House press secretary Jen Psaki wrote on Twitter, adding that Biden “will detail how we will respond to this challenge. He will remind Americans that they can protect themselves from severe illness from COVID-19 by getting vaccinated and getting their booster shot when they are eligible.”

The speech, coming just before Christmas and New Year’s Day, underlines Biden’s struggle to contain the pandemic nearly a year into office. On top of the emergence of new variants and attendant challenges, the administration has at times faced criticism for what some have described as mixed signals.

Biden won high marks from the public during the first half of the year as cases declined, the country opened up from shutdowns and vaccines became widely available. But the past few months have been more difficult. After he gave a speech on July 4 saying the country was “closer than ever to declaring our independence from a deadly virus,” the situation started changing. Case rates increased as the delta variant gained a foothold and many Americans refused to get vaccinated.

And despite Biden’s promise that at-home rapid tests would become a widely available tool to fight the coronavirus, the tests remain hard to find in many parts of the country and are more expensive than in some other places across the globe.

Fauci conceded Sunday that the administration needed to do better on increasing the availability of at-home coronavirus rapid tests, though he emphasized that the country was in a much better place than it was a year ago, with 200 million to 500 million tests available per month, many of them free.

“We’re going in the right direction,” he said on CNN. “We really need to flood the system with testing. We need to have tests available for anyone who wants them, particularly when we’re in a situation right now where people are going to be gathering.”

The omicron variant also has challenged the nation’s coronavirus medicine cabinet, with evidence that mutations will wipe out or weaken the effectiveness of treatments that can reduce the virus’s severity and keep people out of hospitals. As a result, the Biden administration around Thanksgiving paused distribution of sotrovimab, the one monoclonal antibody that remains effective against the omicron variant, with senior officials such as David Kessler calculating that the drug should be maximally deployed when the variant becomes more prevalent.

By Thursday, administration officials decided to resume shipments of the drug, amid indicators that the omicron variant was spreading faster in states such as New York and Washington than data published by the Centers for Disease Control and Preventionearlier in the week indicated, said two officials with knowledge of the deliberations.

“Shipment of product will begin soon, and jurisdictions will see product arrive as early as Tuesday, December 21, 2021,” the federal health agency said in a statement on Friday, announcing that about 55,000 doses of sotrovimab would soon go out.

Doctors said they were desperate for treatments like sotrovimab as emergency rooms begin to crowd and case numbers soar.

“Too slow! We are already seeing widespread omicron,” texted one infectious-disease doctor at a large New York City hospital, who estimated that at least 50 percent of patients had contracted the variant and requested confidentiality to discuss patient care. “It’s a lot of hospitalizations that could have potentially [been] averted because of slow response.”

Fauci said Sunday that he expected it to be months before antiviral drugs can be mass-produced and available to anyone who needs them. While he did not foresee the kind of shutdowns that were put in place in the early days of the pandemic, Fauci also noted that it would be difficult to keep the virus under control when there remained “about 50 million people in the country who are eligible to be vaccinated who are not vaccinated.”

Similarly, several governors on Sunday shied away from the possibility of implementing more shutdowns to fight the spread of the new variant. Maryland Gov. Larry Hogan (R) said on “Fox News Sunday” that his state, which has seen a 150 percent increase in hospitalizations over the past two weeks, was not considering shutdowns and instead was putting more resources into testing and encouraging vaccinations and boosters. New Jersey Gov. Phil Murphy (D) said on the same show that shutdowns remained “on the table” but that he didn’t think such a move was likely because a high percentage of the state’s population was vaccinated.

Colorado Gov. Jared Polis (D) emphasized that people in his state should keep themselves safe with “individual freedom and local control.” He also said Colorado officials were looking to change the definition of “fully vaccinated” to include three shots, as health officials in the country and around the world have signaled in recent days they are also considering.

“That’s certainly where it’s headed,” Polis said on NBC News’s “Meet the Press.” “I wish they’d stop talking about [the third shot] as a booster. It really is a three-dose vaccine.”

CDC: Omicron accounted for 73% of recent COVID-19 cases

COVID testing in NYC

The Omicron variant accounted for more than 73% of recent COVID-19 cases in the U.S., according to Centers for Disease Control and Prevention’s updated data released on Monday.

The big picture: The data showed nearly a six-fold increase in Omicron’s share of COVID-19 infections in just one week.

What they’re saying: “These numbers are stark, but they’re not surprising,” said Rochelle Walensky, the CDC’s director, adding that the growing infections reflect what has been seen in other countries.

  • While the Delta variant still drives up a lot of new infections, Walensky told AP she anticipates “that over time that Delta will be crowded out by Omicron.”

What’s next: President Biden on Tuesday will deliver a speech outlining new steps the administration will take to address the rapid spread of the new variant.

