3 existing drugs fight coronavirus with ‘almost 100%’ success in Israel lab

 Israeli scientists say they have identified three existing drugs that have good prospects as COVID-19 treatments, reporting that they illustrated high ability to fight the virus in lab tests.

They placed the substances with live SARS‑CoV‑2 and human cells in vitro. The results “showed that the drugs can protect cells from onslaught by the virus with close to 100 percent effectiveness, meaning that almost 100% of the cells lived despite being infected by the virus,” Prof. Isaiah Arkin, the Hebrew University biochemist behind the research, told The Times of Israel.

“By contrast, in normal circumstances, around half the cells would have died after two days following contact with the virus.” He added there are strong indications that the drugs will be robust against changing variants.

Arkin, part of a Hebrew University center that specializes in repurposing existing drugs, said that he screened more than 3,000 medicines for suitability, in what he describes as a needle-in-a-haystack search. This approach can provide a fast track to find treatments as the drugs have already been tried and tested, and he hopes to work with a pharmaceutical company to quickly get the medicines he identified clinically tested for COVID-19.

“We have the vaccine, but we shouldn’t rest on our laurels, and I would like to see these drugs become part of the arsenal that we use to fight the coronavirus,” he said.

The research that paved the way for the lab trial has been peer-reviewed and published, but the lab study itself has not yet been peer-reviewed.

Arkin said his optimism that the drugs will prove effective against future variants is based on what they target.

When confronting SARS‑CoV‑2, the drugs in question — darapladib, which currently treats atherosclerosis; the cancer drug Flumatinib; and an HIV medicine — don’t target the spike protein. Rather, they target one of two other proteins: the envelope protein and the 3a protein. These proteins — especially the envelope protein — hardly change between variants, and even between diseases from the coronavirus family. As such, drugs that target them are likely to remain effective in spite of mutations, Arkin said.

He commented: “The envelope protein in the SARS‑CoV‑2 virus is about 95% identical to that of the first SARS outbreak of 2003, whereas the spike protein is less than 80% identical.

Prof. Isaiah Arkin of the Hebrew University (courtesy of Prof. Isaiah Arkin)

“This means that if we’d had a drug targeting the envelope protein that would have treated the SARS outbreak, there is a high chance we actually would not have had to endure this pandemic.”

Until now, the envelope protein was not seen as a promising target for drugs. But Arkin’s team identified it as an ion channel, a class of proteins that are located in the membranes of all organisms, which because of their structure respond particularly well to drugs — a quality exploited by pharmaceutical products for high blood pressure, angina and many other conditions.

Arkin said: “I am excited about the prospect of helping to widen the arsenal we have against the coronavirus. When you consider what allows us to fight HIV, hepatitis and many other diseases, it’s precisely the fact that we have a variety of treatments — a large arsenal.”

https://www.timesofisrael.com/3-existing-drugs-fight-coronavirus-with-almost-100-success-in-jerusalem-lab/

States are sitting on millions of surplus Covid-19 vaccine doses as expirations approach

 Millions of unused Covid-19 vaccines are set to go to waste as demand dwindles across the United States and doses likely expire this summer, according to public health officials.

Several state health departments told STAT they have repeatedly asked the federal government to redistribute their supply to other countries, many of which are facing a third wave of the Covid-19 pandemic. Officials in Washington have rejected those requests, citing legal and logistical challenges.

“We’re drowning in this stuff,” said Robert Ator, a retired colonel in the Arkansas Air National Guard who is leading that state’s Covid-19 vaccine distribution drive. “It’s starting to get a bit silly and we want to make sure we’re being good stewards.”

Some of the wastage could be forestalled if U.S. health officials extend the shelf life of the vaccine developed by Pfizer, but such expiration dates can only be extended so far.

Currently, states have administered 52.36 million fewer doses than have been distributed to them, according to federal data.

Part of that vaccine gap can be attributed to reporting delays and everyday wastage, while some unused vaccine includes second doses that haven’t been administered yet. Still, even a conservative estimate suggests at least half is likely excess vaccine, said Jennifer Kates, director of global health at the Kaiser Family Foundation. That would leave 26.2 million unused doses at the state level — enough to protect at least 13.1 million people.

A significant tranche of Pfizer doses is expected to expire in August. “We’re staring down the barrel, we know it’s happening,” said Jenny Ottenhoff, senior policy director of global health and education at the ONE Campaign, the nonprofit seeking to end extreme poverty and preventable disease. Given waning domestic vaccine demand, those doses are unlikely to be fully used before they must be tossed.

“We’re seeing demand falling off across all the states,” said Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials. “It’s not like, if Connecticut doesn’t need theirs, it can go to Alabama. There just isn’t the demand.”

