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Thursday, April 1, 2021

Germans under 60 advised not to get second AstraZeneca vaccine

 Germany’s vaccine commission, known as STIKO, recommended on Thursday that people under 60-years old who have had a first shot of AstraZeneca’s COVID-19 vaccine should receive a different product for their second dose.

Earlier in the week, Germany said only people aged 60 and over should be administered the AstraZeneca vaccine due to the rare but severe occurrence of thromboembolic side effects. It said it would make a separate recommendation later on younger people who had already received a first shot.

In an updated recommendation on its website, STIKO said there was no scientific evidence on the safety of a mixed series of vaccines.

“Until the appropriate data is available, STIKO recommends for people under 60 years old that instead of the second AstraZeneca dose, a dose of an mRNA-vaccine should be given 12 weeks after the first vaccine,” STIKO said.

Messenger RNA (mRNA) vaccinations include those made by Pfizer-BioNTech and Moderna.

https://www.reuters.com/article/us-health-coronavirus-germany-astrazenec/german-experts-say-under-60s-should-not-get-second-astrazeneca-vaccine-idUSKBN2BO6KZ

White House knew of J&J vaccine contamination problems last week

 The White House knew last week about the contamination of about 15 million doses of the Johnson & Johnson vaccine, press secretary Jen Psaki told reporters on Thursday.

Psaki told a daily briefing there was no disruption in the U.S. supply of the J&J vaccine.

https://www.reuters.com/article/us-health-coronavirus-biden-vaccine/white-house-knew-of-jj-vaccine-contamination-problems-last-week-idUSKBN2BO6G8

U.S. COVID vax rollout analysis hampered by tech, state data reporting

 When a dose of a COVID-19 vaccine leaves a U.S. manufacturing plant, its path can be traced all the way to the hospital or clinic representative signing for the shipment at its destination. What happens next is not always clear.

Federal agencies overseeing the rollout are relying on a tangled web of aging state vaccine registries complicated by state laws and practices.

Data collection has improved since the national vaccination campaign began in December, with county-level reporting in most states. But gaps and tech issues remain that could compromise equitable distribution of doses, analysis of vaccine protection, and identification of pockets of vaccine hesitancy, experts said.

It is a monumental task as the national vaccination campaign gathers steam with an average of 2.4 million shots going into arms each day and rising, and some 196 million doses distributed since December.

As the vaccine rollout opens to all American adults, analysts will be watching whether the less advantaged lose out.

“Are we achieving our equity goals?” said Dr. William Moss, executive director of the International Vaccine Access Center at Johns Hopkins University. “That would be very hard to tease out at a federal level, given the variation in how states are reporting.”

The uncoordinated nature of data collection in Marin County, California, across the Golden Gate bridge from San Francisco, “makes it virtually impossible for me to have that global view that I need to be able to see who is getting vaccinated and who isn’t,” said Dr. Matt Willis, county public health officer.

The U.S. vaccine data system has two main parts: recently developed federal software from Palantir Technologies Inc that closely tracks distribution of doses, and a range of systems used by states that report into decade-old federal systems developed for limited tracking of child vaccinations.

“We know where every single dose was delivered; we know when it was delivered; we know who ordered it; we know who signed for it; we know who dropped it off at the location,” said one person involved in tracking vaccine distribution. “Where we lose sight of it is when (the providers) take it.”

Matthew Ritchey, an epidemiologist and data expert at the U.S. Centers for Disease Control and Prevention (CDC), said vaccine data collection has improved significantly since the beginning of the rollout. The CDC, which is leading the nation’s vaccine data collection, now has a more detailed view of inoculations across the country.

“Does that mean perfect? No, it’s not perfect. But the amount of information that we’re collecting now on a daily basis is pretty astounding,” he said, with most vaccinators reporting shots within the required 72 hours.

Last week, the CDC also publicly released county level data for the first time since the rollout began. A Kaiser Family Foundation (KFF) report using the data found counties with high Black and Hispanic populations had lower vaccination rates than others, confirming what many health experts had feared.

