Molecular Partners Shares Drop 14% After Novartis Deal

 Molecular Partners AG shares fell 14% to $27.29 after the company said it and Novartis entered into a license agreement under which Novartis will in-license global rights to ensovibep.

Ensovibep is a DARPin antiviral therapeutic candidate to treat Covid-19, which recently reported positive topline data from a Phase 2 clinical study.

Molecular Partners said the agreement finalization triggers a milestone payment of 150 million Swiss francs ($163.8 million) to the company.

Under the license agreement, Molecular Partners will be eligible to receive a 22% royalty on sales in commercial countries and agreed to forgo royalties in lower income countries.

Molecular Partners said it expects to report CHF133 million cash and cash equivalents as of Dec. 31 and estimates its cash runway to extend well into 2025, excluding any potential royalty income as well as potential further cash flows to or from its research and development partners.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Molecular-Partners-Shares-Drop-14-After-Novartis-Deal-37577151/

Gates, Wellcome pledge $150 mln each to pandemic preparedness group

 Global health charities the Bill & Melinda Gates Foundation and Wellcome Trust each pledged $150 million to the Coalition for Epidemic Preparedness Innovations (CEPI) to fund its COVID-19 pandemic response and help put it on better footing for future major health crises.

The pledges, announced on Tuesday, come ahead of a March 8 fundraising event sponsored by the UK government that aims to raise $3.5 billion on behalf of CEPI, an international coalition set up five years ago to prepare for future disease threats.

CEPI's five-year strategy aims in part to compress vaccine development timelines to 100 days, around a third of the time it took the world to develop the first COVID-19 vaccines.

"The unprecedented spread of the highly infectious Omicron variant around the world over the past two months exemplifies the ways in which we must be ready both in terms of speed and the scale of our response to future threats," CEPI Chief Executive Richard Hatchett told reporters in a briefing on Tuesday.

"We must endeavor to take pandemic threats off the table if we can," he said.

Hatchett said that delivering COVID-19 vaccines within 11 months was unprecedented, but not good enough. Had they been developed within 100 days, CEPI's pandemic goal, a COVID-19 vaccine could have been available as early as April 2020.

Dr. Jeremy Farrar, director of Wellcome, said an important lesson from the pandemic has been the need to have systems in place that allow for a rapid response when a crisis arrives.

"None of us believe Omicron will be the last variant or that COVID-19 will be the last pandemic," he said.

Bill Gates, co-chair of the Gates Foundation, said research and development investment should be commensurate with the future risk of pandemics.

The latest Gates pledge brings the charity's investment in CEPI to $270 million over the last five years, and its total pandemic investment to $2 billion.

"We want the world not to forget about how bad this pandemic was," he said.

CEPI made early investments in 14 COVID-19 vaccine candidates, including those from Oxford-AstraZeneca and Novavax, which recently received a World Health Organization emergency listing.

The group is also working on next-generation COVID-19 vaccines effective across variants and future coronaviruses in the same family. 

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Gates-Wellcome-pledge-150-mln-each-to-pandemic-preparedness-group-37580335/

Valneva shares dip after EU regulator comments on status of covid-19 vaccine approval

 

Shares in biotech firm Valneva dropped as much as 6.9% on Tuesday after the European Union drug regulator said the firm's COVID-19 vaccine was under an EU rolling review but it was still awaiting some additional data.

Valneva's share price has fluctuated sharply in recent weeks on news about the company's COVID-19 vaccine candidate.

https://www.marketscreener.com/quote/stock/VALNEVA-SE-54466/news/Valneva-shares-dip-after-EU-regulator-comments-on-status-of-covid-19-vaccine-approval-37577286/

Are hospital admissions still the best way to gauge the COVID crisis?

 

Using the number of people in hospital with COVID-19 to gauge the severity of the pandemic may not give an accurate picture in the Omicron era as more and more patients with the virus are being admitted for other reasons, some scientists say.

Governments have focused on hospitalisations to determine the need for restrictions but the data does not typically differentiate between people admitted because of COVID-19, and those who test positive on wards during routine checks.

