Cuomo: NY counties can vaccinate restaurant workers, taxi drivers

 New York Gov. Andrew Cuomo said Tuesday that he was giving county officials the authority to add taxi drivers and restaurant workers to the list of people eligible for a coronavirus vaccine.

The governor’s announcement came days after the governor slammed elected officials for pushing to vaccinate restaurant workers when supply is limited.

But Cuomo said Tuesday the federal government is signaling that it will send New York more doses in coming weeks, which could free up more doses. 

With the incoming increase, Cuomo says localities can also add developmentally disabled facilities to the 1B prioritization group.

"If a local government is now getting more, and they believe in their local circumstance, they want to prioritize taxi drivers, Uber drivers, -- because they think that’s been a problem – or developmentally disabled facilities, or restaurant workers, they have that flexibility," said Cuomo. "And again, they are getting more, so theoretically they would have additional supply to make those decisions. But that’s going to be up to the local government to add in the 1B category, if they think it makes sense."

The federal government is expected to increase state supply 20% for the next three weeks, up from the inital 16% announced last week.

Private pharmacies in the state focusing on vaccinating the 65-plus population will also receive an additional 10%, which is about 30,000 doses.

https://www.wktv.com/content/news/Cuomo-Counties-can-begin-vaccinating-restaurant-workers-taxi-drivers-573711671.html

White House plans to send vaccine doses to retail pharmacies

 The White House will launch a new program shipping coronavirus vaccines directly to retail pharmacies starting next week in an effort to increase Americans' access to shots, a top aide said on Tuesday.

President Joe Biden's COVID-19 response coordinator, Jeff Zients, said the program will launch on Feb 11 and make 1 million doses available to 6,500 stores. As supply grows, the program could expand to as many as 40,000 stores, he said.

Biden said last month that the COVID-19 vaccine rollout has been a "dismal failure" so far and vowed to boost the speed at which shots are given to Americans, with a focus on ensuring equitable access regardless of geography, race, or ethnicity.

The federal government will distribute a million vaccine doses to the 6,500 stores next week, Zients said, adding that the amount will grow over time.

That is in addition to 10.5 million doses that the federal government plans to ship weekly to states and territories for the next three weeks, he added.

"This will provide more sites for people to get vaccinated in their communities," Zients said, adding that supply constraints will limit the program in its early days.

The initial pharmacy locations were selected to improve access to vaccines in hard to reach areas and among socially vulnerable communities, Zients said.

CVS Health Corp said in a news release that its pharmacies will be participating in the program.

Zients also said the Federal Emergency Management Agency (FEMA) will reimburse states for some COVID-related costs they had taken on since the pandemic began last January, such as for personal protective equipment and deployment of the national guard.

He said Congress does not need to approve funds for FEMA to do this and that the total payments to states will be between $3 billion and $5 billion.

Zients added that the federal government has acquired supplies of equipment healthcare providers need to get six doses from each vial of Pfizer Inc's COVID-19 vaccine rather than five.

The Biden administration has said it is willing to use emergency wartime powers if necessary to secure the specialized low dead space syringes and other supplies needed to eliminate vaccine waste and improve administration efficiency.

The major winter storm that hit the east coast of the United States this week has not disrupted vaccine deliveries but has forced some vaccine administration sites to shut down or reduce operating hours, Zients said.

https://www.marketscreener.com/quote/stock/WALGREENS-BOOTS-ALLIANCE-19356230/news/White-House-plans-to-send-vaccine-doses-to-retail-pharmacies-32339246/

Oxford Covid vaccine study shows jab can halt transmission

 The AstraZeneca vaccine requires two doses for the highest efficacy against coronavirus infection, but new research has shown the first dose provides 76 percent protection. A new study shows the jab has 76 percent efficacy after a single dose, with efficacy improving further after a second shot was given. Oxford University also found the jab also has "substantial effect" on reducing transmission of coronavirus.

Oxford University said the findings of the pre-print paper, which had not been peer-reviewed, supported Britain's decision to extend the interval between initial and booster doses of the shot to 12 weeks.

The UK has decided to give as many people as possible some protection from the deadly virus by lengthening the amount of time given between the first and second shot of the vaccines. 

AstraZenca, the Anglo-Swedish pharmaceutical firm, has welcomed the findings and said flexibility to extend the time between doses is the best strategy for the vaccine.

Oxford academics said: "Vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 post vaccination was 76 percent, and modelled analysis indicated that protection did not wane during this initial 3 month period."

Oxford academics said: "Vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 post vaccination was 76 percent, and modelled analysis indicated that protection did not wane during this initial 3 month period."

The results were gathered from trials in Britain, Brazil and South Africa, and showed some protection was given after one dose and that immune responses were boosted after the second shot, among participants aged 18-55 years old. 