America Is Not Ready for Omicron

America was not prepared for COVID-19 when it arrived. It was not prepared for last winter’s surge. It was not prepared for Delta’s arrival in the summer or its current winter assault. More than 1,000 Americans are still dying of COVID every day, and more have died this year than last. Hospitalizations are rising in 42 states. The University of Nebraska Medical Center in Omaha, which entered the pandemic as arguably the best-prepared hospital in the country, recently went from 70 COVID patients to 110 in four days, leaving its staff “grasping for resolve,” the virologist John Lowe told me. And now comes Omicron.

Will the new and rapidly spreading variant overwhelm the U.S. health-care system? The question is moot because the system is already overwhelmed, in a way that is affecting all patients, COVID or otherwise. “The level of care that we’ve come to expect in our hospitals no longer exists,” Lowe said.

The real unknown is what an Omicron cross will do when it follows a Delta hook. Given what scientists have learned in the three weeks since Omicron’s discovery, “some of the absolute worst-case scenarios that were possible when we saw its genome are off the table, but so are some of the most hopeful scenarios,” Dylan Morris, an evolutionary biologist at UCLA, told me. In any case, America is not prepared for Omicron. The variant’s threat is far greater at the societal level than at the personal one, and policy makers have already cut themselves off from the tools needed to protect the populations they serve. Like the variants that preceded it, Omicron requires individuals to think and act for the collective good—which is to say, it poses a heightened version of the same challenge that the U.S. has failed for two straight years, in bipartisan fashion.

The coronavirus is a microscopic ball studded with specially shaped spikes that it uses to recognize and infect our cells. Antibodies can thwart such infections by glomming onto the spikes, like gum messing up a key. But Omicron has a crucial advantage: 30-plus mutations that change the shape of its spike and disable many antibodies that would have stuck to other variants. One early study suggests that antibodies in vaccinated people are about 40 times worse at neutralizing Omicron than the original virus, and the experts I talked with expect that, as more data arrive, that number will stay in the same range. The implications of that decline are still uncertain, but three simple principles should likely hold.

First, the bad news: In terms of catching the virus, everyone should assume that they are less protected than they were two months ago. As a crude shorthand, assume that Omicron negates one previous immunizing event—either an infection or a vaccine dose. Someone who considered themselves fully vaccinated in September would be just partially vaccinated now (and the official definition may change imminently). But someone who’s been boosted has the same ballpark level of protection against Omicron infection as a vaccinated-but-unboosted person did against Delta. The extra dose not only raises a recipient’s level of antibodies but also broadens their range, giving them better odds of recognizing the shape of even Omicron’s altered spike. In a small British study, a booster effectively doubled the level of protection that two Pfizer doses provided against Omicron infection.

Second, some worse news: Boosting isn’t a foolproof shield against Omicron. In South Africa, the variant managed to infect a cluster of seven people who were all boosted. And according to a CDC report, boosted Americans made up a third of the first known Omicron cases in the U.S. “People who thought that they wouldn’t have to worry about infection this winter if they had their booster do still have to worry about infection with Omicron,” Trevor Bedford, a virologist at Fred Hutchinson Cancer Research Center, told me. “I’ve been going to restaurants and movies, and now with Omicron, that will change.”

Third, some better news: Even if Omicron has an easier time infecting vaccinated individuals, it should still have more trouble causing severe disease. The vaccines were always intended to disconnect infection from dangerous illness, turning a life-threatening event into something closer to a cold. Whether they’ll fulfill that promise for Omicron is a major uncertainty, but we can reasonably expect that they will. The variant might sneak past the initial antibody blockade, but slower-acting branches of the immune system (such as T cells) should eventually mobilize to clear it before it wreaks too much havoc.

To see how these principles play out in practice, Dylan Morris suggests watching highly boosted places, such as Israel, and countries where severe epidemics and successful vaccination campaigns have given people layers of immunity, such as Brazil and Chile. In the meantime, it’s reasonable to treat Omicron as a setback but not a catastrophe for most vaccinated people. It will evade some of our hard-won immune defenses, without obliterating them entirely. “It was better than I expected, given the mutational profile,” Alex Sigal of the Africa Health Research Institute, who led the South African antibody study, told me. “It’s not going to be a common cold, but neither do I think it will be a tremendous monster.”

That’s for individuals, though. At a societal level, the outlook is bleaker.

Omicron’s main threat is its shocking speed, as my colleague Sarah Zhang has reported. In South Africa, every infected person has been passing the virus on to 3–3.5 other people—at least twice the pace at which Delta spread in the summer. Similarly, British data suggest that Omicron is twice as good at spreading within households as Delta. That might be because the new variant is inherently more transmissible than its predecessors, or because it is specifically better at moving through vaccinated populations. Either way, it has already overtaken Delta as the dominant variant in South Africa. Soon, it will likely do the same in Scotland and Denmark. Even the U.S., which has much poorer genomic surveillance than those other countries, has detected Omicron in 35 states. “I think that a large Omicron wave is baked in,” Bedford told me. “That’s going to happen.”

