UK covid booster shots for over 50s to begin next week

 U.K. Health Secretary Sajid Javid on Tuesday outlined the government’s fall-winter plan to tackle the coronavirus crisis, detailing a series of policies aimed at averting the need for more lockdowns.

His comments come shortly after British officials gave the green light to offer Covid-19 vaccine boosters to vulnerable people and everyone aged over 50-years-old six months after their second dose.

The U.K.’s Joint Committee on Vaccination and Immunisation said it recommended that the Pfizer-BioNTech vaccine was used for the booster dose, or alternatively a half-dose of a Moderna shot.

Javid said he had accepted this advice from the JCVI, and the National Health Service in England expects to begin next week. Wales’ health minister has accepted JCVI’s advice on booster vaccines.

Health and care policy is devolved across the U.K., with different provisions made in Wales, Scotland and Northern Ireland.

Separately, all children aged 12 to 15 years old in England will be offered one dose of the Pfizer-BioNTech shot. The move, which follows in the footsteps of many other countries, is designed to help reduce disruption to education.

Prime Minister Boris Johnson is set to comment further on the country’s fall-winter Covid plan when he hosts a press conference from Downing Street later this afternoon.

It is expected that Johnson will declare that he is firmly opposed to introducing lockdown measures once again. He is also seen as likely to scrap the country’s so-called “traffic light” system for overseas travel and higher-risk “red list” countries are expected to be significantly reduced.

Winter could be ‘bumpy at times’

Professor Neil Ferguson, a leading epidemiologist from Imperial College London, said earlier this week that another nationwide lockdown could not be ruled out “completely” in the coming months.

Speaking to BBC Radio 4′s “Today” show on Monday, Ferguson was asked whether another lockdown would not be necessary following the country’s vaccination drive. “I hope so,” he said. “I don’t think that you can rule out anything completely but I hope so.”

“I think with this level of immunity that we have in the population, if we do need to further drive down transmission then it may not require full lockdown,” Ferguson said.

To date, the U.K. has recorded almost 7.3 million Covid cases and 134,587 deaths, according to data compiled by Johns Hopkins University.

On Monday, the country reported 30,825 new coronavirus cases and 61 deaths within 28 days of a positive test. This compares to 29,173 infections and 56 fatalities recorded on Sunday, while over 41,000 cases and 45 deaths were announced this time last week.

England’s deputy chief medical officer, Professor Jonathan Van-Tam, warned on Tuesday that the coronavirus crisis in the coming months could be “bumpy at times.”

He said other respiratory viruses were “highly likely” to make a return over this period, saying the government’s aim was to “stay on top of things.”

In winter, people tend to spend more time indoors clustered together, with less ventilation and less personal space than in summer.

Respiratory infections, such as coronaviruses, are spread by droplets that are released when a person coughs or sneezes. Health experts say colder and drier conditions in winter strongly affects the transmission of flu-like illnesses.

https://www.cnbc.com/2021/09/14/uk-sets-out-covid-plan-for-fall-and-winter-booster-shots-to-begin-next-week.html

CureVac slashes COVID-19 vaccine production plans

 German biotech firm CureVac said on Tuesday it cancelled contract manufacturing deals for its experimental COVID-19 vaccine with two prospective partners, after rivals with approved shots have boosted production.

Agreements with Celonic Group of Switzerland and Germany's Wacker would be terminated but existing production deals with Rentschler Biopharma and Novartis would remain unchanged, CureVac said in a statement.

Manufacturing contracts with Bayer and Fareva were also unaffected, a spokesperson added.

CureVac fell far behind rivals BioNTech, a partner of Pfizer, and Moderna, in trying to develop an mRNA-based COVID-19 vaccine. The BioNTech-Pfizer alliance, in particular, has been a dominant force among suppliers to Western countries, with well over 1 billion doses delivered so far.

"The continuous increase in mRNA manufacturing capacity together with the progress of large-scale vaccination efforts have strongly changed the demand for our first-generation COVID-19 vaccine, CVnCoV, over the last months,” said CureVac Chief Operating Officer Malte Greune.

Financial terms of the cancellation would not be disclosed, the company added.

