Category: Corona Virus Vaccine

The prevalence of comorbid chronic obstructive pulmonary disease (COPD) among patients hospitalized with coronavirus 2019 (COVID-19) is actually lower than its presence in the general population, according to a new observational cohort analysis.

In new data presented online during the American College of Chest Physicians (CHEST) 2020 Annual Meeting this week, investigators reported just 1 in 20 observed patients hospitalized with COVID-19 suffered from COPDversus significantly greater rates of cardiometabolic disease among the most severely ill patients.

Study authors Vikramaditya Samala Venkata, MD, and Gerard N. Kiernan, MD, both of Dartmouth-Hitchcock Medical Center, conducted a systematic electronic search-based assessment of COVID-19 clinical trials to define associations between baseline COPD and overall outcomes of hospitalized patients.

Current understanding of such associations is not yet comprehensive, but nonetheless troubling given the respiratory burden of the pandemic virus.

Although clinical data is limited, studies published so far raise concerns about an association between COPD and worse clinical outcomes in COVID-19, they wrote.

The systematic search included retrospective studies including original hospitalized COVID-19 patient data from any of 3 major databases. Venkata and Kiernan used pooled analysis with a random-effects model in order to interpret the associations between COPD and COVID-19.

Their analyses included 22 studies from 8 countries including 11,000-plus patients hospitalized with COVID-19. Mean patient age was 56 years old, with 58% reported as male.

Among all comorbidities, hypertension was the most prevalent in hospitalized patients, at 42%. Another 23% of patients had diabetes mellitus.

Investigators observed a COPD prevalence rate of just 5% (n = 437) in patients hospitalized with COVID-19. However, such patients faced a three-fold greater risk of mortality (odds ratio [OR], 3.23; 95% CI, 1.59 6.57; P <.05). They noted the global prevalence of COPD among patients >40 years old is approximately 9%.

One explanation may be precautions put in place by COPD patients and their friends, family, and neighbors to limit their risk of COVID-19 exposure, given fears of more severe disease risks for such patients.

While one would expect patients with prior lung disease to have greater mortality with COVID-19, it is curious to see that the prevalence of COPD was lower than the general population may reflect greater measures taken by COPD patients to avoid coronavirus exposure, investigators wrote.

Uniquely, Venkata and Kiernan also found that smoking was present in more than one-third (37%) of COVID-19 patientsyet patients who smoked faced only a 52% worsened risk of disease severity (OR, 1.52; 95% CI, 0.81 2.87; P = .20). Reasoning for a mixed association, they noted, is still unclear.

Investigators concluded that more randomized trials are necessary to understand relationships between COPD, smoking status, and hospitalized COVID-19 prognosis in patients.

This will alert clinicians to the worse prognosis of COVID-19 infection in patients with history of COPD and it will raise a question for future studies to look at the association between baseline COPD and COVID-19, they concluded.

The study, COVID-19 and COPD: Pooled Analysis of Observational Studies, was presented at CHEST 2020.

Excerpt from:

COPD Linked to Three-Fold Greater Mortality Risk in Severe COVID-19 Patients - MD Magazine

Throughout Michigan's worst public health crisis in a century, Senate Majority Leader Mike Shirkey has decried Gov. Gretchen Whitmer's management of the coronavirus pandemic as heavy-handed.

The Republican from Jackson County has even gone as far as saying the Democratic governor is "very comfortable being a dictator."

Shirkey and House Speaker Lee Chatfield sued Whitmer over her emergency powers and encouraged a petition drive to strip the governor of these extraordinary powers just in case they lost in the courts.

The Michigan Supreme Court ultimately sided with the GOP-run Legislature in a different lawsuit over the 1945 emergency powers law the governor used to keep certain businesses closed for months and limit social gatherings to contain the virus was unconstitutional.

Shirkey, who has long argued government cannot eliminate all risk, says people should have the freedom to choose their own level of risk in contracting or spreading this deadly virus.

Call this the Shirkey Doctrine.

It's a let-it-burn-through strategy with the virus that, in his words, includes "an element of herd immunity."

Except there's no safe, effective and readily available vaccine yet to inoculate the herd.

And just as new cases of coronavirus, hospitalizations and deaths are starting to rise again in Michigan in what might be a second wave of the pandemic, we're now sort of trying out the Shirkey Doctrine.

In the absence of Whitmer's executive orders, there's now a patchwork of regulations for businesses and individuals to follow from the Michigan Department of Health and Human Services, the Michigan Occupational Safety and Health Administration and county health departments.

In Detroit, there's another set of rules for businesses to adhere to with some slight differences. Other cities hard-hit by the virus are considering ordinances that are more restrictive than state-level orders under the public health and workplace statutes.

But none of these government bodies has the full weight and force of Michigan's chief executive.

Few people know who Robert Gordon or Sean Egan are (they're the director of MDHHS and MIOSHA's COVID workplace safety director, respectively).

