Showing: 1 - 10 of 190 RESULTS

New FDA COVID-19 vaccine guidance requires two months of follow-up data for approval

Oct. 6 (UPI) — New guidelines issued by the U,S. Food and Drug Administration on Tuesday require manufacturers of potential new COVID-19 vaccines to provide two months’ worth of “follow-up” data on safety and possible adverse events.

The mandate would appear to dash President Trump’s hopes of having a new vaccine approved by the Nov. 3 election.

The two-month period was decided upon because agency research suggests that most adverse events or severe side effects with vaccines emerge within two to three months after administration, an FDA administrator said.

“Ideally, we’d like to have longer-term safety follow-up, but we are in the middle of a pandemic and people are dying,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Marks was among several top public health officials who spoke during a virtual symposium Tuesday entitled “Preserv[ing] the Scientific Integrity of COVID-19 Vaccine Development and Allocation,” hosted by Johns Hopkins University and the University of Washington.

The FDA released the new guidance earlier in the day amid reports suggesting that Trump administration officials were pressuring the agency to streamline the vaccine approval process, with an eye toward the presidential election.

The new guidance focuses on the FDA’s emergency use authorization process, which allows the agency to more quickly approve products in response to a national crisis.

The normal safety and effectiveness requirements for drugs, vaccines and medical devices approved under the emergency use program are “deliberately set lower,” Marks said. However, the “known and potential benefits [still] have to outweigh risks,” he said.

To receive an emergency authorization based on the new guidance, potential vaccines will have to provide an “interim analysis” of data proving effectiveness from Phase 3 clinical trials — the final stage of the drug evaluation process.

In addition, data from Phase 3 studies must “include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the guidelines state.

This includes information on adverse events, cases of severe COVID-19 disease among study participants and cases of COVID-19 “occurring during the time frame when … the vaccine would be responsible for a protective effect.”

During Tuesday’s symposium, Moncef Slaoui, the scientific head of Operation Warp Speed — the Trump administration’s initiative to spur COVID-19 drug treatment and vaccine research and development — said that several candidate vaccines have begun Phase 3 trials.

However, although he and his colleagues are “reasonably pleased with the progress,” the vaccines farthest along in the process won’t have their “first results” on effectiveness until late November or early December.

Still, “we feel comfortable that we will have one or two vaccines and we will have enough doses to immunize 30 million people in November and December and another 50 million in January and have a serious impact this pandemic,” Slaoui said.

He had told Science magazine in September that he would resign if politics interfered with the vaccine evaluation process.

Bill Gates Says Antibody Drugs Could Sharply Reduce Covid-19 Death Rate

Antibody drugs that are in testing and were administered to President Trump could significantly reduce the death rate from Covid-19 once they are approved by regulators and more widely available, billionaire philanthropist Bill Gates said Tuesday.

The drugs, in a class of medicines known as monoclonal antibodies, have shown promise in early-stage patients with Covid-19. “That’s actually pretty exciting,” Mr. Gates told The Wall Street Journal’s CEO Council Summit. “The reduction in death rate there could be pretty high, and those will be out in volume by the end of the year, at least in the rich countries.”

The drugs, developed by

Regeneron Pharmaceuticals Inc.,

Eli Lilly

and others, are designed in laboratories to mimic antibodies that the immune system produces to fight off viruses and other pathogens. They are injected intravenously and have the potential to work soon after a person is infected and only mildly ill. Scientists believe they also hold promise as a preventive tool, blocking infection temporarily.

President Trump received Regeneron’s antibody drug cocktail late last week under a compassionate use program.

Mr. Gates also expressed optimism about vaccines in development. An effective vaccine could help return life to “pretty close to normal” by late next year in the developed world, he said. Eliminating or stopping virus transmission completely would take two to three years, he said.

Progress on both drugs and vaccines will take longer in the developing world, he said, emphasizing a divide that his foundation and other global players are seeking to close.

Some public health experts are concerned that misinformation, along with any rush by governments to approve vaccines before testing is complete, will make people hesitant to receive one. If only a small percentage of populations are vaccinated, the new coronavirus will continue to spread.

Covid-19 has put a spotlight on how misinformation on social media can be harmful. Bill Gates discusses why and how to best control it, at the WSJ CEO Council Summit. Photo: Qin Lang/Xinhua via ZUMA Wire

Mr. Gates said U.S. political and business leaders should speak out and help explain the value and safety of the vaccines to their constituents and employees, to lead by example and ease concerns. For example, he said, the Bill & Melinda Gates Foundation worked with religious leaders in northern Nigeria to persuade parents to allow their children to be vaccinated against polio.