"Say you're having a heart attack, come into hospital, and end up testing positive," said Paul Hunter, a professor of medicine at Britain's University of East Anglia.

"Is COVID-19 the cause of your heart attack? We know it could be. But we can't know at an individual level," he said.

In Britain, the Omicron variant has driven case numbers to record highs since it emerged at the end of November but the number of hospital patients with COVID-19 on mechanical ventilation has barely changed, government data shows.

The number of people with COVID-19 in hospital overall has risen, but not proportionately with the rise in infections, while intensive care unit (ICU) occupancy is little changed, according to British Health Minister Sajid Javid.

With death rates relatively stable despite the Omicron surge, some countries such as Spain are looking at whether to adopt new ways of tracking the virus, though epidemiologists say shifting the goal posts does not change the fact hospitals and their staff are still overloaded with COVID-19 sufferers.

Data from New York this month showed that 42% of patients hospitalised with COVID-19 were so-called incidental cases, people admitted for other reasons and only found to be infected during routine testing.

British Prime Minister Boris Johnson even said last week that as many as 30% of people in hospital with COVID-19 actually become infected while hospitalised - something Hunter partly attributed to Omicron's overwhelming contagiousness.

SYSTEM OVERHAUL

Hunter said intensive care occupancy was a better measure of the real severity of an outbreak: "If you're in an ICU bed with COVID, you're probably there because of COVID, rather than just with it."

In Italy, regional governments have argued that the nuances within the statistics on coronavirus hospitalisation may warrant overhauling their monitoring systems to better reflect the relatively lower severity of Omicron.

Italy's Health Ministry said last week it was examining a draft proposal from the regions to exclude asymptomatic people hospitalised for other reasons from the COVID admissions data.

Critics denounced the proposal as a non-scientific bid by the regions to avoid hitting "red zone" levels of hospitalisations that would trigger tighter coronavirus curbs.

"The change in criteria cannot be a make-up operation that disguises the tragic nature and scale of the pandemic," Filippo Anelli, president of Italy's national federation of doctors, said on Friday.

"The numbers of infected people admitted to non-critical areas and intensive care units, however they are counted, are overloading hospitals ... and exhausting the professionals who have been managing the pandemic for two years," he said.

The committee of scientists advising the Italian government recommended on Saturday that the current criteria measuring the spread of COVID-19 be maintained. The Health Ministry said, however, that the "preliminary" debate was ongoing.

The question of how to classify patients in hospital who are largely asymptomatic is set to preoccupy European nations as they look to ease curbs - even though it remains unclear to what extent Omicron may have exacerbated their medical conditions.

FROM IRELAND TO SPAIN

In Ireland, 58% of those in hospital testing positive did not have any symptoms, according to the Infectious Diseases Society of Ireland, which looked at about 45% of all positive COVID-19 cases admitted to Irish hospitals on Jan. 11.

It found more than 70% of those hospitalised with COVID-19 did not need oxygen therapy, suggesting they suffered from a less severe form of disease than previously seen.

In Denmark, about 15% of people hospitalised people over the course of 18 months had tested positive for coronavirus, but displayed no symptoms and had been admitted for other reasons, a study published this month by the country's top infectious disease authority the Statens Serum Institut showed.

In Spain, meanwhile, more than 18,800 people currently in hospital have COVID-19, a 79% increase on previous peaks.

However, 25% to 40% of those testing positive in hospital were not being treated for COVID-19, according to a report in newspaper El Pais this month.

"40% of patients hospitalised in Madrid with positive PCR tests aren't (being admitted) for COVID," Madrid's deputy health counsellor Antonio Zapatero said last week on Twitter.

But Simon Clarke, associate professor in cellular microbiology at Britain's Reading University, said even if COVID-19 levels in hospital partly reflected the prevalence of the virus in the population, they ought not be dismissed.

"There's this narrative that if you come into hospital and pick up COVID it's like a free infection and often dismissed, whereas that's not true: you come into hospital for a reason, you're vulnerable, and it's likely COVID will worsen your condition," Clarke said.