Their orders don't carry nearly the same kind political and legal weight as the governor.

The MDHHS public health orders and MIOSHA's temporary rules are left open to potential legal challenges, adding more confusion among the masses about what's the law and what's not.

Confusion and sowing doubt in the science also is part of the Shirkey Doctrine moving forward.

For months, he has publicly encouraged mask-wearing and social distancing. He's even in the mask-sanitizing business.

But Shirkey has resisted any kind of public mandate and has been casting doubt on the effectiveness of two layers of cloth stopping droplets from the nose and mouth from escaping into the air other people breathe in confined indoor places.

He's resisting the precautions that the public had grown accustomed to in the interest of protecting their own health and the health of others.

Shirkey has, so far, resisted having the Legislature temporarily write a universal mask mandate into law, leaving the door open for more court battles for the Whitmer administration and counties to defend the various orders.

The Whitmer Doctrine has centered on the governor using the centralized powers of her office to try to limit the ways people can come in contact with COVID-19.

Whitmer's approach has, at times, been frustrating to many and financially devastating to some of the businesses that were left hanging in the wind for months on end.

The governor's communication of the reasoning and science behind keeping certain businesses closed and letting others reopen has been downright maddening at times.

But there's almost no debating that the spring lockdown produced the curve-flattening results that Whitmer promised.

By mid-June, as the economy was reopening, the daily case count was down to an average of about 150 new COVID-19 infections each day.

The 4,045 new cases reported Thursday and Friday pushed the new seven-day average to 1,425 nearly 10 times more COVID cases each day than four months ago when the Whitmer Doctrine was Michigan's strategy for navigating a once-in-a-lifetime pandemic.

As Whitmer gradually reopened sectors of the economy and people let their guard down, the virus started spreading again.

It was an inevitable outcome, especially when schools and college campuses reopened.

And, yes, the death rate from this virus for young people is very, very low.

But the death rate for their parents and grandparents is alarmingly high not to mention the long-term health scars COVID is leaving in people in already poor health.

A group of nationally recognized infectious disease experts wrote Shirkey a letter last week saying that in order to achieve herd immunity, 6.5 million people in Michigan alone would have to get infected.

"At the current mortality rate, this would mean more than 30,000 additional deaths more than four times the number of deaths to date," wrote the group of public health experts that included former Centers for Disease Control Director Tom Frieden.

There are 2.4 million residents in Michigan over the age of 60 (Shirkey being one of them).

The death rate for people in their 60s who have contracted COVID-19 in the past three months is about 3 percent, according to state data.

For people in their 70s, that death rate jumps to between 8 percent and 10 percent. For those older than 80, the death rate approaches 20 percent, according to state data.

One-in-five people over age 80 who contract COVID-19 are succumbing to this virus.

But what will happen if the societal expectation to wear masks, wash your hands and not go to a rock concert dissipates without a clear legal mandate from the people who write this state's laws?

That's something to bear in mind as we enter this period of trying it Shirkey's way.

Read the original here:

Commentary: As COVID-19 cases surge, Michigan shifts from the Whitmer Doctrine to the Shirkey Doctrine - Crain's Detroit Business

Hospitals in and around Kansas City, Missouri, are overwhelmed amid a troubling spike in COVID-19 cases that has forced some facilitates to refuse non-emergency care and others to turn away ambulances due to over-occupancy.

Average daily COVID-19 hospitalizations were up about 10% this week across the Kansas City region as the Midwest grapples with record-breaking daily infection rates and intensive care unit bed shortages, according to the Mid-America Regional Council's dashboard.

Earlier this week, the Kansas City metro area saw its highest number of new COVID-19 hospitalizations on record with the seven-day average rising to about 133. Separately, hospitals in the area reported a 28% increase in the average number of patients on ventilators, week-over-week, while daily ICU occupancy rose about 11% from last week, according to the dashboard.

All in all, total weekly hospitalizations jumped to 867, compared to 835 last week, pushing several area hospitals to refuse ambulances due to lack of beds.

Marc Larsen, operations director of Saint Luke's COVID Response Team, the second-largest care provider in the region, said Kansas City area hospitals are "bursting at the seams."

Saint Luke's daily patient average rose to about 85 for the month of October, compared to about 63 per day in September, Larsen said. The system reported a daily patient average of only about 15 COVID-19 patients a day in May and June.

"The current trajectory and the rapid increase in infections is a big concern for me," Larsen told ABC News in an interview Friday. "And with our numbers where they are coming into influenza season, I worry that the facilities will continue to be pushed to the brink on our ability to care for each and every single one of these patients like we need to."

He added, "As a result, our emergency departments and having to leverage alternative care units in our facilities, meaning that we wind up seeing emergency department patients in our pre-anesthesia care units, recovery rooms and sometimes in waiting rooms."

