Tag Archives: BioNTech SE

BioNTech says it will start cancer vaccine trials in the UK from September

A NHS vaccinator administers the Pfizer-BioNTech Covid-19 booster jab to a woman, at a vaccination centre in London. BioNTech is launching a large-scale trial of mRNA therapies to treat cancer and other diseases in the U.K.

Sopa Images | Lightrocket | Getty Images

LONDON — The U.K. government on Friday announced a partnership with German firm BioNTech to test potential vaccines for cancer and other diseases, as campaigners warned any breakthrough must remain affordable and accessible.

Cancer patients in England will get early access to trials involving personalized mRNA therapies, including cancer vaccines, which aim to spur the immune system to attack harmful cells.

They will be administered to early and late-stage patients and target both active cancer cells and preventing their return.

BioNTech will set up new research and development centers in the U.K., with a lab in Cambridge and headquarters in London, and aim to deliver 10,000 therapies to patients from September 2023 until the end of the decade.

The company developed one of the most widely-distributed Covid-19 vaccines alongside U.S. pharma firm Pfizer. Its CEO, Ugur Sahin, said it had learned lessons from the coronavirus pandemic about collaboration between the British National Health Service, academics, regulators and the private sector in the development of drugs that it was applying now.

“Our goal is to accelerate the development of immunotherapies and vaccines using technologies we have been researching for over 20 years,” he said in a statement. “The collaboration will cover various cancer types and infectious diseases affecting collectively hundreds of millions of people worldwide.”

Peter Johnson, Britain’s National Clinical Director for Cancer, said mRNA technology had the potential to transform approaches to a number of illnesses.

The government confirmed to CNBC the announcement represented a private investment into the U.K., but would be supported by a new Cancer Vaccine Launch Pad funded by the NHS.

Other mRNA cancer vaccines, including a collaboration between U.S. firms Moderna and Merck, are also being trialed.

Tim Bierley, a campaigner at U.K.-based group Global Justice Now, said big pharmaceutical companies had “terrible record of price gouging on new medicines, even where public money has played a key role in bringing them to the market.”

“The government has a moral duty to push BioNtech to set the price of this potentially life-saving vaccine so it is accessible to all,” he said.

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Mohga Kamal-Yanni, policy co-lead for the People’s Vaccine Alliance — a global group of health organizations, economists and activists — said news of the trial was good, but that any outcome “belongs to the people” due to the amount of public funding involved.

“The U.K. government must say how it will ensure any new medicine, vaccine or technology will be made available and affordable to developing countries,” Kamal-Yanni said.

A government spokesperson told CNBC the research was at too early a stage to discuss pricing and distribution, but pointed to its record in distributing free Covid-19 vaccines.

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BioNTech says it will start cancer vaccine trials in the UK from September

A NHS vaccinator administers the Pfizer-BioNTech Covid-19 booster jab to a woman, at a vaccination centre in London. BioNTech is launching a large-scale trial of mRNA therapies to treat cancer and other diseases in the U.K.

Sopa Images | Lightrocket | Getty Images

LONDON — The U.K. government on Friday announced a partnership with German firm BioNTech to test potential vaccines for cancer and other diseases, as campaigners warned any breakthrough must remain affordable and accessible.

Cancer patients in England will get early access to trials involving personalized mRNA therapies, including cancer vaccines, which aim to spur the immune system to attack harmful cells.

They will be administered to early and late-stage patients and target both active cancer cells and preventing their return.

BioNTech will set up new research and development centers in the U.K., with a lab in Cambridge and headquarters in London, and aim to deliver 10,000 therapies to patients from September 2023 until the end of the decade.

The company developed one of the most widely-distributed Covid-19 vaccines alongside U.S. pharma firm Pfizer. Its CEO, Ugur Sahin, said it had learned lessons from the coronavirus pandemic about collaboration between the British National Health Service, academics, regulators and the private sector in the development of drugs that it was applying now.

“Our goal is to accelerate the development of immunotherapies and vaccines using technologies we have been researching for over 20 years,” he said in a statement. “The collaboration will cover various cancer types and infectious diseases affecting collectively hundreds of millions of people worldwide.”

