Category: Corona Virus Vaccine

Pfizer and Moderna have both announced promising results in the phase 3 trials of their COVID-19 vaccines. Here's how they differ. Storyful

Nearly seven months after Operation Warp Speed was created, Americans are finally starting to get answers about the candidate vaccines that could potentially slow the coronavirus pandemic.

Operation Warp Speed,the White House-led task force on coronavirus vaccine treatment and development,was created on May 15. Since then, vague and contradicting timelines made by both the Trump administration and leading scientists have muddled predictions about when a COVID-19 vaccine would be available to the public.

However, two big companies leading the race for a vaccine have released promising results from their Phase 3 trials.

Heres what we know about both trials and what theymightmean forthe future of the pandemic.

Pfizer and the German biotechnology company BioNTechdeveloped one of the candidate vaccines. They announced early findings of their vaccine, BNT162b2, on Nov. 9.

Moderna, a Cambridge, Massachusetts-based biotechnology company, released data early Monday on its candidate vaccine, mRNA-1273, which was developed in collaboration with the U.S. government.

Both results are preliminary, with final results expected in as soon as a few weeks.

Pfizer released interim results that showed its candidate vaccine was more than 90% effective, after 94 patients developed COVID-19 the vast majority of whom received the placebo.

Out of Pfizer's 44,000 volunteers,half the participants received a placebo and half the vaccine, so the new data shows that more people who received the placebo than the vaccine came down with COVID-19.

They were protected a week after the second dose of the vaccine. The two doses are given 21 days apart. Pfizer/BioNTechwill do a final check of effectiveness when 164 study participants have fallen ill.

Modernas vaccine appears to be 94.5% effective against the disease, after 95 people out of the 30,000 volunteers came down with COVID-19, 90 of whom received the placebo. Eleven people all in the placebo group developed serious cases of the disease.

A final analysis is expected to include 151 trial volunteers, by which point, statistically, the company can be 90% sure that its findings will hold true.

Both candidate vaccines reported mild or moderate side effects, mostly pain at the injection site, fatigue and aching muscles and joints for a day or two.

A sore arm and feeling crummy for a day or two is a lot better than COVID, said Dr. William Schaffner, professor of health policy and of preventive medicine at the Vanderbilt University School of Medicine.

The Chinese government publicly released the genetic sequence of the virus that causes COVID-19, called SARS-CoV-2, in mid-January, a few weeks after recognizing an outbreak was underway. Scientists focused on the sequence for the so-called "spike protein" found on the surface of the virus, which allows the virus to attach itself to host cells to infect them.

The Moderna and Pfizer vaccines are based on delivering strands of genetic material to turn peoples cells into spike protein factories. The spike proteins created by the body arent dangerous because the rest of the virus isnt present, however, the body now sees the protein and designs immune soldiers to fight it upon future exposure.

What a vaccine volunteer has to say: I volunteered for Moderna's COVID vaccine trial. Here's why I think I got the vaccine, not a placebo

This technology has never been used before in an approved vaccine, and other vaccines have taken 15-20 years to develop and test. The mRNA technology was chosen this time because scientists knew it could be developed quickly. Other COVID-19 vaccine candidates being supported by the U.S. government target the spike protein via a carrier virus or tiny particle.

Before the companies can apply to the U.S. Food and Drug Administration for authorization to provide their vaccine to the public, they must clear several more hurdles.

About half the trial participants must be two months past their second shot, to prove that the candidate vaccinesare safe. If someone were to develop a severe vaccine reaction, its likely to happen within six weeks of receiving it. Pfizer will pass that safety milestone this week.Moderna will take longer becauseit took longer to enroll trial participants.

The final hurdle concerns production. Both companies will have to show that they can safely produce their vaccine at scale. Pfizer said it will provide the FDA that information before this week, but its not clear when Moderna will complete this process.