CureVac in June and July published disappointing trial data on its initial vaccine candidate, and European regulatory approval is yet outstanding.

It is also working with GlaxoSmithKline on a next generation of COVID-19 vaccines.

https://www.yahoo.com/news/curevac-slashes-covid-19-vaccine-115308657.html

Potential blockbusters awaiting FDA decisions this year

 This year has already witnessed a handful of memorable FDA approvals. And if one thing’s clear, the pandemic hasn’t slowed biopharma’s ability to push prospects over the agency’s finish line.

There’s been Biogen’s historic and controversial accelerated approval for Aduhelm in Alzheimer’s disease. That’s not to mention Amgen’s closely watched nod for Lumakras, the first lung cancer treatment to target what was once considered “undruggable” KRAS mutations.

But the race isn’t over yet. Looking to close out 2021 with FDA approvals stand four potential blockbusters from the likes of Argenx, UCB, Pfizer and Roche, according to Evaluate Pharma. Those meds combined are worth roughly $7.1 billion in sales cumulatively by 2026, according to Evaluate’s estimates. 

Another heavy-hitting hopeful in Evaluate’s mid-year report, Ascendis Pharma’s long-acting growth hormone lonapegsomatropin-tcgd, nabbed its own go-ahead in late August. Now dubbed Skytrofa, that drug is expected to rake in $1.5 billion in sales by 2026. 

Scoring an FDA approval isn't a sure thing for the remaining contenders. For one, Pfizer’s abrocitinib could face additional hurdles now that the agency has chalked up new safety warnings for a handful of JAK inhibitors following its investigation into Xeljanz. Other pipeline prospects, such as UCB’s bimekizumab and Roche’s faricimab, will almost certainly face fierce rivals if they win the agency’s blessing. 

Here’s a look at most valuable outstanding FDA decisions remaining in 2021, according to Evaluate: 

Efgartigimod 

Taking the top spot for the most lucrative remaining FDA decision this year is Argenx’s efgartigimod in myasthenia gravis (gMG), an autoimmune disorder that leads to loss of muscle function. The drug is up for a Dec. 17 decision date. 

If approved, efgartigimod would become the first anti-neonatal Fc receptor (FcRn) med to cross the agency’s finish line. Its prize? The first crack at a market that could be worth up to $25 billion in U.S. sales by 2030, according to SVB Leerink’s estimates. 

As for Argenx, Evaluate sees efgartigimod bringing in $3 billion in sales by 2026. The Belgian company guesses it will have a three-year head start against some heavyweight FcRn competitors, such as Johnson & Johnson’s Momenta Pharmaceuticals, UCB and AstraZeneca’s Alexion Pharmaceuticals.  

Efgartigimod is designed to block FcRn, a protection receptor of immunoglobulin G (IgG). That method is thought to lower the pathogenic IgG antibodies implicated in several autoimmune diseases.

In MG, efgartigimod sits at the FDA’s doorstep after posting promising late-stage trial data that showed it alleviated symptoms far better than placebo after 26 weeks, the first phase 3 win for an FcRn drug. 

Among patients who took efgartigimod and tested positive for acetylcholine receptor antibody—an indicator of MG—nearly 68% responded to the drug compared to just 29.7% of those on placebo, according to the company. Meanwhile, 56.8% of patients responded to efgartigimod for at least eight weeks, which dipped to 34.1% at 12 weeks.

Argenx is also trying to push efgartigimod through five other indications and is under review for gMG in Europe and Japan. 

Bimekizumab 

UCB’s bimekizumab has tough competition ahead if the psoriasis monoclonal antibody scores an FDA nod come its Oct. 15 decision date. 

If granted the agency’s go-ahead, the anti-IL-17A and IL-17F injection will enter the market with proof already in hand that it can top heavyweights from Johnson and Johnson and Novartis. It's expected to round up $2 billion in sales by 2026, Evaluate estimates. 

In two separate, late-stage studies, UCB’s bimekizumab managed to beat out J&J’s megablockbuster Stelara and Novartis’ Cosentyx when it came to clearing moderate to severe plaque psoriasis patients’ skin. 

