Novavax Inc. NVAX reported positive results from three vaccine trials on Tuesday, one targeting both COVID and flu, one for stand-alone flu and one a high-dose COVID vaccine. All three candidates produced robust immune response in Phase 2 trials and showed a reassuring preliminary safety profile, said Novavax. “The stand-alone influenza vaccine candidate achieved statistically significant hemagglutination inhibition (HAI) antibody responses 31 to 56% higher for all four strains compared to Fluad,” said the company. The highest-dose stand-alone COVID vaccine achieved statistically significant neutralization responses that…
While many have been focused on the apparent explosion of COVID cases in China, and the lack of reliable data from China’s government, there are signs suggesting the U.S. situation is also getting worse even as case counts and deaths are falling.
At first look, initial fears of another COVID surge in the U.S. over the holidays may be overblown. About a week after the year-end holiday gatherings began, the seven-day average of new COVID cases fell to a more than three-week low of 58,354 on Thursday, down 9% from two weeks ago and down 17% from a recent peak of 70,508 on Christmas Eve, according to a New York Times tracker.
And the daily average for deaths fell has fallen to a three-week low of 355, and has dropped 5% in two weeks.
But as the NYT tracker has been warning, case and death counts could be “artificially low” this week, as officials who track those numbers take vacation for the Christmas and New Year’s holidays. Therefore, hospitalization data, which is typically not affected by holidays, should remain more reliable.
And by that measure, the numbers are getting worrisome.
The daily average of hospitalizations rose to 41,620 on Thursday, up 3% from two weeks ago but also the highest number seen since mid-August.
There are 29 states that have seen hospitalizations increase from two weeks ago, including 20 states that have seen double-digit percentage increases, led by South Carolina at 54%, West Virginia at 52% and Louisiana at 47%.
The number of severe COVID cases is also seeing a troubling rise, the daily average of COVID-related patients in intensive care units (ICUs) climbed to 5,080 on Thursday. That’s up 10% from two weeks ago, and the most seen since July 30.
The New York Times
Another sign that the fall in case counts is artificial is that the test positivity rate has been rising, to a four-month high above 14% on Thursday, with 41 states seeing double-digit positivity rates.
“Higher test positivity rates are a sign that many infections are not reported — even if they are tested at home. This results in a more severe undercount of cases,” the NYT tracker said.
Meanwhile in China, amid a “lack of adequate and transparent” data from China’s government, there is reason to believe the situation will still get a lot worse before it gets better.
U.K. health firm Airfinity estimates that new daily COVID cases in China is currently running at about 1.8 million, based on data from China’s regional provinces, and on new-case trajectories from areas that also lifted zero-COVID policies, such as Hong Kong.
That case number is expected to more than double, to about 3.7 million a day, in mid-January, Airfinity estimates, before another surge in March takes the number up to about 4.2 million per day.
As a result of the concerns over surging case counts, Spain joined the growing number of countries that are requiring COVID tests for air passengers arriving from China, as the Associated Press reported. This comes after the European Union said Thursday that it is “assessing” the situation in China.
The U.S. will also require those arriving from China to take a PCR test, starting Jan. 5, while Japan started requiring a test on Friday. Other countries requiring a test for air passengers from China include Italy, India and South Korea.
The BBC reported that the U.K. was set to announce that travelers will need to show a negative COVID test before they board a plane from China.
In other COVID news, China’s National Medical Products Administration has given emergency approval to Merck & Co. Inc.’s MRK, -0.33% COVID antiviral molnupiravir. That joins Pfizer Inc.’s PFE, -0.96%
Paxlovid, which has already been approved for use in China. Merck’s stock, which fell 0.4% in afternoon trading Friday, has soared 44.0% in 2022, while the Dow Jones Industrial Average DJIA, -0.88%
has lost 9.4%.