Fans take in a flyover before the Kansas City Chiefs take on the Las Vegas Raiders at Arrowhead Stadium in Kansas City, Mo., Oct. 11, 2020.

Larsen, who is also an emergency care physician at the downtown Kansas City hospital, said at least eight metro hospitals and emergency departments had to temporarily stop accepting ambulances due to the high volume of patients on Tuesday and Wednesday.

"We had eight facilities at one given time that were on 'diversion,' or what we call high-volume status," he said. "That doesn't mean that we don't still take the time-critical diagnoses -- we still take our stroke patients, our trauma patients and our heart attack patients -- but it does limit our ability to provide care to the remainder of ambulances."

"When we get to that volume and when we get to that capacity we're force to hold patients, because may not physically even have a bed available," he added.

Hospitals volumes were in much better shape as of Friday afternoon, but he said he "would not be surprised if this evening and throughout the weekend that we continue to see high volumes and emergency departments across the region."

He said Saint Luke's hospitals were currently experiencing volumes that they only see during peak flu season, warning the public that the situation could get a lot worse by winter.

"Peak flu season is always our busiest time of the year. We have a lot of sick patients and our volumes are a lot higher," Larsen said. "The volumes that we're seeing at this moment are very similar to what we see, typically, in January or February. If we're already at that level and we have this large influx of influenza patients -- as we typically do -- where will we take care of all these patients?"

Like many health officials, he urged all Americans to get a flu shot this year, even if you've never gotten one before.

"Aside from the social distancing, masking and hand hygiene, we don't have a way to prevent this, but we do have one for the other pandemic that we're looking at and that's influenza," Larsen said. "I've been encouraging all my patients to get their flu shots now because I think that's gonna really help us prevent this second surge, not of COVID patients but other patients that need the same type of resources that COVID patients need."

As of Friday, Missouri had reported 2,017 new confirmed cases over the last 24 hours, bringing the total number of cases since the start of the pandemic to 152,571.

The state now ranks fourth nationally in reported deaths over the past seven days, and eighth in the number of new cases, according to the statewide dashboard.

In this Aug. 6, 2020 file photo, Missouri Republican Gov. Mike Parson speaks during a news conference in St. Louis.

Missouri also reported 17 new virus-related deaths on Friday, pushing the total number of COVID-19 fatalities to 2,459, state officials said Friday.

As of late Thursday, COVID-19 hospitalizations were up to 1,443 across the state, the highest on record. Health officials had not released Fridays data as of the time of publication.

Gov. Mike Parson recently announced that the state had submitted its plan for administering the impending COVID-19 vaccine to the Centers for Disease Control and Prevention in an effort to be proactive about slowing the spread.

"This has been an incredible collaborative effort, and I want to thank all of the agencies and partners involved for their hard work and dedication. In the midst of an ever-changing and unprecedented situation, our team of professionals has done outstanding work to develop a detailed plan," Parson said in a statement this week after submitting the plan. "We are in a great place in the planning process and will be well-prepared to take action as soon as a vaccine becomes available."

See more here:

Kansas City hospitals overwhelmed, some forced to divert ambulances as COVID-19 cases jump - ABC News

Just south of the Galapagos Marchena Island, theres a dive spot known by locals as the fish arena.

There, within the choppy, cool waters of the Pacific, thousands of colorful fish swim in schools, lobsters poke their long antennae out of rocky outcrops, dolphins bear their young and moray eels gape menacingly at visitors who swim too close.

Charles Darwin documented the rich biota of these islands in the early 1800s. In more recent times, an unofficial network of local tour boats and fishing vessels has worked to protect it, by keeping an eye out for those who might harm the marine bounty. But the pandemic has grounded this surveillance fleet, creating an opening for outsiders.

Earlier this summer, more than 300 Chinese fishing vessels many designed to hold 1,000 tons of catch waited at the marine preserves border, ready to snatch up sea life as it migrated south toward the waters off Peru and Chile.

By some estimates, China has a distant water fishing fleet of 17,000 vessels that has been involved in fishing conflicts off the coasts of West Africa, Argentina and Japan in recent years. Now this fleet is triggering similar anger off Ecuador and Peru, two nations highly dependent on their robust near-shore fisheries.

This is an attack on our resources, said ngel Ynez Vinueza, the mayor of Santa Cruz canton, the Galapagos equivalent of a province. They are killing the species we have protected and polluting our biota with the plastic waste they drop overboard. They are raping the Galapagos.

The fleet is hardly the only threat to this park, a UNESCO world heritage site.

As a result of the COVID-19 pandemic, tourism has plummeted tour boats have been moored in Santa Cruz Islands Academy Bay for months, while shops and restaurants are shuttered along Puerto Ayoras main drag, Avenida Charles Darwin.

It has laid bare the vulnerability of an economic model that is 90% dependent upon tourism dollars, while also highlighting the extraordinary beauty and remoteness of the islands and the magic that is lost when thousands of tourists descend daily into this fragile ecosystem.