“Here in the U.S., we should already be thinking about which voices will help reduce the hesitancy,” he said.

“The CDC that normally speaks out on these things hasn’t yet had that much visibility,” he added, referring to the U.S. Centers for Disease Control and Prevention.

If the data on the safety and efficacy of vaccines are clear, he said, “I think enough people will be interested and then you’ll build up that confidence as more and more people are taking the vaccine and getting good results.”

The Microsoft co-founder acknowledged that misinformation amplifies quickly on digital platforms, and said he doesn’t yet see a solution.

Covid-19 Medical

HHS whistleblower Rick Bright resigns from government

Rick Bright, the federal vaccine chief-turned-whistleblower who was reassigned to a different agency and subsequently criticized the Trump administration’s pandemic response, has left the federal government, Bright’s lawyers announced on Tuesday.

“Dr. Bright was forced to leave his position at NIH because he can no longer sit idly by and work for an administration that ignores scientific expertise, overrules public health guidance and disrespects career scientists, resulting the [sic.] in the sickness and death of hundreds of thousands of Americans,” lawyers Debra Katz and Lisa Banks said in a statement.

HHS declined comment.

“We can confirm that Dr. Bright has resigned, effective today,” an NIH spokesperson said, adding that the agency “does not discuss personnel issues beyond confirming employment.”

Bright was abruptly removed as director of the Biomedical Advanced Research and Development Authority in April and reassigned to NIH, and he alleges that he was demoted because he opposed political pressure linked to an unproven Covid-19 treatment. In his updated filing with the Office of Special Counsel, Bright said that he was assigned “no meaningful work” at NIH since Sept. 4, further alleging that NIH Director Francis Collins “declined to support” his recommendations about coronavirus testing “because of political considerations.”

Bright testified to a House panel in May that he was punished by Health and Human Services Department leaders for raising concerns about hydroxychloroquine, the drug favored by President Donald Trump to treat the coronavirus despite scant evidence. Bright also used the hearing and other media appearances to speak out against the administration’s handling of the pandemic, saying that HHS had missed opportunities to prepare for the spread of Covid-19 and raising further charges of cronyism.

Bright appears in an upcoming documentary, “Totally Under Control,” which faults the Trump administration’s handling of the outbreak and is set to be released next week. The New York Times first reported Bright’s resignation.

HHS has spent months rebuffing Bright’s claims, saying that as vaccine chief he lacked full visibility into the administration’s efforts and noting that Bright played a key role in the government’s acquisition of hydroxychloroquine. The health department also issued a document called “CLAIM vs. REALITY” that sought to rebut Bright’s points.

Meanwhile, Trump repeatedly dismissed Bright as a “disgruntled” employee.

Other officials have subsequently echoed Bright’s criticisms of the Trump administration’s handling of the outbreak, including Olivia Troye, who advised Vice President Mike Pence on the coronavirus response before leaving the White House this summer.

Source Article

In a first, 2 counties move backward on state’s reopening plan; Ventura moves forward

Patrons ate in May at Ventura's BusyBee 50's Cafe. In July, Gov. Gavin Newsom closed all indoor dining at restaurants, but on Tuesday, Ventura County advanced in the state's reopening blueprint, allowing a return to limited indoor seating. <span class="copyright">(Wally Skalij / Los Angeles Times)</span>
Patrons ate in May at Ventura’s BusyBee 50’s Cafe. In July, Gov. Gavin Newsom closed all indoor dining at restaurants, but on Tuesday, Ventura County advanced in the state’s reopening blueprint, allowing a return to limited indoor seating. (Wally Skalij / Los Angeles Times)

Although a handful of counties advanced in the state’s COVID-19 reopening plan Tuesday, two moved backward — the first time since California launched its tiered system that parts of the state have regressed.

Following an increase in cases, Tehama County moved back to Tier 1, the most restrictive, and Shasta County moved back to Tier 2. The setbacks will affect business sectors that had been given the green light to reopen or expand capacity in those areas.

Shasta County, which averaged 173.7 COVID-19 cases per 100,000 residents in the last seven days, and Tehama County, with 124.3 cases per 100,000 residents during the same period, are among the five counties in the state where the most new cases are concentrated, according to The Times’ tracker.

Among the counties that moved forward was Ventura, the fourth in Southern California to advance on the state’s blueprint for reopening. It joined Merced and Yuba counties in advancing from Tier 1, also known as the purple tier, with widespread risk of the virus, to Tier 2, or the red tier, with substantial risk of the virus.