More positively, Omicron cases have thus far been relatively mild. This pattern has fueled the widespread claim that the variant might be less severe, or even that its rapid spread could be a welcome development. “People are saying ‘Let it rip’ and ‘It’ll help us build more immunity,’ that this is the exit wave and everything’s going to be fine and rosy after,” Richard Lessells, an infectious-disease physician at the University of KwaZulu-Natal, in South Africa, told me. “I have no confidence in that.”

To begin with, as he and others told me, that argument overlooks a key dynamic: Omicron might not actually be intrinsically milder. In South Africa and the United Kingdom, it has mostly infected younger people, whose bouts of COVID-19 tend to be less severe. And in places with lots of prior immunity, it might have caused few hospitalizations or deaths simply because it has mostly infected hosts with some protection, as Natalie Dean, a biostatistician at Emory University, explained in a Twitter thread. That pattern could change once it reaches more vulnerable communities. (The widespread notion that viruses naturally evolve to become less virulent is mistaken, as the virologist Andrew Pekosz of Johns Hopkins University clarified in The New York Times.) Also, deaths and hospitalizations are not the only fates that matter. Supposedly “mild” bouts of COVID-19 have led to cases of long COVID, in which people struggle with debilitating symptoms for months (or even years), while struggling to get care or disability benefits.

And even if Omicron is milder, greater transmissibility will likely trump that reduced virulence. Omicron is spreading so quickly that a small proportion of severe cases could still flood hospitals. To avert that scenario, the variant would need to be substantially milder than Delta—especially because hospitals are already at a breaking point. Two years of trauma have pushed droves of health-care workers, including many of the most experienced and committed, to quit their job. The remaining staff is ever more exhausted and demoralized, and “exceptionally high numbers” can’t work because they got breakthrough Delta infections and had to be separated from vulnerable patients, John Lowe told me. This pattern will only worsen as Omicron spreads, if the large clusters among South African health-care workers are any indication. “In the West, we’ve painted ourselves into a corner because most countries have huge Delta waves and most of them are stretched to the limit of their health-care systems,” Emma Hodcroft, an epidemiologist at the University of Bern, in Switzerland, told me. “What happens if those waves get even bigger with Omicron?”

The Omicron wave won’t completely topple America’s wall of immunity but will seep into its many cracks and weaknesses. It will find the 39 percent of Americans who are still not fully vaccinated (including 28 percent of adults and 13 percent of over-65s). It will find other biologically vulnerable people, including elderly and immunocompromised individuals whose immune systems weren’t sufficiently girded by the vaccines. It will find the socially vulnerable people who face repeated exposures, either because their “essential” jobs leave them with no choice or because they live in epidemic-prone settings, such as prisons and nursing homes. Omicron is poised to speedily recap all the inequities that the U.S. has experienced in the pandemic thus far.

Here, then, is the problem: People who are unlikely to be hospitalized by Omicron might still feel reasonably protected, but they can spread the virus to those who are more vulnerable, quickly enough to seriously batter an already collapsing health-care system that will then struggle to care for anyone—vaccinated, boosted, or otherwise. The collective threat is substantially greater than the individual one. And the U.S. is ill-poised to meet it.

America’s policy choices have left it with few tangible options for averting an Omicron wave. Boosters can still offer decent protection against infection, but just 17 percent of Americans have had those shots. Many are now struggling to make appointments, and people from rural, low-income, and minority communities will likely experience the greatest delays, “mirroring the inequities we saw with the first two shots,” Arrianna Marie Planey, a medical geographer at the University of North Carolina at Chapel Hill, told me. With a little time, the mRNA vaccines from Pfizer and Moderna could be updated, but “my suspicion is that once we have an Omicron-specific booster, the wave will be past,” Trevor Bedford, the virologist, said.

Two antiviral drugs now exist that could effectively keep people out of the hospital, but neither has been authorized and both are expensive. Both must also be administered within five days of the first symptoms, which means that people need to realize they’re sick and swiftly confirm as much with a test. But instead of distributing rapid tests en masse, the Biden administration opted to merely make them reimbursable through health insurance. “That doesn’t address the need where it is greatest,” Planey told me. Low-wage workers, who face high risk of infection, “are the least able to afford tests up front and the least likely to have insurance,” she said. And testing, rapid or otherwise, is about to get harder, as Omicron’s global spread strains both the supply of reagents and the capacity of laboratories.

Omicron may also be especially difficult to catch before it spreads to others, because its incubation period—the window between infection and symptoms—seems to be very short. At an Oslo Christmas party, almost three-quarters of attendees were infected even though all reported a negative test result one to three days before. That will make Omicron “harder to contain,” Lowe told me. “It’s really going to put a lot of pressure on the prevention measures that are still in place—or rather, the complete lack of prevention that’s still in place.”

