Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine. This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series. The booster interval recommendation for people who received the J&J vaccine (2 months) or the Moderna vaccine (6 months), has not changed.
Additionally, consistent with our prior recommendation for adults, CDC is recommending that moderately or severely immunocompromised 5–11-year-olds receive an additional primary dose of vaccine 28 days after their second shot. At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for children aged 5-11.
China is now dealing with three serious outbreaks as the eastern port city of Ningbo reported 16 cases over the weekend, while the city of Yuzhou, a smaller city with 1.3M residents, has seen some of its neighborhoods placed on lockdown.
Fortunately for China's economy, the Ningbo Zhoushan Port, the largest port in the world, said in a statement published on Weibo late Sunday that its operations are basically stable despite the strict COVID controls to try and contain the outbreak. Of the 16 cases, authorities said nine were imported and seven were local.
According to a statement posted by Yuzhou's city government to its Weibo account, a lockdown has been imposed upon the downtown district, even though the city reported just 3 cases on Monday. Public transit, taxis and school have all been suspended in the district.
Fortunately for the Chinese economy, the numbers in Ningbo are much smaller than the number of new cases still being reported in Xi'an, which is in the middle of a mass lockdown, leaving many in the city of 13M without easy access to essentials like food and medicine.
As the virus continues to spread, the Ningbo Containerized Freight Index has just reached an all-time record high of $4,264/FEU at a time when shipping costs around the world have surged.
The port city has already undergone 3 partial lockdowns in the past 6 months, according to China's state-controlled press. Meanwhile, some 200 pilots have been put into quarantine over the past week after two pilots tested positive for the virus.
It's fair to assume the world is curious about the conditions inside Xi'an, as critics of China pointed out on Twitter that there are no "citizen journalists" in Xi'an reporting on the latest lockdown. That's unlike the situation in Wuhan, which was covered by several citizen journalists. However, most of these people were disappeared or otherwise disciplined by Chinese authorities, setting a pretty clear example for anybody else who might want to try it.
Still, even China's state-controlled press has acknowledged that people in the city had been struggling to buy food. It's unclear whether this situation has eased.
Beijing must contain the situation in Ningbo: freezing the port would have broad-based ramifications for the entire Chinese economy, and the global economy more broadly.
China finished off 2021 last week by reporting the most new cases since the end of the lockdown in Wuhan, and overall, the number of new cases has been nearing 200/day since the start of the New Year.
As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's fourth-quarter 2021 results will be published on February 4, 2022.
ALLN-346, an orally administered enzyme in development for the treatment of hyperuricemia and gout, demonstrates a statistically significant reduction in serum uric acid and a well-tolerated safety profile in first cohort of patients with hyperuricemia and chronic kidney disease in the Phase 2a Study 201
Allena to host webinar to discuss the initial Study 201 data with Key Opinion Leaders Robert Terkeltaub, M.D. and David S. Goldfarb, M.D. today at 8:00 am ET; log-in information below
ALLN-346 Phase 2a Study 202 is actively enrolling patients with gout and stages 2 and 3 chronic kidney disease in parallel cohorts; data from both cohorts expected in Q1 2022
Company currently evaluating potential modifications to the pivotal URIROX-2 Phase 3 trial of Reloxaliase in Enteric Hyperoxaluria in an effort to reduce the size and duration of the trial and plans to discuss such modifications with the FDA during Q1 2022
Company retains Stifel, Nicolaus & Company, Incorporated to assist in exploring strategic and financing alternatives
Webinar Today to Review ALLN-346 Study 201 Data with Key Opinion Leaders
Allena will be hosting a KOL webinar at 8:00 am ET today to review today’s ALLN-346 data announcement with Key Opinion Leaders, Robert Terkeltaub, M.D. of the University of California, San Diego and David S. Goldfarb, M.D. of NYU Langone Medical Center.
A listen-in only webcast of the conference call with corresponding slides can be accessed at this link and also via Allena’s website, within the Investors & News/Events & Presentations section. A replay of the webcast can also be accessed at this same link.
Omicron is shaking the Big Apple to its core thanks to crippling staffing shortages caused by the raging COVID-19 variant.
Between vital transportation and emergency services, retailers and schools, workers are calling in sick by the thousands while grappling with the coronavirus and mandatory quarantines.