In North Carolina, 119,756 doses from all three vaccines authorized by the Food and Drug Administration will expire in July; an additional 854,548 is set to expire in August, and hundreds of thousands more will expire in the fall. Arkansas hasn’t accepted new orders since April, when it had 500,000 doses, and has since worked its way down to 380,000, some 100,000 of which will expire at the end of July. “We’re still chopping away at it,” said Ator. “I don’t want to waste a thing.” Delaware said 25,768 vaccines will expire in August, while Colorado has 352,533 doses that will expire in the next two months.

Meanwhile, stockpiles of vaccines continue to build at the federal level. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are expected to arrive in the U.S. from July 2021 until the end of the year, according to Airfinity, a life sciences analytics firm. The White House announced plans to share 80 million doses of its supply last month, and purchased an additional 500 million vaccines for low- and middle-income countries.

The federal government previously extended the shelf life of J&J vaccine that was set to expire as new stability data emerged, and several state health departments hope that the “Pfizer cliff,” as it’s called, will also be pushed back.

Vaccines already distributed to U.S. states are especially valuable from an international perspective, as they’re ready to use immediately. “They’re real doses sitting on shelves and not waiting to be manufactured. That could change the game in terms of speed,” said the ONE Campaign’s Ottenhoff. “Right now, the most important thing in terms of sharing doses internationally is sharing it fast.”

Many states started seeking federal assistance in redistributing excess vaccine internationally in April, Plescia said, with the Covid-19 crisis flaring in India. Some wealthier states, such as New York and California, have the financial capability to arrange international transportation themselves, said Plescia. And there are plenty of vaccines close to the border, where it would be easy for providers to give supply to those in Canada or Mexico. The federal government owns these vaccines, however, and does not permit states to redistribute them.

“We would prefer to waste zero doses. If we have it, let’s get it in somebody’s arm,” said Chris Kopach, Covid incident commander at the University of Arizona, which has capacity to store 1.6 million vaccines in ultra-cold freezers. The center is currently holding 100,000 doses, with large quantities of Pfizer vaccine set to expire in August. Kopach asked in May if mobile clinics could help take the doses over the border to Mexico. “It’s a great opportunity to partner with our neighbors,” he said. “Could we just give it to Mexico? In reality, it’s not for me to give.”

Kody Kinsley, operations lead for North Carolina’s Covid-19 response, said he was also told he didn’t have the rights to arrange redistribution: “It was a U.S. government-funded product, and it was given to us. We can’t just give it away.”

The U.S. Department of Health and Human Services said it has looked into redistributing vaccines currently held at state level, but said moving doses from 80,000 providers has so far been too legally and logistically complex. “Overall, the federal government has done a very efficient job of managing vaccine supply, and we are doing everything we can to help states use the supply they ordered and still have in their inventory,” said spokesperson Kirsten Allen. “We are doing everything we can to help states administer all of their doses and avoid any wastage and maximize getting shots in arms.”

States are permitted to donate vaccines that have been allocated to them but not yet distributed to the federal pool, which could potentially be sent elsewhere. The federal government also responded to state health department concerns by allowing them to request only specific quantities of vaccine rather than receiving a set amount determined by population.

For now, there’s still hope something can be done. Public health experts believe doses could be returned to the federal government to then be centrally redistributed. Doing so would be a challenge and take resources, they said, but would be worthwhile given the global need.

“It might take some extraordinary effort. We’ve seen extraordinary effort throughout this pandemic,” said Ottenhoff. “That’s why we have enough vaccines for Americans who want them. I’m hoping we can see that extraordinary effort expand beyond Americans for those who need them internationally.”

Kates, from Kaiser Family Foundation, agreed: “This is an unprecedented situation,” she said. “This is urgent. What happens elsewhere affects us, and vice versa. This truly is a global phenomenon and challenge.”

https://www.statnews.com/2021/07/20/states-are-sitting-on-millions-of-surplus-covid-19-vaccine-doses-as-expiration-dates-approach/

US renews ‘public health emergency’ declaration due to COVID-19

 The United States remains under a state of “public health emergency” due to the Covid-19 pandemic.

On Monday, US Department of Health and Human Services Secretary Xavier Becerra signed a renewal of the determination that a “public health emergency” exists due to the Covid-19 pandemic.

The determination was last renewed in April and was set to expire — as it is up for renewal every 90 days. This latest renewal is effective starting Tuesday and will continue for another 90 days.

A public health emergency declaration, which can last for the duration of the emergency or 90 days, allows for the emergency use authorization of vaccines, the access of certain funds to address the emergency, and the deployment of military trauma care providers, among other factors.