The various measures that controlled the spread of other variants—masks, better ventilation, contact tracing, quarantine, and restrictions on gatherings—should all theoretically work for Omicron too. But the U.S. has either failed to invest in these tools or has actively made it harder to use them. Republican legislators in at least 26 states have passed laws that curtail the very possibility of quarantines and mask mandates. In September, Alexandra Phelan of Georgetown University told me that when the next variant comes, such measures could create “the worst of all worlds” by “removing emergency actions, without the preventive care that would allow people to protect their own health.” Omicron will test her prediction in the coming weeks.

The longer-term future is uncertain. After Delta’s emergence, it became clear that the coronavirus was too transmissible to fully eradicate. Omicron could potentially shunt us more quickly toward a different endgameendemicitythe point when humanity has gained enough immunity to hold the virus in a tenuous stalemate—albeit at significant cost. But more complicated futures are also plausible. For example, if Omicron and Delta are so different that each can escape the immunity that the other induces, the two variants could co-circulate. (That’s what happened with the viruses behind polio and influenza B.)

Omicron also reminds us that more variants can still arise—and stranger ones than we might expect. Most scientists I talked with figured the next one to emerge would be a descendant of Delta, featuring a few more mutational bells and whistles. Omicron, however, is “dramatically different,” Shane Crotty, from the La Jolla Institute for Immunology, told me. “It showed a lot more evolutionary potential than I or others had hoped for.” It evolved not from Delta but from older lineages of SARS-CoV-2, and seems to have acquired its smorgasbord of mutations in some hidden setting: perhaps a part of the world that does very little sequencing, or an animal species that was infected by humans and then transmitted the virus back to us, or the body of an immunocompromised patient who was chronically infected with the virus. All of these options are possible, but the people I spoke with felt that the third—the chronically ill patient—was most likely. And if that’s the case, with millions of immunocompromised people in the U.S. alone, many of whom feel overlooked in the vaccine era, will more weird variants keep arising? Omicron “doesn’t look like the end of it,” Crotty told me. One cause for concern: For all the mutations in Omicron’s spike, it actually has fewer mutations in the rest of its proteins than Delta did. The virus might still have many new forms to take.

Vaccinating the world can curtail those possibilities, and is now an even greater matter of moral urgency, given Omicron’s speed. And yet, people in rich countries are getting their booster six times faster than those in low-income countries are getting their first shot. Unless the former seriously commits to vaccinating the world—not just donating doses, but allowing other countries to manufacture and disseminate their own supplies—“it’s going to be a very expensive wild-goose chase until the next variant,” Planey said.

Vaccines can’t be the only strategy, either. The rest of the pandemic playbook remains unchanged and necessary: paid sick leave and other policies that protect essential workers, better masks, improved ventilation, rapid tests, places where sick people can easily isolate, social distancing, a stronger public-health system, and ways of retaining the frayed health-care workforce. The U.S. has consistently dropped the ball on many of these, betting that vaccines alone could get us out of the pandemic. Rather than trying to beat the coronavirus one booster at a time, the country needs to do what it has always needed to do—build systems and enact policies that protect the health of entire communities, especially the most vulnerable ones

Individualism couldn’t beat Delta, it won’t beat Omicron, and it won’t beat the rest of the Greek alphabet to come.

Self-interest is self-defeating, and as long as its hosts ignore that lesson, the virus will keep teaching it.

What should you take if you get Covid-19? 

https://link.vox.com/view/608adc4e91954c3cef03e60dfi7ya.jor/68bd1086

Hey readers, 

Last week, Florida Surgeon General Joseph Ladapo released a public service announcement talking about protecting your health from Covid-19. The PSA stood out for a couple of reasons:

1. While “vaccination” briefly appeared onscreen in a list of options, it didn’t merit a mention in the video.

2. The surgeon general listed guidance on “emerging” treatments that was … remarkably on point.

The absence of focus on vaccines in the video is unfortunate, if entirely in keeping with the GOP’s willingness to play to its anti-vax base. That’s bad, but not surprising.

What was surprising was No. 2. The information Ladapo shared about treatments was fairly accurate. In the video, he told Floridians to ask their doctor about monoclonal antibodies, fluvoxamine, and inhaled budesonide should they come down with Covid-19. 

I’ve been reporting on the Covid-19 treatment beat for much of this year, and I’ve uncovered a massively confusing pile of contradictory information. But those are the top three treatments I’d recommend sick loved ones talk to doctors about, and while there’s much we still don’t know, solid science suggests they have real promise.

That said, the fact that such important (and accurate) information stood out in a government PSA indicates just how dismal the state of public communications on treatments is — and just how much misinformation and distrust are hampering the fight against Covid-19. 

What should you take if you get Covid-19? 

There’s been little public health communication about which treatments to pursue if you get Covid-19, perhaps because for much of the pandemic, it’s been unclear what options are better for mild Covid than just resting at home. While in 2021 the best treatment recommendations have gotten clearer, public health messaging over the last year has rightly been focused on vaccination.