“There’s hardly a sector that’s not impacted,” Manhattan Borough President Mark Levine told The Post on Monday.
“The impact is real.”
EMERGENCY SERVICES
As the Big Apple continues to battle its latest surge of COVID-19 cases, the NYPD had 14 percent – or nearly 5,000 of the force’s 35,000 uniformed officers – out sick Monday.
Almost 2,000 cops had COVID, while the other 3,000 were experiencing flu-like symptoms, a source told The Post.
“There’s hardly a sector that’s not impacted,” Manhattan Borough President Mark Levine told The Post on Monday.Getty Images
Meanwhile, the FDNY said 30 percent of its 4,200 EMS staff and 18 percent of its 11,000 firefighters were sick.
The state changed its isolation guidance two weeks ago — in accordance with the CDC — to allow fully vaccinated workers to quarantine for just five days instead of 10, in a bid to avoid entire industries being wiped out as the Omicron variant raged.
But even the regulations can be muddled, Levine said.
“The CDC should have specified that you needed a test to exit isolation in Day 5,” the beep said.
He noted that the agency is now suggesting it may soon recommend that, causing “unnecessary confusion in the meantime.”
People must wait in line for hours in some parts to get tested because of demand and a shortage of tests.Xinhua News Agency via Getty Ima
City officials confirmed Monday they are adhering to the state and CDC revised isolation guidelines.
Even so, COVID-19 is leaving city departments and scores of businesses short-staffed, a bad situation worsened by the fact that people must wait in line for hours in some parts to get tested because of demand and a shortage of tests.
TRANSPORTATION
The MTA won’t say how many of its 70,000 employees have been sidelined because of Omicron, but sources said Monday that the figure is “very high” – estimated to be at least several thousand.
The transit worker shortages have already forced a cut back to train services, including shutting down three lines – the B, W and Z – through Monday. Other train and bus routes also have suffered, including the cancelation of 56 scheduled bus runs on New Year’s Eve.
By Monday afternoon, 118 flights out of LaGuardia Airport had already been canceled, according to the Flight Aware tracking site. John F. Kennedy International Airport saw 43 of its scheduled flights axed – part of a nationwide trend amid Omicron cases and wintry weather conditions.
More than 100 travelers – many of them tourists trying to return home after visiting New York City for the holidays — were forced to stand outside in freezing temperatures Monday as they waited for COVID tests at LaGuardia’s Terminal B, with some missing their connecting flights for international destinations.
“We need a PCR test to return to Canada, and now I understand I will likely need to rebook again because these results will take a few days,” traveler Aneita Mason said. “This is tough.”
New York allows fully vaccinated workers to quarantine for just five days instead of 10.Anadolu Agency via Getty Images
HEALTH AND THE DATA
COVID cases remain high across the Big Apple, with the daily average of confirmed infections for the past seven days at nearly 27,000, city health data shows.
Nearly 34 percent of NYC residents who got tested ended up with a positive result on average in the past week.
The seven-day average for hospitalizations is at least 492 per day, according to the data.
“It is a relief that only a very small percentage of cases require hospitalization,” said Levine, former chairman of the City Council’s Health Committee. “Having said that, a small percentage of a big number is still a big number.”
“Fifteen thousand or 20,000 wasn’t imaginable two weeks ago. Because those numbers are so big, it’s now beginning to flood the hospitals.
“The impact on the hospitals where staff were – even before this wave – exhausted, this is a very, very difficult time,” he said.
Northwell Health, the largest private hospital system in the Empire state, said Monday that it hasn’t had to cancel or postpone any treatments over staffing concerns.
“Any staffing shortages we are experiencing have so far been managed with no impact to quality of patient care,” a rep told The Post.
Exact numbers of shortages at Northwell Health, which has more than 77,000 employees statewide and runs Lenox Hill Hospital, weren’t immediately available.
Nearly 34 percent of NYC residents who got tested ended up with a positive result on average in the past week.Anadolu Agency via Getty Images
A spokesperson for NYC Health + Hospitals insisted Monday that the city’s public system was “stable” – although the system’s president, Dr. Mitchell Katz, had warned last month of potential shortages brought on by staffers being exposed to Omicron.