Finally, the FDA will take some time to review each application, as will an independent committee. While no one knows how long this will take, the regulatory agency is expected to an issue an emergency use authorization for the Pfizer/BioNTech vaccine before the end of the year.

President Donald Trump has promised that vaccine would be distributed within 24 hours of an FDA authorization. It would first go to front-line health care workers.

Moderna said Monday it will have 20 million doses available by the end of this year and another 500 million to 1 billion next calendar year. Pfizer has said it will have as much as 50 million doses of its vaccine manufactured by the end of this year, and another 1.3 billion next year.

While the gearshave been oiled up to start cranking out vaccines, scientists have predicted vaccines wont be available to the general public until summer or fall of 2021.

Follow Adrianna Rodriguez and Karen Weintraub on Twitter: @AdriannaUSAT@kweintraub

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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There are now two promising potential COVID vaccines. This is what we know about them. - USA TODAY

Clinical data for Moderna's COVID-19 vaccine showed it was nearly 95% effective in preventing disease, according to an interim analysis described in a company release Monday. Maddie Meyer/Getty Images hide caption

Clinical data for Moderna's COVID-19 vaccine showed it was nearly 95% effective in preventing disease, according to an interim analysis described in a company release Monday.

A second COVID-19 vaccine now also appears highly effective in preventing illness following exposure to the virus that causes the disease.

The biotech company Moderna Inc. said Monday that its experimental vaccine was 94.5% effective in preventing disease, according to an analysis of its clinical trial.

The news comes a week after Pfizer and BioNTech said their vaccine was more than 90% effective.

The results for both vaccines come from interim analyses of large clinical studies. In the Moderna study there were 30,000 volunteers. Half got two doses of the vaccine 28 days apart; half got two shots of a placebo on the same schedule.

There were 95 instances of COVID-19 illness among the study participants; only five of those cases were in the vaccinated group. Ninety were in the group receiving the placebo. Of these, there were 11 cases of severe disease. The results indicate the vaccine was inducing the kind of immune response that protects people if they were exposed to the coronavirus.

"This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," Stphane Bancel, chief executive officer of Moderna, said in a statement.

Both the Moderna and Pfizer vaccines use the same technology to make their vaccines. It's based on a molecule known as mRNA, or messenger RNA. That molecule contains genetic instructions for making proteins inside cells.

For the vaccine, researchers created an mRNA with the code for making the coronavirus spike protein. The protein is the key to the virus infecting cells. It's also what can trigger someone's immune system to make antibodies against the virus, but without causing infection since the rest of the virus is missing.

That two mRNA vaccines appear to be working is remarkable, since the technology is new and there hasn't been an mRNA vaccine approved by the Food and Drug Administration made to date.

The Moderna and Pfizer studies were conducted using slightly different protocols. To be counted as a COVID-19 case, participants in the Moderna study had to have at least two symptoms of disease in addition to a positive test for the virus. The Pfizer study required only one symptom. Also, Moderna waited 14 days following the second injection to begin counting cases; Pfizer's study started counting at seven days.

The vaccines also differ in their storage requirements. Moderna says its vaccine can be safely stored in freezers at about 25 degrees Fahrenheit (minus 4 degrees Celsius), a temperature easily reached by a home refrigerator freezer. Pfizer's vaccine required storage in specialized ultracold freezers capable of cooling below minus 94 degrees Fahrenheit (minus 70 degrees Celsius). Moderna also says its vaccine will remain potent for up to 30 days at normal refrigerated temperatures, which should ease distribution.

Both companies' vaccine studies managed to recruit a reasonably diverse group of people. Moderna reports 6,000 enrollees who identified as Hispanic or Latinx and more than 3,000 participants who identified as Black or African American, as well as 7,000 people older than 65, and 5,000 with high-risk chronic diseases.

Pfizer and Moderna are still gathering safety data the Food and Drug Administration has said is necessary for consideration of an emergency use authorization that would allow the companies to distribute the vaccine during the pandemic.