Novavax Inc. NVAX, +0.21%
said Friday that it has initiated a Phase 2 trial for its COVID-19-Influenza Combination (CIC) vaccine candidate in people aged 50 through 80. “We believe that like influenza, COVID-19 will also be seasonal moving forward, and that there is room in the market for new alternatives to provide better protection against the impact of influenza, particularly in older adults, and to explore the potential to combine this with protection from COVID,” said Chief Executive Stanley Erck. Novavax’s stock, which eased 0.3% Friday, has plunged 93.2% year to date while the S&P 500 index SPX, -1.03%
has dropped 20.1%.
Novavax, Inc. focuses on the discovery, development and commercialization of vaccines to prevent infectious diseases. It provides vaccines for COVID-19, seasonal flu, respiratory syncytial virus, Ebola, and Middle East respiratory syndrome. The company was founded in 1987 and is headquartered in Gaithersburg, MD.
The White House has unveiled a fresh push to increase COVID preparedness heading into the holidays and will again make free tests available to Americans, after a three-month hiatus.
Starting Thursday, households can order four rapid virus tests through covidtest.gov, a senior administration official told the Associated Press.
The head of the International Monetary Fund on Tuesday joined the chorus of people urging China to adopt a more targeted approach to the coronavirus pandemic as the country’s zero-COVID policy sparks protests over lockdowns and hobbles the world’s second-biggest economy.
IMF Managing Director Kristalina Georgieva urged a “recalibration” of China’s tough “zero-COVID” approach, which is aimed at isolating every case, “exactly because of the impact it has on both people and on the economy,” as the Associated Press reported.
Georgieva made the comments in an interview with the AP on Tuesday, after protests erupted in Chinese cities and in Hong Kong over the weekend, marking the strongest public dissent in decades.
“We see the importance of moving away from massive lockdowns, being very targeted in restrictions,” Georgieva said Tuesday in Berlin. “So that targeting allows [China] to contain the spread of COVID without significant economic costs.”
Georgieva also urged China to look at vaccination policies and focus on vaccinating the “most vulnerable people.”
A low rate of vaccinations among the elderly is a major reason Beijing has had to resort to lockdowns, while the emergence of more-contagious variants has made it increasingly hard to halt the spread of the virus.
In a rare show of defiance, crowds in China gathered for the third night as protests against COVID restrictions spread to Beijing, Shanghai and other cities. People held up blank sheets of paper, symbolizing censorship, and demanded the Chinese president step down. Photo: Kyodo News/Zuma Press
Chinese health officials said Tuesday they are preparing a push to get more older people vaccinated, the Guardian reported. The National Health Commission told reporters it would target more vaccinations at people older than 80 and would reduce to three months the gap between basic vaccination and booster shots for elderly people.
But experts, including President Joe Biden’s chief medical adviser, Anthony Fauci, have expressed concern that China’s homegrown vaccines are not effective enough. China has not yet approved the vaccines developed by Pfizer PFE, -0.39%,
BioNTech BNTX, +1.16%
and Moderna MRNA, -0.17%
for public use. The shortcomings of China’s vaccines have led Chinese doctors to warn that a lifting of the zero-COVID policy could lead to a massive surge in cases that could overwhelm China’s healthcare system.
Meanwhile, with police out in force, there was little news of protests in Beijing, Shanghai or other cities on Tuesday, the AP reported separately.
In the U.S., known cases of COVID are rising again, with the daily average standing at 41,755 on Monday, according to a New York Times tracker, up 6% from two weeks ago. Cases are rising in 22 states, as well as Guam and Washington, D.C., and are flat in Nebraska. They are rising fastest in Arizona, where they are up 82% from two weeks ago, followed by Michigan, where they are up 77%.
The daily average for hospitalizations is flat at 28,135, while the daily average for deaths is up 6% to 314.