Queens city Councilman Robert Holden said he recently had to take his 3-month-old grandson to Long Island Jewish Cohen Children’s Medical Center for bronchitis — only to find the emergency room overwhelmed with COVID patients.
The pol added that half his staff of 10 people is currently out with the virus.
“We had to shut the office,” he said.
His Middle Village office is now serving as a COVID testing site.
RESTAURANTS, NIGHTLIFE AND OTHER BUSINESSES
Rank-and-file New Yorkers have not been spared Omicron’s wrath — and consequently, nor have the establishments they visit.
“I get the feeling we’ll stay stuck in this purgatory, always waiting for things to get better,” said Brooklyn video producer Philip Sanchez, 38.
“At the rate things are going, we’ll almost certainly get another variant after Omicron.
“I now barely eat inside at restaurants, and when I do, I go at odd hours to avoid crowds,” Sanchez said. “Occasionally, I would go for drinks with friends outdoors, but with such cold weather, I’m not even doing that.”
Caroline Larsen, 19, said she has severely curtailed her social life, too.
“Any staffing shortages we are experiencing have so far been managed with no impact to quality of patient care,” a rep told The Post.Anadolu Agency via Getty Images
“I only see a few people, and I don’t go out anymore,” the teen said.
She said she has no idea what the future holds.
“My brother still doesn’t believe in COVID, even after everything we have been through. And while we still have such stubborn people who refuse the vaccine, I don’t think anything will change,” Larsen said.
The social-life strife was hardly news to Andrew Rigie, executive director of the New York City Hospitality Alliance.
The city’s already struggling restaurant industry has been struck hard by Omicron — with many establishments forced to shut down during the busy holiday season as staffers tested positive or were exposed to COVID.
Rigie said Monday that staffing shortages were just part of the problem affecting the industry.
“Restaurants are facing serious challenges, from a critical labor shortage made worse by the spike and COVID cases, to fewer customers and lots of debt,” he said.
“We need government to step up and replenish the Restaurant Revitalization Fund grant program, bring back the popular ‘alcohol to go,’ and again allow propane heaters for winter outdoor dining, and a lot more.”
Firms such as Goldman Sachs were asking their workers to just stay home till at least Jan. 18 to address the surge in cases.
Adams and United Federation of Teachers President Michael Mulgrew both said staffing was stable overall as school resumed Monday morning – and there were sufficient substitutes to fill any gaps.
“We’re going to adjust and pivot based on the numbers. We’re going to have real-time updates, creating our own command center, [if] we see a drop in staffing, we’re going to draw from our pool of employees who are waiting, and we’re going to go all out,” Adams said in an MSNBC interview.
Mayor Eric Adams has insisted that public schools will continue with in-person amid the Omicron surge.Bloomberg via Getty Images
“If you’re a superintendent, if you’re an administrator, you have a teaching license, we want you in that school building,” he said. “We’re going to shift and adjust in real time.”
His remarks came after the principal of PS 58 in Brooklyn told families Sunday evening that it would hold remote learning Monday due to COVID-19 cases — without authorization from the city Department of Education.
Mulgrew also sent out a letter to union members over the weekend suggesting they push for remote learning this week amid the surge in new cases.
“We advised the new mayor that it would be safest to allow our school system to go remote temporarily until we could get a handle on the staffing challenges that each school is about to face as we return,” Mulgrew said in the note. “However, he feels strongly that schools need to remain open.”
The mayor doubled down later Monday, declaring: “I am keeping my schools open.”
He also claimed, “When a mayor has swagger, the city has swagger.
“We’ve allowed people to beat us down so much that all we did was wallow in COVID –that’s all we did — and we no longer believed this is a city of swagger, this is a city of resiliency.”
It wasn’t immediately clear how many schools staffers were out sick as students returned after winter break.
The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.
Coronavirus leaves survivors with self-attacking antibodies
Months after recovering from SARS-CoV-2 infection, survivors have elevated levels of antibodies that can mistakenly attack their own organs and tissues, even if they had not been severely ill, according to new findings.