Side effects seen for the Moderna vaccine at the interim analysis included pain at the injection site, fatigue and aching muscles and joints. The data safety and monitoring board didn't identify "any significant safety concerns."

Moderna said it intends to file "in the coming weeks" with the FDA for authorization of the company's vaccine for emergency use.

The federal Operation Warp Speed project to hasten development of COVID-19 vaccines awarded Moderna a $1.5 billion contract in August to ramp up manufacturing and deliver 100 million vaccine doses, enough for 50 million people. The government has an option to buy up to 400 million more doses.

Moderna said Monday that it expects to be able to ship about 20 million vaccine doses in the U.S. by the end of 2020. Next year, the company said it expects to be able to make 500 million to 1 billion doses worldwide.

The research and development of the Moderna vaccine was aided by $955 million in federal funding from the Biomedical Advanced Research and Development Authority. Moderna has also been developing this vaccine alongside the National Institute for Allergy and Infectious Diseases, which in July told NPR it expects to spend about $410 million on the effort.

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Moderna's Coronavirus Vaccine Nearly 95% Effective, Analysis Finds : Shots - Health News - NPR

The Moderna COVID-19 vaccine trial that started in Seattle is nearly 95% effective, the company reports.

Eight months ago to the day, a clinical trial started in Seattle which may lead to a coronavirus vaccine. Moderna announced its vaccine appears to be 94.5% effective, according to preliminary data from an ongoing study.

The trial's first participants were thrilled by the news.

"I was so excited this morning to wake up and hear that Moderna has an almost 95% efficacy rate," said Jen Haller of Seattle.

Haller and Neal Browning of Bothell were the first to receive the experimental injection in the race for a COVID-19 vaccine.

"It's a momentous occasion," Browning said Monday. He had two injections and blood draws during the trial, and said he had no side effects from any of it. "I've noticed none other than the next morning, after each of the two injections, my arm was a little bit sore, much like you'd have with a typical flu shot."

The results, along with the news last week about positive results surrounding a Pfizer version, lends to the idea that the FDA could issue emergency approval of a vaccine as early as December for hospital, front line and vulnerable groups. It could take months longer to fully implement.

"We don't want to celebrate too early," Browning said. "We don't want to let our guard down, especially in light of the new restrictions that are going into place that Governor Inslee talked about yesterday. It's important to just keep doing what we need to now. Because, even if the vaccine is approved tomorrow, it's not out there in wide enough consumption for people to resume normal life."

Despite being the first to receive Moderna's trial vaccine, Haller continues to maintain her distance and wear a mask around others.

She said, "I really hope that this serves as a good example, certainly for my kids and for my community to think larger than yourself and to consider the privilege that you have in your life and to be able to use that to help others. And that's what I did. I hope that that other people can be inspired to do similar acts for our community."

Haller said the vaccine trial was a smooth experience for her, "The only side effects I had was soreness at the site of injection. Both times that I had that I had the vaccine, you know, my arm was sore the next day, but besides that, I've felt great and normal." Haller said.

Read more from the original source:

COVID-19 vaccine trial that started in Seattle reports stellar success rate - KING5.com

The first doses of coronavirus vaccine could be available as early as mid-December in Alabama for healthcare providers and people with chronic health conditions, according to the Alabama Department of Public Health.

They will be available at no charge, regardless of insurance coverage, according to a press release. Large amounts of vaccines have already been produced and are in storage, under the protection of armed guards.

On Monday, the drug company Moderna announced positive results for its vaccine candidate, which showed about 94 percent effectiveness. Pfizer also announced good results for its coronavirus vaccine, which uses the same technology as Moderna.

Dozens of other companies have coronavirus vaccines in the works. Some may be available as nasal sprays. Others will be injected. The U.S. Food and Drug Administration is expected to take about two weeks to review trial data before distributing the first doses. The federal government will be in charge of distributing the first doses to the states, which will get them to members of high-priority groups.