The Galapagos marine reserve faces threats from industrial fishing, climate change and reduced funding for conservation.

During a recent visit to the Galapagos, a Times reporting team the only visitors touring the park by boat witnessed penguins swimming alongside tropical fish and sea turtles, krill blooms clouding the shallow waters with pink flotsam, and migrating tuna and hammerhead sharks meandering through the darker, deeper waters.

Normally, pods of dolphins and whales stay out of the busy harbor in Academy Bay. But with the tourist boats out of commission, they are swimming around the area for the first time in decades. Brown pelicans are nesting in the nearby cliffs and mangroves a sight Fiddi Angermeyer, 68, a local tour operator and business owner, says he hasnt seen since he was a kid.

Animals like these Galapagos penguins have flourished as the pandemic keeps visitors away, but the lack of tourism could devastate the parks funding and has left an opening for poachers to move in.

(Carolyn Cole / Los Angeles Times)

The situation has prompted politicians, environmentalists and business owners to wonder how the region can regrow and provide a vibrant economy and jobs for its residents while maintaining the wild essence of the park and tamping down on its carbon-intensive requirements the jet planes and cruising boats of international tourism.

Its like it was 30 or 40 years ago, said Mary Crowley, the director of Ocean Voyages Institute, a Sausalito, Calif., environmental organization working to rid the oceans of plastic. Shes been to the Galapagos 23 times since 1972. That splendor has returned.

Its also exposed the critical role tourism plays in the upkeep and safety of the park: Without visitors traveling to the outer islands and local fishing crews patrolling the parks waters, no one is watching for poaching or picking up the litter and plastic floating in from the mega-fleets and mainland.

The calculus is clear, said Angermeyer: If there are no tourists, there is no park. And if theres no park, there are no tourists.

A world heritage site, the Galapagos marine reserve faces threats from industrial fishing, climate change and a drastic drop in tourism and funding for conservation.

Mosquera Island is not much more than a skinny spit of sand and rock off Baltra Island, where the Galapagos Islands main airport is located.

On a recent afternoon, baby sea lions, Galapagos pigeons and Sally Lightfoot crabs scrambled across the rocks or lolled in the sunbaked sand on Mosqueras southern shore. The airport and the channel separating the islands were largely silent just the sound of waves lapping and sea lion moms and pups barking back and forth.

But a walk around the rocky edge of the island showed something deeply distressing to Fernando Ortiz, a park guide and former director of the regions chapter of Conservation International: Scores of plastic bottles, shoes and equipment packaging labeled with Chinese characters poked out of the jagged rocks.

Fernando Ortiz, a park guide and former director of the regions chapter of Conservation International, picks up bottles, shoes and equipment packaging from the jagged rocks of Mosquera Island in the Galapagos.

(Carolyn Cole / Los Angeles Times)

These are from those boats, said Ortiz, pointing south, toward the horizon, where the fleet of Chinese fishing vessels had congregated roughly 200 nautical miles away. He noted the newness of the items, with labels not faded by sun or sea.

In July, the Ecuadorian navy had become alarmed as the fleet approached the edge of the 200-mile zone around the park where commercial fishing is illegal.

For years, fishing crews have trawled this zone, hoping to capitalize on the fruits of conservation increasingly healthy and robust fish stocks said Boris Worm, a researcher at Dalhousie University in Canada who has studied the fishery.

But last summer, the number of vessels exploded. In late August, a U.S. Coast Guard cutter was called in to help Ecuadors navy patrol the area.

Capt. Brian Anderson, commanding officer of the Coast Guard cutter Bertholf, said the Chinese brought in a tanker ship, which provided fuel to the other ships, and processing ships, where the fishing vessels could dump their harvest and go out and collect more.

It was like a city, he said, noting the fleet had all the pieces it needed to stay out for months without returning to home ports.

Several of the Chinese vessels werent reporting their location electronically, he said, and one was reporting its location as Alaska. But without jurisdiction in the area, and nothing blatantly illegal to report to the Ecuadorian navy, the Coast Guard was relegated to watching, he said.

A Chinese fishing boat off the coast of Peru lights up the surrounding water to attract squid in 2018.

(Simon Ager Photography)

For its part, China has contended it has zero tolerance toward illegal fishing. In a July 23 statement, the Chinese Embassy in Quito said China respects Ecuadors measures to protect the environment and preserve marine resources.

But John Serafini, chief executive of a Virginia-based military defense and commercial data analytics start-up called HawkEye 360, said his companys research which relies on radio frequency and satellite imagery to process movement showed many suspicious signals coming from within the zone this summer.

In 2017, a Chinese fishing vessel intercepted off of the Galapagos was found to be hauling 300 tons of fish, which included tens of thousands of illegally caught sharks.

Mayor Vinueza said the continuing presence of the fleet is an assault on the preserve and his residents livelihood, especially in the face of the economic devastation the park is suffering.

