AstraZeneca said on Monday it will transfer global rights for respiratory medicines Eklira and Duaklir to Covis Pharma Group for $270 million, as the Anglo-Swedish drugmaker looks to offload its older portfolio of medicines.
The London-listed company also said that under the deal, which is expected to close in the fourth quarter of 2021, Covis will also cover certain ongoing development costs related to the medicines.
AstraZeneca, which has several new medicines in its pharmaceutical pipeline, including COVID-19 drugs and a vaccine, expects the agreement to help sharpen its focus on priority medicines in its respiratory and immunology portfolio.
Covis had previously acquired the rights to other respiratory medicines Alvesco, Omnaris and Zetonna from AstraZeneca in 2018.
Eklira and Duaklir, used to treat chronic obstructive pulmonary disease (COPD) or smokers' lung, had generated revenues of $143 million for AstraZeneca in geographies covered by a previous deal when the drugmaker had bought those rights.
More than 24,000 city workers will be forced to stay home Monday when Mayor de Blasio’sCOVID-19 vaccine mandate goes into effect, raising concerns about the impact on emergency response times in the five boroughs.
“That’s the question everyone’s asking: How many more minutes will it take to respond, how many more lives will be lost as a result?” one Manhattan patrol cop told The Post on Sunday.
“There’s a correlation between time and mortality that a lot of people in City Hall don’t understand. Unfortunately, the only way they’re going to get the message is by seeing the numbers rise and rise. And seeing how crime is already on the rise, they really need to look at their priorities and decide if this is a good idea, and they need to do it soon.”
Despite a 14 percent bump in the number of city government workers who have gotten at least one shot since de Blasio announced the mandate on Oct. 20, thousands of others would still rather be placed on unpaid leave than get jabbed.
According to the latest numbers, about 24,000 city workers will not be able to report to work on Monday due to New York City’s COVID-19 vaccine mandate.Matthew McDermott26 firehouses across the city had to shut down on Saturday due to staff shortages.Paul Martinka
That includes, roughly, more than 8,000 cops, 3,700 FDNY employees — including smoke eaters and EMS — and nearly 2,000 sanitation workers, according to City Hall statistics.
The latest data from City Hall showed that 91 percent of the city workforce has adhered to the mandate to get the first dose of the COVID-19 vaccine but that 24,200 are unvaxxed, as of 8 p.m. Saturday.
Members of the FDNY have been among those vehemently opposed to de Blasio’s order, which included a Friday 5 p.m. deadline for a $500 bonus for getting the shot.
On Saturday, 26 fire companies across the five boroughs were shuttered due to manpower shortages — with at least 20 still out of action Sunday.
Thousands of unvaccinated NYPD employees will be allowed to continue to remain on the job, but only if they applied for medical or religious exemptions which will be reviewed by the NYPD Equal Employment Opportunity Division.
A crowd of people protesting the vaccine mandate for city workers outside of Gracie Mansion on October 28, 2021.Matthew McDermott
On Friday, Ladder Co. 45 in Washington Heights had to respond to a building fire on W. 186th Street without Engine Co. 93, which was undermanned and out of service.
Fire officials confirmed that ladder company firefighters had to run into the burning building to save two people — before any water was sprayed on the flames because the nearest backup engine company was 11 minutes away, fire officials confirmed.
“They’re lucky to be alive,” one emergency response expert said, calling the rescue “incredibly dangerous.”
That source added, “It’s forcing the guys and gals who are on duty to take extra risks here. Firefighting is a very coordinated, a very multitasked operation.”
The mandate may cause about 3,700 FDNY employees to not be able to work on Monday.Gregory P. Mango
In fiscal year 2021, the emergency response time average was 5 minutes and 23 seconds, while response time for structure fires was an average of 4 minutes, 52 seconds. For the NYPD, response time to critical calls clocked in at 6 minutes, 42 seconds for this same week in 2019, according to city data.
FDNY sources said desperate brass have ordered firefighters who went on duty Sunday night to stay at their firehouses until it can be staffed — with 2,000 smoke eaters currently on medical leave.
More than half of those have yet to be vaccinated, the sources said.
Meanwhile, sources said 700 cops on non-patrol assignments are being dispatched to city street beats to fill in the gaps.
“They want to maintain the staffing levels of patrol,” one cop told The Post, “to handle emergencies and take care of the public.”