The White House had signaled for weeks that it planned to extend the public health emergency determination. In June, local health officials told CNN that the White House was expected to extend its declaration of a national public health emergency due to the pandemic.

“They are committed to ensuring that the emergency order remains in place through the end of the year — even as they recognize that the current order is about to expire in July,” Lori Tremmel Freeman, chief executive officer of the National Association of City and County Health Officials, told CNN last month.

“There are a lot of things tied to that public health emergency order, including it helps states and local jurisdictions with the pandemic response, but it can be impactful to other forms of assistance like Medicaid eligibility coverage provisions that were changed under the declaration of a public health emergency order,” Freeman said. “If an emergency order is lifted, some people could no longer be eligible for some of the health-related coverages that they had gotten under the emergency.”

The nation’s public health emergency has been in place since late January 2020.

https://whdh.com/news/us-renews-public-health-emergency-declaration-due-to-covid-19-pandemic/

CDC Advisors to Discuss 3rd COVID Vaccine Dose for Immunocompromised

 Giving a third dose of COVID-19 vaccines to adults with weakened immune systems — the immunocompromised — will be up for discussion during a U.S. Centers for Disease Control and Prevention advisory panel meeting next week.

At the meeting scheduled for July 22, the Advisory Committee on Immunization Practices will focus on the 2% to 4% of U.S. adults with weakened immune systems. These include organ transplant recipients, people receiving cancer treatments, and those living with rheumatologic conditions, HIV and leukemia, the Washington Post reported.

The director of the U.S. National Institutes of Health doesn't consider giving an additional dose of currently approved two-dose vaccines to immunocompromised people a "booster" shot.

"I wouldn't call that a booster," Francis Collins said, the Post reported. "I would call that trying to get the primary immunization into the effective place."

Advisory committee member Camille Kotton, a transplant-medicine physician at Massachusetts General Hospital in Boston, expressed support for the idea.

"From my perspective as someone who takes care of immunocompromised people, including organ transplant recipients, who seem to have a diminished response to vaccination, and based on the data we have seen recently … it does seem like an additional dose of vaccine would be appropriate for this population. And as far as we can tell, it would be safe and likely to augment immunity," Kotton told the Post.

But not all experts agree.

"I haven't seen evidence that a booster would be indicated for anybody, including the immunocompromised," said Helen Boucher, an infectious disease physician at Tufts Medical Center in Boston.

"A lot of that data is still emerging," Boucher told the Post.

Booster shots have become a hot topic since Pfizer-BioNTech said last week it would seek emergency use authorization for a third shot of its two-dose vaccine amid growing concerns about the highly transmissible Delta variant, but U.S. health officials have said a third dose is not widely needed, the Post reported.

Critics, including the World Health Organization, say drug companies like Pfizer should focus on getting desperately needed shots to billions of people in the developing world, not boosters for already-vaccinated people in wealthy countries.

Next week's CDC advisory panel meeting won't deal with Pfizer-BioNTech's request for regulatory approval of a third booster dose. It will focus on updating clinical considerations for coronavirus vaccines, something that doesn't require a panel vote.

This week, Israel said it would start giving a third dose of the Pfizer vaccine to severely immunocompromised adults, and Britain plans to start giving booster shots in September, first to those with weakened  immune systems, people older than 70 and front-line health care workers, the Post reported.

https://www.usnews.com/news/health-news/articles/2021-07-16/cdc-advisors-to-discuss-3rd-covid-vaccine-dose-for-immunocompromised

Israel reports sharp decline in Pfizer coronavirus vaccine efficacy

 

Israel on Tuesday reported a sharp decline in the efficacy of Pfizer/BioNTech's coronavirus vaccine after receiving data from a recent analysis.

Data from the analysis conducted by the Health Ministry suggest the efficacy of the vaccine declines over time in preventing infection and severe illness.

Health officials presented their findings during a meeting of the ministry's Epidemic Management Team on Monday night, which showed that protection from coronavirus infections among vaccinated people decreased by 42% since the start of the inoculation drive in Israel.

In addition, protection from severe illness has also recorded a sharp drop of up to 60% among those who were inoculated in the early stages of the vaccine rollout.

However, most people who had been vaccinated at the early stage of the vaccine drive appear to be over the age of 65 and findings may not reflect the vaccine's efficacy among those in other age groups.

Ministry officials deemed the findings disturbing but claimed those were only preliminary analyses of very raw data. It was not yet clear whether the results were linked to an apparent erosion of the vaccine's protection against the virus or greater resistance of the Delta variant to the inoculation.

Health Ministry Director General Prof. Nachman Ash is expected to convene further rounds of consultations on the data with health experts. He is also scheduled to meet with Prime Minister Naftali Bennett on Tuesday afternoon.