Local fishermen try to sell lobster to boaters in Santa Cruz Islands Academy Bay. The pandemic has caused a desperate economic situation for the residents who depend on tourism in the Galapagos.

(Carolyn Cole / Los Angeles Times)

In August, hundreds of Santa Cruz canton residents took to the streets to protest the fishing fleet worried it was depleting the parks natural resources, potentially giving one more reason for tourists not to return.

On Sept. 24, a commercial flight from Guayaquil to Baltra Island had only nine passengers aboard. Though Avianca Airlines once had daily flights to the island, those have dropped to a sporadic two or three a week.

The lack of tourists has clearly hit the businesses that rely on them, as well as the fishermen and farmers who supply the industry.

Denato Rendon, a local fisherman, has been giving his fish away while his cooperative tries to find new buyers on the mainland and overseas. William and Noralma Cabrera, farmers in the hills outside Puerto Ayora, are also giving food away, and sometimes bartering trading their tomatoes and cucumbers for goods such as fish, chicken or milk.

Were a close-knit community, the father of two said as he stood in front of greenhouses where beans, lettuce and tomatoes were ripening.

The dearth of tourists has also hit the park, which relies on $100 entry fees from visitors. The fees provide money for preservation, conservation, upkeep and enforcement. More than 97% of the Galapagos is protected parkland; the rest is residential.

On Sept. 24, the park pulled in $1,240 from tourist fees at the islands two airports just 4% of last years collection for the same day, said Norman Wray, president of the Government Council of Galapagos.

Noralma Cabrera and her husband, William, are farmers in the hills outside Puerto Ayora. Without tourism driving the economy, theyve started giving food away.

(Carolyn Cole / Los Angeles Times)

We cant keep things going like this, Wray said of the high unemployment and tourism exodus from the islands. To try to counteract that, Wray and others are underscoring the safety of the islands and the seriousness with which the industry takes the pandemic.

Look around you, Vinueza said, it is safe here. We have strict protocols. We wont let the virus in.

Proof of a negative PCR coronavirus test, taken within 96 hours of arrival in the Galapagos, is required for entry. Thats more stringent than the requirement to get into Ecuador, which requires a PCR coronavirus test to be taken within 10 days of arrival.

Seemingly everyone in the now-quiet Puerto Ayora wears a mask, and all businesses require patrons to douse their hands and shoe soles in alcohol before entry. Boat crews are even spraying the hands of scuba divers just emerging from the ocean before they let them back on their boats.

We just cant be too careful, said Ortiz, who works on Angermeyers ship, the Passion, as a guide. And its important that people know how seriously we take this disease.

As a result of the pandemic, tourism has plummeted in the Galapagos and tour boats have been moored in Academy Bay for months, while shops and restaurants are shuttered.

(Carolyn Cole / Los Angeles Times)

Still, theres the sense here that the pandemic may have changed the tourist economy in the islands forever and in some respects, Wray said, that may be for the better.

He noted that broadband cables are being laid along the ocean floor, which soon will connect the islands with high-speed internet making it possible for a high-tech academic center or industry, such as Google or Amazon, to relocate or establish satellite offices in the islands.

What a laboratory to work in, he said, describing the wildness, beauty and history of the islands. And such a prospect, he said, could help park managers imagine a future that didnt require international tourists to board jumbo jets or gas-guzzling pleasure cruisers to meander around the islands.

For the park to survive and its wildlife to thrive, the future of tourism on the island and in the region must change, Wray said.

Though the pandemic and Chinese fishing fleet pose threats, he said, they also have offered a moment for the parks leaders to consider more sustainable models for the Galapagos and the flora and fauna that tourists come to see.

We cant survive without them, he said. But we need to find a balance.

See more here:

Galapagos Islands threatened by fishing fleets and COVID-19 - Los Angeles Times

PIERRE, S.D. (KELO) Eight new COVID-19 deaths were announced along with a new active case count record in the latest update from the South Dakota Department of Health.

The death toll in South Dakota rose to 315. The eight new deaths included four men and four women. One death was listed in the 50-59 age range, two in the 70-79 age range and five victims listed in the 80+ age range. The new deaths were listed in the following counties: Day, Douglas, Kingsbury, Lincoln (3) and Minnehaha County (2).

There have been 92 deaths in October, the deadliest month of the pandemic so far.

On Saturday, 806 new coronavirus cases were announced, bringing the states total case count to 32,611 up from Friday (31,805). Total recovered cases is now at 24,528, up 342 from Friday (24,186).

Active cases increased to 7,768 from Fridays 7,312.

Current hospitalizations are now at 295, down from Friday (299). Total hospitalizations are at 2,077, up from Friday (2,044).

Total persons tested negative is at 196,593, up from Friday (195,185).

There were 2,214 new persons tested reported on Saturday.