Inyo County moved from Tier 2 to Tier 3, also known as the orange tier, with moderate risk of the virus. Humboldt, Plumas, Siskiyou and Trinity counties moved from Tier 3 to Tier 4, also known as the yellow tier, with minimal risk of the virus.

Ventura County officials were prepared for the move following a decrease in positivity rate and case count. The progressive step will allow the county to expand operations and capacity at business sectors, including restaurants and shopping centers, and to partially reopen other businesses, including movie theaters, for the first time.

If the county remains in the tier for two consecutive weeks, it will be allowed to open all schools. That is true for any county that moves to Tier 2.

Ventura County is currently reporting 5.5 infections per 100,000 residents and a seven-day average positivity rate of 3.0%.

Those metrics have also dipped statewide. The seven-day average for daily infections is 3,005, and the current 14-day positivity rate is 2.7%.

“Our cases have decreased from our peak over the summer, but they have been plateauing,” acting state health officer Dr. Erica Pan said Tuesday. The state’s goal is to continue to see a steady decrease in infections in order to ensure that the projected transmission rate does not rise.

Additionally, the state’s health equity metric went into effect Tuesday.

In order to ensure that communities disproportionately affected by COVID-19 — including Black and Latino residents, Pacific Islanders and low-income residents — get ample attention as each county progresses, the state will examine the positivity rate of a county’s lowest quartile and compare it to the countywide

George Washington University Hospital recovers from cyberattack that forced operations offline

The IT network and medical record system at GWU Hospital were restored this week and the facility’s online applications are being reconnected, Jane Crawford, a UHS spokeswoman, said in an email. The hospital had its systems taken offline shortly after the cyberattack was detected.

Staff at the hospital relied on offline record-keeping while UHS dealt with the attack that affected some of the system’s clinical and financial operations, officials from the national hospital chain said.

Patients’ electronic medical records were not directly affected by the cyberattack, according to a statement issued Monday. There also was no indication that employee data had been accessed.

Crawford did not immediately respond to a request to comment on reports that the hospital chain was hit by ransomware. But the Associated Press reported that the company’s description of the attack is consistent with the type of malware where data can only be restored with software keys after ransoms are paid.

UHS this week has made “substantial progress toward restoration of online operations” across its U.S.-based hospitals, outpatient clinics and behavioral health centers, according to the statement issued Monday. The cyberattack did not affect UHS’s facilities based in the United Kingdom, officials said in the statement.

Despite the network troubles that affected UHS, staff at the Foggy Bottom hospital were still able to treat patients safely, officials said.

Source Article

Trump Has ‘No Symptoms,’ Returns to Downplaying Virus | Washington, D.C. News

By ZEKE MILLER, JILL COLVIN and AAMER MADHANI, Associated Press

WASHINGTON (AP) — President Donald Trump, said to be making progress in his recovery from COVID-19, expressed eagerness to return to the campaign trail Tuesday even as the outbreak that has killed more than 210,000 Americans reached ever more widely into the upper echelons of the U.S. government.

As Trump convalesced out of sight in the White House, the administration defended the protections it has put in place to protect the staff working there to treat and support him. Trump again publicly played down the virus on Twitter after his return from a three-day hospitalization.

In one significant national coronavirus action, he declared there would be no action on economic-stimulus legislation — an announcement that came not long after the Federal Reserve chairman said such help was essential for recovery with the nation reeling from the human and economic cost of the pandemic. Stocks fell on the White House news.

As for Trump’s own recovery, his doctor, Navy Cmdr. Sean Conley, said in a letter that the president had a “restful” night at the White House and “reports no symptoms.”

Meanwhile, Trump was grappling with next political steps exactly four weeks from Election Day. Anxious to project strength, Trump, who is still contagious with the virus, tweeted Tuesday morning that he was planning to attend next Thursday’s debate with Democrat Joe Biden in Miami and “It will be great!”

Elsewhere in the government, the scope of the outbreak was still being uncovered. On Tuesday, the nation’s top military leaders including the chairman of the Joint Chiefs of Staff, Gen. Mark Milley, and the vice chairman, Gen. John Hyten, were in quarantine after exposure to Adm. Charles W. Ray, the vice commandant of the Coast Guard.

It was not known how Ray contracted the virus, but he attended an event for military families at the White House on Sept. 27. The Coast Guard said in a statement that Ray felt mild symptoms over the weekend and was tested on Monday.

Trump on Monday made clear that he has little intention of abiding by best containment practices, when he removed his mask before entering the White House after his discharge from Walter Reed National Military Medical Center. Waiting aides were visible when he entered the Blue Room without a face covering.