The official CDC page on what to do if you get sick with Covid-19 advises you to wear a mask, wash your hands, and clean high-touch surfaces to avoid infecting those around you. If your breathing deteriorates or you show signs of severe illness like confusion or an inability to stay awake, the CDC advises you to go to the hospital. 

All sound guidance — but what it doesn’t offer is advice on a question that patients who aren’t sick enough for hospitalization might desperately need to know: What medication should I take if I come down with Covid-19? 


That’s not because there’s a lack of options. For instance, the FDA has approved monoclonal antibodies as a treatment for Covid-19 patients at risk of progressing to severe disease. They recently expanded this approval to include monoclonal antibodies for children as well. The treatment has to be administered in a clinic, as an IV infusion or as four shots, but it is highly effective, with some high-quality studies finding an 85 percent reduction in the risk of hospitalization or death.

Meanwhile, large, high-quality, peer-reviewed, and published randomized controlled trials (RCTs) have found promise for cheap therapies that are already FDA approved for other purposes and have an established safety profile. 

One medication, fluvoxamine, is an antidepressant that appears to reduce hospitalizations from Covid-19 by about 30 percent. Another, budesonide asthma inhalers, was found in one large RCT to speed at-home recovery considerably and in another to reduce risk of hospitalization. In the US, there’s been no formal guidance on when to consider budesonide, but in the UK, health agencies have advised doctors they can consider prescribing it off-label to help older and at-risk patients recover at home, while in Canada doctors are encouraged to consider budesonide on a case-by-case basis.

Research underway will help provide a better understanding of both of these therapies, but there’s enough evidence that some doctors are already prescribing them to patients. If you have the opportunity to enroll in an ongoing clinical trial of these medications, you can get access to a potentially promising treatment and help contribute to our scientific understanding of whether these treatments really work.

Another exciting treatment in the pipeline is Paxlovid, an antiviral developed by Pfizer that showed impressive 90 percent efficacy in preventing hospitalization — so effective that in November, the clinical trial stopped enrolling new participants because investigators concluded it’d be unethical to put them in the control group. It has not yet been approved by the FDA, but it might be a game changer if, as is expected, it’s approved in January.

The FDA is also in the process of considering molnupiravir, another repurposed drug that looks to be moderately effective, though there are some concerns it could spur new viral variants.

Why is it so hard to find good guidance about treatments?

The US government has communicated little about Covid-19 treatment options. NIH guidelines about treatments like fluvoxamine haven’t been updated since this past spring, meaning results from recent high-quality studies haven’t been incorporated into that guidance. Without it, physicians considering whether to prescribe these medications can’t turn to official public health resources for help. 


From a certain perspective, that reticence is understandable. Learning which Covid-19 treatments work is very hard. While large-scale RCTs found promising evidence for fluvoxamine and inhaled budesonide, “promising” is still the most we can say — it could absolutely turn out that the real-world effects are much smaller than hoped for, or even fail to materialize altogether.

But it’s precisely because this area is so difficult to navigate for doctors and patients that the CDC, FDA, and NIH could play an important role in pointing out good treatments — yet it’s a role they have been puzzlingly reluctant to play.

Perhaps because of the dearth of formal federal government guidance on treatments — and because of politically driven crazes over drugs like hydroxychloroquine and ivermectin, which evidence thus far suggests do little to fight Covid-19 — Florida media has been critical of Ladapo’s PSA and its recommendations.

Politicians who pander to anti-vax sentiment are harming their constituents, and it’s very reasonable to be frustrated with their conduct. Ladapo is a DeSantis appointee who has forcefully opposed Covid-19 restrictions — and has refused to wear a mask in meetings with immunocompromised legislators — and lots of people are reasonably reading his PSA in that light. 

But that justified irritation shouldn’t get in the way of a needed conversation about the possible benefits and drawbacks of monoclonal antibodies, fluvoxamine, and budesonide. As the US braces for an omicron surge that is likely to hit even vaccinated people, effective treatment is going to be essential for saving lives. Yes, promoting vaccines is a must, but tens of thousands of Americans are getting sick each day, which makes clear, accurate communication about which treatments to ask your doctor about extremely important. 

The more society and public health get aligned on what works, the better off we’ll be in confronting omicron and other future variants.

Michigan this week counted more people hospitalized with COVID-19 than at any other time during the pandemic

https://www.cnn.com/2021/12/09/us/hospital-covid-19-deaths-michigan/index.html

Coronavirus: Michigan's highest-in-the-U.S. case count exceeds California,  Texas combined | CTV News

Nurse Katie Sefton never thought Covid-19 could get this bad — and certainly not this late in the pandemic. “I was really hoping that we’d (all) get vaccinated and things would be back to normal,” said Sefton, an assistant manager at Sparrow Hospital in Lansing, Michigan. But this week Michigan had more patients hospitalized for Covid-19 than ever before. Covid-19 hospitalizations jumped 88% in the past month, according to the Michigan Health & Hospital Association.