All Americans can receive their initial vaccine treatment without any charge, including people with no health insurance, according to the press release.

Most vaccines will require two doses administered three to four weeks apart. Federal guidelines prioritize health care workers and other essential employees at the front lines of the pandemic, followed by residents and workers in long-term care facilities and people with underlying health conditions. More doses of vaccine should be available later in 2021.

Distribution of the vaccine will be made equitably to those most at risk, the chronically ill and seniors in all 67 Alabama counties," according to the press release.

Read more:

COVID-19 vaccine in Alabama will be free, first doses could be available by December - AL.com

A second experimental COVID-19 vaccine this one from Moderna Inc. yielded extraordinarily strong early results Monday, another badly needed dose of hope as the pandemic enters a terrible new phase.

Moderna said its vaccine appears to be 94.5% effective, according to preliminary data from an ongoing study. A week ago, competitor Pfizer Inc. announced its own vaccine looked 90% effective news that puts both companies on track to seek permission within weeks for emergency use in the U.S.

The results are truly striking, said Dr. Anthony Fauci, the U.S. governments top infectious-diseases expert. The vaccines that were talking about, and vaccines to come, are really the light at the end of the tunnel.

A vaccine cant come fast enough, as virus cases topped 11 million in the U.S. over the weekend 1 million of them recorded in just the past week and governors and mayors are ratcheting up restrictions ahead of Thanksgiving. The outbreak has killed more than 1.3 million people worldwide, over 246,000 of them in the U.S.

Stocks rallied on Wall Street and elsewhere around the world on rising hopes that the global economy could start returning to normal in the coming months. Moderna was up 7.5% in the morning, while companies that have benefited from the stay-at-home economy were down, including Zoom, Peloton and Netflix.

Both vaccines require two shots, given several weeks apart. U.S. officials said they hope to have about 20 million Moderna doses and another 20 million of the vaccine made by Pfizer and its German partner BioNTech to use in late December.

Dr. Stephen Hoge, Modernas president, welcomed the really important milestone but said having similar results from two different companies is whats most reassuring.

That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives, Hoge told The Associated Press. He added: It wont be Moderna alone that solves this problem. Its going to require many vaccines to meet the global demand.

If the Food and Drug Administration allows emergency use of Modernas or Pfizers candidate, there will be limited, rationed supplies before the end of the year.

Exactly who is first in line has yet to be decided. But Health and Human Services Secretary Alex Azar said the hope is that enough doses are available by the end of January to vaccinate adults over 65, who are at the highest risk from the coronavirus, and health care workers. Fauci said it may take until spring or summer before anyone who is not high risk and wants a shot can get one.

The National Institutes of Health helped create the vaccine Moderna is manufacturing, and NIHs director, Dr. Francis Collins, said the exciting news from two companies gives us a lot of confidence that were on the path towards having effective vaccines.

But were also at this really dark time, he warned, saying people cant let down their guard during the months it will take for doses of any vaccines cleared by the FDA to start reaching a large share of the population.

Modernas vaccine is being studied in 30,000 volunteers who received either the real thing or a dummy shot. On Sunday, an independent monitoring board examined 95 infections that were recorded after volunteers second shot. Only five of the illnesses were in people given the vaccine.

Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.

The study is continuing, and Moderna acknowledged the protection rate might change as more COVID-19 infections are detected. Also, its too soon to know how long protection lasts. Both cautions apply to Pfizers vaccine as well.

But Modernas independent monitors reported some additional, promising tidbits: All 11 severe COVID-19 cases were among placebo recipients, and there were no significant safety concerns. The main side effects were fatigue, muscle aches and injection-site pain after the second dose.

Scientists not involved with the testing were encouraged but cautioned that the FDA still must scrutinize the safety data and decide whether to allow vaccinations outside of a research study.