Trump’s attitude alarmed infectious disease experts. And it suggested his own illness had not caused him to rethink his often-cavalier attitude toward the disease, which has also infected the first lady and more than a dozen White House aides and associates.

Republican Sen. Susan Collins said Tuesday, “When I saw him on the balcony of the White House, taking off his mask, I couldn’t help but think that he sent the wrong signal, given that he’s infected with COVID-19 and that there are many people in his immediate circle who have the virus,.”

Trump, for his part, falsely suggested that the virus was akin to the seasonal flu.

“Many people every

Study: Pot users may need more anesthesia, painkillers during, after surgery

Marijuana users appear to need more anesthesia than nonusers, and also more opioids to relieve their pain after surgery, a new, preliminary study reports.

Users of cannabis products who had surgery for a broken leg required higher doses of sevoflurane, an inhaled anesthetic that keeps you asleep during a procedure. These folks also required nearly 60% more opioid painkillers per day while recuperating in the hospital, the researchers found.

The results jibe with earlier studies indicating that marijuana users might need more anesthesia initially to put them under, said lead author Dr. Ian Holmen, a resident anesthesiologist with the University of Colorado Anschutz Medical Campus in Aurora.

“It’s similar to flying a plane. You have a takeoff section, and then you have your cruising section and then your landing. These in anesthesia are induction, maintenance and emergence,” Holmen said. “We found that it’s not just in the induction phase of anesthesia that you need more anesthesia, but even during that cruising phase you need more inhaled anesthetic.”

The findings were reported Monday at an online meeting of the American Society of Anesthesiologists. Research presented at meetings is typically considered preliminary.

The implications for most marijuana users are not dire, according to Holmen and Dr. David Dickerson, vice chair of the ASA’s Committee on Pain Medicine.

Pot users should simply be honest with their doctors about their marijuana consumption, so they can dial in their anesthetic dose more accurately, said Dickerson.

“We want to know there might be a need for more anesthesia,” he said. “The last thing we want to do is to be under-dosing if someone is going to have an increased requirement. The more information we have, the more we can react and monitor to keep a patient safe during a procedure.”

But marijuana users who have heart or lung health issues might face some danger in the operating room, depending on how much additional anesthetic they need during surgery, Holmen added.

“Sevoflurane has a very clear dose-dependent effect on blood pressure,” he said. “The more sevoflurane you receive in the OR, the more a patient’s blood pressure drops. If you have heart problems or lung problems coming into the OR, it could be dangerous.”

For this study, Holmen and his colleagues reviewed the records of 118 patients who had surgery at the University of Colorado hospital for a broken shin bone.

Of those, 30 patients reported using cannabis. Holmen said that the amount and frequency of use were not recorded, nor was the type of cannabis product used — CBD, THC, edibles or smoked pot.

During surgery, marijuana users not only needed more inhaled sevoflurane anesthetic, but also higher doses of hydromorphone painkillers, the researchers found.

They also reported higher post-surgery levels of pain that needed larger doses of opioid painkillers to quell.

There are a few potential explanations. It could be that marijuana use alters the way that anesthetic and pain medications are processed by the body, Dickerson said.

“Cannabis is metabolized in the liver. Medications

Six U.S. States Report Record COVID Hospitalizations, New Restrictions in Place | Top News

By Gabriella Borter and Lisa Shumaker

(Reuters) – Six states reported record numbers of hospitalized COVID-19 patients, including Wisconsin, where officials on Tuesday issued a new order limiting the size of indoor public gatherings.

The surge of COVID hospitalizations and new cases in some states coincides with U.S. President Donald Trump and several members of his White House staff testing positive for the novel coronavirus. Trump’s doctors on Tuesday said he was not displaying any acute symptoms after he left the Walter Reed Medical Center, where he was treated for three days.

The spike in reported hospitalizations on Monday hit states in the Midwest the hardest, with Montana, Nebraska, North Dakota, South Dakota, and Wyoming reporting their highest figures, according to a Reuters tally. Wisconsin has 782 hospitalized coronavirus patients, compared with 433 two weeks ago.

Wisconsin’s Department of Health Services issued a directive that gatherings will be limited to no more than 25% of a room or building’s total occupancy.

“We’re in a crisis right now and need to immediately change our behavior to save lives,” Wisconsin Governor Tony Evers said in a statement. “We are continuing to experience a surge in cases and many of our hospitals are overwhelmed, and I believe limiting indoor public gatherings will help slow the spread of this virus.”