“We have more patients than we’ve ever had at any point, and we’re seeing more people die at a rate we’ve never seen die before,” said Jim Dover, president and CEO of Sparrow Health System.

“Since January, we’ve had about 289 deaths; 75% are unvaccinated people,” Dover said. “And the very few (vaccinated people) who passed away all were more than 6 months out from their shot. So we’ve not had a single person who has had a booster shot die from Covid.”

Among the new Covid-19 victims, Sefton said she’s noticed a disturbing trend.

We’re seeing a lot of younger people. And I think that is a bit challenging,” said Sefton, a 20-year nursing veteran.She recalls helping the family of a young adult say goodbye to their loved one. “It was an awful night,” she said. “That was one of the days I went home and just cried.”

‘We haven’t peaked yet’

It’s not just Michigan that’s facing an arduous winter with Covid-19. Nationwide, Covid-19 hospitalizations have increased 40% compared to a month ago, according to data from the US Department of Health and Human Services. This is the first holiday season with the relentless spread of the Delta variant — a strain far more contagious than those Americans faced last winter.

“We keep talking about how we haven’t peaked yet,” Sefton said.Health experts say the best protection against Delta is to get vaccinated and boosted. But as of Thursday, only about 64.3% of eligible Americans had been fully vaccinated, and less than a third of those eligible for boosters have gotten one.

Sparrow Hospital nurse Danielle Williams said the vast majority of her Covid-19 patients are not vaccinated — and had no idea they could get pummeled so hard by Covid-19.“Before they walked in the door, they had a normal life. They were healthy people. They were out celebrating Thanksgiving,” Williams said. “And now they’re here, with a mask on their face, teary eyed, staring at me, asking me if they’re going to live or not.”

‘The next few weeks look hard’

Dover said he’s saddened but not surprised that his state is getting walloped with Covid-19.“Michigan is not one of the highest vaccination states in the nation. So it continues to have variant after variant grow and expand across the state,” he said.

“The next few weeks look hard. We’re over 100% capacity right now,” Dover said.”Most hospitals and health systems in the state of Michigan have gone to code-red triage, which means they won’t accept transfers. And as we go into the holidays, if the current growth rate that we’re at today, we would expect to see 200 in-patient Covid patients by the end of the month — on a daily basis.”And that would mean “absolutely stretching us to the breaking point,” Dover said.”We’ve already discontinued in-patient elective surgeries,” he said. “In order to create capacity, we took our post-anesthesia recovery care unit and converted it into another critical care unit.”

‘There’s a lot of frustration’

Nurse Leah Rasch is exhausted. She’s worked with Covid-19 patients since the beginning of the pandemic and was stunned to see so many people still unvaccinated enter the Covid unit.

“I did not think we’d be here. I truly thought that people would be vaccinated,” the Sparrow Hospital nurse said.”I don’t remember the last time we did not have a full Covid floor.”The relentless onslaught of Covid-19 patients has impacted Rasch’s own health. “There’s a lot of frustration,” she said. “The other day, I had my first panic attack … I drove to work and I couldn’t get out of the car.”

‘We need everybody to get vaccinated’

Dover said many people have asked how they can support health care workers.”If you really want to support your staff, and you really want to support health care heroes, get vaccinated,” he said. “It’s not political. We need everybody to get vaccinated.”

He’s also urging those who previously had Covid-19 to get vaccinated, as some people can get reinfected.”My daughter’s a good example. She had Covid twice before she was eligible for a vaccine,” Dover said. “She still got a vaccine because we know that if you don’t get the vaccine, just merely having contracted Covid is not enough to protect you from getting it again. And I know that from personal experience. “And those who are unvaccinated shouldn’t underestimate the pandemic right now, Dover said.

“The problem is, it’s not over yet. I don’t know if people realize just how critical it still is,” he said.”But they do realize it when they come into the ER, and they have to wait three days for a bed. And at that point, they realize it.”

A tale of two New Yorks: COVID-19 hospitalization rate surging upstate

https://www.yahoo.com/gma/tale-two-yorks-covid-19-100301204.html

COVID-19-related hospitalizations have been on an upward trend in New York state since last month, but there appears to be a drastic divide between the Big Apple and some of the state’s more rural areas, health data shows.

In New York City, the seven-day average of new COVID-19 hospitalizations per 100,000 people rose from 0.5 on Nov. 10 to 1.1 on Dec. 7, the New York State Department of Health said.

The story is different in several counties hundreds of miles north, where new COVID-19 hospitalizations are rising at a higher rate. In the Finger Lakes region, officials in several counties declared a state of emergency after the seven-day average of new COVID-19 hospitalizations per 100,000 people went from 2.9 on Nov. 10 to 4.9 on Dec. 7.

David Larsen, an associate professor of public health at Syracuse University, told ABC News that there are several factors behind this divide, but the most important one is the lower vaccination rates in certain counties upstate.