In the trial against Stelara, bimekizumab helped 85% of patients achieve a 90% or greater reduction in the area and severity of psoriasis symptoms at 16 weeks, according to results published in The Lancet last year. Complete skin clearance—indicated by a score of PASI 100—occurred in 59% of patients. 

Meanwhile, Stelara helped just half of patients reach the 90% threshold and complete skin clearance. With those results in hand, analysts estimated that bimekizumab’s prospects could grow if the drug managed to do the same against Cosentyx. And it did. 

In results published in The New England Journal of Medicine in August, bimekizumab managed to completely clear about 62% of patients' skin after 16 weeks compared to Cosentyx’s nearly 50% showing. However, bimekizumab was tied to higher rates of mild to moderate oral candidiasis cases, or a fungal infection in the mouth. 

To be sure, UCB may face other hurdles outside the clinic. There’s some concern that the crowded psoriasis field, which also includes AbbVie’s Skyrizi and Humira, Eli Lilly’s Taltz and Amgen’s Otezla, could outmaneuver bimekizumab with their massive marketing budgets. And even more rivals may be on the way from Bristol Myers Squibb and Pfizer. 

Faricimab 

During the pandemic, Bayer and Regeneron weathered the storm with their blockbuster eye drug Eylea and even managed to grow their med's market share along the way.

Now, Roche is hoping to tip the scale back in its direction with its up-and-comer faricimab as the FDA weighs decisions in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), expected by year’s end. 

The Swiss pharma has proven that faricimab can at least match the world’s sixth best-selling drug last year in the clinic. Roche found in four phase 3 trials that the bispecific antibody, which targets VEGF and Ang2, didn’t do worse than Eylea despite the majority of patients taking it during longer dosing intervals. 

Across the trials, about half of patients were able to last four months on faricimab compared with two months on Eylea. That could give Roche a much-needed leg up given that the drugs are injected through a patient’s eye. 

But it may not be a big enough boost to catch up with Regeneron’s sizable lead. Evaluate pegs faricimab’s 2026 sales at $1.1 billion, far less than what Eylea is currently generating.

Abrocitinib 

Now that federal regulators have finally concluded their months-long safety investigation into Pfizer’s Xeljanz, a wave of JAK decisions loom on the agency’s horizon. That includes one for the Big Pharma’s other atopic dermatitis drug, abrocitinib. 

But how well abrocitinib fares is now up in the air given that inquiry turned up unfavorable results that have already reverberated throughout the JAK class, analysts wager. The FDA recently pegged new heart safety and cancer warnings for Xeljanz, AbbVie’s Rinvoq and Lilly’s Olumiant, and some analysts expect a similar warning could be coming for abrocitinib, too. 

For its part, Evaluate has estimated abrocitinib could reach blockbuster status with $1 billion in sales by 2026. That’s just a third of Pfizer’s own expectations for potential peak revenues. 

Regulators have shot down other JAK inhibitors in the past over safety concerns, notably for Gilead's filgotinib in rheumatoid arthritis. Pfizer nor the FDA have given any indication on whether the investigation could hinder abrocitinib’s ability to cross the finish line. 

Nonetheless, abrocitinib has turned up some wins on its way to the agency’s decision desk. In late August, Pfizer said its oral med bested Sanofi and Regeneron’s Dupixent when clearing patients’ itch and eczema symptoms at weeks 2 and 4, although key details surrounding its safety remain unknown. 

https://www.fiercepharma.com/pharma/from-pfizer-to-argenx-a-look-at-potential-blockbusters-awaiting-fda-decisions-to-close-out

JAK drugs could suffer in rheumatoid arthritis, atopic dermatitis; how FDA warnings affect other inflammatory uses

 After the FDA last week slapped safety warnings and use restrictions on AbbVie’s Rinvoq, Eli Lilly’s Olumiant and Pfizer’s Xeljanz, Wall Street has started rethinking its calculations for the JAK inhibitor class.

Based on discussions with three industry experts, analysts with SVB Leerink believe the FDA’s warning could have a range of effects on the meds’ opportunities across inflammatory diseases.

