Tag: Mexico

 

New Mexico building infrastructure for vaccine distribution

ALBUQUERQUE, N.M. (AP) — It could be well into next year before a COVID-19 vaccine is widely available, but top health officials in New Mexico said Tuesday that they have submitted their plan to the federal government for building the infrastructure, tracking systems and partnerships that will be needed for distribution.

The focus will be on vaccinating health care workers and first responders, then nursing home residents and staff. They acknowledged that supplies will likely be limited early on and immunizations for the general public would come later.

Health officials outlined New Mexico’s plan for lawmakers amid a surge in infections. Lawmakers had questions about everything from cost and security to whether the state would have to compete for doses as it did for personal protective equipment at the onset of the pandemic.

Dr. Aja Sanzone, a leader of the planning team and medical director of the state’s Infectious Disease Bureau, said officials have estimated that immunity through vaccination would require immunizing about 70% of the population. In New Mexico, that means distributing 2.9 million doses if two doses per person were needed.

“So definitely a heavy lift there. It would be more than twice the amount of annual flu vaccine that we administer,” she said.


A White House-backed initiative called “Operation Warp Speed” is pushing to have a vaccine ready for distribution in the coming months. The government is spending billions of dollars to manufacture vaccines even before they receive U.S. Food and Drug Administration approval, thereby cutting the timeline for delivery. FDA officials say the program won’t interfere with their own science-based decisions and that vaccines not meeting the test for approval would be discarded.

Sanzone noted that the FDA in June advised vaccine makers that the federal agency would want to see evidence that vaccines can protect at least 50% of those receiving it.

States had until Oct. 16 to submit their distribution plans to the Centers for Disease Control and Prevention. New Mexico officials described the plans as “living documents” with gaps that will be filled in as more information is released by the federal government.

“They keep updating us every week,” said Daniel Burke, chief of the Infectious Disease Bureau. “Really, they’re building the plane as we fly it nationally. They’re adding more and more pieces of information, and it’s now really well laid out.”

While there are still some unknowns, he said New Mexico’s plan addresses logistics, communication, data collection and partnerships with pharmacies and community health centers, among other things.

The state Health Department is surveying hospitals, pharmacies and others to identify capacity to administer vaccines. That information is being plugged into an interactive map to help with planning.

One of the biggest challenges will be what Sanzone said is fading public confidence in the development of a vaccine. She said recent survey results suggest there’s growing concern that the regulatory approval process has been politicized.

“So our goal really is to restore public confidence in the safety and efficacy of vaccines. It

Mexico will not follow FDA in approving Gilead’s COVID-19 drug

MEXICO CITY (Reuters) – Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc’s antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said on Friday.

Mexico’s health regulator Cofepris has already twice denied approval for the drug with a “non-favorable” opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.

“We have no mandate from the FDA,” he said. “Cofepris has identified that the evidence does not suggest a usefulness, a sufficient efficacy.”

The FDA approved remdesivir on Thursday, making it the first and only drug approved for the disease in the United States.

Remdesivir, given intravenously, was one of the drugs used to treat U.S. President Donald Trump during his bout with COVID-19.

The World Health Organization’s (WHO) Solidarity drug trial last week concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19, and a top WHO scientist on Friday recommended the FDA consider all available evidence.

Lopez-Gatell said Gilead had sent a letter to doctors in Mexico refuting the results of the Solidarity trial, and that officials were looking to see if the letter could be cause for sanction, given that remdesivir is not registered with Mexican health authorities.

“It confuses the population and generates a false expectation of the possibility of having a treatment option,” he said.

Gilead did not immediately respond to a request for comment.

(Reporting by Sharay Angulo and Daina Beth Solomon; Editing by Sonya Hepinstall and Tom Hogue)

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Business mandates mount as New Mexico deals with virus surge

ALBUQUERQUE, N.M. (AP) — New Mexico Gov. Michelle Lujan Grisham on Tuesday unveiled more requirements for businesses after a string of record-breaking daily case counts prompted renewed restrictions just last week.

Starting Friday, restaurants, breweries, retail stores, gyms and other businesses will be required to close for two weeks if they have more than four separate incidents of COVID-19 among employees within a 14-day period. Those businesses that have had at least two outbreaks will be listed on the state’s new watch list.