Peter Johnson, Britain’s National Clinical Director for Cancer, said mRNA technology had the potential to transform approaches to a number of illnesses.

The government confirmed to CNBC the announcement represented a private investment into the U.K., but would be supported by a new Cancer Vaccine Launch Pad funded by the NHS.

Other mRNA cancer vaccines, including a collaboration between U.S. firms Moderna and Merck, are also being trialed.

Tim Bierley, a campaigner at U.K.-based group Global Justice Now, said big pharmaceutical companies had “terrible record of price gouging on new medicines, even where public money has played a key role in bringing them to the market.”

“The government has a moral duty to push BioNtech to set the price of this potentially life-saving vaccine so it is accessible to all,” he said.

CNBC Health & Science

Read CNBC’s latest global health coverage:

Mohga Kamal-Yanni, policy co-lead for the People’s Vaccine Alliance — a global group of health organizations, economists and activists — said news of the trial was good, but that any outcome “belongs to the people” due to the amount of public funding involved.

“The U.K. government must say how it will ensure any new medicine, vaccine or technology will be made available and affordable to developing countries,” Kamal-Yanni said.

A government spokesperson told CNBC the research was at too early a stage to discuss pricing and distribution, but pointed to its record in distributing free Covid-19 vaccines.

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Omicron BA.5 is declining as emerging variants gain ground: CDC data

The U.S. faces at least seven different versions of Covid-19 omicron as the nation heads into winter when health officials are expecting another wave of viral infections.

Although the omicron BA.5 variant remains dominant in the country, it is starting to lose some ground to other versions of the virus, according to data from the Centers for Disease Control and Prevention published on Friday.

Omicron BA.5 has splintered into several new but related variants that include BQ.1, BQ.1.1 and BF.7. The U.K. Health Security Agency, in a report earlier this month, said these three variants are demonstrating a growth advantage over BA.5, which was the most contagious version to date.

In the U.S., omicron BA.5 makes up about 68% of all new infections, down from about 80% at the beginning of October. BQ.1, BQ.1.1 and BF.7 are now causing about 17% of new infections combined, according to the CDC data.

About 3% of new infections are attributable to BA.2.75. and BA.2.75.2, which are related to the omicron BA.2 variant that caused a bump in cases during the spring but was pushed out.

Scientists at Peking University in China found that omicron BA.2.75.2 and BQ.1.1 were the most adept at evading immunity from prior BA.5 infection and several antibody drugs. The study, published earlier in October, has not been peer reviewed.

Dr. Ashish Jha, the White House Covid response coordinator, said earlier this week that U.S. health officials are closely monitoring these variants because they are good at evading prior immunity.

“The reason we’re tracking them is because they either have a lot more immune invasiveness or they render many of our treatments ineffective,” Jha said. “Those are the two major things that get our attention.”

But Jha said the new omicron boosters that the U.S. started rolling out last month should provide better protection than the first-generation vaccines against these emerging variants. The boosters target BA.5 and the emerging variants are all omicron and most descend from BA.5.

Jha called on all eligible Americans to get the new boosters by Halloween so they will have full protection for Thanksgiving when family holiday gatherings kick into full swing.

But the scientists at Peking University said the immune evasiveness of variants like BA.2.75.2 and BQ.1.1 could mean that the BA.5 booster shots will not provide sufficiently broad protection.

It’s unclear how much more effective the boosters will prove in the real world. The Food and Drug Administration authorized the shots without direct human data, relying instead on clinical trials from a similar shot that was developed against the original version of omicron, BA.1.

Pfizer and BioNTech on Thursday published the first human data from their BA.5 shots. They triggered a significant boost to the immune system against omicron BA.5 in a lab study that looked at blood samples from adults ages 18 and older, the companies said.

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Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed

The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.

Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron.

“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner

Robert Califf

said in a recent tweet. The FDA pointed to Dr. Califf’s tweets when asked for comment.

Clearance of the doses, without data from human testing known as clinical trials, is similar to the approach the FDA takes with flu shots, which are updated annually to keep up with mutating flu viruses.

Some vaccine experts have urged the agency to wait before clearing the new Covid-19 booster doses.