Were not to the finish line yet, said Dr. James Cutrell, an infectious-disease expert at UT Southwestern Medical Center in Dallas. If theres an impression or perception that theres just a rubber stamp, or due diligence wasnt done to look at the data, that could weaken public confidence.

States already are gearing up for what is expected to be the biggest vaccination campaign in U.S. history. First the shots have to arrive where theyre needed, and Pfizers must be kept at ultra-cold temperatures around minus 94 degrees Fahrenheit. Modernas vaccine also starts off frozen, but the company said Monday it can be thawed and kept in a regular refrigerator for 30 days, easing that concern.

Beyond the U.S., other governments and the World Health Organization, which aims to buy doses for poor countries, will have to separately decide if and when vaccines should be rolled out broadly.

There are many, many questions still remaining, including how long protection lasts and if the first vaccines to emerge work as well in older people as in the young, said WHO chief scientist Dr. Soumya Swaminathan. We also hope the clinical trials will continue to collect data, because its really going to be important for us to know in the long term.

The vaccine from Cambridge, Massachusetts-based Moderna is among 11 candidates in late-stage testing around the world, four of them in huge studies in the United States. Collins stressed that more U.S. volunteers are needed for those studies.

Elsewhere around the world, China and Russia have been offering different experimental vaccines to people before completing final-stage testing.

Both Modernas shots and the Pfizer-BioNTech candidate are so-called mRNA vaccines, a brand-new technology. They arent made with the coronavirus itself, meaning theres no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.

Pfizer CEO Albert Bourla tweeted that he was thrilled at Modernas news, saying, Our companies share a common goal defeating this dreaded disease.

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Second virus vaccine shows overwhelming success in U.S. tests - Herald-Banner

We're making this important information about the pandemic available without a subscription as a public service. But we depend on reader support to do this work. Please consider joining others in supporting independent journalism in Alaska for just $3.23 a week.

More than 500 medical staffers around the state are not working because of COVID-19 as coronavirus-related hospitalizations reached another new high as of Monday.

Cases reported over the weekend -- 745 Saturday and 654 Sunday -- marked the highest and second-highest daily numbers in the state since the pandemic began in March. The state has reported weeks of climbing case numbers and rising death tolls across Alaska.

The aggressive spread of the virus is taking a toll on the states medical staffing.

An informal poll of Alaskas hospitals and nursing homes revealed that as of last Friday there were more than 530 health-care workers unable to do their jobs due to either a positive COVID-19 test, a close exposure to someone who tested positive, or quarantine related to travel.

Thats according to the Alaska State Hospital and Nursing Home Association, the organization that conducted the poll.

The association did a back of the envelope calculation after asking facilities around the state how many employees were out either for 10-day isolations after testing positive or 14-day quarantines for close contact or travel, according to senior vice president Jeannie Monk. It wasnt immediately clear how many employees the states health-care facilities have in total.

About half, or 255, work at hospitals in Anchorage or Mat-Su, Monk said. Another 238 work outside those places. Roughly 40 of the workers are at nursing homes.

The work force reduction is significant, and means that other staffers have to fill in behind their missing colleagues, pulling extra shifts with fewer people -- working harder under already stressful conditions, she said.

Alaskas hospitals are managing to keep up with the increasing patient loads, Monk said. But the high weekend numbers mean more patients hitting hospitals in two weeks.

The health-care system right now, were OK. Were not closing facilities, were not turning people away, she said. But the trend is whats very worrisome.

Since March, 98 Alaskans with COVID-19 have died and one nonresident has died. Alaskas overall death rate per capita remains among the lowest in the country.

Hospitalizations reached a new high Monday as the state reported 121 patients with COVID-19. Another 22 people who were hospitalized were suspected to have COVID-19. Health officials have stressed for weeks that the rising case numbers could overwhelm Alaskas hospitals struggling with staffing capacity.

