India orders unapproved COVID-19 shots as it reels from devastating second wave

India signed its first order for an unapproved COVID-19 vaccine on Thursday, a day after criticism from the Supreme Court over its bungled vaccine rollout that has left millions of people vulnerable after almost 338,000 deaths.

So far, only 4.7% of the 950 million adult population have been given two vaccine doses. The world's second most populous country is reeling from a widespread second wave of infections that killed around 170,000 people in April and May alone.

The government will buy 300 million vaccine doses from local firm Biological-E and has put down an advance of $205.6 million, the health ministry said, even though the vaccine is still going through Phase III clinical trials.

"The arrangement with Biological-E is part of the wider endeavour of the government of India to encourage indigenous vaccine manufacturers by providing them support in research & development and also financial support," the ministry said in a statement.

India has been inoculating its people with AstraZeneca shots produced at the Serum Institute of India, as well as Covaxin made by local firm Bharat Biotech, and is set to commercially launch Russia's Sputnik V in mid-June.

But supplies are running short after the government opened vaccinations to all adults last month. Some vaccination centres have had to close down, prompting criticism from the Supreme Court about a lack of planning.

While the federal government gave free vaccines to the elderly and frontline workers, it left state governments and private hospitals to administer doses to people in the 18-45 age group at a price.

"The policy of the central government of conducting free vaccination themselves for groups under the first two phases, and replacing it with paid vaccination...is, prima facie, arbitrary and irrational," the Supreme Court said.

The government said this week it could have as many as 10 million doses each day in July and August, up from just under three million now.

Pressure is set to mount further on the government to speed up vaccinations, as several states prepare to ease economically damaging lockdowns even amid high numbers of daily infections and deaths.

The western state of Maharashtra, home to financial hub Mumbai, is planning to lift most restrictions across 18 districts this month, based on availability of oxygen beds and infection rates, officials said.

India on Thursday announced 134,154 new infections over the past 24 hours, down more than 65% from a peak of 414,188 reported on May 7. The official recorded caseload since the start of the pandemic now stands at 28.4 million, the second-highest in the world after the United States.

India added 2,887 deaths overnight, pushing the overall toll to 337,989, the world's third-highest toll after the United States and Brazil.

On Thursday, a spokesman for India's foreign ministry said New Delhi was in dialogue with Washington to ensure a supply of raw materials for vaccine production.

India also raised the issue during the recent U.S. visit of its foreign minister, the spokesman said, adding: "It is in our mutual interest to combat the global pandemic by expediting vaccination efforts."

New Delhi's high court has said that some federal officials should be charged with manslaughter over the halting vaccine rollout.

"Who are they referring to, you think? This effectively concludes the debate on that subject," Sanjay Jha, a former Congress official and political commentator, said on Twitter. "This government has failed. And failed its people miserably."

https://news.trust.org/item/20210603111245-5w356/

U.S. appeals court leaves CDC residential eviction ban in place

 A federal appeals court on Wednesday refused to overturn the U.S. Centers for Disease Control and Prevention's (CDC) national ban on residential evictions.

In a blow to landlords, a three-judge panel of the U.S. Court of Appeals for the District of Columbia said it would not lift a stay of a lower court ruling that had declared the eviction ban unlawful.

In language suggesting that the government’s eviction ban was lawful, the panel said the government "has made a strong showing that it is likely to succeed on the merits" of its appeal. The moratorium, which is set to expire on June 30, covers renters whose incomes were hit by COVID-19.

Ever since the CDC implemented the eviction ban in September, landlord groups, arguing that they are on the brink of financial collapse after going months without being paid, have filed challenges in courts across the country, with mixed results.

Legal experts said that Wednesday's ruling means that for now, the eviction ban will remain in effect until its planned expiration date on June 30, though other court challenges are pending.

For low-income housing advocates, "This is a sigh of relief," said Eric Dunn, director of litigation for the National Housing Law Project.

As the coronavirus pandemic moves into its second year, an estimated 7 million renters across the country owe $40 billion in back rent, utilities and fees, Moody’s Analytics estimates. This is more than twice the number of homeowners who lost their homes to foreclosure in the 2008 financial crisis.

Many eviction cases are pending, and some tenants may receive a lifeline from the $50 billion in rent relief approved by Congress, even though so far that aid has been slow to trickle out.

"If the CDC eviction moratorium expires or is overturned before those funds are expended, millions of renters would be at immediate risk of losing their homes. The result would be a historic wave of evictions, with tremendous, harmful consequences to individuals, communities, and our nation’s public health," said Diane Yentel, president of the Low Income Housing Coalition.

