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Tuesday, March 9, 2021
Talis Bio coverage started with 3 Buys, 1 Neutral
California launches way any resident can become vaccine eligible
The state of California launched a new program Friday that gives the residents the opportunity to get vaccinated by volunteering to help get others inoculated at sites across the state.
MyTurnVolunteer is an online tool that allows you to look for clinics and mass vaccine sites seeking help based on your zip code.
"If you sign up on the tool, you'll be able to register for a general support or medical positions, depending on your background," said Cristina Valdivia Aguilar, a spokesperson for California Volunteers. "You can find a location near your home."
Medical volunteers — including registered nurses, doctors, pharmacists, and dentists — may assist in vaccination efforts, whether prepping vaccines or injecting and observing patients. Nonmedical volunteers may assist with tasks like providing in-language support, greeting vaccine recipients, sanitizing surfaces, directing traffic, and registration.
While some locations are asking for eight-hour shifts, Aguilar said if you work four hours or more, you can receive a vaccine with approval from the clinic administrator—even if you're not eligible within the state's framework that's prioritizing health care workers, seniors and some essential workers such as teachers.
"If you volunteer for four hours or more you're classified within one of the tiers," she said. "You're classified as a community health worker from the California essential workforce list."
Many locations are asking for volunteers to be 18 years old or older, but it's dependent on the site, she said.
The program is new and on Monday morning opportunities remained limited but Aguilar said volunteers will be able to find locations near them as more opportunities become available.
"We were at a site in Los Angeles on Friday and they need 200 volunteers a day," she said. "It's a really big site... the Kedren Community Health Center in South Los Angeles. It's a great way to feel like a part of the solution and like you're helping in a pandemic."
The state-sponsored volunteer campaign is also calling on residents to help educate family and friends in their communities about the vaccine by downloading and sharing materials and offering to schedule a vaccine appointment for a neighbor or or offer a ride.
ViiV: Positive proof-of-concept data for GSK3640254, novel HIV treatment
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK’254). The study showed the antiviral activity of GSK’254, establishing a relationship between dose and antiviral response, with the 140 mg and 200 mg doses showing the greatest reduction in plasma HIV-1 RNA. These findings were presented today at the (virtual) 2021 Conference on Retroviruses and Opportunistic Infections (CROI).
Maturation inhibitors are a class of antiretroviral medicines that target the late stage of the HIV viral life cycle. They can prevent the HIV replication process by blocking key enzyme activity at this stage, which results in the formation of immature virus particles. Because maturation inhibitors use a unique mechanism of action that targets HIV differently than other antiretrovirals currently available, they have the potential to offer new treatment options for individuals who may have experienced resistance to other classes of HIV treatment.
The phase IIa study was adaptive in design and divided into two parts to evaluate the antiviral activity, safety, and tolerability of once-daily GSK’254 among 34 treatment-naïve adults living with HIV. In part one, participants received GSK’254 10 mg, 200 mg, or placebo for 10 days. A planned interim analysis showed treatment emergent resistance associated mutations in the 200 mg arm after dosing was complete. As a result, in part two, participants received GSK’254 40 mg, 80 mg, 140 mg, or placebo for a shortened period of seven days. The primary endpoint was the maximum change in plasma HIV-1 RNA during parts one and two while secondary endpoints measured safety, tolerability, and pharmacokinetic (PK) parameters.
At the conclusion of the study, the largest mean changes in viral load were -1.5 log 10 and -2.0 log 10 copies/ml in the 140 mg and 200 mg groups, respectively.
Treatment with GSK’254 was generally well-tolerated throughout the study. There were no adverse events (AEs) leading to discontinuation and no deaths reported. AEs were reported by 22 (65%) participants, with the most common being headache (n=4).
https://www.argus-press.com/news/national/article_16a718de-c7f3-53f0-a62c-2ebe5269c509.html
New CDC guidelines a blow for ailing airline industry
The Centers for Disease Control and Prevention (CDC) this week delivered a tough blow to the airline industry, which is struggling to recover from the coronavirus pandemic.
While the CDC issued a number of recommendations that allow vaccinated and low-risk people more freedom to gather, Director Rochelle Walensky said Monday that the agency’s advice on travel remains the same for both vaccinated and unvaccinated Americans: Don’t do it.
But some experts called that guidance confusing and the airline industry, while saying it would continue to work with the CDC, stressed its efforts to prevent coronavirus transmission aboard aircrafts and its confidence that its approach is safe.
“We remain confident that this layered approach significantly reduces risk and are encouraged that science continues to confirm there is a very low risk of virus transmission onboard aircraft,” said a spokesperson for Airlines for America (A4A), which advocates for major U.S. airlines.
President Biden early in his term made the wearing of masks during air travel a federal mandate, rather than a requirement from U.S. airlines. The White House also recently paused consideration of a testing requirement for traveling domestically by air.
“We continue to work with the CDC and other appropriate authorities to ensure the implementation of travel policies and measures that prioritize the safety and wellbeing of all passengers and employees,” the A4A spokesperson said.
Delta, Southwest, United and American Airlines all deferred to A4A for comment.
