A Tale of Two Vaccine Programs

 Last year, British prime minister Boris Johnson passed up an offer to participate in the European Union’s joint Covid-19 vaccination scheme. The response in pro-European corners of the British press was hostile. Johnson and company were accused of playing politics with people’s lives, with the implication being that British grannies and grandpas were being sacrificed on the altar of Brexit.

Six months later, even Johnson’s fiercest critics have acknowledged, sometimes through gritted teeth, that the wisdom of the government’s decision to go it alone on vaccines. The difference in outcomes between the British and European vaccination programs is stark. On a per-capita basis, Britain has outperformed every major country except Israel when it comes to the speed of the vaccine rollout. The U.K. has administered 18.5 vaccine doses per 100 people, while the EU figure is a paltry 3.8 per 100. On the current pace, that gap will only grow wider.

Frustration in Brussels over the difference between the bloc and its newly independent neighbor (one line on the chart surging upward, the other skidding along the bottom) bubbled over recently. French president Emmanuel Macron churlishly referred to the U.K.’s vaccine rollout as “not serious” and claimed, incorrectly, that the Oxford/AstraZeneca vaccine was “almost ineffective” against Covid-19 in people over 65. That same day, the EU regulator approved the AstraZeneca vaccine for use, including for people in that age group.

Then, in an extraordinary move, Brussels announced its intention to impose a hard border on Ireland—its biggest non-negotiable of the last four years of Brexit negotiations—in order to block vaccine exports to the U.K. By suggesting this step, the EU managed to unite almost everyone in the U.K. and Ireland in opposition (no easy feat), before being forced to make a humiliating U-turn.

The row is a reminder that vaccine distribution is almost the only thing that political leaders are being judged on right now. And in the U.K., Johnson’s government looks to be transforming an initially lackluster pandemic response into a more impressive record.

With 1,632 deaths per million, the U.K. has been harder hit by Covid-19, per capita, than almost anywhere else. Last month, the country passed a grim milestone: 100,000 lives lost to the pandemic. Government interventions have frequently been sluggish and contradictory. Early on, the U.K. locked down too late and botched deliveries of personal protective equipment. And yet, Britain’s vaccination program has proved the most effective part of its pandemic response. What explains the turnaround?

Throughout the vaccine development and distribution process, the U.K. has moved swiftly and decisively, seemingly more aware than other governments that overcautiousness could cost lives. When negotiating purchase agreements, Johnson’s government appeared to appreciate that being at the front of the queue mattered more than getting value for its money. While the EU bartered over price, the U.K. focused on guaranteeing vaccine delivery. Britain was also first to approve the Oxford/AstraZeneca vaccine. It then adopted a “first doses first” strategy that, judging by a study published last week, appears to have been the right move.

The mastermind behind the vaccine rollout is Kate Bingham, a biotech venture capitalist who volunteered her services to the government last year. The gap in performance between her Vaccine Task Force, set up directly by 10 Downing Street, and public bodies like Public Health England and SAGE (the Scientific Advisory Group for Emergencies) surely contains lessons for a government keen to reinvigorate a civil service that many think no longer lives up to its reputation as a “Rolls Royce” operation. According to the Spectator, the apparent success of the vaccine rollout is forcing government officials to ask themselves: “Is it possible to get things done at this speed and with this competence outside of a pandemic?”

The competence of the British vaccine scheme will also be a huge confidence boost for Brexit Britain. The contrasting fortunes of the British and European programs confirm many of the Brexiteers’ charges about the shortcomings of the EU: you could hardly dream up a better example of the cost of leaving important tasks to sluggish, risk-averse bureaucracies. The vaccine rollout also shows what stands to be gained by Britain’s making the most of its newfound freedom.

Externally, the vaccine rollout could become a source of “soft” power, as “Global Britain” reimagines its place on the world stage. If things continue at their current pace, the question will soon become where Britain should send its spare vaccines. Some say Ireland, in part to help repair relations after a bruising four years. Others want to stick to the original plan and donate doses to the developing world.

Whether one looks at it as a case study in good governance or a PR win for Brexit Britain, the lesson is the same: a Britain that capitalizes on its innovation, entrepreneurial spirit, and newfound agility can thrive outside of the EU—and after the pandemic.

Oliver Wiseman is the U.S. editor of The Critic.

https://www.city-journal.org/british-vaccine-distribution-outpaces-european-union

Struggling to Vaccinate New York's Home Care Workers

 At the beginning of January, an oft-overlooked sector of the frontline healthcare workforce scored a significant win in New York state: officials classified home healthcare workers as priority 1A to receive COVID-19 vaccines, a move pushed by advocacy groups and unions.

But weeks later, many home healthcare agencies in the state -- especially smaller ones with limited resources -- are facing new challenges in getting their personnel inoculated.