Read more from the original source:

COVID-19 in South Dakota: 806 total new cases; Death toll rises to 315; Active cases at 7,768 - KELOLAND.com

While coronavirus vaccine trials are ongoing and a U.S. vaccine has yet to be approved, state health officials are planning ahead for how to eventually immunize a large swath of the population. Chandan Khanna/AFP via Getty Images hide caption

While coronavirus vaccine trials are ongoing and a U.S. vaccine has yet to be approved, state health officials are planning ahead for how to eventually immunize a large swath of the population.

Updated at 1 pm, to include comment from the White House and the Department of Health and Human Services

Even the most effective, safest coronavirus vaccine won't work to curb the spread of the virus unless a large number of people get immunized. And getting a vaccine from the manufacturers all the way into people's arms requires complex logistics and will take many months.

Now, public health officers across the country are rushing to finish up the first draft of plans for how to distribute a coronavirus vaccine if and when it is authorized, and they're grappling with a host of unknowns as they try to design a system for getting the vaccine out to everyone who wants it.

The Centers for Disease Control and Prevention gave state immunization managers only 30 days to draft a comprehensive COVID-19 vaccine distribution plan. Friday is the day those plans are due.

The timing of vaccine research and planning is politically fraught with the presidential election a few weeks away. When the CDC announced the October deadline last month, critics worried that political pressure was tainting the process, since President Trump has repeatedly promised a vaccine will be ready soon.

"If you listen to the White House, [vaccine distribution] could be just a matter of weeks away," New York Gov. Andrew Cuomo told reporters on Thursday. He and Arkansas Gov. Asa Hutchinson sent a letter to Trump on behalf of the National Governors Association asking for a meeting to talk through the many unanswered questions about the process.

"We need to know: What is the plan? What does the federal government do, what do you expect the states to do? When does it start? Who funds it?" Cuomo said. "Let's figure it out now because this virus has been ahead of us every step of the way it's about time this country catches up."

In a written response to the governors on Friday, Trump administration official Douglas Hoelscher said the White House has already provided states with several opportunities to discuss plans for vaccine distribution, and that a meeting with Health and Human Services Secretary Alex Azar was being arranged.

Planning fast with changing expectations

For dozens of public health officials across the country, the process over the past month has been like "herding a lot of cats," says Claire Hannan, director of the Association of Immunization Managers. "It's really cramming three to six months worth of strategic discussions ... into 30 days," she says.

States need to lay the groundwork for distribution now, says James Blumenstock, vice president for pandemic response and recovery for the Association of State and Territorial Health Officials. That means deciding who's in charge of responsibilities such as ordering supplies, signing up vaccine providers, training staff, and running mass vaccination clinics and outreach campaigns, he explains. They'll also need a data management system to track who received an initial vaccine dose and to remind them to come back for their second dose.

"We have been working feverishly over the past few weeks," says Decrecia Limbrick, assistant director of the Department of Health in Houston, which is one of several large cities that receives funding directly from the CDC. "I think we're ready to submit a plan a 'Version 1' of a plan."

Then there are conflicting messages from the Trump administration. "Originally there had been talk about hurrying up and getting your plan done because the vaccine will be ready before the election," says Kris Ehresmann, director of infectious disease for Minnesota's Department of Health. When the Food and Drug Administration recently said that vaccine trials must allow two months after the last experimental dose is administered, that guidance "changes the timeline" again.

"It's pretty much like being in a continuous earthquake," she adds. "The ground is constantly moving."

Despite the tight timeline, "all jurisdictions appear to be on target to meet the [Friday] deadline," Michael Pratt, spokesperson for the U.S. Department of Health and Human Services, wrote in a statement to NPR. "Once received at CDC, we will conduct a review of the draft plans and provide feedback to jurisdictions in the next two weeks. The team reviewing each plan will include CDC and [Department of Defense] staff."

Pratt noted that CDC has been holding weekly conference calls with immunization managers, and has already "answered nearly 400 distinct questions from states."

Overcoming logistical hurdles

Nobody knows which vaccine will be authorized first, when that will happen, which populations it will be authorized for, and how many initial doses will be available.

Adding to this uncertainty is the likelihood that the first coronavirus vaccines will be extremely challenging to handle. The CDC playbook notes that the vaccines will likely require cold chain storage (possibly "ultra-cold" storage, which is colder than Antarctica), must be given in two doses a certain number of days apart, and could have a minimum order of 1,000 doses.

"For routine vaccines, [providers] will order 10 doses at the time or 20 doses at a time," explains Michigan Department of Health and Human Services immunization director Bob Swanson. "It makes it more difficult to think about how are we going to use a thousand doses for at risk populations across a rural county?"

Initially, the focus will be on the priority groups who will be first in line to get immunized. The specifics of who that will be are still getting worked out by a CDC advisory committee, although front-line health workers will almost certainly be at the top of the list. There are also concerns about distributing the vaccine equitably to communities that, for instance, speak different languages or are difficult to reach, especially at first when doses are limited.