Photo:

EMILY ELCONIN/REUTERS

The approach has raised concerns, however, among some vaccine experts who have urged the agency to wait.

“I’m uncomfortable that we would move forward—that we would give millions or tens of millions of doses to people—based on mouse data,” said

Paul Offit,

an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

The comparison with flu vaccines isn’t sound, Dr. Offit said, because flu viruses mutate so rapidly that shots from one year don’t offer protection for the next, while currently available Covid-19 shots continue to keep people out of the hospital.

In addition to evaluating the boosters without clinical-trial data, the FDA won’t convene another element from its earlier Covid-19 vaccine reviews: a meeting of advisers who make recommendations whether the agency should authorize a shot.

Retooled Covid-19 boosters are similar to the original shots, including Moderna’s Covid-19 vaccines, seen last year, but have been customized to fight the latest variants.



Photo:

andrew caballero-reynolds/Agence France-Presse/Getty Images

The FDA scrapped the meeting, Dr. Califf said in his tweets on the subject, because the committee discussed the matter in June, and the agency doesn’t have new questions warranting its input.

The Covid-19 vaccines available in the U.S., which were first authorized for use in December 2020, haven’t been modified until now, though the virus they were designed to target has evolved.

The shots held up well against earlier strains, researchers found, but weren’t as effective against the newest Omicron subvariants like BA.5.

In planning for a fall booster campaign, federal health authorities in late June directed

Pfizer Inc.

and its partner

BioNTech SE,

and

Moderna Inc.

to update their shots to target BA.5, an Omicron subvariant called BA.4 and the original strain of the virus.

“We’ve validated the process several times over and continue to produce safe and effective vaccines against Covid-19,” a Pfizer spokeswoman said. Moderna said all current data indicates its shots are safe and effective.

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Human trials for Moderna’s vaccine targeting the subvariants have started, and for the Pfizer-BioNTech vaccine are expected to start this month, the companies have said. Results won’t be available, however, before the U.S. government’s planned fall booster campaign.

“If we waited for clinical-trial results, thank you very much, we’d get them in the spring. It takes time to do clinical trials,” said

William Schaffner,

professor of medicine at Vanderbilt University Medical Center and a nonvoting liaison to the Centers for Disease Control and Prevention committee that will decide whether to recommend the shots, should the FDA sign off. “This is just an updating of the previous vaccine that we used.”

The retooled shots are similar to the original shots, but customized to fight the latest variants, much like keys that are nearly identical but have slightly different ridges and valleys, said

John Grabenstein,

director of scientific communications for Immunize.org, a nonprofit that seeks to boost immunization rates.

With each mutation, the Covid-19 virus is becoming more transmissible. WSJ’s Daniela Hernandez breaks down the science of how Covid variants are getting better at infecting and spreading. Illustration: Rami Abukalam

The similarities make it very reasonable for regulators to weigh the overwhelmingly safe track record of the original series when considering the new shots, he said.

The FDA has reviewed test results from a shot that Moderna modified to target an early version of Omicron as well as the ancestral strain of the coronavirus. The study found the shot generated a significant amount of antibodies in humans compared with the company’s currently available booster shot. That shot is now approved in the U.K.

The agency also looked at human data from Pfizer and BioNTech finding that their experimental shots, updated to target an earlier form of Omicron, also boosted antibody levels significantly. The companies have submitted one of those shots to the U.K., EU and Canada for authorization, Pfizer has said.

Such findings give the FDA confidence that the newest modified shots will also work well, said a person familiar with the agency’s deliberations.

“As we know from prior experience, strain changes can be made without affecting safety,” Dr. Califf said in a tweet.

Dr. Offit, however, said he would like to wait for clinical-trial data showing the shots are effective before asking people to take them.

“If you have some evidence that this is likely to be of value, sure,” he said. “But if you don’t have evidence, and you know that the current vaccine does offer protection against severe disease, I don’t think it’s fair to ask people to take risks.”

Write to Liz Essley Whyte at liz.whyte@wsj.com

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Medical professionals are skeptical on a fourth Covid vaccine dose

There hasn’t been enough research on how much protection a fourth dose can offer, medical professionals told CNBC.