There are shortages of the vaccine, and difficulties reaching a decentralized workforce. Most agencies lack the resources to set up their own inoculation sites, and vaccine hesitancy is still a significant concern.

The challenges are especially troubling to those who represent agencies and staff. Most of the 200,000-plus home healthcare workers in New York are women of color, and the profession is at high risk of exposure to COVID-19 due to providing care inside patients' homes. Additionally, patients who receive home care are elderly or disabled, often both; most have conditions that make them more vulnerable to severe outcomes should they contract the virus.

Weeks into January, 85% of home care and hospice agencies reported that 10% or less of their staff had received at least one dose of the COVID-19 vaccine, the Home Care Association of New York State told MedPage Today.

"We had the week of January 4 where home care was explicitly identified [for priority vaccination] and that was something that was a challenge in the beginning -- we so appreciated being included," said Roger Noyes, director of communications for the association. "However, by the end of the week, due to federal guidelines, the state opened up priority 1B. That brought in 3 million New Yorkers newly eligible outside the healthcare space."

That left just one week for home healthcare agencies to take advantage of their staff being recognized as a priority population, Noyes said. And vaccine supply -- as in other states -- hasn't yet been sufficient to meet demand.

"They're on the front line like other workers," said Joe Pecora, vice president of Home Healthcare Workers of America, a union with some 20,000 workers in New York.

Tragically, Pecora said, the union has lost more than a dozen home healthcare workers during the pandemic. "There's a need, there's a desire to get the vaccine," he said.

Pecora said he continues to call health departments multiple times a day to see if new shipments of the vaccine have come in. "Maybe I call too much?" he wondered.

As he waits for doses, the union is doing what it can to help its members get vaccinated, including through inoculation appointments at clinics that already provide their regular medical care, Pecora said. But as of the end of January, only about 2,000 of the union's members had been vaccinated.

Aside from supply shortages, there are logistical challenges. Unlike hospital-based workers receiving the vaccine at their place of work, or pharmacies descending upon nursing homes to inoculate staff on-site, there isn't a universal approach for reaching home healthcare workers, Noyes and Pecora noted. Frontline workers in the field are spread out across areas of service, are challenged to reschedule appointments, and spend much of their time taking public transportation to their next patient.

As of Feb. 10, the statewide percentage of hospital workers vaccinated was 75%, according to the New York Department of Health. A little less than half of staff at skilled nursing facilities had been vaccinated. The state is not publicly tracking the same data for home healthcare workers.

However, one home healthcare agency that has been able to take vaccination into its own hands is the Visiting Nurse Service of New York (VNSNY). The sprawling organization serves tens of thousands of patients and health plan members a year and, unlike smaller entities, has the resources to set up an inoculation site for staff.

Since early December, VNSNY's regulatory and government affairs team worked with regulators and associations to help ensure that home care and hospice workers were a priority for vaccination, the organization told MedPage Today. VNSNY immediately registered as a vaccine administration facility, and continues to work with local and state health departments, as well as the Greater New York Hospital Association on its efforts.

The organization is making appointments for and vaccinating eligible staff at its main office near New York City's Grand Central Terminal, a central public transportation hub, said Andria Castellanos, executive vice president and chief of provider services at VNSNY.

VNSNY currently has about 9,500 eligible employees, Castellanos said. As of last week, it had vaccinated some 2,500 of those employees, using every vaccine it had received from the city. By the end of this week, it's expecting to up that number to 3,400.

The organization is spending tens of thousands of dollars per week to do so, according to Castellanos, and hopes to secure federal reimbursement for its efforts.

One of the most significant challenges has been reaching staff who hesitate to receive the vaccine.

"You can't ask people one time," Castellanos said. "When they say 'no' or 'not yet,' you have to go back. We are seeing the 'no's' and 'not yet's' turn into 'yes's.'"

Noyes of the Home Care Association of New York State also noted the concern.

About 55% of the association's member agencies saw 1% to 10% of their staff refusing the vaccine, with higher numbers for the other 45%, he said. About 40% of agencies plan to offer incentives such as paid time off, gift cards, lottery prize drawings, and other strategies.

"It's hard to gauge how that translates into the rates because of all of these logistical challenges," Noyes said. Once the vaccine supply increases, "we'll know a little more about how much hesitancy is a factor."

https://www.medpagetoday.com/special-reports/exclusives/91163

From China's CanSino, Mexico welcomes biggest vaccine shipment yet

 Mexico received its biggest COVID-19 vaccine shipment yet on Thursday, in the form of the active ingredient for 2 million doses of China’s CanSino shot, a relief for the Latin American country after slow delivery on orders from Western companies.

Foreign Minister Marcelo Ebrard recognized China’s support and thanked CanSino Biologics Inc for the “timely shipment” in a tweet.