Leana Wen, a public health professor at George Washington University and former Baltimore health commissioner, called the guidance on Monday "far too cautious."
“A lot of families are separated from one another and need to travel to see one another. I’m really befuddled by why the guidance around travel was not changed. Travel is very low risk—imagine if you’re traveling in your individual car or even by plane—whenever everyone is wearing masks, the risk of coronavirus is very low," she said.
The airline industry has not asked for any changes on mask-wearing policies but it has called for a set of criteria that could be used to adjust their travel guidance.
“We continue to urge the CDC to establish and release a set of criteria that will be used to adjust their guidance regarding travel,” an industry source said.
The U.S. Travel Association stressed that getting past the pandemic is the priority, but also that goals should be set for relaxing some restrictions.
“[W]e feel it is critical for U.S. public health officials to set goals for relaxing the official guidance around travel. The year-long pause of travel has kept people apart and caused serious damage to the economy and jobs, and with vaccines progressing and encouraging case trends in many areas, it should be possible to consider a timeframe for a broader reopening of travel,” said Tori Emerson Barnes, executive vice president of public affairs and policy.
Sara Nelson, international president of the Association of Flight Attendants-CWA, wasn’t critical of the CDC recommendation on Monday and said that the U.S. is on the road to recovery.
“The CDC’s policy has not changed. This reinforces the urgency of increasing vaccine capacity and distribution, and overall efforts to end the pandemic. COVID is the problem. We must remain vigilant and get people vaccinated as quickly as possible,” she said.
The CDC did not respond to a request for comment on what needs to be done for them to lift the travel restriction.
“We are really trying to restrain travel at this current period of time, and we’re hopeful that our next set of guidance will have more science around what vaccinated people can do, perhaps travel being among them,” Walensky said on Monday.
Rep. Rodney Davis (R-Ill.), a member of the House Transportation and Infrastructure Committee, said the White House should stop "embracing lockdown mentality."
"The whole point of vaccinating Americans against COVID is to save lives while expediting our country’s return to normal. People who continue to support the status quo of COVID restrictions even as millions more Americans are vaccinated each day will end up deterring a huge number of Americans from even getting the vaccine at all,” he said.
The CDC also recommended vaccinated individuals do not need to quarantine or get tested if they come into contact with someone with COVID-19 and do not develop symptoms.
Wen said that guidance is confusing.
“If they’re saying that you don’t even need to quarantine after being exposed to someone with known COVID-19, can you not get on a plane and sit there, masked, with people who, chances are, don’t have COVID-19? It just doesn’t make common sense," she said.
Air travel is slowly returning but has not yet reached pre-pandemic levels. The Transportation Security Administration (TSA) screened 1,277,719 passengers on Sunday and the last time the volume was that high was on Jan. 3 when 1,327,289 passengers were screened for holiday travel.
On Saturday, TSA screened 991,547 passengers. The previous year on March 6, the agency screened 2,198,517 passengers.
The coronavirus relief legislation the Senate passed on Saturday is set to provide some help to the industry. Airlines got a $15 billion boost and an extension of the Payroll Support Program, which was a key provision in the CARES Act that was set to expire April 1.
The extension will allow airlines to keep workers on payroll through Sept. 30.
When pressed about what guidance the CDC would give to a governor regarding vaccinated people traveling back to their state, Walensky emphasized that the recommendations haven’t changed.
“Our travel guidance is unchanged, and so we would maintain whatever travel guidance is currently in place. We would like to give the opportunity for vaccinated grandparents to visit their children and grandchildren who are healthy and who are local, but our travel guidance currently has been unchanged,” he said.
Harvard University’s National Preparedness Leadership Initiative found “scientific evidence showing that consistently following a layered approach serves as a strong risk mitigation strategy for SARS-COV-2 transmission on an aircraft,” according to a report released last month.
The report, which assessed the risk of COVID-19 transmission during air travel, found a “very low probability” of being infected with COVID-19 from an aircraft and recommended following the multi-layered approach of wearing a mask and physical distancing while boarding and deplaning.
Wen fears that not allowing vaccinated people to travel could mean unvaccinated people aren't incentivized to view vaccination as a return to normal.
"We need to become a lot clearer about the freedoms that an individual can have once they have proof of vaccination," she said. "I think that people who are fully vaccinated should be able to travel and should be in fact encouraged to travel, of course with all the precautions."
https://thehill.com/business-a-lobbying/542229-new-cdc-guidelines-a-blow-for-ailing-airline-industry
NY expanding vaccine eligibility to age 60+ starting Wednesday
Governor Andrew Cuomo announced that New York is expanding its vaccine eligibility to include individuals age 60 and above starting at 8 a.m. Wednesday. It was previously for ages 65+.
Starting March 17th, public-facing public employees will become eligible for the vaccine.
Not-for-profit public-facing emergency-facing employees, essential public workers, and public-facing building workers also will be eligible.