One order specifically addresses rural concerns about travelers bringing in the virus: the state is recommending that anyone from a rural community who spends three days hours or less on the road system or the state ferry system get a COVID-19 test five days after returning home. Anyone who spends more than three days should get tested within three days (72 hours) of returning to rural communities. If the person isnt tested, they should practice strict social distancing for two weeks, the order says.

The 72-hour standard reflects how long generally it takes to get test results back, state officials said at a Monday briefing.

The changes came about as a result of discussions with rural leaders and health organizations, which requested state support to make sure people knew how important it was to protect rural places with limited health-care capacity, Health and Social Services Commissioner Adam Crum said.

Separately, officials at Bethel-based tribal health organization Yukon-Kuskokwim Health Corp. on Monday issued a statement recommending a monthlong regional lockdown due to exponential transmission of the virus in the Yukon-Kuskokwim Delta.

Of the 556 cases reported in Alaska residents, 351 were in Anchorage, five in Chugiak, 35 in Eagle River and one in Girdwood; eight were in Homer, six in Kenai, two in Seward, 12 in Soldotna and one in Sterling; one was in Kodiak; 15 were in Fairbanks and three in North Pole; eight were in Delta Junction; six were in Palmer, one in Sutton-Alpine, and 21 in Wasilla; three were in Nome; two were in Kotzebue; one was in Douglas and eight were in Juneau; one was in Sitka; 39 were in Bethel; one was in Chevak and one in Hooper Bay.

Among communities smaller than 1,000 people that are not named to protect privacy, there were two cases in the northern Kenai Peninsula Borough and four in the southern portion of the borough; one was in Kodiak Island Borough; two were in the Valdez-Cordova Census Area; one was in the Yukon-Koyukuk Census Area; one was in Northwest Arctic Borough; 11 were in the Bethel Census Area; and two were in the Kusilvak Census Area.

Another seven cases were reported in nonresidents Sunday, including two in Anchorage, one in Homer, and four in unknown regions, the state reported.

Of the new cases, it is not reported how many patients were showing symptoms of the virus when they tested positive. While people might get tested more than once, each case reported by the state health department only represents one person.

The states testing positivity as of Monday was 8.31% over a seven-day rolling average. A positivity rate over 5% can indicate high community transmission and not enough testing, health officials have said.

Read the rest here:

Tracking COVID-19 in Alaska: 563 new cases reported Monday as virus keeps hundreds of health-care workers at home - Anchorage Daily News