“Our gratitude always,” Ebrard said.

Mexico has inked a deal with CanSino for at least 8 million doses to be delivered between February and March. Its health regulator granted authorization for the vaccine’s emergency use on Wednesday, helping drive CanSino shares to record highs.

Mexico also approved China’s Sinovac Biotech Ltd vaccine the same day.

The CanSino shipment is the latest example of Mexico seeking alternatives to supplement its flailing vaccine campaign as mainstream Western companies like Pfizer announce global shipment slow downs.

The situation is urgent in Latin America’s No. 2 economy, with the world’s third highest coronavirus death toll at 169,760, according to government data. The real tally is believed to be much higher.

Mexico also has a deal for 24 million doses of the Russian Sputnik V vaccine, in one of its larger agreements.

It was unclear whether Mexico would begin to distribute CanSino’s vaccine, which will be packaged in the central state of Queretero, before it begins administering doses of AstraZeneca, which it is also packaging locally, in addition to importing 2 million doses from India.

The CanSino shipment far outweighs Mexico’s other expected deliveries, including the 870,000 doses of AstraZeneca expected from India this month, according to data from the foreign ministry.

CanSino conducted phase III trials in Mexico with 14,425 participants. Mexico had said it was one of the world’s largest COVID-19 clinical trials.

The company also ran trials in Pakistan, Argentina, Chile and Russia.

Pakistan said earlier this week that CanSino’s vaccine showed 65.7% efficacy in preventing symptomatic cases and a 90.98% success rate in stopping severe disease, according to an interim analysis of global trials.

Mexico had been relying on the Pfizer vaccine for weekly deliveries of some 400,000 doses before shipments were delayed due to demand by the World Health Organization (WHO) for inclusion in the COVAX program.

Mexico pre-purchased 51.5 million vaccine doses through COVAX, though shipments have yet to begin.

https://www.reuters.com/article/us-health-coronavirus-mexico-vaccine/our-gratitude-always-from-chinas-cansino-mexico-welcomes-biggest-vaccine-shipment-yet-idUSKBN2AB2LP

Biden: 'Won't be enough COVID vaccines by end of summer to vaccinate all Americans'

 President Joe Biden said on Thursday the United States would not have enough coronavirus vaccine doses by the end of the summer to vaccinate all Americans.

Biden made the remark during a visit to the Viral Pathogenesis Laboratory at the National Institutes of Health in a suburb of Washington.

https://www.reuters.com/article/us-health-coronavirus-biden-vaccines/biden-says-there-will-not-be-enough-covid-vaccines-by-end-of-summer-to-vaccinate-all-americans-idUSKBN2AB2N6

Merck canned own COVID vax, now in talks to make other companies' shots

 After Merck & Co. got off to a late start in the COVID-19 vaccine race and made an early exit, the drug giant is in talks to aid the global vaccine manufacturing effort.

The drugmaker is “actively involved” in discussions with governments, health agencies and other pharmaceutical companies to “identify the areas of pandemic response where we can play a role, including potential support for production of authorized vaccines," a spokesman said via email.

News of the talks comes about two weeks after Merck abandoned both its coronavirus vaccine candidates—one it acquired through its Themis buyout and the other it was studying in partnership with IAVI. Merck said the two shots had produced immune responses weaker than those prompted by natural infections as well as by other COVID-19 vaccines.

Still, the company believes it has an “important responsibility to contribute to the pandemic response," the spokesman said, and remains "at the ready to do so."

While Merck hasn't indicated which companies it could help with production, there has been industry talk about a potential tie-up with Novavax. After the vaccine biotech last month presented positive phase 3 data on its candidate, Evercore ISI analyst Josh Schimmer said he suspected Merck might "step up" as Novavax's manufacturing partner.

Novavax CEO Stan Erck then told CNBC's Meg Tirrell that Merck "could be a good partner for us as they don't have a competing product." He also named GSK as a company with those capabilities. At the time, Merck told Tirrell it was focused on therapeutics.

Meanwhile, Merck has two coronavirus therapeutics in development—MK-4482 and MK-7710—and the company believes it can make a “meaningful contribution” to the fight against the pandemic by focusing its resources on those candidates, its spokesman said.

Last summer, as COVID-19 vaccine programs raced forward, Merck CEO Ken Frazier said the hype about vaccines launching in late 2020 was doing a “grave disservice” to the pandemic fight. Vaccines previously took years to develop, he pointed out, and Merck itself was responsible for many of them.  

He wasn't alone. Merck and other major vaccine players were taking a slower, time-tested approach, experts said, but their vaccines could end up reaching more people worldwide than more revolutionary shots would. Things didn’t turn out that way. Pfizer, Moderna, AstraZeneca and other programs are now either rolling out or nearing rollouts, while several leading vaccine giants have either exited the field or faced R&D setbacks.