Among 177 healthcare workers who had recovered from confirmed coronavirus infections contracted before the availability of vaccines, all had persistent autoantibodies, including ones that can cause chronic inflammation and injury of the joints, skin and nervous system. "We would not normally expect to see such a diverse array of autoantibodies elevated in these individuals or stay elevated for as long six months after full clinical recovery," said Susan Cheng of the Cedars-Sinai Smidt Heart Institute in Los Angeles. Patterns of elevated autoantibodies varied between men and women, the researchers reported on Thursday in the Journal of Translational Medicine .
"We don't yet know how much longer, beyond six months, the antibodies will stay elevated and/or lead to any important clinical symptoms," Cheng said. "It will be essential to monitor individuals moving forward." Her team is investigating whether autoantibody elevations are linked with persistent symptoms in people with long COVID and planning to study autoantibody levels after infections with newer variants of the virus.
B cells' effects weakened but not defeated by Omicron
The effects of antibodies produced by the immune system's "memory B cells" against the Omicron variant of the coronavirus, while weakened, could still be significant, researchers believe.
Once the body learns to recognize SARS-CoV-2, either after infection or vaccination, B cells generate fresh antibodies against the virus if there are not already enough antibodies circulating in the blood that can neutralize it. In a study reported on bioRxiv ahead of peer review, researchers analyzed the strength of more than 300 antibodies produced by memory B cells obtained from vaccinated volunteers, including some who had a prior SARS-CoV-2 infection.
"Omicron seemed to evade a very large share of the memory B cells pool," researchers said, adding that it "seems to still be efficiently recognized by 30% of total antibodies and close to 10% of all potent neutralizing antibodies," said Matthieu Mahevas and Pascal Chappert of Universite de Paris in a joint email. Memory B cells' robust ability to proliferate and produce antibodies might compensate "in less than two days" for those antibodies' reduced effectiveness, they speculate.
In combination with other immune system components, particularly T cells, the effects of B cells likely help to explain why most vaccinated individuals who become infected do not become sick enough to require hospitalization, they said.
Virus variants' activity in cells makes them more effective
Along with spike mutations that help the coronavirus break into cells, mutations that change how the virus behaves inside the cells are a big factor in why some variants have been more transmissible, researchers have discovered.
The findings, published in Nature, show that scientists "have to start looking at mutations outside the spike," which has so far been the main focus of vaccines and antibody drugs, said Nevan Krogan of the University of California, San Francisco. Studying the Alpha variant, his team found a mutation at a non-spike site that causes infected cells to ramp up their production of a protein called Orf9B. Orf9b in turn disables a protein called TOM70 that cells use to send signals to the immune system. With higher levels of Orf9B disabling TOM70, the immune system does not respond as well and the virus can better evade detection, the researchers said.
Referring to the increase in Orf9B, Krogan said, "It's rare that mutations 'turn up' a protein. It's a very sneaky thing for this virus to do." The same mutation was identified on Delta, "and sure enough, almost the same mutation is on Omicron," he said, which suggests they may have similar effects on the immune system. The new information could spur development of drugs that target the interaction of Orf9b and TOM70.
CT-P63 demonstrated a well- established safety profile in the global Phase I trial
CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529) based on structural analysis by X-ray crystallography and neutralisation data from pseudo- virus testing
Celltrion plans to provide dual treatment options for COVID-19; Regkirona™ for hospitalised patients and a nebulised cocktail therapy (CT-P63 in combination with Regkirona™) for at- home settings
Celltrion Group announced today results for its cocktail therapy candidates including neutralisation data against the Omicron variant (B.1.1.529).
The Phase I clinical trial is a randomised, double- blind and placebo- controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P63 in 24 healthy subjects in Poland.1 The study met its primary objectives with data showing CT-P63 to be safe and well tolerated, with no significant drug- related adverse events (AEs).
In an experiment conducted in partnership with the National Institutes of Health (NIH), CT-P63 showed strong neutralising activity against the Omicron variant based on structural analysis by X- ray crystallography and neutralisation data from pseudo- virus testing. Celltrion anticipates results of the SARS-CoV-2 Omicron variant assays and animal model studies by the end of the first quarter this year.
In order to elicit potent neutralising antibody response against the new emerging variants, Celltrion previously identified a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 (CT-P63) produced high neutralisation titres against new emerging strains. CT-P63 has previously been demonstrated to have neutralising activity against the most common variants, including the Alpha, Beta, Gamma and Delta variants.