Physicians are reporting high numbers of respiratory illnesses like RSV and the flu earlier than the typical winter peak. WSJ’s Brianna Abbott explains what the early surge means for the winter months. Photo illustration: Kaitlyn Wang
• The World Health Organization has issued an emergency-use listing for the Novavax NVAX, +6.19%
protein-based COVID vaccine as a primary series for children ages 12-17 and as a booster for those ages 18 and older, Novavax said Tuesday. The WHO previously granted an emergency-use listing for the Nuvaxovid vaccine in adults ages 18 and older in December 2021, the company said. The new listing also paves the way for adults to get a booster shot of the vaccine about six months after completing the primary two-dose series.
• New Jersey Gov. Phil Murphy, a Democrat, said Monday his administration has launched a promised review of its handling of the pandemic, the AP reported. The administration hired regional law firm Montgomery McCracken Walker & Rhoads — which has offices in the state as well as Delaware, Pennsylvania and New York — along with management consulting firm Boston Consulting Group to conduct the review. The review is expected to end with a report in late 2023, the governor said.
• A Connecticut program that offered “hero pay” to essential workers at the peak of the pandemic got so many applicants that state lawmakers had to go back into session Monday to provide extra funding and put new limits on who could get the biggest bonuses, the AP reported. Initially, the state had expected to award about $30 million in bonuses to people who had to go to work, in person, in jobs in healthcare, food distribution, public safety and other essential services. But after getting 155,730 applications from eligible people, lawmakers realized they would have to either put more money in or slash benefits.
The U.S. leads the world with 98.6 million cases and 1,079,477 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 228.4 million people living in the U.S., equal to 68.8% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 37.6 million Americans have had the updated COVID booster that targets the original virus and the omicron variants, equal to 12.1% of the overall population.
A fresh analysis of data on the immune response generated by the bivalent COVID-19 booster showed strong results against the newer omicron sublineages, Pfizer and German partner BioNTech said Friday.
The bivalent booster targets the BA.4 and BA.5 omicron variants as well as the original virus, and it also appears to be effective against the sublineages dubbed BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1.
The data, which have been posted on the preprint server bioRxiv, show that the booster induces a greater increase in neutralizing-antibody titers than the companies’ original COVID vaccine.
“Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved protection against COVID-19 due to Omicron BA.4 and BA.5 sublineages as well as new sublineages that continue to increase in prevalence,” the companies said in a joint statement.
Specifically, one month after a booster dose of the bivalent COVID-19 vaccine, neutralizing-antibody titers against the sublineages increased 3.2-fold to 4.8-fold compared with the original COVID vaccine.
Neutralizing-antibody titers against BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1 increased 4.8-fold to 11.1-fold from prebooster levels following a booster dose of the bivalent vaccine.
The companies PFE, -0.72% BNTX, +0.08%
said BA.5 is still the most prevalent sublineage in the U.S., accounting for nearly 30% of cases at time of publication, while the emerging BA.1.1 sublineage accounts for nearly 25% of cases and is spreading globally.
In the New York region, BQ.1 and BQ.1.1 accounted for 64.8% of new cases, while BA.5 accounted for 14.0%.
The bivalent booster has been granted emergency-use authorization by the U.S. Food and Drug Administration for people ages 5 and older and has also been allowed in the European Union for that group.
The news comes as U.S. COVID cases have been rising again, although the daily average edged lower on Thursday to 39,562, according to a New York Times tracker, down 1% from two weeks ago.
Cases are rising in roughly half the states and falling in the rest, but there are wide discrepancies between individual states. In Nebraska, cases are up 540% from two weeks ago, the tracker shows, followed by Arizona, where they are up 110%; California, where they have climbed 53%; and Colorado, where they are up 50%.
Meanwhile, Kentucky is seeing a 54% decline in cases from two weeks ago, and Michigan cases are down 48%.
The daily U.S. average for hospitalizations is up 2% to 27,818, while the daily average for deaths is down 4% to 325.