"There needs to be a recognition that regardless of admission reason, people in hospital with COVID is pressure on the hospitals."

https://www.marketscreener.com/quote/stock/ON-SEMICONDUCTOR-CORPORAT-10340/news/Are-hospital-admissions-still-the-best-way-to-gauge-the-COVID-crisis-37581463/

Kaiser offers additional shots to 3,900 given light dose of Pfizer vaccine

 Kaiser Permanente has notified 3,900 patients vaccinated with at its Walnut Creek Medical Center last fall they may have received less than a full dose of the Pfizer shot.

Kaiser is sending notices this month offering those who received the light shots appointments for a “repeat” dose if they want one. But the HMO said that after consulting with experts and reviewing guidelines from the U.S. Centers for Disease Control and Prevention, the dosing error should not significantly reduce immunity.

“The health and safety of our members and patients is our highest priority,” Kaiser Permanente said in a statement. “As a trusted health care provider, we are committed to informing patients of circumstances that could affect them, even if any potential impact is not considered significant, as in this matter.”

Patients who received the Moderna or Johnson and Johnson vaccines are not affected.

It’s not the first time Bay Area patients have been given improper doses of COVID-19 vaccines. In November, a Sutter Health pediatric clinic in Antioch gave 14 kids ages 5-11 twice the proper dose of Pfizer‘s children’s version of the COVID-19 vaccine.

Last March, KTVU reported that 4,300 people were administered a third less than the recommended dose while getting a shot at the Oakland Coliseum mass vaccination clinic. In that case, state officials told the TV station that no one was offered additional doses because the dosage error wasn’t considered significant.

Problems have arisen nationally as well. Last fall 112 children at a Virginia pharmacy received one-tenth of the formulation of the vaccine intended for adults, and 98 kids in Maryland received over-diluted doses at a school clinic.

In the most recent incident involving Kaiser, the health care organization said patients who were supposed to have been given the 0.30 milliliter dose of the Pfizer vaccine for teens and adults instead received 0.26 to 0.29 milliliter doses between Oct. 25 and Dec. 10, 2021.

“Once we became aware of this issue, we immediately consulted with experts in infectious diseases and vaccine science and reviewed guidelines from the Centers for Disease Control,” Kaiser said. “All experts agreed the difference between the recommended dose and the dose an individual may have received was not significant and not likely to reduce their protection against COVID-19.”

According to the CDC, vaccine administrators are required to notify patients of any dosage errors, report them to the agency’s Vaccine Adverse Event Reporting System even if they did not cause any problems, and consult with state authorities on how the erroneous dosage should be recorded.

The CDC says that when a lower-than-authorized dose is given to adults, such as when the patient pulls away, the syringe leaks or equipment fails, the dose should be repeated immediately.

Kaiser said it “took immediate steps to confirm that the issue was isolated and promptly retrained staff and validated their understanding of the correct procedure.”

“We are continuously monitoring so this does not happen again,” Kaiser said. “We sincerely apologize for any concern or inconvenience this may cause for those patients we are contacting.”

https://www.mercurynews.com/2022/01/17/kaiser-gave-walnut-creek-3900-patients-low-covid-19-vaccine-doses/

Florida to prioritize transplant hospitals, cancer centers for scarce COVID-19 therapeutic

A scarce monoclonal antibody for people who cannot build immunity from COVID-19 vaccines will be prioritized for distribution to Florida hospitals with large numbers of organ transplant and cancer patients, the Florida Department of Health said on Tuesday, signaling a change in strategy more than three weeks after the state passed over large medical centers and delivered the first shipment of the drug to a small clinic in Broward County.

 Florida’s health department said that as of Jan. 14 “every registered provider that requested Evusheld received an allocation” and that the agency had identified 11 hospitals in the state with transplant and cancer patients and prioritized them to receive the drug, called Evusheld, which is manufactured by AstraZeneca.

 “Evusheld is an important tool for providers to help protect these very high-risk patients,” Weesam Khoury, a health department spokeswoman, said in an email. “To efficiently distribute this vital therapy, the Department prioritizes and ensures that transplant and oncology centers receive allocations of AstraZeneca for their patients.”