Restaurants that want to continue offering limited indoor dining must also complete specific training and keep a log of customers for at least three weeks. Retail stores must close by 10 p.m., and state-operated museums and historical sites will be closed until further notice.

Lujan Grisham said the restrictions are not meant to punish businesses but rather curb what has become one of the highest rates of spread in the U.S. New Mexico on Tuesday reported an additional 599 cases, bringing the total to nearly 37,900 since the pandemic began. Another seven deaths were reported, and hospitalizations have increased nearly 90% over the last two weeks.

“We don’t have much time,” the governor said during a briefing. “If we don’t attack and snuff out the virus right now by working collectively with businesses and each other, then the virus will win and it leaves us very little opportunity to save lives and to keep our health systems from being overrun.”

Despite having some of the strictest rules in the country, Lujan Grisham’s administration has been struggling in recent weeks with a surge in cases and increases in transmission and positivity rates. The governor said she believes the exponential increase is the result of people letting their guard down and not taking precautions.


The Republican Party of New Mexico called the latest requirements another attack on businesses, saying the Democratic governor’s policies during the pandemic have led to a collapsed economy, tens of thousands of job losses and hundreds of permanently shuttered restaurants.

“Locking down New Mexico more is not the answer,” party chairman Steve Pearce said, suggesting that the governor’s rules were arbitrary.

Under the state’s rapid response program, officials responded to more than 830 businesses during the past week. That marked a six-fold increase over the last month. Businesses on the watch list range from hospitals and medical marijuana operations to law firms, car dealerships, grocery stores and gas stations.

Sandia National Laboratories is among them. The state’s Occupational Health and Safety Bureau has opened an investigation of the lab after receiving a complaint about alleged violations of the state public health order.

A letter sent Monday by the bureau and obtained by The Associated Press alleges that Sandia failed to comply with the health order by not limiting operations to remote work to the greatest extent practicable to prevent the spread of COVID-19. The state claims employees were ordered to cease telework and report to work in-person.

The state is requiring the lab to inform

Lab under investigation as New Mexico deals with virus surge

ALBUQUERQUE, N.M. (AP) — New Mexico Gov. Michelle Lujan Grisham is scheduled Tuesday to provide an update on COVID-19 cases after a string of record-breaking daily case counts prompted more restrictions last week and officials continue to crack down on employers who they say aren’t following the rules.

The state’s Occupational Health and Safety Bureau has opened an investigation of Sandia National Laboratories after receiving a complaint about alleged violations of the state public health order.

A letter sent Monday by the bureau and obtained by The Associated Press alleges that the national laboratory failed to comply with the health order by not limiting operations to remote work to the greatest extent practicable to prevent the spread of COVID-19. The state claims employees were ordered to cease telework and report to work in-person.

The state is requiring the lab to inform all employees and contractors of the investigation. The lab also has been ordered to complete an internal investigation to identify the root cause of COVID-19 cases that occurred in the last two weeks for each employee and contractor who tested positive.

If the lab doesn’t comply, the state says it’s authorized to post a notice of imminent danger on lab property and assess civil penalties up to $134,904 per violation.


“It is clear that neither federal (Occupational Safety and Health Administration) nor the (U.S. Department of Energy) are effectively holding Sandia National Laboratories accountable for protecting its employees from occupational exposure of COVID-19,” the letter states.

Lab spokeswoman Kristen Meub said Sandia’s top priority is to keep employees safe and healthy and that stringent safety measures have been implemented during the pandemic. She said Sandia is coordinating with the Energy Department and National Nuclear Security Administration to respond to the state in a timely manner.

“From the start of the pandemic through Oct. 15, the majority of Sandia COVID cases were acquired offsite and outside work hours,” Meub said. “As a result of our protective measures, such as safety protocols onsite, contact tracing has confirmed the vast majority of cases among Sandia employees was caused by community spread transmission away from the worksite.”

More than 100 workers at Sandia locations in New Mexico and California have tested positive since the start of the pandemic. The lab has more than 14,000 workers, with more than 12,000 of those located in New Mexico.

While the majority of employees work from home, Sandia officials say the lab has essential work that must be performed onsite to meet national security responsibilities. For those workers, the lab provides personal protective materials such as masks and sanitizer and daily health checks are done before they’re allowed onsite.