If Merck does strike a manufacturing deal with a COVID-19 vaccine player, it won’t be the first company to do so. After an R&D setback on its GSK-partnered vaccine, Sanofi last month said it would produce 100 million doses of the Pfizer-BioNTech mRNA vaccine for Europe.

The Pfizer-BioNTech team has also enlisted Swiss drugmaker Novartis in its global push to produce billions of doses. In a deal unveiled in late January, Novartis said it would allow BioNTech access to its site in Stein, Switzerland. Manufacturing there will start next quarter, and doses will be ready from the site by the third quarter.

Also this week, Teva said it was in talks to help with COVID-19 vaccine production. The company has sites in Israel, Europe and the U.S. that could be used in the global effort, CEO Kåre Schultz said, according to The Wall Street Journal.

https://www.fiercepharma.com/pharma/merck-after-canning-covid-19-vaccine-programs-talks-to-help-shot-production

Indian state rejects Bharat Biotech vax OKed without efficacy data

 

An opposition-ruled Indian state said on Thursday it had asked the federal government to halt the supply of a homegrown COVID-19 vaccine until its efficacy could be proven in an ongoing late-stage trial.

India, which has reported the world's second-highest number of COVID-19 cases after the United States, has vaccinated more than 7 million front-line workers since Jan. 16 using COVAXIN developed by Bharat Biotech as well as a vaccine licensed from AstraZeneca and Oxford University.

Bharat Biotech, which created COVAXIN with the state-run Indian Council of Medical Research, has said efficacy data from the late-stage clinical trial on nearly 26,000 volunteers will be out by next month, leading to criticism from epidemiologists that it was approved too hastily for emergency use.

The developers and India's drug regulator say the vaccine is safe and effective based on early and intermediate studies.

Chhattisgarh, a east-central state of some 32 million people, said it was likely to be sent COVAXIN shots soon after starting its campaign with 588,000 doses of the AstraZeneca product.

"There's an inhibition/concern among the community in general regarding the use of COVAXIN," state health minister T.S. Singh Deo wrote in a letter to his federal counterpart, Harsh Vardhan, and shared on Twitter.

"This concern arises from the fact that the clinical trials of phase 3 are yet to be completed."

Vardhan responded with a letter stating that both vaccines were "safe and immunogenic and should be used expeditiously to rapidly confer protection to prioritised beneficiaries".

He rebutted Singh Deo's assertion that COVAXIN vials carry no expiry details, attaching a picture marking the manufacturing and use-by dates affixed to a Bharat Biotech vaccine bottle.

Vardhan urged Chhattisgarh to step up inoculations, saying it had covered only 9.6% of its front-line workers, like those in the police and sanitation, despite having vaccine stocks. It, however, has given the first dose to 70% of its healthcare workers, one of the best coverage rates in the country.

Bharat Biotech did not respond to a request for comment. It plans to export the shot to Brazil and the United Arab Emirates soon.

So far the Indian government has ordered 10 million COVAXIN doses and 21 million AstraZeneca shots, locally made by the Serum Institute of India for low- and middle-income countries.

India's COVID-19 infections rose 12,923 in the past 24 hours to 10.87 million in total. Deaths increased by 108 to 155,360.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Chhattisgarh-rejects-Bharat-Biotech-vaccine-approved-without-efficacy-data-32420403/

Dermtech Rallies On Health Insurance Contract For Skin Cancer Detection Test

 DermTech Inc 

DMTK 25.82% shares were soaring to a new high Thursday after the company unveiled a contract with Blue Cross Blue Shield of Texas for its melanoma gene express test.

La Jolla, California-based DermTech, a precision dermatology company, said it has entered into a contract with the BCBSTX for making its pigmented lesion assay, or PLA, which became available to the health insurer's 6 million members in the state of Texas Feb. 1.

The company's non-invasive, gene expression-based PLA helps in early detection of melanoma, and is proven to have a 99% negative predictive value, or a less than 1% probability of missing a melanoma when administered properly.

The test is now available as an in-network option for Blue Cross Blue Shield of Texas' Blue Essential, Traditional Indemnity and PPO/POS members. 

"This agreement with BCBSTX shows DermTech's commitment to making its transformative PLA test accessible to more patients," DermTech exec Dan Visage said in a statement. 

DermTech reported a 220% year-over-year increase in assay revenues for the third quarter ended October 2020, thanks to higher billable sample volume and revenue recognition of Medicare samples that have been covered by Medicare.

https://www.benzinga.com/general/biotech/21/02/19611751/dermtech-rallies-to-record-high-on-health-insurance-contract-for-skin-cancer-detection-test