As immunization managers look ahead to the coming year, different places around the country face a range of challenges.

Then there are seasonal issues. During a North Dakota winter, freezing temperatures and snowfall make outdoor drive-through clinics untenable, says Molly Howell, North Dakota's immunization program manager, so they're considering using warehouses or sporting venues for mass vaccination campaigns so that people can gather indoors while maintaining physical distance. "Those are some of the ways that we're trying to be creative about vaccinating people safely during the pandemic," she says.

In Houston, officials are thinking ahead to the complications of the hot and humid summer. "If we get those hot days, we want to obviously ensure that we maintain the integrity of the vaccine," says Limbrick of the Houston Department of Health, and they have to think about taking care of the medical staff who have to administer the vaccine in those conditions.

"After [health officials] push that button on Friday afternoon, on Saturday morning, they're going to continue to work on their planning efforts going forward over the days and weeks and months ahead," says Blumenstock of ASTHO. And when the first vaccine is authorized, "it's going to be close to a yearlong effort," he says, to immunize everyone across the country who wants to be vaccinated.

Finding the money to execute plans

CDC Director Robert Redfield told Congress last month that states are going to need about $6 billion to distribute vaccines.

"This is going to take substantial resources," Redfield told lawmakers. "The time is now for us to be able to get those resources out to the state[s]."

On Thursday, ASTHO and the Association of Immunization Managers wrote a letter formally requesting $8.4 billion from Congress for these efforts.

The letter notes that so far the CDC has distributed $200 million to states, territories and a few large cities to fund the vaccine planning process but it describes this sum as "merely a down payment." And with the election looming, the chances of a new COVID-19 relief bill getting through the legislature anytime soon are dim.

"The funding I don't have control over, but I do have control over how we're going to get vaccines out when they're available," says Swanson. "And I will tell you, public health is strong, and public health works hard, and immunizations are public health's bread and butter."

Michigan has received $5.9 million so far, and Swanson says that money has gone to getting the state's immunization registry up to speed, and to local health departments for staffing.

The lack of clarity about funding troubles Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition and the former director of Tennessee's immunization program.

States need additional funds to be able to carry out the plans they're submitting to the CDC, she says. "They need to be able to invest in manpower, in I.T. systems and in the people to use them," she explains, adding that those who are brought in to run the vaccination campaigns from other parts of the health department like STD clinics and family planning will also need to be backfilled.

"A lot of things need to be paid for with these billions of dollars," she says. "Even the best laid plans can't be executed if you don't have the resources to do so."

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COVID-19 Vaccine Distribution Will Be Challenging. States Rush To Plan Ahead : Shots - Health News - NPR

Scientific consensus on the COVID-19 pandemic: we need to act now  The Lancet

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Scientific consensus on the COVID-19 pandemic: we need to act now - The Lancet

AUSTIN, Texas The share of Texans who think that the coronavirus is a significant crisis continues to decrease, according to data from the latest in a series of polls measuring Texas attitudes toward the COVID-19 pandemic and Texans reported behavior in response to it.

In April, 66% of Texans felt that the coronavirus was a significant crisis. In June, that belief was held by 57%, and now in October, 53%. The latest poll, conducted Sept. 25 to Oct. 4 by The University of Texas at Austin and The Texas Tribune, repeats similar sets of questions from polls conducted in April and June.

A team of researchers affiliated with the Texas Politics Project and the Department of Government at The University of Texas at Austin designed the poll. The April and October polls were conducted in partnership with The Texas Tribune, and the June poll was conducted by the Texas Politics Project in response to the pandemics continuing impact on Texas. All three polls surveyed samples of 1,200 self-declared registered voters in Texas. Data was collected over the internet by YouGov.

Most of this drop in perceived seriousness can be attributed to changes in the attitudes of Republicans and political independents, said James Henson, co-director of the statewide poll and director of the Texas Politics Project at UT Austin. Among Texas Democrats, the share saying that COVID-19 is a significant crisis has changed very little.

The polls also registered a decrease between the June and October polls in the share of Texans who say they would try to get a coronavirus vaccine if it became available at low cost. Less than half of Texans (42%) said they would try to get a vaccine in the most recent poll, a significant drop from the 59% who said they would in the June UT/Texas Politics Project poll.

It seems that the question of a COVID vaccine has become somewhat partisan, said Daron Shaw, co-director of the poll and Frank C. Erwin, Jr. Chair of State Politics at UT Austin. Beyond the normal reticence about vaccines, some others mostly on the political left are suspicious about the efficacy of a vaccine approved by people who might be influenced by the current administration.

The polls showed that individuals concerns about community spread and contracting the virus continue to drop, even as case counts fluctuate. In April, 54% of Texans said that they were either extremely (28%) or very (26%) concerned about the spread of the coronavirus in their community, but that concern dropped to 47% in June and now stands at 40%. The share that are not very or not at all concerned has also seen an increase, from 17% in April, to 26% in June, to 30% in October.