Physicians are reporting high numbers of respiratory illnesses like RSV and the flu earlier than the typical winter peak. WSJ’s Brianna Abbott explains what the early surge means for the winter months. Photo illustration: Kaitlyn Wang
• China’s southern manufacturing hub of Guangzhou is planning to build quarantine facilities for nearly 250,000 people to fight surging COVID outbreaks, even as the national government tries to reduce the impact of zero-COVID controls that have confined millions of people to their homes, the Associated Press reported. Guangzhou, a city of 13 million and the biggest of a series of hotspots across China with outbreaks since early October, reported 9,680 new cases in the past 24 hours. That was about 40% of the 23,276 cases reported nationwide.
• Racial disparities in COVID cases and deaths have widened and narrowed over the course of the pandemic, but age-adjusted data still show that Black, Hispanic and American Indian/Alaska Native people have been at higher risk for cases, hospitalizations and deaths, according to a new report from the Kaiser Family Foundation. “While disparities in COVID-19 vaccinations have narrowed over time and have been reversed for Hispanic people, they persist for Black people,” the report found. The pattern is also evident in uptake of the new bivalent booster, with Black and Hispanic people about half as likely as white people to have had one. Black people are also less likely to have access to antivirals, antibody treatments and other therapies.
• The Indian Health Service announced Thursday that all tribal members covered by the federal agency will be offered a vaccine at every appointment when appropriate under a new vaccine strategy, the AP reported. Throughout the pandemic, American Indians and Alaska Natives have had some of the highest COVID vaccination rates across the country. But Indigenous people are especially vulnerable to vaccine-preventable illness, and IHS officials recently noted that fewer patients have been getting vaccines for COVID-19. Monkeypox is now an additional health concern.
• Novavax NVAX, -6.11%
said its COVID vaccine has received expanded authorization in Canada as a booster for adults aged 18 and older who had it as their primary shot. The protein-based vaccine has already been approved as a booster in the U.S., European Union and U.K., among other countries, Novavax said.
The U.S. leads the world with 98.3 million cases and 1,076,683 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 228.2 million people living in the U.S., equal to 68.7% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 35.3 million Americans have had the updated COVID booster that targets the original virus and the omicron variants, equal to 11.3% of the overall population.
Shares of Novavax Inc. NVAX, -3.17%
were up 2.4% in premarket trading on Friday after the company said its COVID-19 booster was authorized for adults in Canada who were previously immunized with Novavax’s protein-based vaccine. The company’s stock is down 85.4% this year, while the S&P 500 SPX, -0.31%
has declined 17.2%.
The southern Chinese manufacturing hub of Guangzhou is the latest to see lockdowns amid a surge in COVID-19 cases, as the government presses ahead with the strict zero-COVID policy that has frustrated citizens.
The latest lockdowns have further disrupted global supply chains and sharply slowed growth in the world’s second-largest economy, as the Associated Press reported.
Residents in districts encompassing almost 5 million people have been ordered to stay home at least through Sunday, with one member of each family allowed out once a day to purchase necessities, local authorities said Wednesday.
The order came after the densely populated city of 13 million reported more than 2,500 new cases over the previous 24 hours.
China has retained its strict zero-COVID policy despite relatively low case numbers and no new deaths. The country’s borders remain largely closed, and internal travel and trade is complicated by ever-changing quarantine regulations.
Apple AAPL, -3.32%
and iPhone manufacturer Foxconn 2317, -1.95%
said over the weekend that restrictions are crimping production and will delay shipments of the high-end iPhone 14.
In the U.S., known cases of COVID are climbing again for the first time in a few months. The daily average for new cases stood at 39,578 on Tuesday, according to a New York Times tracker, up 5% versus two weeks ago.
As always, the increase in cases is not uniform across the nation. Some states are seeing sharp spikes, led by Nevada, where cases are up 96% from two weeks ago. Tennessee is second with cases up 69%, followed by Louisiana with cases up 68%, New Mexico, where they are up 62%, and Utah, where they have climbed 61%.
Cases are up by a double-digit percentage in 22 states.
The daily average for hospitalizations was up 3% to 27,713, while the daily average for deaths was down 14% to 308.