Justin Sullivan | Getty Images

Countries are beginning to offer a fourth dose of the Covid-19 vaccine to vulnerable groups, but medical professionals are undecided on whether it would benefit the wider population.

The U.S. Food and Drug Administration has so far authorized a fourth shot only for those aged 50 and above, as well as those who are immunocompromised. And the U.S. Centers for Disease Control and Prevention was skeptical of the need for a fourth dose for healthy adults in the absence of a clearer public health strategy.

Those decisions came as a study from Israel found that although a fourth dose of the Pfizer-BioNTech vaccine offers protection against serious illness for at least six weeks after the shot, it provides only short-lived protection against infection, which wanes after just four weeks.

No ‘good evidence’ yet

The medical consensus so far is that there hasn’t been enough research on how much protection a fourth dose can offer.

The World Health Organization hasn’t given an official recommendation on a fourth dose, and “there isn’t any good evidence at this point of time” that it will be beneficial, said WHO chief scientist Soumya Swaminathan.

“What we know from immunology is that if you give another booster, you will see a temporary increase in the neutralizing antibodies. But what we’ve also seen is that these neutralizing antibodies will wane quite rapidly,” Swaminathan told CNBC in an interview.

A fourth dose doesn’t really do much of anything … I’m not sure we need to get out and just jump up and down screaming that everybody needs to get aboard.

Paul Goepfert

professor at the University of Alabama

“This happened after the third dose. And it’s happened again after the fourth dose,” she added.

Paul Goepfert, professor of medicine at the University of Alabama, shared that view, saying that “a fourth dose doesn’t really do much of anything … I’m not sure we need to get out and just jump up and down screaming that everybody needs to get aboard.”

Since the study from Israel shows the fourth dose can provide protection against serious disease, countries such as Israel, Denmark and Singapore have made a second booster shot available to high-risk groups.

“Rather than saying that the protection wanes, I would say that this boost effect is strongest shortly after the vaccine was administered, but that it remains protective overall,” said Ashley St. John, an associate professor at Duke-NUS Medical School.

“Importantly there was no waning of protection against severe disease, which is the most key effect of vaccination we aim to achieve,” she added.

Annual booster shots?

Questions are being raised over the need for more booster shots as the emergence of more Covid variants may require more targeted vaccines.

Anthony Fauci, White House chief medical advisor, told NBC News in January that people may need to get booster shots every year or two.

However, blanket vaccine approaches may not continue to work.

It is possible that high-risk groups — such as the elderly — may need an annual vaccine, said Swaminathan. But “it’s not clear whether a healthy adult is going to need a regular annual shot.”

It’s also important to note that the current vaccines being administered may not work for future variants of Covid-19, she said.

If the virus “changes so much that you need to change your vaccine composition, then you won’t need another shot,” Swaminathan added. “The challenge of changing the vaccine composition is that you’re always playing catch-up.”

Goepfert said “only time will tell” how long more the population has to take booster shots, but the safest approach would be to “plan on a booster every year, and maybe combine it with the flu vaccine.”

Omicron subvariant

The WHO announced on Tuesday that weekly new Covid deaths had fallen to the lowest level since March 2020.

But the more contagious omicron BA.2 subvariant remains the dominant strain in the United States, making up 68.1% of all cases in the country during the week that ended on April 23, according to data from the CDC.

Although experts predict that the BA.2 subvariant is unlikely to be more severe than the original omicron strain, it should remain a concern.

“I do think infections are going to continue … it’s taken over most parts of the country, said Goepfert. “But in terms of severe infections, I think that’s going to continue to be less and less.”

Patients from locations with adequate vaccination coverage would experience only “mild or manageable disease” and this would reduce “burden on the healthcare system compared to waves of Covid pre-vaccines,” St. John said.

“Just like studying for an exam, a vaccine booster can trigger immune system memories and increase performance during the real test,” she added.

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Covid-19 Vaccines Carry Low Risk of Heart Conditions, Studies Find

The risk of developing inflammatory heart conditions after Covid-19 vaccination is relatively low, two large studies found, especially when compared with the heart-related risks from Covid-19 disease itself and from vaccines against other diseases.