The lab also provides onsite testing with results in less than 24 hours, contact tracing, increased cleaning and disinfecting and other measures per Centers for Disease Control and Prevention guidelines. Lab officials say Sandia’s protocols exceed the state requirements in many cases.

Despite having some of the strictest rules in the U.S., Lujan Grisham’s administration has been struggling

Coronavirus restrictions reinstated in Wisconsin as New Mexico sounds the alarm

(Reuters) – As Wisconsin battled one of the worst coronavirus surges in the United States, a judge on Monday reinstated an order from Governor Tony Evers’ administration limiting indoor public gatherings.

Registered nurse (RN) Tammy Fellenz, wearing an NFL Green Bay Packers headband, takes a patient’s nasal swab at a coronavirus disease (COVID-19) drive-thru testing site at Froedtert North Hills Health Center in Menomonee Falls, Wisconsin, U.S., October 18, 2020. REUTERS/Bing Guan

The order, issued earlier this month to stem rising new COVID-19 infections in the state, put a 25% capacity limit on the number of people who may gather indoors, including at bars and restaurants, until Nov. 6.

“This critically important ruling will help us prevent the spread of this virus by restoring limits on public gatherings,” Evers said in a statement.

Wisconsin, one of several battleground states in the upcoming U.S. presidential election, is scrambling to contain a resurgence of the coronavirus that officials fear could overwhelm the state’s hospitals.

Evers’ emergency directive was challenged in court shortly after it was issued on Oct 6., and a judge initially blocked it on Oct. 14.

Wisconsin is one of five states where more than 20% of COVID-19 tests are coming back positive. Local health officials last week warned about “very intense community spread in all age groups” as they announced a string of grim records.

However, a field hospital erected at fairgrounds outside Milwaukee for COVID-19 patients was empty as of Sunday, according to Wisconsin health authorities.

FALL SURGE

The number of new COVID-19 cases in the United States last week rose 13% to more than 393,000, approaching levels last seen during a summer peak, according to a Reuters analysis.

(Graphic: Where U.S. coronavirus cases are rising and falling – here)

Thirty-four of 50 states have seen cases increase for at least two weeks in a row, up from 29 the prior week. They include Pennsylvania, Ohio, Michigan and North Carolina — all battleground states for the Nov. 3 election.

Deaths fell 2% to about 4,900 people for the week ended Oct. 18, according to the analysis of state and county reports. Since the outbreak started, nearly 220,000 people in the country have died and over 8.1 million have become infected with the novel coronavirus.

In New Mexico, the governor warned on Monday that the state’s healthcare resources might not be sufficient if coronavirus cases continue to rise at the current pace.

“If COVID-19 continues to exponentially spread like last week, New Mexico will not have the health care and hospital capacity for every New Mexican who needs care,” Governor Michelle Lujan Grisham, a Democrat, wrote in a tweet.

(Graphic: Global COVID-19 tracker – here)

Reporting by Lisa Shumaker in Chicago and Rich McKay in Atlanta; additional reporting and writing by Maria Caspani in New York, Editing by Cynthia Osterman

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New Mexico sets another one-day COVID-19 record

ALBUQUERQUE, N.M. — New Mexico health officials on Friday confirmed the state set another single-day record with 819 COVID-19 cases, bringing the statewide total to 35,770 since the pandemic began.

New rules to limit gatherings to five people or less, reduce hotel capacities and impose a 10 p.m. closing time for bars and some restaurants also took effect Friday after successive days of record-breaking daily infection rates.

The previous record of 672 on Thursday already had eclipsed records set in recent days.

The state on Friday also reported six additional deaths related to the pandemic, bringing that total to 928.

At the University of New Mexico, eight football players and one assistant coach have tested positive for the coronavirus and high positivity rates in the county where the school is located have forced the postponement of practice.

University athletic director Eddie Nuñez said if the team is unable to practice for the next week, they will not be able to safely play their first scheduled game on Oct. 24 against Colorado State.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— France records 30,000 virus cases, highest single-day rise

— WHO study finds remdesivir didn’t help COVID-19 patients

— U.S. testing 3 drugs to try to tamp down coronavirus

— Coronavirus cases are rising in key U.S. presidential battleground states ahead of Election Day.