• Novavax Inc. NVAX, -5.19%
on Tuesday tweaked its full-year sales outlook to the low end of its expected range and reported a surprise quarterly loss, but sales for the COVID-19 vaccine maker were far better than expected. The company reported a net loss of $168.6 million, or $2.15 a share, compared with a loss of $322.4 million, or $4.31 a share, in the same quarter a year ago. Sales were $735 million, compared with $178.8 million in the prior-year quarter. Analysts polled by FactSet expected Novavax to earn $1.57 a share on revenue of $586 million.
• A Food and Drug Administration advisory committee said this week that Veru Inc.’s VERU, +3.95%
COVID treatment Sabizabulin demonstrated a clear clinical benefit with a favorable benefit-to-risk profile. Veru is seeking emergency-use authorization for treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome.
• A Massachusetts man who admitted to lying on his application for federal coronavirus business stimulus funds and using some of the $400,000 he received to pay his mortgage has been sentenced to 15 months in prison, federal prosecutors said, as the AP reported. In addition to the time behind bars, Adley Bernadin, 44, of Stoughton, was sentenced last week to three years of supervised release and ordered to forfeit more than $280,000, according to a statement from the U.S. attorney’s office.
The U.S. leads the world with 97.8 million cases and 1,072,943 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 227.3 million people living in the U.S., equal to 68.5% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 26.3 million Americans have had the updated COVID booster that targets the original virus and the omicron variants, equal to 8.4% of the overall population.
The Centers for Disease Control and Prevention has refuted claims that it’s planning to add the COVID-19 vaccine to immunization schedules for schoolchildren, saying that the authority for that decision lies with states and other local entities.
Carlson tweeted that the agency would make the vaccine mandatory in order for children to attend school, a claim the CDC quickly shot down. While an advisory committee to the CDC voted to recommend that the vaccine be added to immunization schedules, the CDC “only makes recommendations for use of vaccines, while school-entry vaccination requirements are determined by state or local jurisdictions,” CDC spokeswoman Kate Grusich told the AP.
Grusich explained that the action was meant to streamline clinical guidance for healthcare providers by adding COVID-19 vaccines to a single list of all currently licensed, authorized and routinely recommended vaccines.
“It’s important to note that there are no changes in COVID-19 vaccine policy,” she said.
The news comes as U.S. known cases of COVID are continuing to ease and now stand at their lowest level since mid-April, although the true tally is likely higher given how many people overall are testing at home, where data are not being collected.
The daily average for new cases stood at 38,077 on Thursday, according to a New York Times tracker, down 8% from two weeks ago. Cases are currently rising in 14 states, as well as Washington, D.C., and Puerto Rico.
The daily average for hospitalizations was down 2% to 26,669, although hospitalizations are rising in almost all northeastern states as cold weather arrives. The daily average for deaths was down 7% to 360.
• Pfizer PFE, +4.42%
is planning to sell the COVID vaccine it developed with German partner BioNTech BNTX, +9.88%
for $110 -$130 a dose once the U.S. market for COVID-19 shots becomes commercial, likely in the first quarter of next year, MarketWatch’s Jaimy Lee reported. Pfizer and BioNTech are currently paid $30.50 per vaccine dose by the U.S. government, which contracted with the companies, as well as with other vaccine makers like Moderna MRNA, +9.07% and Novavax NVAX, +11.35%,
and then made the COVID-19 shots available at no cost to people in the U.S. during the public-health emergency. The emergency declaration in the U.S. isn’t expected to be renewed next year, which will lead to the formation of an official commercial market for COVID-19 vaccines, tests and treatments.
• Johnson & Johnson JNJ, +1.91%
said the volume of surgical procedures is returning to prepandemic levels in many parts of the world, a trend that cheered Wall Street and could bode well for other medical-technology heavyweights like Stryker Corp. SYK, +0.57%
and Zimmer Biomet Holdings ZBH, +0.18%.