One study, an analysis of 22 previous studies, found that the risk of the conditions including myocarditis in people who received a Covid-19 vaccine wasn’t significantly different from that for non-Covid-19 vaccines such as those against flu, polio and measles. And the heart risk associated with Covid-19 shots was lower than the risk after smallpox vaccination. The results of the analysis, which included data on the effects of more than 400 million doses of various vaccines, were published online Monday by The Lancet Respiratory Medicine.

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UK to roll out additional vaccine shot for over 75s, vulnerable people

A member of the military vaccinates a woman at the COVID-19 mass vaccination centre at Pentwyn Leisure Centre on February 3, 2021 in Cardiff, Wales.

Matthew Horwood | Getty Images News | Getty Images

The U.K. will roll out an additional Covid vaccine shot for the elderly and its clinically vulnerable population, the country’s vaccines regulator announced on Monday.

Adults over the age of 75, nursing home residents and immunosuppressed over-12s will be given an extra dose of a Covid vaccine in the spring as a “precautionary strategy for 2022,” Britain’s Joint Committee on Vaccination and Immunisation said in a press release.

Over-18s will be offered the Pfizer-BioNTech or the Moderna Covid vaccine for their spring dose, while 12 to 18-year-olds will be given the Pfizer-BioNTech vaccine only.

An extra booster shot will be given 6 months after an eligible individual’s most recent dose, the JCVI said.

For older people in the U.K., this will be the fourth vaccine dose they have been offered. For people with a severely weakened immune system, it will be the fifth vaccine shot they have been offered. The bulk of the population has been offered three shots, two vaccinations and one booster.

The regulatory body noted in the release on Monday that “there remains considerable uncertainty with regards to the likelihood, timing and severity of any potential future wave of Covid-19 in the U.K.”

“There may be a transition period of a few years before a stable pattern, such as a regular seasonal wave of infection, is established,” the JCVI said.

Many of the U.K.’s oldest, and most vulnerable, adults received their most recent Covid vaccine in September or October. The JCVI noted that the immunity this group gained through their booster shot may wane substantially before the fall, when it plans to roll out a wider booster program.

Details on the fall program have not yet been publicized.

Of the eligible population in the U.K. — those aged 12 and over — 85% have been fully immunized with two doses of a Covid vaccine, and two-thirds have received a booster shot.

The JCVI’s announcement came as U.K. Prime Minister Boris Johnson prepares to announce an end to all remaining Covid restrictions in England, a move which has faced heavy criticism from medical professionals.

Many of England’s restrictions had already been lifted, but some — such as the legal requirement to self-isolate after testing positive for the virus — currently remain in place.

Johnson is also expected to announce on Monday that access to free Covid tests will be scaled back.

The U.K. recorded 25,696 new cases of the coronavirus on Sunday, with around 508 people per 100,000 people currently infected with the virus. Provisional data shows that there were 74 deaths in the U.K. due to Covid.

“Thanks to our COVID-19 vaccination rollout, we are already the freest country in Europe,” U.K. Health Secretary Sajid Javid said in a statement on Monday. “It has saved countless lives, reduced pressure on the [National Health Service] and is allowing us to learn to live with the virus.”

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Pfizer (PFE) earnings Q4 2021

Pfizer CEO Albert Bourla addresses a press conference after a visit to oversee the production of the Pfizer-BioNtech COVID-19 vaccine at the factory of U.S. pharmaceutical company Pfizer in Puurs, Belgium April 23, 2021.

John Thys | Pool | Reuters

Pfizer projects it will generate record-high revenue in 2022, saying Tuesday it expects to sell $32 billion of its Covid-19 shots and $22 billion of its antiviral coronavirus treatment pill Paxlovid this year.

However, the company posted mixed fourth-quarter results, beating on earnings but slightly missing on revenue. Pfizer’s stock was down more than 3% in pre-market trading.