JAKs could see big use reductions in rheumatoid arthritis in the near term, and they’re vulnerable to new competition in atopic dermatitis, the SVB Leerink analysts said in recent notes. On the other hand, inflammatory bowel disease still represents a big market for JAK inhibitors, while smaller indications such as psoriatic arthritis and ankylosing spondylitis remain unchanged, according to the team.

As one of the largest indications for JAKs, rheumatoid arthritis is already an approved use for Xeljanz, Olumiant and Rinvoq. But after Xeljanz’s post-marketing study found heart-related side effects and cancer risks, a rheumatology industry leader SVB Leerink interviewed stopped starting new arthritis patients with the Pfizer drug, even though he had “considerable experience” with JAKs and liked their strong efficacy and oral dosing.

While the expert still prescribes Olumiant and Rinvoq to new patients, he expects to reduce up to one-third of his use of JAKs in rheumatoid arthritis in general. About 10% to 15% of his current rheumatoid arthritis patients are on JAKs now. As the final labels from the FDA kick in, JAKs will mostly be used after methotrexate and other small-molecule drugs, as well as TNFs and even other biologics such as Roche’s IL-6 inhibitor Actemra, the expert said.

Nevertheless, the rheumatologist suggests JAKs may regain share three years from now as doctors get used to the labels and if no new safety signals appear. Among the three drugs, the expect prefers Rinvoq given available clinical data and marketing strategies. Rheumatoid arthritis makes up half of AbbVie’s $8 billion estimate for Rinvoq sales in 2025.

At $2 billion in potential 2025 sales, atopic dermatitis, or eczema, represents the second-largest indication AbbVie has planned for Rinvoq. That drug, plus Olumiant and Pfizer’s investigational JAK inhibitor abrocitinib, all await FDA decisions on their eczema applications.

In eczema, Sanofi and Regeneron’s Dupixent has become the doctor's go-to option, and analysts have always been expecting JAKs’ use behind the IL-4/13 biologic. But now that the FDA has restricted JAKs’ existing uses to patients who’ve tried but failed on at least one TNF inhibitor, a dermatologist that SVB Leerink has spoken with suggested novel pipeline drugs might jump ahead of JAKs in the treatment order.

These possible new meds include IL-13 inhibitors such as Eli Lilly’s lebrikizumab, anti-OX40 agents, and others, SVB Leerink proposed.

In addition to newcomers, the FDA’s cautious view on oral JAKs’ safety profile threatens potential approvals for the meds at high doses for eczema, the dermatologist suggested. He argued the high doses are “critical to the efficacy claims” of JAKs. That’s because JAKs have topped Dupixent on efficacy markers only at the higher strengths, the SVB Leerink analysts noted.

“The dermatologist notes that atopic dermatitis has variable disease symptoms, and without the flexibility to dose higher, patients may derive inadequate control of itch and other symptoms, thus limiting JAK usefulness,” the SVB Leerink team wrote in a note last week.

Among the three JAK applications in eczema, the dermatology expert also favored Rinvoq because of its better efficacy-safety balance.

Beyond rheumatoid arthritis and eczema, inflammatory bowel disease (IBD) is another large potential market for JAKs; AbbVie’s 2025 IBD sales projection for Rinvoq is $1 billion. There, a gastroenterology specialist figured the FDA’s changes to labeling don’t affect JAK inhibitors’ advantage as oral agents, and their strong efficacy still far outweighs the potential risks.

What’s more, the doctor pointed out the safety signals from Xeljanz were from rheumatoid arthritis, where patients are typically older with more cardiovascular risk factors.

The gastroenterologist, who works at “a large New York medical system,” said about 70% of ulcerative patients either don’t respond to TNF inhibitors or can’t remain in remission and therefore need further treatment. JAKs currently reach about 10% to 15% of IBD patients in the second-line setting and could expand to 25% to 35% in the next five years, the expert estimated.

The IBD treatment paradigm is shifting toward oral drugs, the gastroenterologist predicted. To him, the trend favors JAK inhibitors, especially AbbVie’s Rinvoq, which he suggested is “modestly differentiated” from other in-class rivals. The SVB Leerink team, more bullish on JAKs’ opportunity in IBD than AbbVie, pegged $3 billion IBD sales for Rinvoq in 2025.