The university also found the vaccine can stop transmission of COVID-19.

They added: “Analyses of PCR positive swabs in UK population suggests vaccine may have substantial effect on transmission of the virus with 67 percent reduction in positive swabs among those vaccinated.”

The report states the vaccine “may have a substantial impact on transmission by reducing the number of infected individuals in the population”.

In December the Government announced the second dose would be given towards the end of 12 weeks rather than in the previously recommended 3-4 weeks.

They said they want to give a single dose of the jab to as many members of priority groups as possible.

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) said: “Given data indicating high efficacy from the first dose of both Pfizer-BioNTech and AstraZeneca vaccines, the committee advises that delivery of the first dose to as many eligible individuals as possible should be initially prioritised over delivery of a second vaccine dose.

“This should maximise the short-term impact of the programme. The second dose of the Pfizer-BioNTech vaccine may be given between three to 12 weeks following the first dose.

“The second dose of the AstraZeneca vaccine may be given between four to 12 weeks following the first dose.”

The four UK chief medical officers agreed to follow the JCVI advice, as they believe the benefit of vaccinating more people outweighs the risk of individuals not having as strong protection against infection as they might have with two doses.

https://www.express.co.uk/news/uk/1392491/Oxford-Covid-vaccine-latest-news-Astrazeneca-protection-transmission-coronavirus-update

Primary care docs key to speeding COVID-19 vaccine rollout: study

 Vaccinating millions of Americans against the COVID-19 virus is proving to be a complicated process already plagued with many setbacks.

But there's already a ready-made vaccine distribution system that can be tapped into to accelerate the rollout, some experts say: primary care doctors.

Primary care doctors provide nearly half of all vaccines in the U.S. and their role may help assure successful delivery of the COVID-19 vaccines to communities across the nation, including rural and remote communities, according to a preprint study published in the Annals of Family Medicine."Bottom line, if we engage and activate the ready-made primary care practices, we can accelerate COVID-19 vaccine distribution and reach herd immunity through immunization sooner," said John Westfall, M.D., a co-author of the study and director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care.

"Vaccine manufacturers already know who orders vaccines and could deliver vaccines to those same primary care offices. Medicare knows who provides COVID-19 to Medicare beneficiaries and actually know how many beneficiaries get their vaccines from these practices. They could ship out that number of vaccines to each primary care practice for their seniors. Or do so in waves," Westfall said.

There’s growing frustration among medical groups about being shut out of the vaccine distribution process with primary care docs even missing out on getting the vaccines themselves.

The Medical Group Management Association (MGMA) is urging the Biden administration to include medical group practices in COVID-19 vaccine distribution strategies moving forward. A survey reflecting responses from 403 medical group practices showed 85% of independent practices actively seeking the COVID-19 vaccine for their patients received some as of Jan. 21-24. Nearly half (45%) of hospital- or health system-owned practices seeking vaccines still hadn't gotten any. Meanwhile, the majority of practices that have gotten the vaccine (54%) say they only received enough to vaccinate 1% or less of their patients.

The COVID-19 pandemic recovery will require a broad and coordinated effort for infection testing, immunity determination, and vaccination, the study authors said.

The study evaluated the delivery of vaccinations, using 2017 Medicare Part B Fee-For-Service data and the 2013-2017 Medical Expenditure Panel Survey at the service, physician, and visit level. The data shows that primary care physicians have played a crucial role in delivery of vaccinations to the U.S. population, including the elderly, between 2012-2017.

Overall, PCPs provided the most vaccinations (46%), followed closely by mass immunizers (45%), then nurse practitioners/physician assistants (5%). There were clusters of counties that had over 50% of vaccinations provided by PCPs throughout states such as Louisiana, Pennsylvania and Massachusetts, the study found.

In addition to physically administering vaccinations, PCPs can provide clinical and personal support to enable patients to understand their current COVID-19 immunologic status, how that may impact their vaccine decisions, and to counter vaccine hesitancy and misinformation, the study said.

There continues to be a high level of distrust in the COVID-19 vaccine among some populations. The new vaccines may face more vaccine hesitancy, misinformation, and refusal than other vaccines, the study said.

It's important to leverage the trusted relationship that primary care physicians have with patients when distributing the COVID-19 vaccine.

"Primary care practices may play an even more important role in vaccine counseling, building local community trust, and serving as a source of scientific knowledge about the COVID-19 vaccine," the study authors said.