“At the end of the day, you’re more likely to get severe COVID-19 symptoms and go to the hospital if you’re not vaccinated,” Larsen said.

Health experts and state officials predict the situation upstate is only going to get worse during the holidays and colder months, but the tide can be turned if more people get their shots and heed health warnings.

As of Dec. 8, 74.9% of all New York state residents have at least one COVID-19 vaccine dose, but those numbers vary by region, according to state health data.

New York City and Long Island had over 78% of their populations with at least one shot, the state data showed. Further north, the rates for at least one dose in the Mohawk Valley, the Finger Lakes and North Country sections were 60.6%, 68.5%, and 63% respectively.

There is even more division within the regions when it comes to vaccination, the data shows; for example, counties that are along the Interstate 87 corridor, such as Hamilton, Schenectady and Saratoga, all have rate of at least one dose above 75% of their populations.

Counties directly west of those locations, Schoharie, Fulton and Montgomery, have one-dose vaccination rates under 65%, the state data showed.

New York Gov. Kathy Hochul has repeatedly highlighted that the unvaccinated are the ones suffering and being hospitalized.

“It is a conscious decision not to be vaccinated. And the direct result is a higher rate of individuals in those regions upstate as well as it has a direct correlation to the number of hospitalizations,” she said during a Dec. 2 news conference.

Dr. Isaac Weisfuse, an adjunct professor of public health at Cornell University, told ABC News that there are fewer options for upstate residents to turn to for medical help and fewer hospitals in the area are handling patients from more locations.

Weisfuse, a former deputy health commissioner for New York City’s Health Department, noted that New York City residents have much closer access to amenities like free testing sites and medical clinics than their upstate counterparts.

“If you live in a rural county in New York state and it takes a while to get to a doctor, you may put it off. So when you do eventually go get care, you may be sicker versus someone who lives closer and gets a quicker diagnosis,” he said.

Larsen added that there has been pandemic fatigue across the country, and many Americans have scaled back on mitigation measures, especially mask-wearing indoors.

While New York City requires proof of vaccination for indoor activities, such as movie theaters and restaurants, there are no such rules in many upstate counties. As a result, some upstate residents have less of an incentive to get their shots, and are less cautious in indoor group settings, according to Larsen.

PHOTO: A sign asks for proof of COVID-19 vaccination in Manhattan at the entrance to a museum on Nov. 29, 2021, in New York City. (Spencer Platt/Getty Images)

“We’re doing less mask wearing. What that does is it increases transmission, which is fine for the vaccinated people but it does go to the unvaccinated people and they are higher risk,” he said.

Weisfuse said the hospitalizations are likely to grow upstate and have ripple effects for those regions. The governor has ordered elective surgeries to be postponed at 32 hospitals upstate that have seen their available beds decrease.

PHOTO: Tse Cowan, 8, winces as he is administered the Pfizer COVID-19 vaccine at a pop-up vaccine site at P.S. 19 on Nov. 08, 2021 in the Lower East Side of New York City. (Michael M. Santiago/Getty Images)

State officials said they are beefing up their marketing efforts to encourage eligible New Yorkers to get their shots.

Weisfuse said this outreach needs to be done meticulously if upstate officials want to avoid more overcrowded emergency rooms this winter.

“The state needs to take a good look at the pockets of non-vaccination,” he said. “They need to make some targeted intervention in those neighborhoods.”

Anyone who needs help scheduling a free vaccine appointment can log onto vaccines.gov.

Omicron variant ‘almost certainly’ not more severe than Delta, Fauci tells AFP

https://www.france24.com/en/live-news/20211207-omicron-variant-almost-certainly-not-more-severe-than-delta-fauci-tells-afp

 Top US scientist Anthony Fauci said Tuesday that while it would take weeks to judge the severity of the new Covid-19 variant Omicron, early indications suggested it was not worse than prior strains, and possibly milder.

Speaking to AFP, President Joe Biden’s chief medical advisor broke down the knowns and unknowns about Omicron into three major areas: transmissibility, how well it evades immunity from prior infection and vaccines, and severity of illness.

The new variant is “clearly highly transmissible,” very likely more so than Delta, the current dominant global strain, Fauci said.

Accumulating epidemiological data from around the world also indicates re-infections are higher with Omicron.

Fauci, the long-time director of the National Institute of Allergies and Infectious Diseases (NIAID), said lab experiments that tested the potency of antibodies from current vaccines against Omicron should come in the “next few days to a week.”

On the question of severity, “it almost certainly is not more severe than Delta,” said Fauci.

“There is some suggestion that it might even be less severe, because when you look at some of the cohorts that are being followed in South Africa, the ratio between the number of infections and the number of hospitalizations seems to be less than with Delta.”

But he added it was important to not over-interpret this data because the populations being followed skewed young, and were less likely to become hospitalized.

“I think that’s going to take another couple of weeks at least in South Africa,” where the variant was first reported in November, he said.

“As we get more infections throughout the rest of the world, it might take longer to see what’s the level of severity.”