"Make an appointment starting tomorrow 8 a.m., remember it's still uneven, we still don't have enough supply, but do your best," Cuomo said. "I know it requires patience. But 60-year-olds start tomorrow. Next week, March 17, all sites can administer vaccines to any eligible population except pharmacies. Pharmacies will only be doing 60+ and teachers. Also next Wednesday, March 17 the everyday heroes, the essential workers, YWCA, essential workers, will be eligible for the vaccine."
"Make an appointment starting tomorrow 8 a.m., remember it's still uneven, we still don't have enough supply, but do your best," Cuomo said. "I know it requires patience. But 60-year-olds start tomorrow. Next week, March 17, all sites can administer vaccines to any eligible population except pharmacies. Pharmacies will only be doing 60+ and teachers. Also next Wednesday, March 17 the everyday heroes, the essential workers, YWCA, essential workers, will be eligible for the vaccine."
Meantime, Mayor Bill de Blasio announced that the city is hiring 2,000 vaccine center workers.
They will be hired from within the neighborhoods of 33 task force locations.
To apply, visit nyc.gov/vaccinejobs.
They will be hired from within the neighborhoods of 33 task force locations.
To apply, visit nyc.gov/vaccinejobs.
So far, New York City has administered 2,405,191 doses of the COVID vaccine. That's more than the population of the city of Houston.
On Monday, Cuomo announced that as the federal vaccine supply continues to increase, New York will establish 10 additional state-run mass vaccination sites.
Officials say those sites will be located in New York City, Long Island, Hudson Valley, Capital, Southern Tier, Mohawk Valley and Western New York regions to further grow New York's vast distribution network.
The sites remain in development and are expected to launch in the coming weeks.
Appointment scheduling information and hours of operation will be released in the coming days.
For a list of locations, CLICK HERE.
On Monday, Cuomo announced that as the federal vaccine supply continues to increase, New York will establish 10 additional state-run mass vaccination sites.
Officials say those sites will be located in New York City, Long Island, Hudson Valley, Capital, Southern Tier, Mohawk Valley and Western New York regions to further grow New York's vast distribution network.
The sites remain in development and are expected to launch in the coming weeks.
Appointment scheduling information and hours of operation will be released in the coming days.
For a list of locations, CLICK HERE.
Digital insurer Health IQ weighs $1.5 billion SPAC merger
Health IQ is weighing strategic options, including a merger with a blank-check acquisition firm that could take the digital health insurance provider public at a valuation of more than $1.5 billion, people familiar with the matter said.
Health IQ is currently working with an investment bank that has reached out to a small number of parties, including so-called special purpose acquisition companies (SPACs), to solicit their interest in a deal, three sources said.
The sources cautioned a deal was not certain and spoke on condition of anonymity because the matter is confidential. Health IQ did not respond to a request for comment.
Insurance technology, or ‘insuretech’, companies have been growing in popularity during the COVID-19 pandemic, as consumers seek out digital platforms to buy financial products.
SPACs have sought to tap into this trend. Last week, home insurance provider Hippo Enterprises said it would go public through a $5 billion merger with a SPAC backed by Silicon Valley heavyweights Reid Hoffman and Mark Pincus.
SPACs are shell companies that raise funds through an initial public offering to take a private company public.
Based in Mountain View, California, Health IQ uses data gleaned from quizzes on someone’s fitness and wellness habits to get them quotes from insurance companies, and offers incentives such as smart watches, juicers and vitamins to customers who maintain healthy lifestyles. It focuses on life insurance and Medicare Advantage plans.
Founded in 2013, Health IQ is backed by investors including Andreessen Horowitz, Hanwha Asset Management and the venture fund of Aquiline Capital Partners. It last raised money privately, a $55 million Series D round, in May 2019, according to its website.
NanoViricides Pan-coronavirus COVID Drugs 'Highly Effective' in Pre-clinical Studies
NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the strong effectiveness of its two COVID-19 clinical drug candidates in an animal model of coronavirus infection.
The Company is preparing a pre-IND application encompassing its two clinical drug candidates for the treatment of COVID-19 infected patients. Of these, NV-CoV-2 is the Company's broad-spectrum anti-coronavirus drug candidate based on its nanoviricides® platform that is expected to be capable of attacking most, if not all, SARS-CoV-2 variants and other coronaviruses. In addition, the Company is also developing NV-CoV-2-R that combines (1) the power of NV-CoV-2 to attack and potentially dismantle the virus particles outside cells, and (2) the power of remdesivir to block further production of virus particles inside cells. Blocking the complete lifecycle of the virus in this manner could provide a cure for the viral disease. The Company intends to perform human clinical studies to establish the effectiveness of NV-CoV-2 and NV-CoV-2-R in treating COVID-19 viral infection.
Both NV-CoV-2 and remdesivir are broad-spectrum drugs and are expected to be effective against most, if not all, variants of the coronavirus that continue to emerge in the field, based on pre-clinical studies. The broad-spectrum effectiveness of the Company's drug candidates is very important as coronavirus variants that may evade antibodies and cause disease in spite of vaccination are becoming widespread as the COVID-19 global pandemic is progressing into its second year. The need for antiviral drugs that are developed against coronaviruses is now well recognized.
https://finance.yahoo.com/news/nanoviricides-inc-pan-coronavirus-covid-104500037.html
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