According to City Hall, 91 percent of city employees have gotten at least one dose of the COVID-19 vaccine.Gregory P. Mango
The re-assigned officers will spread out over three shifts.
The impact on city residents goes beyond first-responders, with sanitation workers now working overtime to tackle mounting track piles.
“To help meet service needs, sanitation workers are working 12-hour shifts and will be working Sundays as needed, including today to continue our work picking up trash and recycling,” department spokeswoman Belinda Mager said in an email Sunday. “
The Police Benevolent Association, the NYPD’s largest police union, mounted legal challenges to the mandate, though so far to no avail.
Hundreds of city workers have also taken to the streets, last week protesting the mandate at a rally outside Gracie Mansion in Manhattan.
The mayor issued an ultimatum when he announced the mandate, giving all city workers until 9 a.m. Monday to get at least one COVID-19 shot or get furloughed and go home.
A declassified U.S. intelligence report saying it was plausible that theCOVID-19 pandemicoriginated in a laboratory is unscientific and has no credibility, Chinese foreign ministry spokesman Wang Wenbin said in a statement on Sunday.
The updated U.S. intelligence briefing, published on Saturday, said that a natural origin and a lab leak were both plausible hypotheses to explain how SARS-CoV-2, the virus responsible for COVID-19, first infected humans, but that the truth may never be known.
In a response Sunday on the website of China's Ministry of Foreign Affairs, Wang said "a lie repeated a thousand times is still a lie", adding that U.S. intelligence services "have a reputation for fraud and deception."
"The tracing of the origins of the novel coronavirus is a serious and complex issue that should and can only be researched through the cooperation of global scientists," he said.
China has consistently denied allegations that the virus was leaked from a specialist laboratory in the city of Wuhan, where COVID-19 was first identified at the end of 2019.
Wang also repeated China's calls for the United States to open up its own laboratory at Fort Detrick to international experts.
A joint study by China and the World Health Organization published this year all but ruled out the theory that COVID-19 originated in a laboratory, saying that the most likely hypothesis was that it infected humans naturally, probably via the wildlife trade.
Critics said the study failed to investigate the Wuhan labs and did not examine the raw data required to understand the virus's early transmission routes.
The WHO last month established a new Scientific Advisory Group on Pandemic Origins (SAGO) and called on China to supply the raw data to help any new investigation. China has declined, citing patient privacy rules.
In an open letter to WHO Director General Tedros last week, a group of scientists critical of the organisation said that although they welcomed a new investigation into COVID-19's origins, the proposed composition of the SAGO panel lacked the necessary skills and impartiality.
There is growing concern about possible cognitive consequences of COVID-19, with reports of ‘Long COVID’ symptoms persisting into the chronic phase and case studies revealing neurological problems in severely affected patients. However, there is little information regarding the nature and broader prevalence of cognitive problems post-infection or across the full spread of disease severity.
Methods
We sought to confirm whether there was an association between cross-sectional cognitive performance data from 81,337 participants who between January and December 2020 undertook a clinically validated web-optimized assessment as part of the Great British Intelligence Test, and questionnaire items capturing self-report of suspected and confirmed COVID-19 infection and respiratory symptoms.
Findings
People who had recovered from COVID-19, including those no longer reporting symptoms, exhibited significant cognitive deficits versus controls when controlling for age, gender, education level, income, racial-ethnic group, pre-existing medical disorders, tiredness, depression and anxiety. The deficits were of substantial effect size for people who had been hospitalised (N = 192), but also for non-hospitalised cases who had biological confirmation of COVID-19 infection (N = 326). Analysing markers of premorbid intelligence did not support these differences being present prior to infection. Finer grained analysis of performance across sub-tests supported the hypothesis that COVID-19 has a multi-domain impact on human cognition.
Interpretation
Interpretation. These results accord with reports of ‘Long Covid’ cognitive symptoms that persist into the early-chronic phase. They should act as a clarion call for further research with longitudinal and neuroimaging cohorts to plot recovery trajectories and identify the biological basis of cognitive deficits in SARS-COV-2 survivors.