The premier and health officials will discuss various solutions to the surging morbidity and may entertain the possibility of administering a third booster shot to the country's elderly population.

Last week, Israel began administering a third shot of the Pfizer/BioNTech inoculation to patients with compromised immune systems, including people who have had heart, lung and kidney transplants.

https://www.ynetnews.com/health_science/article/bytq34n0u

Telehealth use stabilizing at 38 times pre-COVID-19 levels: McKinsey

 

• Telehealth use overall has stabilized at levels 38 times higher than before the COVID-19 pandemic, ranging from 13% to 17% of visits across all specialties, according to new data from McKinsey released roughly a year since the first major spike in COVID-19 cases.
• Of all the office visits and outpatient care the consultancy originally projected would be done virtually last year, more than two-thirds are actually being conducted virtually.
• And though usage has dropped slightly since its peak in spring 2020, patient and physician attitudes toward telehealth have improved. About 40% of surveyed consumers said they planned to continue using telehealth moving forward, up from 11% prior to COVID-19.

Telehealth surged last year during COVID-19 as consumers sought a way to access care in the safety of their homes, oiled by lax regulations from Washington enabling broader access and reimbursement. In April last year, overall telehealth utilization was a whopping 78 times higher than in February, according to a McKinsey analysis of telehealth claims volumes.

But after that initial spike, utilization levels have dipped and been largely stable since June last year, the consultancy said. McKinsey in 2020 estimated up to $250 billion of the country's annual healthcare spend could be digitized — but that's "not a foregone conclusion," the new report warns, as it necessitates continued consumer demand, clinician usage and sustained adoption of virtual modalities.

McKinsey surveyed consumers over the first half of this year and found ongoing consumer interest in the modality. Between 40% and 60% of patients expressed interest in broader virtual health tools beyond simple telehealth visits, including a "digital front door" to the healthcare system, or a cheaper virtual-first health plan.

But a gap has historically existed between consumers' expressed interest in digital health products and actual utilization, McKinsey pointed out.

"Continuing to focus on creating a seamless consumer interface, breaking down silos in care provision (across virtual and in-person) with improved data integration and insights, and proactive consumer engagement will all be important to sustaining and growing consumer use of virtual health as the pandemic wanes," the consultancy wrote.

On the provider side, 58% of physicians continue to view virtual care more favorably than before the pandemic, though that's down slightly from September, when 64% of physicians were in support. As of April this year, 84% of doctors were offering telehealth, and 57% said they'd prefer to continue offering it.

However, that's largely dependent on reimbursement: 54% of doctors said they wouldn't provide virtual care if it was paid at a 15% discount to physical services.

Providers are closely tracking reimbursement levels. Federal regulators and private payers are still ironing out how much they'll pay for virtual care after the public health emergency expires, expected at the end of this year, but it's unlikely virtual visits will be paid at parity to in-person care.

CMS has already significantly expanded reimbursable telehealth codes, adding 144 telehealth services in 2020 temporarily covered by Medicare and codifying nine permanently in a December payment rule. However, the new additions only apply to patients in rural areas in a medical facility, and any more meaningful changes would require congressional approval.

But those looming regulatory question marks haven't stymied historic levels of investment in the red-hot digital health space. The first half of 2021 has already smashed a previous record for venture capital funding in digital health set just last year, bringing in $14.7 billion compared to 2020's full-year total of $14.6 billion, per data collected by Rock Health.

The unprecedented influx of cash is spurring the creation of new virtual models spanning a range of services and clinical needs, McKinsey said, with particular growth in the traditionally underserved mental health arena. But the sector is still facing acute growing pains, including better data integration and smoother integration of virtual offerings into existing workflows, and greater alignment with value-based models, according to the consultancy.

https://www.healthcaredive.com/news/telehealth-use-stabilizing-at-38-times-pre-covid-19-levels-mckinsey-says/603153/

EU Drug Agency Begins Rolling Review of Sanofi Covid-19 Vaccine Candidate

 The European Union's medicines authority has begun a rolling review of French pharmaceutical company Sanofi SA's Covid-19 vaccine candidate, Vidprevtyn, after preliminary study results suggest it could be effective in protecting against the virus.

The European Medicines Agency's human medicines committee, or CHMP, will evaluate data as they become available to see if the benefits of Vidprevtyn outweigh its potential risks, the agency said on Tuesday. The rolling review will continue until enough evidence is available for a formal marketing-authorization application.

The EMA said it can't estimate overall timelines, but an eventual application should take less time than normal in light of the review.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/EU-Drug-Agency-Begins-Rolling-Review-of-Sanofi-Covid-19-Vaccine-Candidate-35902104/