Fauci said a more transmissible virus that doesn’t cause more severe illness and doesn’t lead to a surge of hospitalizations and deaths was the “best case scenario.”

“The worst case scenario is that it is not only highly transmissible, but it also causes severe disease and then you have another wave of infections that are not necessarily blunted by the vaccine or by people’s prior infections,” he added.

“I don’t think that worst case scenario is going to come about, but you never know.”

PFIZER AND BIONTECH PROVIDE UPDATE ON OMICRON VARIANT

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-omicron-variant

Pfizer shot provides partial omicron shield, study finds | The Japan Times
  • Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers
  • Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are comparable to titers observed after two doses against the wild-type virus which are associated with high levels of protection
  • As 80% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, two doses may still induce protection against severe disease
  • The companies continue to advance the development of a variant-specific vaccine for Omicron and expect to have it available by March in the event that an adaption is needed to further increase the level and duration of protection – with no change expected to the companies’ four billion dose capacity for 2022

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccinees one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to thoseobserved for the wild-type SARS-CoV-2 spike protein after two doses.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211208005542/en/

Sera from individuals who received two doses of the current COVID-19 vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the Omicron variant compared to wild-type, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the Omicron variant. However, as the vast majority of epitopes targeted by vaccine-induced T cells are not affected by the mutations in Omicron, the companies believe that vaccinated individuals may still be protected against severe forms of the disease and are closely monitoring real world effectiveness against Omicron, globally.

A more robust protection may be achieved by a third dose as data from additional studies of the companies indicate that a booster with the current COVID-19 vaccine from Pfizer and BioNTech increases the antibody titers by 25-fold. According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron. These antibody levels are associated with high efficacy against both the wild-type virus and these variants. A third dose also strongly increases CD8+ T cell levels against multiple spike protein epitopes which are considered to correlate with the protection against severe disease. Compared to the wild-type virus, the vast majority of these epitopes remain unchanged in the Omicron spike variant.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Ensuring as many people as possible are fully vaccinated with the first two dose series and a booster remains the best course of action to prevent the spread of COVID-19.”

“Our preliminary, first dataset indicate that a third dose could still offer a sufficient level of protection from disease of any severity caused by the Omicron variant,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Broad vaccination and booster campaigns around the world could help us to better protect people everywhere and to get through the winter season. We continue to work on an adapted vaccine which, we believe, will help to induce a high level of protection against Omicron-induced COVID-19 disease as well as a prolonged protection compared to the current vaccine.”

While these results are preliminary, the companies will continue to collect more laboratory data and evaluate real-world effectiveness to assess and confirm protection against Omicron and inform the most effective path forward. On November 25, the companies started to develop an Omicron-specific COVID-19 vaccine. The development will continue as planned in the event that a vaccine adaption is needed to increase the level and duration of protection against Omicron. First batches of the Omicron-based vaccine can be produced and are planned to be ready for deliveries within 100 days, pending regulatory approval. Pfizer and BioNTech have tested other variant-specific vaccines as well, which have produced very strong neutralization titers and a tolerable safety profile. Based on this experience the companies have high confidence that if needed they can deliver an Omicron-based vaccine in March 2022. The companies have also previously initiated clinical trials with variant-specific vaccines (Alpha, Beta, Delta & Alpha/Delta Mix) and data from these studies will be submitted to regulatory agencies around the world to help accelerate the process of adapting the vaccine and gaining regulatory authorization or approval of an Omicron-specific vaccine, if needed. The companies have previously announced that they expect to produce four billion doses of BNT162b2 in 2022, and this capacity is not expected to change if an adapted vaccine is required.

About the Pfizer-BioNTech Laboratory Studies

To evaluate the effectiveness of BNT162b2 against the Omicron variant, Pfizer and BioNTech immediately tested a panel of human immune sera obtained from the blood of individuals that received two or three 30-µg doses of the current Pfizer-BioNTech COVID-19 vaccine, using a pseudovirus neutralization test (pVNT). The sera were collected from subjects 3 weeks after receiving the second dose or one month after receiving the third dose of the Pfizer-BioNTech COVID-19 vaccine. Each serum was tested simultaneously for its neutralizing antibody titer against the wild-type SARS-Cov-2 spike protein, and the Omicron spike variant. The third dose significantly increased the neutralizing antibody titers against the Omicron strain spike by 25-fold. Neutralization against the Omicron variant after three doses of the Pfizer-BioNTech COVID-19 vaccine was comparable to the neutralization against the wild-type strain observed in sera from individuals who received two doses of the companies’ COVID-19 vaccine: The geometric mean titer (GMT) of neutralizing antibody against the Omicron variant measured in the samples was 154 (after three doses), compared to 398 against the Delta variant (after three doses) and 155 against the ancestral strain (after two doses). Data on the persistence of neutralizing titers over time after a booster dose of BNT162b2 against the Omicron variant will be collected.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.