The U.S. received more good news on the vaccine front this week with Moderna's clinical trial data showing its vaccine is more than 94% effective. But the country is still battling a COVID-19 crisis that's ravaging communities and hospital systems and is projected to get a lot worse before a possible vaccine could offer any help."We have learned that these colder months when people are clustering inside, the numbers are going to go up," CNN's Chief Medical Correspondent Dr. Sanjay Gupta said Monday night. "Hospitalizations are expected to maybe even hit 100,000.""We used to talk about the number of people becoming newly infected on any given day hitting 100,000 seemed outrageous. There may be that many people in the hospitals," he added.The U.S. has now recorded more than 100,000 daily infections for two weeks straight and on Monday reported more than 166,000 new cases. On the same day, another new high: more than 73,000 COVID-19 hospitalized patients nationwide, according to data from the COVID Tracking Project.Across the country, hospitals are filling up."When you look at Utah, or Montana or the Dakotas, they just have such a fewer number of ICU beds and specialists, that when they get at capacity, it's going to be a breaking point for them in a way it wasn't for us in the coastal cities and states," Dr. Dara Kass, an emergency medicine physician at Columbia University Medical Center, said Monday at an online event hosted by Stat.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 St. Louis, officials announced modeling data suggesting ICU capacity could run out around the first week of December if current rates continue."COVID-19 is spreading much too quickly and sending far too many people to our hospitals and intensive care units," Incident Commander of the St. Louis Metropolitan Pandemic Task Force Dr. Alex Garza said Monday. "We are now at a tipping point. The actions that we take today will determine what the next weeks and months will look like."And while hundreds of Americans continue to die every day, that number will likely only rise as hospitalizations keep going up, former FDA Commissioner Dr. Mark McClellan told CNN Monday."The problem is that we've got these outbreaks, these hot spot areas where we're approaching health system capacity really all over the country now, it's not just one part of the country or region," he said. Preparing for a vaccineAnd while the high efficacy rates coming out of the Moderna and the Pfizer/BioNTech vaccine trials are a good first step, a vaccine has yet to be approved and experts will also have to decide which groups should get vaccinated first.An advisory committee to the Centers for Disease Control and Prevention is scheduled to meet next week to decided who will get the vaccine first, a longtime member of the committee said.Members of the Advisory Committee on Immunization Practices received notice last week that they'll meet Nov. 23 for five hours, according to committee member Dr. William Schaffner.Among the first to be vaccinated will likely be health care workers and essential workers as well as people over the age of 65 and people with underlying conditions. The question is what order those groups should come in, Schaffner said."Health care workers are baked in that's the first thing to happen, no doubt about that," he said. But after that, committee members will need to define what underlying conditions would merit getting a vaccine early on and what defines "essential workers" a group that could include everyone from police officers to supermarket clerks.And even once a vaccine is approved and more doses become available, it will be months before the U.S. returns to anything resembling normalcy."There's not going to be one day when, you know, the light switch is going to go on and everybody is going be immune," McClellan said. "But we should do a gradually better and better job of containing spread, of avoiding hospitalizations and moving beyond the pandemic in the months to come.""But we have got a couple of tough months to get through first," he added.Statewide measures taking effect this weekMore state leaders have in the past week announced new restrictions in efforts of helping to slow the spread.Oklahoma's governor announced that starting Thursday, all tables in restaurants must be at least six feet apart and added that bars and restaurants will have to close by 11 p.m. Only restaurant drive-thru windows or curbside pickup will be allowed after that. And starting Tuesday, all 33,000 state employees under the executive branch will be required to wear a mask in common areas or when they're around other people, the governor's office said.In California, Gov. Gavin Newsom said the state is experiencing the "fastest increase in cases we have seen yet" and announced 28 counties were moving into the most restrictive tier of the state's reopening plan.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New restrictions went into effect in Washington state Monday, which limit bars and restaurants to outdoors with capacity limits and to-go service. Indoor social gatherings with people from outside the home are also prohibited under the restrictions, unless participants quarantine for 14 days prior, or quarantine for seven days before the gathering and receive a negative COVID-19 test result no more than 48 hours prior.New measures will also take effect in Oregon Wednesday, when the state will go into a "Two-Week Freeze." Social gatherings will be limited to no more than six people total from a maximum of two households and restaurants will be limited to delivery and takeout only, among other measures.Guidance for college students returning homeAs the Thanksgiving holiday nears, Connecticut Gov. Ned Lamont issued guidance on Monday for out-of-state college students who are planning on returning home to the state for Thanksgiving.Lamont asked the returning students to self-quarantine for 14 days before or after returning home, get tested for the virus both before leaving school and after getting home, not attend parties or reunions and not quarantine with any elderly or high-risk family members."We can't enforce this," he said. "I'm going to have to depend upon your good judgment ... that you follow the protocols, you follow the quarantine, and you follow the testing."Public health officials and state leaders have repeatedly emphasized how critical the upcoming holidays are and have expressed concern that family and friend gatherings will help fuel an already rampant spread."Separation should be the norm," this year, Schaffner also previously urged."Less is more this Thanksgiving," he said. "It is the COVID Thanksgiving. We don't want to give the virus while we're giving thanks."

The U.S. received more good news on the vaccine front this week with Moderna's clinical trial data showing its vaccine is more than 94% effective. But the country is still battling a COVID-19 crisis that's ravaging communities and hospital systems and is projected to get a lot worse before a possible vaccine could offer any help.