 The health department did not name the hospitals. Khoury added that the health department was working with transplant and oncology centers to inform medical providers about the benefits and availability of Evusheld, collect data on patient services and “streamline a direct allocation model” for hospitals with high-risk patients to register their facilities and order the drug through the state. Prior to establishing online registration and ordering, the health department said it was calling hospitals and other providers to gauge their interest in and ability to provide Evusheld. 

 Florida’s health department said it would prioritize transplant hospitals and cancer centers for Evusheld after the Miami Herald reported last week that the agency had shipped the state’s first doses of the drug to a small Broward clinic in December, bypassing Jackson Memorial Hospital’s Miami Transplant Institute, which performs hundreds of organ transplants a year and provides follow-up care to thousands of immunocompromised patients. The state did not send Evusheld to any South Florida hospital in December. Jackson Memorial Hospital in Miami received its first shipment of Evusheld, a monoclonal antibody to prevent COVID-19 in immuno-compromised people, on Jan. 13.

 JACKSON GETS SHIPMENT, SYLVESTER IS WAITING, DATA SHOWS

 The Miami Transplant Institute, which is the busiest organ transplant center in the Southeastern United States, received its first shipment — 840 courses of Evusheld — on Thursday, Jan. 13, a spokeswoman confirmed.

But other South Florida medical centers, representing thousands of patients who would likely benefit from the scarce drug, were still awaiting shipment on Jan. 14, according to distribution data from the federal Department of Health and Human Services. The University of Miami Health System’s Sylvester Comprehensive Cancer Center, the only National Cancer Institute-designated facility in South Florida, has yet to receive its allotment of 648 doses, HHS data shows. UHealth would not confirm whether Sylvester has received Evusheld, and a Jackson Memorial spokeswoman declined the Herald’s interview request about the hospital’s need for Evusheld and how it would prioritize the drug for patients. Broward County’s public hospital networks, Memorial Healthcare System and Broward Health, are not listed on the HHS data as institutions that will receive Evusheld though both medical centers provide organ transplant and cancer care. 

A Memorial Healthcare spokeswoman, Yanet Obarrio Sanchez, said the public hospital for South Broward “has requested to be added to the list, and it is our understanding that two of our hospitals will be added to the list shortly.” Jennifer Smith, a spokeswoman for Broward Health, the public hospital for North Broward, said, “We have been working with the state to be added to the Evusheld allocation list.” 

BIG DEMAND, SMALL SUPPLY OF EVUSHELD

 Evusheld, a monoclonal antibody authorized for emergency use by the Food and Drug Administration on Dec. 8, can reduce the risk of severe illness and death from COVID-19 in immunocompromised persons. The federal government has purchased all 700,000 doses of Evusheld manufactured by AstraZeneca and last week the United States ordered an additional 500,000 courses of the drug. Florida’s health department has sole discretion for determining where in the state to send Evusheld and how much. An agency spokesman said last week that the department’s distribution strategy prioritized access to the drug, with treatment available within a two-hour drive of any resident.

 The first medical provider in Florida to receive Evusheld was iCare Mobile Medicine, a concierge medical service in Cooper City incorporated in March 2020 and that advertises house calls and COVID-19 tests, vaccines and therapies on its website. The clinic also has a site in Miami-Dade, near Miami International Airport. 

STAT News first reported on the state’s shipment to iCare. A health department spokesperson said the agency shipped the drug first to iCare because of the clinic’s “proven track record” of quickly receiving and administering other COVID-19 therapeutics to patients. 

The medical director for iCare, Dr. Nicholas Suite, a neurologist who also teaches pre-med at American Heritage Schools, a private school with campuses in Broward and Palm Beach counties, said he prioritizes patients for Evusheld based on their medical condition and eligibility for the drug. Signs direct people to Broward Health’s outpatient monoclonal antibody treatment site. MIAMI Evusheld requires a doctor’s prescription and is indicated for people with weakened immune systems or allergic reactions to the vaccines. Unlike other monoclonal antibodies, Evusheld is administered prior to exposure to the virus that causes COVID-19 and not after exposure or infection.