Given its historic role in immunization counseling and vaccine delivery, primary care, in concert with public health agencies and community health organizations, is essential for immediate and sustainable population health efforts to address COVID-19 recovery, the study said.

https://www.fiercehealthcare.com/practices/primary-care-docs-could-be-key-to-accelerating-covid-19-vaccine-rollout-study

Prothena revives amyloidosis program nearly 3 years after flop

 Prothena canned its AL amyloidosis program in 2018 after it failed a midstage trial and a data monitoring committee deemed a separate phase 3 study doomed to fail. Now, the biotech is resurrecting the program after an analysis of the phase 3 data found the drug helped the sickest patients live longer.

That study, dubbed VITAL, tested the drug, known as birtamimab or NEOD001, against the standard of care in 269 patients with AL amyloidosis, short for amyloid light-chain amyloidosis. After terminating the study for futility, Prothena crunched the data and found that the sickest patients—those whose disease was classed as Mayo stage 4 at the start of the study—did significantly better on birtamimab than on placebo.

At the nine-month mark, the analysis found nearly three-quarters of the sickest patients on birtamimab were still alive compared to about half of the sickest patients taking placebo (74% versus 49%). Granted, these numbers are from just 77 patients, or 30% of the total patients in the trial, but they’ve convinced Prothena and the FDA that there is a future for this drug in these patients.

Under a Special Protocol Assessment agreement with the FDA, Prothena company will kick off a new phase 3 study in mid-2021. It will test the drug, known as birtamimab or NEOD001, in patients with Mayo stage 4 AL amyloidosis. The disease is similar to multiple myeloma in that it stems from dysfunctional plasma cells in the bone marrow. They produce an abnormal version of light chain, a protein that makes up antibodies.

“The normal job of immunoglobulin light chain is to combine with heavy chain to make immunoglobulins, or antibodies,” said Prothena CEO Gene Kinney, Ph.D. The abnormal light chain proteins don’t bind properly with the heavy chain proteins, fold incorrectly and build up in various tissues, most notably in the heart. Over time, this buildup can lead to life-threatening problems, including heart and kidney failure.

“When we talk about Stage IV patients—if we look to the literature—the predicted median survival of those patients is somewhere around six months following diagnosis,” Kinney said.

The standard of care includes chemotherapy and cell-killing drugs that were originally developed for multiple myeloma. These treatments focus on eliminating abnormal plasma cells and reducing the amount of disease-causing protein they produce.

“The limitation is probably obvious for patients who already have an appreciable amount of protein deposition in vital organs,” Kinney said. “It’s essentially turning off the faucet once the bathtub is full.”

Prothena hopes that adding its drug to those already in use will help the sickest patients recover organ function and live longer.

The new phase 3 study, known as AFFIRM-AL, will test birtamimab in 260 patients with AL amyloidosis affecting their heart and who have never been treated. Two-thirds of the patients will receive birtamimab, while the remaining third will receive the standard of care. The primary endpoint is death from any cause. The plan is to conduct an interim analysis when about half of the patients in the study have died, at which point an independent data monitoring committee will recommend it either continue or be stopped for overwhelming efficacy, the company said in a statement.

https://www.fiercebiotech.com/biotech/prothena-revives-amyloidosis-program-nearly-3-years-after-flop

CDMO Catalent trumpets biologics windfall courtesy of COVID-19

 The COVID-19 pandemic has taken a toll on top lines throughout the biopharma industry—but not for New Jersey-based CDMO Catalent,

Instead, the pandemic has been a growth "accelerator," CEO John Chiminski said Tuesday on his company's second-quarter earnings call. With more than 80 pandemic projects under Catalent's belt, he's not kidding. Virus-related drug and vaccine products have given a massive boost to the company's biologics business, and with more shot capacity on the way, Catalent's COVID-19 work shows no signs of slowing down any time soon.

Buoyed by production contracts with major COVID vaccine players Moderna, Johnson & Johnson and AstraZeneca, Catalent saw its biologics revenues hit $403.9 million in the second quarter of its 2021 fiscal year. That's a whopping 76% increase in constant currencies over the same quarter last year.

All told, biologics made up 44% of Catalent's total net revenue for the quarter, which ended December 31, 2020. Taking acquisitions out the equation, net revenues for the company's biologics unit—on deck to crank out pandemic vaccines as well as therapeutics—jumped 65%, while profits for the segment climbed 104% versus the same period in 2019. 

That boost comes courtesy of the company's vast network of COVID-19 manufacturing partners, CEO Chiminski said on a call with analysts. Two of Catalent's vaccine partners—AstraZeneca and Moderna—are already rolling out vaccines to the public, and the CDMO is on deck to manufacture Johnson & Johnson's shot in the U.S., too.

J&J just last week unveiled long-awaited phase 3 data on its single-dose vaccine, showing it was 66% effective overall in global phase 3 trials, with efficacy climbing to 85% in severe disease. 