However, KFF was only able to analyze about 72% of the counties due to low quality or incomplete county-level data from a dozen states, including Colorado, Georgia, and Virginia.

The CDC itself has a Texas-sized gap in its own data. The federal government is not receiving the same detailed information about vaccinations of the Lone Star state’s 29 million residents that it’s getting from other states, because Texas statutes prevent it from sending that data to the federal government. Instead, Texas is sending aggregate reports.

Lynn Gibbs-Scharf, the CDC’s co-lead for data monitoring and reporting for its COVID-19 vaccine taskforce, said the agency had no immediate plans to replace systems from the early and mid-2000s that were developed for tracking childhood vaccinations and repurposed for COVID-19.

“We want (the states) to have systems that can accommodate their unique needs for managing vaccination at the local level, but that conform to a standard that allows them to exchange data beyond their jurisdiction,” Gibbs-Scharf said.

Marin county’s Willis sees much more to be done.

“It says a lot about how poorly the nation is equipped to manage the data challenges when we’re having these problems in the Bay Area, with all our tech and informatics innovation. If anyone should be able to get this right, it’s California,” he said.

https://www.reuters.com/article/us-health-coronavirus-vaccines-data/u-s-covid-19-vaccine-rollout-analysis-hampered-by-technology-state-data-reporting-idUSKBN2BO5UR

Ontario in third COVID-19 lockdown as cases rise, ICU beds fill

 The Canadian province of Ontario will enter a limited lockdown for 28 days on Saturday, as COVID-19 cases and hospitalizations rise and more dangerous virus variants take hold, the premier said on Thursday.

The lockdown for Canada’s most populous province will fall short of enacting a stay-at-home order, which new government modeling released earlier on Thursday suggested would be necessary to avoid a doubling to some 6,000 new COVID-19 cases per day by late April.

Ontario’s third lockdown since the pandemic began will shutter all indoor and outdoor dining, although retailers will remain open with capacity limits, Premier Doug Ford said, calling the measures “pulling the emergency brake” on the entire province.

“We’re now fighting a new enemy,” Ford said. “The new variants are far more dangerous than before. They spread faster and they do more harm than the virus we were fighting last year... That means we need to take action now.”

Schools would remain open, Ontario’s education minister said on Twitter.

The Canadian Federation of Independent Businesses (CFIB) panned the lockdown measures, calling it “unconscionable” for the government to “continue to rely almost exclusively on blanket lockdowns” for controlling cases. It said the new measures were making small businesses “a scapegoat for the Ontario government’s lack of planning or foresight.”

Earlier on Thursday, new modeling released by an expert panel advising the provincial government predicted that new cases of COVID-19 would double unless the government imposes a stay at home order.

The report suggested a two- or four-week stay at home order imposed on April 5 could reverse the rise in new infections.

The new model came as more than 150 critical care doctors published a letter urging Ontario to act to halt a wave of infections there.

“We are seeing younger patients on ventilators - many are parents of school-aged children,” the letter said. “We are seeing entire families end up in our ICUs. We are caring for people who have contracted COVID-19 at work, or who have followed all the rules and only gone out for groceries.”

As new, more contagious and deadly coronavirus variants spread across the province, the number of COVID-19 patients in intensive care units has reached 464, higher than at the peak of the last wave, said Ontario Chief Medical Officer David Williams at a media briefing.

Data confirms that current seriously ill patients are younger with 46% of ICU admissions between March 15 and March 21 under age 60, up from 30% during a December surge, according to the expert panel.

And vaccination rates are lower in neighbourhoods hit hardest by COVID-19. In areas with the highest incidence of infection, about 8% of residents have received the vaccine, compared with 13% in areas with the lowest incidence.

Howard Njoo, Canada’s deputy chief medical officer, said he was particularly concerned about the potential for COVID-19 to spread as people gather for Easter this weekend.

“We have seen in the past a spike in cases following a long weekend,” he told a briefing in Ottawa on Thursday. “We’re very worried and really I would implore all Canadians ... to stay home.”

https://www.reuters.com/article/us-health-coronavirus-canada/ontario-pulling-the-emergency-brake-with-third-covid-19-lockdown-as-cases-rise-icu-beds-fill-idUSKBN2BO5RM

Virginia law denies benefit to some healthcare workers who refuse COVID-19 vax

  Virginia has passed a law making it easier for some healthcare workers who become ill with COVID-19 to collect medical expenses or lost wages.