Here’s how the company performed compared to what Wall Street expected, based on analysts’ average estimates compiled by Refinitiv:

  • Adjusted EPS: $1.08 vs. 87 cents expected
  • Revenue: $23.84 billion vs. $24.12 billion expected

Pfizer’s miss on revenue was driven by lackluster sales in its internal medicine and hospital segments. Fourth-quarter internal medicine sales fell 3% year-over-year to $2.24 billion, while hospital sales were largely flat at $1.88 billion compared to the same quarter in 2020. Pfizer’s oncology sales grew 7% to $3.24 billion compared with the same three months in the previous year.

However, Pfizer’s fourth-quarter revenue more than doubled overall to $23.84 billion year-over year. The company sold $12.5 billion of its Covid vaccine in the fourth quarter.

Pfizer started a clinical trial late last month of a Covid vaccine that targets the omicron variant in adults ages 18 to 55. CEO Albert Bourla has said the company expects to have the vaccine ready by March.

Pfizer and its partner BioNTech are also working with the Food and Drug Administration to expedite authorization of their Covid vaccine for children under 5-years-old this month, the last age group left in the U.S. that is not eligible for immunization. The companies expect kids under 5 will ultimately need three doses, but they are working to get the first two shots FDA authorized while they finish trials on the third dose.

Pfizer is also working to ramp up production and delivery of its Covid treatment pill, Paxlovid. Bourla has said Pfizer expects to produce 6 million to 7 million courses in the first quarter this year and 120 million by the end of the year. The U.S. government has ordered 20 million courses, with 10 million expected by June.

This is breaking news. Please check back for updates.

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The next Covid variant will be more contagious than omicron, WHO says

The next Covid-19 variant that will rise to world attention will be more contagious than omicron, but the real question scientists need to answer is whether or not it will be more deadly, World Health Organization officials said Tuesday.

Roughly 21 million Covid cases were reported to the WHO over the last week, setting a new global record for weekly cases from the rapidly spreading omicron variant, Maria Van Kerkhove, WHO’s Covid-19 technical lead, said during a livestreamed Q&A across the group’s social media channels.

While omicron appears to be less virulent than previous strains of the virus, the sheer volume of cases is crushing hospital systems worldwide.

“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Van Kerkhove said. “The big question is whether or not future variants will be more or less severe.”

She warned against buying into theories that the virus will continue to mutate into milder strains that make people less sick than earlier variants.

“There is no guarantee of that. We hope that that is the case, but there is no guarantee of that and we can’t bank on it,” she said, noting that people should heed public safety measures in the meantime. What’s more, the next iteration of Covid may also evade vaccine protections even more, making the existing vaccines even less effective.

Pfizer and BioNTech on Tuesday started testing a Covid vaccine that specifically targets the omicron variant, as concerns grow that the current shots aren’t holding up against infections and mild illness caused by the strain discovered just over two months ago.

The U.S. Centers for Disease Control and Prevention found in a study published last week that a booster dose of Pfizer’s vaccine was 90% effective at preventing hospitalization from omicron 14 days after the third shot was administered.

Booster doses are also up to 75% effective at preventing symptomatic infection from omicron two to four weeks after the third shot, according to data from the U.K. Health Security Agency published earlier this month. However, the study found that boosters weaken substantially after about 10 weeks, providing 45% to 50% protection against symptomatic infection.

While omicron appears to have peaked in some countries, it’s gaining ground in others, WHO officials said. “You won’t have to wear a mask forever and you won’t have to physically distance, but for now, we need to keep doing this,” Van Kerkhove said.

The virus will continue to evolve before it settles into a pattern, said Dr. Mike Ryan, WHO’s director of emergency programs. He said it will hopefully settle into a low level of transmission with potentially occasional epidemics. It could become more seasonal or may only affect vulnerable groups, he said.

The problem, he said, is that Covid is unpredictable.

“The virus has proven to give us some nasty surprises,” Ryan said. World health officials need to continue tracking Covid as it evolves, he said, and be ready “if there’s a nasty surprise that we can at least put in place measures again that will stop this new variant doing any more damage.”

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5 things to know before the stock market opens Tuesday, Jan. 4

Here are the most important news, trends and analysis that investors need to start their trading day:

1. Dow, S&P 500 set to rise, one day after closing at records

A Wall Street subway station near the New York Stock Exchange (NYSE) in New York, on Monday, Jan. 3, 2022.