Funding
Funding. AH is supported by the UK Dementia Research Institute Care Research and Technology Centre and Biomedical Research Centre at Imperial College London. WT is supported by the EPSRC Centre for Doctoral Training in Neurotechnology. SRC is funded by a Wellcome Trust Clinical Fellowship 110,049/Z/15/Z. JMB is supported by Medical Research Council (MR/N013700/1). MAM, SCRW and PJH are, in part, supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London
A panel of three judges in Shreveport has issued a temporary restraining order preventing Ochsner Health from firing employees in north Louisiana who have not complied with a COVID-19 vaccination requirement.
The employees, 39 of which filed a lawsuit in the 2nd Circuit Court of Appeals, would have been dismissed Friday under a policy Ochsner enacted for all 32,000 employees in August: get vaccinated or an exemption by Oct. 29 or lose your job. The ruling from the state court of appeals came Thursday, one day before the deadline.
Small groups of Ochsner employees — 39 in Shreveport, 9 in Monroe and 48 in Lafayette — have taken the matter to separate courts, where they've argued that the mandate violates employees’ reasonable right to privacy to reject medical treatments.
A lower-court judge had previously dismissed the lawsuit from the Shreveport group. But in its ruling Thursday, the appeals court said the plaintiffs should be allowed a hearing and Ochsner may not fire or discipline employees over failing to comply with vaccine requirements in the meantime.
The ruling applies to employees at hospitals listed on the lawsuit, including Ochsner LSU Health Shreveport and Ochsner LSU Health Shreveport St. Mary. The plaintiffs are 20 registered nurses, four surgical technicians, a physician, a nurse practitioner, a respiratory therapist, a licensed practical nurse, a child life specialist and several others without listed medical credentials.
Attorney Jimmy Faircloth, who was previously executive counsel to former Gov. Bobby Jindal, has filed several lawsuits on behalf of employees in Louisiana arguing that Louisiana law protects an individual’s right to choose their health care.
Faircloth said the restraining order requiring Ochsner to halt firing unvaccinated employees in north Louisiana is encouraging because it suggests the judges think the case has merit.
“To get a temporary restraining order, you must convince the court when you file something that you have a substantial likelihood of success,” said Faircloth. “This very important issue is a resounding wake-up call to all the employers in the state that have been hoodwinked into believing that you can do this.”
But across the country and in the state, hundreds of hospital systems have enacted COVID-19 vaccine requirements, similar to requirements for the flu and hepatitis B vaccine. In September, the federal Centers for Medicare and Medicaid Services, the single largest payer of health care in the United States, said it would require the vaccine for all employees of hospitals that accept payments from the program. That would include Ochsner and all other large hospitals operating in the state.
The ruling for a hearing "just postpones the inevitable," said attorney Joel Friedman, a Tulane Law School professor who specializes in labor law.
According to Friedman and judges who have dismissed similar complaints, the government’s interest in public health outweighs an individual’s right to privacy, which guards against unreasonable government intrusion.
“There's no violation of any right to privacy here because the government has a compelling interest to require vaccinations under the circumstances to promote public health,” said Friedman.
Ochsner Health did not comment on the lawsuit or provide an update on how many employees were vaccinated on the day of the deadline. As of a month ago, 86% of employees had received at least one shot, according to CEO Warner Thomas. Among physicians and hospital leaders, the rate was 98%.
The new ruling is not an indication that the employees’ claim that the hospital is violating their rights has merit, nor does it have legal implications for lawsuits filed outside of the 2nd circuit, said Friedman. It means that the panel agreed that there should be a hearing to decide whether a hospital’s vaccine mandate is unconstitutional.
“They want the judge to actually rule on the merits and give these people at least the hearings,” said Friedman.
The 3rd Circuit Court of Appeal rejected a request for a similar order against Ochsner Lafayette General Health, though Faircloth said it is still moving forward with an appeal.
A lawsuit against Ochsner LSU Monroe was found to have no legal basis, according to ruling Oct. 27 by the Fourth Judicial District Court.
Understanding the trajectory, duration, and determinants of antibody responses after SARS-CoV-2 infection can inform subsequent protection and risk of reinfection, however large-scale representative studies are limited. Here we estimated antibody response after SARS-CoV-2 infection in the general population using representative data from 7,256 United Kingdom COVID-19 infection survey participants who had positive swab SARS-CoV-2 PCR tests from 26-April-2020 to 14-June-2021. A latent class model classified 24% of participants as ‘non-responders’ not developing anti-spike antibodies, who were older, had higher SARS-CoV-2 cycle threshold values during infection (i.e. lower viral burden), and less frequently reported any symptoms. Among those who seroconverted, using Bayesian linear mixed models, the estimated anti-spike IgG peak level was 7.3-fold higher than the level previously associated with 50% protection against reinfection, with higher peak levels in older participants and those of non-white ethnicity. The estimated anti-spike IgG half-life was 184 days, being longer in females and those of white ethnicity. We estimated antibody levels associated with protection against reinfection likely last 1.5-2 years on average, with levels associated with protection from severe infection present for several years. These estimates could inform planning for vaccination booster strategies.