J&J, which reported earnings this week, said its medical-technology business had a “strong September,” with U.S. sales of hip and knee implants and other surgical devices rising 7.7% to $3.3 billion in the third quarter of the year. “We are seeing procedures recovering,” Ashley McEvoy, worldwide chair of J&J’s MedTech business, told investors during this week’s earnings call. “In the U.S., we started to see surgical procedures tick up, predominantly at the latter part of the quarter.”
The new bivalent vaccine might be the first step in developing annual COVID shots, which could follow a similar process to the one used to update flu vaccines every year. Here’s what that process looks like, and why applying it to COVID could be challenging. Illustration: Ryan Trefes
• “As China’s ruling Communist Party holds a congress this week, many Beijing residents are focused on an issue not on the formal agenda: Will the end of the meeting bring an easing of China’s at times draconian ‘zero-COVID’ policies that are disrupting lives and the economy?” the AP reported. It appears to be wishful thinking. As the world moves to a postpandemic lifestyle, many across China have resigned themselves to lining up several times a week for COVID tests, restrictions on travel to other regions and the ever-present possibility of a community lockdown.
• Fantasy Fest, a 10-day annual party, is kicking off in Key West, Fla., on Friday, with a full slate of events for the first time since the pandemic started, the AP reported. “Due to the COVID pandemic, this will be the first full Fantasy Fest since 2019,” the festival’s board chair, Steve Robbins, said. “So I know our guests and staff are excited about getting back to the real Fantasy Fest.” Dozens of themed events are set for the festival, including a nighttime parade Oct. 29 featuring floats and elaborately costumed marching groups. Participants are encouraged to draw costume ideas from the festival’s theme, “Cult Classics & Cartoon Chaos,” and to portray characters inspired by favorite cartoons and television or film productions with a cult following.
The U.S. leads the world with 97.2 million cases and 1,067,190 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 226.5 million people living in the U.S., equal to 68.2% of the total population, are fully vaccinated, meaning they have had their primary shots. Just 111.4 million have had a booster, equal to 49.1% of the vaccinated population, and 26.8 million of those who are eligible for a second booster have had one, equal to 40.6% of those who received a first booster.
The CDC reports that some 19.4 million people have had a dose of the updated bivalent booster that targets omicron and its subvariants along with the original virus.
Pfizer Inc. PFE, +4.17%
said Thursday that it plans to sell the COVID-19 shot it developed with BioNTech SE BNTX, +7.14%
for $110 to $130 per dose once the U.S. market for COVID-19 shots becomes commercial, likely in the first quarter of next year.
Pfizer and BioNTech are currently paid $30.50 per vaccine dose by the U.S. government, which contracted with the companies (as well as other vaccine makers like Moderna Inc. MRNA, +6.57%
and Novavax Inc. NVAX, +8.88%
) and then made the COVID-19 shots available at no cost to people in the U.S. during the public-health emergency.
The emergency declaration in the U.S. isn’t expected to be renewed next year, which will lead to the formation of an official commercial market for COVID-19 vaccines, tests and treatments. That said, this change doesn’t mean most Americans will be on the hook to pay for their shots in 2023 and beyond.
A recent Kaiser Family Foundation analysis said most people with private insurance won’t be expected to pay anything out of pocket for the vaccines, though the costs may eventually be baked into the price of health-insurance premiums, as is done with flu shots. People with Medicare will have their shots covered by Medicare Part B, while those with Medicaid should also have coverage of COVID-19 vaccines. It’s the uninsured who may find it difficult to find free vaccines and boosters in the future.
Wall Street analysts cheered the news, saying Pfizer’s pricing plan came in above expectations. It also bodes well for Moderna’s stock. SVB Securities upgraded the company to market perform from underperform, though the company has not yet announced its pricing plans for its COVID-19 shots.
“Presuming that MRNA prices as a rational duopolist, this substantially improves the company’s ability to meet 2023 revenue guidance,” SVB analyst Mani Foroohar told investors.