Landlords and real estate groups that challenged the moratorium in court said the CDC lacked the power to impose it, and unlawfully took away their right to deal with delinquent tenants.

https://news.yahoo.com/u-appeals-court-leaves-cdc-203018946.html

Amazon starts testing UK staff for variants

 Amazon is testing its front-line staff in Britain for coronavirus variants.

It will then feed the data to public health officials - including in hotspots where a strain first found in India is spreading fast.

The retail giant opened testing labs in the UK and the U.S. last year to provide voluntary testing for staff.

And is now expanding its capabilities to test for variants in Britain.

Aided by a rapid vaccine rollout, the UK is on the verge of reopening its economy after months of lockdowns.

But the variant first found in India, now known as Delta, has spread, including in areas where Amazon has its lab and some fulfilment centres.

The company told Reuters it was open to offering the same service in the U.S.

And did not rule out making its testing programme available to the UK public in future.

Amazon's testing is available to around 30,000 front-line staff in Britain, working in warehouses and logistics departments.

https://news.yahoo.com/amazon-starts-testing-uk-staff-094128771.html

Science chief wants next pandemic vaccine ready in 100 days

 The new White House science adviser wants to have a vaccine ready to fight the next pandemic in just about 100 days after recognizing a potential viral outbreak.

In his first interview after being sworn in Wednesday, Eric Lander painted a rosy near future where a renewed American emphasis on science not only better prepares the world for the next pandemic with plug-and-play vaccines, but also changes how medicine fights disease and treats patients, curbs climate change and further explores space. He even threw in a “Star Trek” reference.

“This is a moment in so many ways, not just health, that we can rethink fundamental assumptions about what’s possible and that’s true of climate and energy and many areas,” Lander told The Associated Press.

Lander took his oath of office on a 500-year-old fragment of the Mishnah, an ancient Jewish text documenting oral traditions and laws. He is the first director of the Office of Science and Technology Policy to be promoted to Cabinet level.

Lander said President Joe Biden’s elevation of the science post is a symbolic show “that science should have a seat at the table” but also allows him to have higher-level talks with different agency chiefs about making policy.

Lander is a mathematician and geneticist by training who was part of the human genome mapping project and directed the Broad Institute at MIT and Harvard. He said he is particularly focused not so much on this pandemic, but the lessons learned from this one to prepare for the next one.

“It was amazing at one level that we were able to produce highly effective vaccines in less than a year, but from another point of view you’d say, ‘Boy, a year’s a long time,’” even though in the past it would take three years or four years, Lander said. “To really make a difference we want to get this done in 100 days. And so a lot of us have been talking about a 100-day target from the recognition from a virus with pandemic potential.”

“It would mean that we would have had a vaccine in early April if that had happened this time, early April of 2020,” Lander said. “It makes you gulp for a second, but it’s totally feasible to do that.”

Scientists were working on so-called all-purpose ready-to-go platform technologies for vaccines long before the pandemic. They’re considered “plug-and-play.” Instead of using the germ itself to make a vaccine, they use messenger RNA and add the genetic code for the germ. That’s what happened with the Pfizer and Moderna COVID-19 shots.

Beyond being optimistic about confronting future pandemics, Lander wonders about the implications for preventing cancer.

“Maybe the same sort of experience about moving so much faster than we thought is applicable to cancer,” said Lander, who during the Obama administration was co-chair of the Presidential Council of Advisors on Science and Technology. A company already has been working on that.

For that matter, the pandemic and telehealth brought the doctor to patients in some ways. Lander said he is reimagining “a world where we rearrange a lot of things” to get more patient-centered health care, including community health workers checking up every few weeks on people about their blood pressure, blood sugar and other chronic problems.

Two of Lander’s predecessor praised him. Neal Lane, President Bill Clinton’s science adviser, said Lander is “perfect” for the pandemic because of the need for a strategy and international agreements. Obama’s science chief, John Holden, called him “a Renaissance man.”

Lander’s nomination had been delayed for months as senators sought more information about meetings he had with the late Jeffrey Epstein, a financier who was charged with sex trafficking before his apparent suicide. Lander said he only met with Epstein twice, in 2012, and never requested or received funds from Epstein or his foundation. At his confirmation hearing, Lander also apologized for a 2016 article he wrote that downplayed the work of two Nobel Prize-winning female scientists.

Lander, who has visited Greenland on a balmy 72-degree day, told the AP he sees climate change as “an incredibly serious threat to this planet in many, many ways.”