Michael Nagle | Bloomberg | Getty Images

U.S. stock futures pointed to gains at Tuesday’s open, which would add to Wall Street’s advance on the first trading day of the year after a strong 2021. The Dow Jones Industrial Average and the S&P 500 each rose 0.6% on Monday, closing at record highs. The Nasdaq gained 1.2%, but it remained 1.4% away from its latest record finish in November. Bond yields jumped to start the year, with the 10-year Treasury yield topping 1.6% and continuing higher early Tuesday.

  • Apple’s premarket gain would put it over the $3 trillion market cap again. The tech giant became the first U.S. company to do so during Monday trading. But it just missed closing above that level.
  • At 10 a.m. ET, the Labor Department is set to release its latest Job Openings and Labor Turnover Survey. JOLTS is expected to show 11.1 million job openings as of the end of November.

2. U.S. reports over 1 million new daily Covid cases as omicron surges

Merline Jimenez (L) administers a COVID-19 nasopharyngeal swab to a person at a testing site located in the international terminal at Los Angeles International Airport (LAX) amid a surge in omicron variant cases on December 21, 2021 in Los Angeles, California.

Mario Tama | Getty Images

The U.S. reported a record number of new Covid cases Monday, with more than 1 million new infections, according to data compiled by Johns Hopkins University. The record single-day total may be due in part to delayed reporting from over the holiday weekend. President Joe Biden on Tuesday is scheduled to meet with the White House Covid response team as the highly infectious omicron variant sweeps the nation. The cumulative number of cases confirmed in the U.S. since the start of the pandemic reached 56,191,733 early Tuesday, with 827,749 total Covid deaths in the U.S.

3. FDA expands Pfizer booster eligibility to kids 12 to 15

A health worker prepares to administer a dose of Pfizer covid-19 vaccine to a girl at the Sanford Civic Center. With the emergence of the Omicron covid-19 variant in numerous countries, including the United States, the US Centers for Disease Control (CDC) encouraged all vaccinated adults to receive their Covid-19 booster shot.

Paul Hennessy | LightRocket | Getty Images

The Food and Drug Administration on Monday expanded eligibility for Pfizer and BioNTech booster shots to children 12 to 15 years old. The Centers for Disease Control and Prevention still has to sign off. The CDC’s expert advisory panel will meet Wednesday. Also on Monday, the FDA shortened the time between the second Pfizer dose and the booster to five months, down from six months. The agency authorized a third vaccine dose as part of the primary series of shots for kids 5 to 11 with compromised immune systems.

4. Biden disapproval hits new high, new CNBC/Change poll says

U.S. President Joe Biden speaks during a video conference with farmers, ranchers and meat processors to discuss meat and poultry supply chain issues, from an auditorium on the White House campus in Washington, January 3, 2022.

Jonathan Ernst | Reuters

Biden’s overall disapproval rating reached a new high in December as more voters signaled their unhappiness with his handling of the economy and the Covid pandemic. Results from a CNBC/Change Research poll show 60% of respondents said they disapprove of Biden’s handling of the economy as he nears the conclusion of his first year in office. A majority of survey respondents, 55%, also signaled disapproval of his leadership during the pandemic, an area in which he previously excelled.

5. Jury finds Theranos founder guilty on multiple charges

Elizabeth Holmes leaves the courthouse accompanied by her partner, Billy Evans, and her parents after the jury requested a note on day 7 of jury deliberation in her fraud trial in San Jose, California, January 3, 2022.

Nick Otto | AFP | Getty Images

Theranos founder Elizabeth Holmes, a one-time billionaire and darling of Silicon Valley who promised a revolutionary blood-testing technology, has been found guilty of four of 11 charges in her criminal fraud trial. The jury of eight men and four women were handed the case in mid-December after three months of proceedings and testimony from 32 witnesses. Deliberations lasted more than 50 hours over seven days. Holmes faces up to 20 years in prison. Theranos dissolved in 2018 following civil and criminal probes. Holmes was indicted that year, following a series of damning articles in The Wall Street Journal.

— Follow all the market action like a pro on CNBC Pro. Get the latest on the pandemic with CNBC’s coronavirus coverage.

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