 “We at iCare have been treating cancer patients, organ transplant patients, and those in immunosuppressive therapy — all which would be in extreme risk from COVID,” Suite said in a text message. “Some of the patients have been referred specifically by infectious disease doctors, oncologists, and transplant centers who wished to selflessly give their immunocompromised patients the best opportunity to survive this global pandemic.” 

Suite said patients found iCare using the state health department’s website listing providers of monoclonal antibody treatments, including Evusheld. However, the state website did not list iCare as an Evusheld provider on Tuesday. While South Florida’s largest hospitals waited for a shipment of Evusheld, Suite said iCare filled the needs of patients. He suggested that hospitals had not been responsive to the state’s queries about the drug.

 “The ethical considerations should properly focus on encouraging those excellent institutions who control large numbers of these immunocompromised patients to be more immediately responsive and accommodating to both the FDOH [Florida Department of Health] and all of their patients regarding this important treatment for COVID-19,” he said in a text message.

 Florida has not released a list of providers who requested and received Evusheld from the state, but there is clearly more demand for the drug than there is supply.

 Experts say that eventually there will be enough Evusheld for everyone who needs it, but that until then the scarce drug should be allocated to those eligible patients who are at greatest risk of severe illness and death from COVID-19.

 PRIORITIZING PATIENTS FOR TREATMENT

 The National Institutes of Health’s COVID-19 Treatment Guidelines Panel recommends that providers prioritize certain immunocompromised patients for Evusheld when there’s a shortage, including all lung transplant recipients, patients within one year of receiving any organ transplant and those taking certain immuno-suppresant drugs or with untreated HIV. At some Florida hospitals, administrators have already begun to prioritize which of their patients will receive the drug first. 

Dr. Mark Parkulo, a specialist in internal medicine at the Mayo Clinic in Jacksonville, said the hospital received 120 doses of Evusheld as of Jan. 12 and was scheduled to receive an additional 700 courses.

 “We’re happy that the state is giving us the supply,” Parkulo said. “We’re in a position to deliver the drug.”

 Parkulo said Mayo Clinic will ration Evusheld much in the same way that institutions managed the COVID-19 vaccines when they were first approved in December 2020.

 “It’s clear that, especially early on, there’s going to be more patients who qualify for the medication than actually we have doses to give,” he said. “My guess is that will still be the case for several weeks and maybe months.” 

The Mayo Clinic, which provides organ transplants and cancer care, used its electronic medical records to identify those patients most likely to need Evusheld and then divided them into tiers, with those most likely to need the drug listed at the top

. “We searched certain pieces of information: transplant status, medication status, those kinds of things that would qualify them for the medication,” he said. In the top category were patients with lung and bone marrow transplants, and those undergoing active chemotherapy for cancer.

 “We’ve identified here at Mayo Clinic 2,000 of those Category 1 patients,” Parkulo said. ”Those aren’t necessarily all the patients who qualify but those are the highest-risk patients. There are probably even more than that.” 

Parkulo said Evusheld is administered in two consecutive injections into a muscle, which takes five minutes, and that the patient must be monitored for at least one hour afterwards for a potential adverse reaction.

 Because Evusheld is given prior to infection, patients who qualify for the drug must be isolated from any area of the hospital where COVID-positive patients are housed. That means Evusheld cannot be given in the same area the hospital uses to provide other monoclonal antibody treatments, which are administered after exposure or infection. 

Administering monoclonal antibodies also requires nurses and other healthcare workers, Parkulo said, noting that many hospitals are struggling with “logistical issues” created by workplace absences due to the latest surge in COVID-19 infections fueled by the highly contagious omicron variant. Mayo Clinic chose to use its COVID-19 vaccine center to deliver Evusheld.

 But finding space and staff to administer the drug is possibly the least of a hospital’s challenges. With Evusheld and other COVID-19 therapeutics authorized for emergency use, physicians have many more tools now to fight the pandemic. 