— White House puts political operatives at CDC to try to control virus information

— Thousands arrive in Hawaii on first day pre-travel testing allowing no quarantine

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— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

SALT LAKE CITY — One of Utah’s largest hospitals had no beds left Friday in its regular intensive-care unit as the governor declared the state’s weekslong spike in coronavirus cases “unsustainable.”

The University of Utah Health had to set up extra ICU beds staffed by doctors and nurses working overtime to care for its critical patients this week as the unit hit 104% capacity, said Chief Medical Officer Dr. Russell Vinik.

“We’ve cut back where we can but it’s precarious,” he said. “We are very concerned about flu season, particularly if people don’t get vaccinated. We can’t take another hit.”

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MIAMI – Florida has reported a slight uptick in daily confirmed COVID-19 cases, adding 3,449 to its total caseload on Friday.

The new state report raises the seven-day average of new infections close to 2,800, a figure that had dropped under 2,300 in late September and early October, when the state lifted restrictions on restaurants and the largest school districts began welcoming students.

The COVID-19 hospitalization and deaths figures have been relatively stable in recent weeks.

The number of people being treated in Florida hospitals peaked in late July at more than 9,500, then declined for about two months. But the figure has leveled off for the past three weeks at around 2,000 to 2,200 without further decline.

The state tallied 98 new virus-related deaths on Friday,

Zhittya Genesis Medicine Announces It Has Been Approved to Initiate Clinical Trials in Mexico …

LAS VEGAS, Oct. 15, 2020 (GLOBE NEWSWIRE) — Zhittya Genesis Medicine, Inc. (Zhittya), a private company, announces that it will initiate clinical trials in Mexico to test a medical hypothesis that has been advanced over the last five years that ALS may be caused by vascular disruption in the areas of the brain which house motor neurons, those neurons which become dysfunctional in patients suffering from ALS. The hypothesis is simply that the micro-vascularization in that area of the brain is blocked or narrowed, restricting the flow of blood needed to nourish the motor neurons. Just as with heart disease, where blockage of coronary arteries can lead to angina and heart attacks, that same process is now thought to underlie the development of ALS.

Dr. Jack Jacobs, Zhittya’s President and Chief Science Officer will be giving a free Zoom webinar on this topic entitled: “Amyotrophic Lateral Sclerosis (ALS): Is Therapeutic Angiogenesis a Potential Treatment to Reverse this Disease?” This webinar will broadcast on Thursday, October 29, 2020 at 9:00 am Pacific time, 12 noon Eastern time.

Click Here to Register for this Webinar

Zhittya is developing a biological drug which in previous US FDA-authorized clinical trials has demonstrated it can trigger “therapeutic angiogenesis” or the growth of new blood vessels in ischemic tissues. Zhittya has prepared a White Paper entitled: “Human FGF-1 as a Potential Treatment for Amyotrophic Lateral Sclerosis (ALS)”, which is available to all, free of charge, by emailing: dan@zhittyamedicine.com

Daniel C. Montano, CEO of Zhittya stated, “I believe we are truly on to something here. Over the last three years, we have continually uncovered data which enhances our belief that therapeutic angiogenesis might be a viable breakthrough treatment for patients that suffer from ALS. If, as we believe, ALS is initiated by micro-vascular disruption in the brain, we hope our molecule can do in the brain, what it has already demonstrated it can do in the US FDA-cleared heart trial, namely, grow new blood vessels.”

Dr. Jack Jacobs added, “ALS is a progressive and fatal neuromuscular disease and the majority of ALS patients die within 2–5 years of receiving a diagnosis. There is no known definitive cause of ALS and hereditary forms of the disease only account for 5%–10% of cases. No cure has been identified and the lack of proven and effective therapies for ALS is an ongoing challenge. There are now multiple lines of evidence that have established that angiogenesis is deficient in this disease, leading directly to the death of motor neurons. I believe therapeutic angiogenesis may be a potentially novel way to halt the progression of ALS and we are pleased that the Mexican regulatory authorities have given us permission to test our biological drug candidate in subjects with ALS.   

About Zhittya Genesis Medicine

Zhittya’s management has been working to advance these medicines for over 21 years and many tens of millions of dollars have been expended in preclinical and clinical studies. Zhittya’s medicine initiates a biological process in the human body referred