In New York, Governor Andrew Cuomo announced new restrictions as the state has seen new hotspots pop up in and around New York City, the hardest-hit metropolitan area in the United States. Among the “intense” cluster areas that will need to apply the governor’s strictest new shutdown orders are parts of Brooklyn, Queens and parts of Rockland and Orange Counties.

The new restrictions affect houses of worship the most – those in hotspots are now required to operate at 25% of capacity with a maximum of 10 people. Schools are being closed in some areas.

Cuomo said that while the new restrictions are necessary – they were “only as good as they’re enforced, and a lack of enforcement has contributed to this problem.”

“There is no way we didn’t see this coming,” Cuomo said.

The news was better farther north – in Maine the governor outlined the next reopening steps.

Governor Janet Mills said Maine was moving into the fourth stage of restarting the state’s economy, saying that as of Oct. 13, churches, restaurants and cinemas in the state would be allowed to operate at 50% capacity.

In Washington, Republican Trump abruptly ended talks https://www.reuters.com/article/idUSL1N2GX0BC with Democrats on an economic stimulus bill to deliver pandemic aid to Americans before the November elections, sending the stock market sliding.

Democratic House of Representatives Speaker Nancy Pelosi said Trump’s decision shows he is “putting himself first at the expense of the country” with cases rising in the United States. The total number of diagnosed infections is an estimated 7.5 million and more than 210,600 people have died in the pandemic, the highest in the world.

(GRAPHIC: Interactive graphic tracking global spread of coronavirus – https://graphics.reuters.com/world-coronavirus-tracker-and-maps/)

(Reporting by

Fruit Sold at Walmart Recalled Due to Listeria Fears


Consumers who purchased products with the affected sell-by dates are urged to throw them away. Meanwhile, Walmart is removing the products from its store shelves.

“Country Fresh takes food safety matters very seriously, stringently follows all mandated regulations and implements preventive measures designed to minimize potential risks,” the supplier said in a news release. “Country Fresh is working in close coordination with FDA in its continuing investigation to resolve the matter promptly and deeply regrets the inconvenience to our consumers and customers.”

What is listeria?

Listeriosis, the infection caused by the germ Listeria monocytogenes, primarily affects older adults, newborns, pregnant women and people with weakened immune systems. It can cause fever and diarrhea, and severe cases can cause infections of the bloodstream or brain. Infections may also affect other parts of the body including bones, joints, chest and abdomen, according to the Centers for Disease Control and Prevention.

No illnesses connected to the current fruit recalls have been reported.

Consumers with any questions are being asked to contact Country Fresh’s customer service line at 877-251-8399, 8 a.m to 5 p.m. CST Monday through Friday.

Source Article

Trump Administration Will Cease Federal Funding to Hospitals That Do Not Report COVID-19 Data | Top News

(Reuters) – The U.S. Department of Health and Human Services will halt some federal funding to hospitals that do not comply with its requirements for reporting data on COVID-19, senior administration officials told reporters on a Tuesday call.

Starting Wednesday, hospitals will be given 14 weeks to provide daily reporting to HHS on COVID-19 cases and deaths, as well as other information such as influenza cases and use of personal protective equipment, the officials said.

Hospitals that fail to comply will lose access to reimbursement from Medicare and Medicaid, federal insurance programs for seniors, the disabled, and people with low incomes, they said.

The data will help coordinate the federal government’s response to COVID-19, including helping allocate supplies of antiviral drug remdesivir, and distribute its stockpile of personal protective equipment, such as surgical masks, said Deborah Birx, the White House Coronavirus Task Force coordinator.

HHS is requiring that hospitals provide daily influenza case reporting because of the likelihood flu season will intersect with the ongoing COVID-19 pandemic, the officials said.

“It is not certain what will happen this fall and winter, however the CDC is preparing for there to be COVID-19 and seasonal flu activity at the same time,” said Centers for Disease Control and Prevention director Robert Redfield.

Earlier this year, the U.S. government struggled to provide sufficient personal protective equipment to hospitals inundated with COVID-19 patients. It has also played a role in allocating Gilead Sciences Inc’s remdesivir to hospitals after U.S. regulators approved the antiviral drug in May for emergency use in some COVID-19 patients.

HHS took over responsibility for collecting hospitals’ COVID-19 data from the Centers for Disease Control and Prevention in July. News reports suggested the Trump administration move was aimed at bypassing the CDC, speculation the CDC director has rejected.

(Reporting by Carl O’Donnell; Editing by David Gregorio)

Copyright 2020 Thomson Reuters.

Source Article