Still, Lander said he was more optimistic now than he and others were a decade ago because “I see a path to doing something about it.”

Lander pointed to a drop of about in 90% in solar and energy wind costs, making them now as cheap as fossil fuels that cause climate change. But he said what’s also needed is “an explosion of ideas” to improve battery life and provide carbon-free energy that is not weather-dependent. Those innovations need federal incentives that are part of Biden’s jobs package, he said.

Reducing methane is key to fighting climate change, Lander added, but first improvements are needed in technology to determine where methane is leaking from.

As for space, Lander said he was too new to comment on whether heading to the moon or Mars should be the goal. The Obama administration redirected NASA away from the Bush-era plan to send astronauts back to the moon and was more aimed for Mars or an asteroid. The Trump administration not only focused back on the moon but set a 2024 goal for a new moon landing.

“Are we going to go to the moon and are we going to go to Mars and are we going to moons of Jupiter? Sure. The exact order I think is great to think about or great to talk about,” Lander said.

He quoted “Star Trek IV: The Voyage Home,” when Captain James T. Kirk’s love interest asked if he was from outer space. He responded: “I’m from Iowa, I only work in outer space.”

Adds Lander: “That was a fun line in ‘Star Trek IV,’ but folks in Iowa are really going to say that.”

https://apnews.com/article/us-news-only-on-ap-technology-climate-change-pandemics-efa1b5a9107d7fc5a3580a96a9abbf31

Teva to Present Latest Data on AJOVY® Injection at American Headache Society

 11 presentations examine clinical and real-world AJOVY data in the reduction of migraine days

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that 11 presentations examining clinical and real-world data for AJOVY® (fremanezumab-vfrm) injection will be presented at the 2021 American Headache Society (AHS) Annual Meeting, taking place virtually June 3-6.

"Our goal is to continue supporting the migraine community through our rigorous and innovative scientific research programs so we can ultimately uncover the full potential of AJOVY for patients," said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. "The data being presented at this year’s AHS meeting underscore the impact AJOVY can have on the healthcare community as seen in clinical analyses and real-world experiences."

Data being presented include results from clinical and real-world analyses and post-hoc Phase 3 data examining the long-term response of AJOVY over the course of 15 months, an analysis of the real-world impact of treatment among patients with comorbid depression, anxiety or hypertension, as well as a Phase 3b analysis examining the consistency in migraine days over the course of a dosing regimen for patients with inadequate responses to 2-4 prior treatments.

This year’s annual AHS meeting is fully virtual. Data presentations can be accessed by registering for the meeting.

https://finance.yahoo.com/news/teva-present-latest-data-ajovy-120000360.html

Seagen: Long-Term Results from TUKYSA® Trial in HER2-Positive Breast Cancer at ASCO

 Updated Analysis Shows Median Overall Survival for TUKYSA Arm Extended to Two Years, with Benefit Maintained Across All Prespecified Patient Subgroups in HER2CLIMB Trial -

- Results Further Support TUKYSA as Well-Tolerated Treatment Option That Improves Survival in Patients with Previously Treated Metastatic HER2-Positive Breast Cancer With and Without Brain Metastases -

https://www.businesswire.com/news/home/20210603005326/en/Seagen-Announces-Long-Term-Results-from-TUKYSA%C2%AE-tucatinib-Pivotal-Trial-in-Patients-with-HER2-Positive-Breast-Cancer-During-the-Virtual-Scientific-Program-of-the-2021-ASCO-Annual-Meeting

Medtronic to Stop Distribution and Sale of HVAD™ System

 Company Developing Support Program for Current HVAD Patients

- Medtronic Coordinating with Global Regulators to Assure Patient Access to Left Ventricular Assist Devices

DUBLIN, June 3, 2021 /PRNewswire/ -- Medtronic (NYSE:MDT), the global leader in medical technology, is stopping the distribution and sale of the Medtronic HVAD™ System. This morning, the company notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.

Medtronic also announced that it is developing a support program for patients who have had an HVAD implanted and for caregivers and health care professionals who participate in their care. This program is being developed with an independent panel of clinician advisors to ensure the ongoing care and safety of patients who are currently supported by the HVAD system. Though the company will stop distribution and sale of the HVAD System, Medtronic is committed to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device.

Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient's heart condition, lead to a heart attack, require hospitalization, and result in death.

Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System, consistent with its commitment to prioritize patient safety.

https://www.biospace.com/article/releases/medtronic-to-stop-distribution-and-sale-of-hvad-system/