As for the smaller indications of psoriatic arthritis and ankylosing spondylitis, the market opportunity for JAKs there has always been limited, the SVB Leerink team noted in a Thursday note. In these two areas, TNFs and IL-17s—mostly, Novartis’ Cosentyx and Eli Lilly’s Taltz—have been “almost universally successful,” and there was little need for JAKs, the rheumatologist that SVB Leerink interviewed observed.

https://www.fiercepharma.com/marketing/jak-drugs-could-suffer-rheumatoid-arthritis-atopic-dermatitis-how-do-fda-warnings-affect

Fauci-mandated shot for flyers would be ‘logistical nightmare'

 Get ready for a snarled mess at airports around the country if airlines are forced to verify that passengers are vaccinated.

After Dr. Anthony Fauci threw his support behind a COVID-19 vaccination requirement for airline passengers, industry watchers on Monday warned of a “logistical nightmare” — lines out the door and a wave of delays and cancelations.

The burden of vaccination checks could weigh on airlines already hammered by the pandemic: Big carriers warned just last week their business could be off by 30 percent of normal by the start of fall.

Conor Cunningham, a senior travel industry analyst at trading firm MKM partners, said a vaccine mandate would be a “logistical nightmare” for airlines and the Transportation Security Administration — and told The Post that a requirement would lead to “a lot of cancellations.” 

Anthony Fauci

Chris Kleponis / CNP / SplashNews

“The experience at the airport would already go from being really, really awful to even worse,” Cunningham said, arguing that many airports and airlines are understaffed and that making workers check vaccine cards would be an additional burden.

“The logistics of it are very hard,” he added.

Fauci, the White House’s chief medical adviser, first threw his support behind the idea in an interview on Friday, while the Biden administration’s coronavirus response team coordinator Jeff Zients has said he has not “ruled out” vaccine mandates for air travel. 

“I would support that if you want to get on a plane and travel with other people that you should be vaccinated,” Fauci said. 

Domestic air travelers in France and Canada are already required to show proof of vaccination, and 61 percent of Americans support the idea, according to a September Gallup poll.

But airlines and analysts have pushed back against the idea. 

Executives for American, Delta and United Airlines have all publicly pushed back on the idea in recent months. 

“It’s very difficult for us to come in and mandate a vaccine that isn’t even federally approved yet,” Delta CEO Ed Bastian said on CNBC in August, shortly before the FDA approved the Pfizer coronavirus vaccine.  

American Airlines CEO Doug Parker, meanwhile, told the New York Times in August that a vaccine mandate “wouldn’t be physically possible to do without enormous delays in the airline system.” 

And United Airlines CEO Scott Kirby has punted, telling CNN the same month that its up to the US government to decide whether to require vaccines and speculating that “it won’t happen domestically.” 

Cunningham, the analyst, said that a potential mandate would mean lower-level employees like gate agents or flight attendants could be asked to “pick up a lot of the slack” when it comes to ensuring airline compliance. Labor union the Association of Flight Attendants did not immediately reply to a request for comment.

Airlines for America — a lobbying group that represents major US airlines including Delta, Southwest and American — opposes requiring vaccines for domestic flights, the New York Times reported in April. 

Airlines warn that they don’t have the staff to deal with a vaccination requirement.

Getty Images

Yet spokesperson Katherine Estep did not answer a question from The Post about whether the group still opposes such mandates, instead saying that companies represented by Airlines for America “comply with all CDC guidelines and requirements, and remain committed to leaning into science to guide policies and protocols that prioritize the wellbeing of all travelers and employees.”

The impact of a potential vaccine mandate could vary by airline, Cunningham said. 

Carriers like United — which has hubs in blue states with higher vaccinations rates like Illinois, California and New Jersey — may have an easier time weathering a mandate than rivals like Southwest, which is concentrated in the less vaccinated state of Texas. 

Nonetheless, he said a vaccine mandate for air travel would be “just bad, period,” regardless of where companies are concentrated. 

https://nypost.com/2021/09/13/fauci-mandated-shot-for-flyers-would-be-logistical-nightmare/

Blood test could reveal who is most likely to get severe covid-19

 A simple blood test could help predict which people with covid-19 are likely to get severely ill and need to go on a ventilator. The test measures levels of antibodies in the blood that are directed against molecules released by dead blood cells, including their own DNA.