Özlem Türeci and Ugur Sahin, founders of German company BioNTech, have been honored several times for developing the first COVID-19 vaccine. They spoke with DW about the future of the virus and vaccines.
DW: What's going to happen with COVID-19, and when will the pandemic be over?
Özlem Türeci: That is a difficult question, because we learn something new about the virus every day, about how it reacts to the vaccine. We need this knowledge in order to judge when the pandemic will be over. But what we can already say for sure is that gradually a new normalcy is settling in. We can already feel that. We are learning how to deal with the virus. Many of us are already vaccinated, and new degrees of freedom are being gained. There is going to be a normalcy where we can act more freely because large parts of the population are immune.
We're going to be dealing with virus for a few more years, for sure. There will also be answers to questions that are currently not clarified. The future will show whether other variants appear that are immune to the current vaccines, and whether these have to be tweaked accordingly. Over the years, the virus will acquire the status of the flu virus, for which some groups of the population are vaccinated every year or every two years. The coronavirus is going to become a more manageable virus.
Are you working on a new generation of your vaccine against other virus mutations?
Ugur Sahin: Yes, we're currently testing variant vaccines in a relatively small group of volunteers. A study on the South African beta variant is almost complete and there is an ongoing one on the delta variant, mainly to collect data. At the moment, there is no need to alter the vaccine. But we want to show that we can produce new variant vaccines and test them clinically to show they are as safe as the one that we are already using.
If a variant turns up in the next few years and the vaccine has to be adapted, we will be able to do this very quickly because we will already have set up the necessary procedure. We will, very calmly, be able to prepare for the fact that the vaccine might have to be adapted to new virus mutations every two years.
Is it necessary to vaccinate children, too?
Sahin: We cannot say whether this is necessary. We generate data and provide this to the authorities in charge. They have already approved vaccinations for children aged 12 to 15(in Germany -- Editor's note).
Türeci: We submitted data for 5- to 11-year-olds three weeks ago and the authorities now have to judge it within the whole context of the population's health.
Sahin: It's very important to us that there be availability. Once vaccines are approved, it is then up to individuals to decide whether they want it or not.
Are you disappointed that after so much research there are still people who refuse to get vaccinated?
Sahin: We're not disappointed at all. What we are doing is providing information in a transparent way. I think it's good that experts are expressing themselves in the media. This way, every person has the chance to understand the situation. The only thing I would recommend to everyone would be not only to look at one-sided information but to inform themselves as broadly as possible, in order to come to a good decision.
Do you understand when people say this is a new technology, and that we don't know the potential future consequences?
Sahin: We understand this, but on the other hand people generally tolerate vaccines very, very well and they are one of humanity's most important achievements. Without vaccines, our society would not have been able to develop to the extent that it has today. And our vaccine might be based on a new technology, but we understand it well because it has already been around for 30 years.
Our vaccine did not just simply appear. It is based on a biomolecule that we have in our body, in every cell. We are not introducing anything alien. We have a very good scientific basis for it because the necessary research has been conducted for over 30 years. That's why it was possible to develop our vaccine so quickly.
All over the world, governments are trying to persuade more people to get vaccinated. Could they do more?
Türeci: Every government is trying, and they have developed smart and interesting means of promoting the willingness of people to get the vaccine. All governments should be looking at others, in other regions of the world. The Cologne mayor told us that she goes out to certain districts herself when there is a vaccine rollout. That is something other decision-makers could learn from.
Dr. Özlem Türeci and Dr. Ugur Sahin are the founders of the Mainz-based company BioNTech. On October 13, 2021, they were awarded this year's Empress Theophano Prize by Greek President Katerina Sakellaropoulou in Thessaloniki, for their work developing the first COVID-19 vaccine.
The interview was conducted by Irene Anastassopoulou, and has been translated from German.