But the complexity of the virus and knowing which treatments work against what variants and the best times to apply them makes a doctor’s job more complex, Parkulo said.

 “The question really is going to come up: What scheme are you using to treat patients who are infected? Do they get monoclonal antibodies? Do they get Paxlovid [antiviral pill]?” he said. “The complexity keeps going up in trying to manage all the different treatments and modalities that are coming out.” 

Most physicians know that one monoclonal antibody, called Sotrovimab, is shown to neutralize the omicron variant while two others are not as effective against the mutated virus. With Evusheld, some doctors have reported breakthrough COVID-19 infections in their patients, though it’s not clear how those cases occurred. 

Dr. Michael G. Ison, a specialist in infectious disease and organ transplant surgery at Northwestern University’s Feinberg School of Medicine in Chicago, posted a comment to the social media website, Twitter, on Monday stating that the hospital had its first COVID-19 breakthrough in a patient taking Evusheld. But Ison, one of the first to question Florida’s distribution of Evusheld after his patients had traveled to South Florida to receive treatments from the Broward clinic because Northwestern had not yet received its shipment, said more research is needed to understand what happened in breakthrough cases.

 “It is too early to understand the efficacy of Evusheld,” he said in an email. “There have been a few reports of breakthrough infections but [we] will need longer follow-up and more data collected to understand the efficacy of the therapy in the setting of Omicron.”

https://www.miamiherald.com/article257445552.html

NHL to stop testing asymptomatic players post-All-Star break

 The NHL will stop testing asymptomatic players, coaches and staff who are fully vaccinated following the All-Star break in early February, saying coronavirus cases continue to decline across the league.

The league and Players’ Association announced the protocol changes Tuesday. The current policy will remain in place until the All-Star break begins Feb. 3.

Carolina Hurricanes coach Rod Brind’Amour, who is expected to be behind the bench for the Metropolitan Division at All-Star Weekend in Las Vegas, called the change “common sense.”

“The players have done all they can, done all their vaccinations — all that stuff that they can do,” Brind’Amour said. “I don’t know why they would be testing them, to be honest with you, if they’re asymptomatic, so I agree with this decision. I think it’s a good one.”

There will still be testing of asymptomatic individuals when it is needed for crossing the U.S.-Canada border. Testing will not be required at All-Star Weekend, with one negative result needed to return to team facilities after the break.

The 90-day testing “holiday” for players, coaches and staff who recover from COVID-19 will remain in place. New York Islanders forward Matt Martin pointed out that with the playoffs a little over three months away, not testing asymptomatic players is a smart move that could keep rosters from being decimated at that time.

“I think it’s a step in the right direction,” Martin said. “Hopefully we can continue to move forward and get back to a normal way of life.”

The NHL and NHLPA also agreed to keep the five-day isolation period that went into effect Dec. 29, a reduction from 10 after the U.S. Centers for Disease Control updated its virus guidance. The league and union will review protocols, including enhanced rules that are currently in place, on Jan. 31 as long as cases keep declining.

A total of 160 players went into COVID protocol from Dec. 29-Jan. 11 after 208 in the two weeks prior to the chance. All players on active rosters are vaccinated except for Detroit’s Tyler Bertuzzi.

So far this season, 104 games have been postponed, including several because of attendance restrictions in Canada. The league is expected to announce a wave of rescheduled games Wednesday, including many getting moved into the two weeks that had previously been set aside for the Olympics, which will go ahead without NHL players because of the schedule disruptions.

Vancouver Canucks captain Bo Horvat and Montreal Canadiens forwards Cole Caufield and Joel Armia went into protocol Tuesday. The Canucks are wrapping up a five-game U.S. road trip, and there is some concern about Horvat, goaltender Jaroslav Halak and forward Conor Garland not being able to cross the border for several more days.

“I’m not the border agent, so I have no idea what the process is,” Vancouver coach Bruce Boudreau said Sunday. “It just seems like it’s one a day with our group. It’s unfortunate.”

https://apnews.com/article/coronavirus-pandemic-nhl-sports-health-canada-63938db5cda6dfa6e733d66c8c12a5ff