The test may also prove helpful in infected people before they reach the stage of needing hospital treatment, says Ana Rodriguez at NYU Langone in New York. It is likely to be less accurate in that group, but it could indicate who needs closer monitoring, she says.

People who get severely ill from covid-19 tend to deteriorate at least a week or more after symptoms begin, when virus levels are falling, suggesting it is something about the person’s reaction to the infection that causes their problems, rather than the virus itself.

Rodriguez’s team looked at blood tests done on 115 people admitted to hospital with covid-19 in 2020. About half of these people became severely ill and needed oxygen support, while the rest recovered quickly.

Those with high levels of antibodies directed against DNA or a fatty molecule from cell membranes called phosphatidylserine had about a 90 per cent chance of deteriorating. But the test only identified about a quarter of people who got worse. “It won’t mean we catch everybody but if you have this, it looks very bad,” says Rodriguez.

It is unclear if the antibodies detected by the test are involved in the person’s deterioration, or if they are innocent bystanders. The DNA and phosphatidylserine seem to come from red blood cells that have burst open, as well as immune cells called neutrophils that release their DNA as they die in a bid to trap bacteria. It is possible that the antibodies may bind to the DNA, contributing to the formation of multiple tiny blood clots, which is often seen in severe covid-19 and causes strokes and kidney damage.

Doctors currently make covid-19 treatment decisions based on people’s clinical signs, such as their blood oxygen levels, and their age and other risk factors.

Journal reference: Life Science Alliance, DOI: 10.26508/lsa.202101180

https://www.newscientist.com/article/2289718-blood-test-could-reveal-who-is-most-likely-to-get-severe-covid-19/#ixzz76Oo15oXP

‘Huge number’ of unvaccinated Delta workers got vaccine after $200 surcharge

 The chief health officer for Delta Air Lines said this week that the carrier’s decision to implement a $200 surcharge for unvaccinated employees has convinced a “huge” portion of the workforce to change their minds about the jab.

Dr. Henry Ting, speaking during a Thursday media briefing with the Infectious Diseases Society of America, said that approximately 20,000 Delta team members had not been vaccinated as of Aug. 25, when CEO Ed Bastian announced a monthly surcharge for unvaccinated employees on Delta’s healthcare plan.

“Just within the two weeks of the announcement, we’ve seen nearly 20%, or one-fifth, of that 20,000 decide to get the vaccine,” said Ting. He added that Delta did not observe any turnover or resignations as a result of the new policy.

Prior to Bastian’s announcement, around 74% of Delta’s workforce had been vaccinated. That number now sits at around 78%.

The increase may not sound like much, but Ting says it’s a “huge number” when taking into consideration the initial reluctance of those 20,000 unvaccinated employees.

“That last 4% is very different from the first 4%,” he said.

CEO Ed Bastian publicly announced Delta’s surcharge policy in late August, saying it was “necessary to address the financial risk the decision to not vaccinate is creating for our company.” (Yuichi Yamazaki/Getty Images)

CEO Ed Bastian publicly announced Delta’s surcharge for unvaccinated employees on Aug. 25, in a memo to colleagues also published at Delta’s website.

“Beginning Nov. 1, unvaccinated employees enrolled in Delta’s account-based healthcare plan will be subject to a $200 monthly surcharge,” reads one of the bulletpoints in Bastian’s memo. “The average hospital stay for COVID-19 has cost Delta $50,000 per person. This surcharge will be necessary to address the financial risk the decision to not vaccinate is creating for our company.”

In the memo, Bastian added that every Delta employee who had been hospitalized with COVID-19, up to that point, had been unvaccinated.

Delta is currently not among the several major carriers that have implemented vaccine mandates for employees, though the airline continues to strongly encourage vaccination for its entire workforce.

The airline has also mandated that all new hires be vaccinated, a decision which has not deterred candidates applying for Delta’s thousands of available jobs, according to Ting.

https://www.nxsttv.com/nmw/news/huge-number-of-unvaccinated-delta-workers-got-vaccine-after-200-surcharge-announcement-official-says/