Individual concern follows a similar pattern, with concern about contracting the coronavirus peaking in April at 54%, but then declining to 48% in June, and 44% in October. The share who report being unconcerned has risen from 17% to 27% to 32% during the same period.

Ultimately, the decline in concern appears to reflect some groups accommodation of pandemic conditions, even if it doesnt correspond with the actual, collective experience of the virus as a dire public health threat, said Joshua Blank, research director for the Texas Politics Project.

As concerns dropped, Texans also became more lax about more serious social distancing practices. The share who say that they are living normally, coming and going as usual increased from 9% in April, to 19% in June, to 27% in October polling. The share only leaving when they have to or not leaving home at all has declined from 72% in April to 34% in October. However, more Texans report wearing masks when they do go out, with 87% saying they wear one when coming into contact with others outside their home in the most recent poll, up 6 points from 81% who said the same in June.

In April, 57% of Texans said that efforts to deal with the coronavirus were going well in the U.S., and 64% felt the same about those efforts in Texas. Today, only 45% say that efforts are going well in the U.S., 51% in Texas. The share saying that things are going badly has similarly increased from 40% to 49% when thinking about the countrys efforts, and from 29% to 44% when considering Texas.

The date files and supporting material for the latest poll are now available at the Texas Politics Project website. Publicly available resources also include hundreds of downloadable graphic files in multiple formats for both the overall sample and major subgroups for teaching, research and presentations. These include more than 180 items related to COVID-19 and the pandemic.

The October University of Texas/Texas Tribune Poll is the 41st statewide poll conducted in Texas by a team of researchers based in the Department of Government and the College of Liberal Arts at UT Austin. For access to data sets and thousands of graphics useful for teaching and presentations, visit theirpolling data archive.

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Half of Texans Consider COVID-19 a Crisis; Willingness to Get Vaccine Declines - UT News | The University of Texas at Austin

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.s vaccine advisory panel, said that pausing a trial is a huge logistical challenge especially for one like Johnson & Johnsons, with plans for 60,000 volunteers in 10 countries.

Its this big warship that you just stop moving, Dr. Offit said.

Once a trial is paused, a safety board may ask for a volunteer who experienced an adverse event to be unblinded in other words, to find out if the volunteer got the placebo or the treatment. If the volunteer received a placebo, then the treatment cant be the cause of the event and the trial can continue.

If it turns out that the volunteer got the treatment, the board does a flurry of detective work. The members look over the medical records. They may ask for more information about volunteers health or even order new tests not just for the people who experienced adverse events, but for everyone in the trial.

The board uses this evidence to come to a conclusion about whether the treatment most likely had anything to do with the event. On very rare occasions, for example, some vaccines can cause a nerve disorder called Guillain-Barr syndrome. But the condition takes weeks to develop. If a volunteer shows signs of Guillain-Barr syndrome on the day of a vaccine injection, it cant be the cause.

Regulators then review the decision of these boards and may accept it or ask for more information. For trials that are running in several countries at once, this review can make pausing a trial even more of a challenge. After AstraZeneca paused its global trials on Sept. 6 for a review, regulators in Brazil, India, Japan, South Africa and the United Kingdom all gave the green light for the trial to resume. But American regulators are still keeping the U.S. trial on pause as they continue to look over the evidence.

If a safety board rules that an adverse event most likely was not a result of the vaccine or treatment, it may allow the trial to start up again. If, on the other hand, theres some urgent problem a contaminated batch of drugs, for example the trial may have to stop. When the evidence isnt so clear, the board may let the trial resume with extra tests or exams. A second case of the same event might be more common than you would expect from chance, forcing the trial to end.

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3 Covid-19 Trials Have Been Paused for Safety. Thats a Good Thing. - The New York Times

by: Nexstar Media Wire and The Associated Press

Democratic presidential candidate former Vice President Joe Biden participates in a town hall with moderator ABC News anchor George Stephanopoulos at the National Constitution Center in Philadelphia, Thursday, Oct. 15, 2020. (AP Photo/Carolyn Kaster)

WASHINGTON Democrat Joe Biden is hedging on whether he would mandate that all Americans be vaccinated against COVID-19.

Biden said Thursday during a town-hall-style event in Philadelphia that it would depend on the reliability of the vaccine.

He says that it would have to have a very positive impact and how you can affect positively 85% of the American public, and that he would likely receive the vaccine if it met that criteria.

Biden says we should be talking about mandating the vaccine, knowing that its difficult to enforce. But likewise, he says, its difficult to enforce a mask mandate, though scientists suggest they slow the spread.

You can go to every governor and get them in a room, he says. The words of a president matter, no matter whether theyre good, bad or indifferent, they matter.

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Biden hedges on whether to mandate coronavirus vaccine - WANE