To match the pandemic's breakneck speed, Catalent has hustled along a number of planned capacity expansions in Europe and the U.S., Chiminski explained. With new filling lines on the way, the company figures it can meet demand for COVID-19 vaccines from its trio of partners and fill out its non-pandemic customer orders without disruption, he said. 

The company recently completed the buildout of a high-speed filling line, plus other capacity expansions, at its Bloomington, Indiana, plant—where the company is producing Moderna and J&J's vaccines. Its team there is now working 24/7 to meet U.S. demand, Chiminski said. 

All told, the company is on track to produce 100 million Moderna doses for the U.S. by March, out of a total 200 million doses it figures it can deliver by the end of June. 

Another high-speed filling line in Bloomington, first announced in 2020, is set to come online in the fourth quarter of the company's 2021 fiscal year. That line will be devoted to the production of Moderna's shot, among other products, Chiminski said. 

Plus, the company is establishing a high-speed flexible syringe cartridge filling line in Bloomington, too. That project won't be used for COVID-19 work, so the company is eyeing completion in the back half of 2021, Chiminski said.  

Those upgrades come in addition to new manufacturing trains being added to Catalent's cell manufacturing facility in Madison, Wisconsin; plans to boost capacity in Anagni, Italy; and a fill-finish facility in Limoge, France, that the company expects to complete this year, Chiminski said. 

During the call, analysts pressed the company about whether the U.S. government could order Catalent to prioritize production of COVID-19 vaccines through the Defense Production Act—a move that caused issues for drugmaker Horizon Therapeutics late last year when Catalent was forced to divert manufacturing slots for thyroid eye disease med Tepezza in favor of pandemic products. 

The short answer is no, Chiminski said. With a new high-speed filling line in place in Bloomington and another on the way, the company says it's equipped to meet capacity for government-mandated production as well as non-COVID orders. 

Overall, the company raked in $910.8 million in second-quarter revenues, up 24% in constant currencies from the $721.4 million reported for the same quarter last year. Armed with a slew of successful COVID-19 contracts, the company has raised full-year guidance to a range of $3.8 billion to $3.9 billion, up from its earlier projection of $3.5 billion to $3.7 billion. 

https://www.fiercepharma.com/manufacturing/cdmo-catalent-trumpets-76-biologics-revenue-boost-courtesy-covid-19

Pfizer's new rare-disease meds reach blockbuster stage despite pandemic hurdles

 While the COVID-19 pandemic dominated headlines at Pfizer and beyond last year, behind the scenes, the company has been busy with its launch of rare heart disease meds Vyndaqel and Vyndamax. And those efforts are showing. 

Vyndaqel and Vyndamax, approved in May 2019 to treat cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM), passed the blockbuster threshold in their first full year on the market as the company has been working to raise awareness of the disease and boost diagnosis rates. In 2020, despite challenges from the pandemic, the meds generated $1.3 billion, up from $473 million the prior year. 

At the end of last year, the diagnosis rate among ATTR-CM patients was 21%, Pfizer CEO Albert Bourla said on Pfizer’s fourth-quarter earnings call on Tuesday. That compares with 2% from when the drugmaker launched its medicines, which carry list prices of $225,000 per year. 

At the end of 2020, more than 20,000 patients had been diagnosed, and 8,500 had received Pfizer's drugs, Bourla said, including some who received them at no cost. After COVID-19 shutdowns affected patient-doctor visits last year, Pfizer has seen an improvement in diagnosis rates since the third quarter, Bourla said—though the resurgence of COVID-19 cases might affect that recovery, he cautioned.

Aside from the rare-disease meds, several of Pfizer’s other growth products “contributed significantly” to the company’s performance last year, Bourla said. Revenues for blood thinner Eliquis jumped 17% to $4.95 billion, while biosimilar revenues jumped 68% to $1.53 billion. Cancer therapies Xtandi and Inlyta and anti-inflammatory agent Xeljanz all chipped in to growth, too. In all, Pfizer's sales swelled 8% last year to $41.9 billion.

For its part, Prevnar 13—the company’s pneumoccocal vaccine and best-selling product—benefitted outside of the U.S. as the pandemic drove vaccine awareness. The shot’s sales grew 11% outside the U.S. 

Meanwhile, thanks to Pfizer's move last year to spin off its Upjohn business—which it combined with Mylan to form standalone company Viatris—the pharma giant's “decade-long conversion into a pure-play" science-based company is now complete, Bourla said in a statement. 

It's that effort that enabled the company’s quick success with its BioNTech-partnered COVID-19 vaccine program, which will be a major focus for Pfizer looking forward. The company expects $15 billion in sales from the shot this year, and it’s focused on producing 2 billion doses with manufacturing partners. 

https://www.fiercepharma.com/pharma/pfizer-s-vyndaqel-vyndamax-reach-blockbuster-threshold-despite-pandemic-s-challenges