But there’s a catch: the law excludes healthcare workers who are offered a vaccine at work and refuse it.

The bill, retroactive to March 12, 2020, was signed into law by Governor Ralph Northam late on Wednesday, according to an aide to Chris Hurst, a member of the state House of Delegates who drafted the legislation.

The new law presumes that death or disability from COVID-19 for healthcare workers who have had contact with a known COVID positive patient is an occupational hazard, allowing them to collect workers compensation insurance benefits.

The bill allows potentially hundreds of workers to claim benefits they were previously denied because of the difficulty of proving where a worker was infected with COVID-19.

If, however, the employer offered a vaccine and a worker refused, the presumption does not apply. The bill contains an exception for people with a medical condition that puts them at risk from a vaccine.

Nearly one-third of Americans have received at least one shot to date. 

Similar bills have been introduced in Illinois, Indiana and Maryland as states test ways to encourage vaccines without triggering a backlash over government mandates.

“It’s this cowardly way of trying to sort of implement a mandate through the backdoor that you know you probably couldn’t get away with through the body politic explicitly,” said Mike Duff, a professor at University of Wyoming College of Law.

Critics worry about tying a benefit to vaccines that have been approved only on an emergency basis.

Dr. Liz Mumper, a Virginia pediatrician, said: “Whenever there is risk to an individual, there must be choice.”

In the United States, the workers compensation system largely protects employers from lawsuits, while allowing workers to collect benefits for injuries without having to prove fault or negligence. The system was designed for factory accidents, not airborne illnesses.

Only 1% of healthcare workers in Virginia have been awarded COVID-19 workers compensation benefits, according to the Virginia Nurses Association.

Some legal experts and proponents of the Virginia bill say it is lawful for states to offer incentives to take the vaccine and that doing so will make the workplace safer.

“If you choose not to get the vaccine, you have to adopt some amount of personal risk,” Hurst said in an interview.

Attorneys who specialize in workers compensation said the vaccine requirement was similar to safety protocols such as hard hats, which must be followed for an injured worker to claim benefits.

https://www.reuters.com/article/us-health-coronavirus-vaccines-virginia/virginia-law-denies-benefit-to-some-healthcare-workers-who-refuse-covid-19-vaccine-idUSKBN2BO6GE

Royalty Pharma Acquires Royalty Interest in Cabozantinib From Glaxo

 Royalty Pharma plc (Nasdaq: RPRX) today announced that it has acquired a royalty interest in the cabozantinib products Cabometyx and Cometriq from GlaxoSmithKline (GSK) for an upfront payment of $342 million and up to $50 million in additional payments contingent on the achievement of regulatory approvals of cabozantinib for prostate cancer and lung cancer in the U.S. and Europe.

Cabometyx, a multi-tyrosine kinase inhibitor (TKI), is approved for the treatment of patients with advanced renal cell carcinoma (RCC) both as monotherapy and in combination with Bristol Myers Squibb’s Opdivo (nivolumab) as a first line treatment. Cabometyx is also approved for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib. Cometriq is approved for progressive, metastatic medullary thyroid cancer. Cabometyx and Cometriq are marketed by Exelixis in the United States, and by their partner Ipsen in regions outside the U.S. and Japan. Cabometyx is marketed in Japan by Exelixis’ partner Takeda.

https://finance.yahoo.com/news/royalty-pharma-acquires-royalty-interest-113000002.html

PTC Therapeutics sale triggers $20M milestone payment from Roche

 PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that a $20 million milestone payment was triggered by the first commercial sale of Evrysdi (risdiplam) in the European Union under its License and Collaboration Agreement with Roche. Approval for Evrysdi from the European Medicines Agency was received on March 30 for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older.

https://finance.yahoo.com/news/ptc-therapeutics-announces-commercial-milestone-120000028.html