"We have learned that these colder months when people are clustering inside, the numbers are going to go up," CNN's Chief Medical Correspondent Dr. Sanjay Gupta said Monday night. "Hospitalizations are expected to maybe even hit 100,000."

"We used to talk about the number of people becoming newly infected on any given day hitting 100,000 seemed outrageous. There may be that many people in the hospitals," he added.

The U.S. has now recorded more than 100,000 daily infections for two weeks straight and on Monday reported more than 166,000 new cases. On the same day, another new high: more than 73,000 COVID-19 hospitalized patients nationwide, according to data from the COVID Tracking Project.

Across the country, hospitals are filling up.

"When you look at Utah, or Montana or the Dakotas, they just have such a fewer number of ICU beds and specialists, that when they get at capacity, it's going to be a breaking point for them in a way it wasn't for us in the coastal cities and states," Dr. Dara Kass, an emergency medicine physician at Columbia University Medical Center, said Monday at an online event hosted by Stat.

In St. Louis, officials announced modeling data suggesting ICU capacity could run out around the first week of December if current rates continue.

"COVID-19 is spreading much too quickly and sending far too many people to our hospitals and intensive care units," Incident Commander of the St. Louis Metropolitan Pandemic Task Force Dr. Alex Garza said Monday. "We are now at a tipping point. The actions that we take today will determine what the next weeks and months will look like."

And while hundreds of Americans continue to die every day, that number will likely only rise as hospitalizations keep going up, former FDA Commissioner Dr. Mark McClellan told CNN Monday.

"The problem is that we've got these outbreaks, these hot spot areas where we're approaching health system capacity really all over the country now, it's not just one part of the country or region," he said.

And while the high efficacy rates coming out of the Moderna and the Pfizer/BioNTech vaccine trials are a good first step, a vaccine has yet to be approved and experts will also have to decide which groups should get vaccinated first.

An advisory committee to the Centers for Disease Control and Prevention is scheduled to meet next week to decided who will get the vaccine first, a longtime member of the committee said.

Members of the Advisory Committee on Immunization Practices received notice last week that they'll meet Nov. 23 for five hours, according to committee member Dr. William Schaffner.

Among the first to be vaccinated will likely be health care workers and essential workers as well as people over the age of 65 and people with underlying conditions. The question is what order those groups should come in, Schaffner said.

"Health care workers are baked in that's the first thing to happen, no doubt about that," he said. But after that, committee members will need to define what underlying conditions would merit getting a vaccine early on and what defines "essential workers" a group that could include everyone from police officers to supermarket clerks.

And even once a vaccine is approved and more doses become available, it will be months before the U.S. returns to anything resembling normalcy.

"There's not going to be one day when, you know, the light switch is going to go on and everybody is going be immune," McClellan said. "But we should do a gradually better and better job of containing spread, of avoiding hospitalizations and moving beyond the pandemic in the months to come."

"But we have got a couple of tough months to get through first," he added.

More state leaders have in the past week announced new restrictions in efforts of helping to slow the spread.

Oklahoma's governor announced that starting Thursday, all tables in restaurants must be at least six feet apart and added that bars and restaurants will have to close by 11 p.m. Only restaurant drive-thru windows or curbside pickup will be allowed after that. And starting Tuesday, all 33,000 state employees under the executive branch will be required to wear a mask in common areas or when they're around other people, the governor's office said.

In California, Gov. Gavin Newsom said the state is experiencing the "fastest increase in cases we have seen yet" and announced 28 counties were moving into the most restrictive tier of the state's reopening plan.

New restrictions went into effect in Washington state Monday, which limit bars and restaurants to outdoors with capacity limits and to-go service. Indoor social gatherings with people from outside the home are also prohibited under the restrictions, unless participants quarantine for 14 days prior, or quarantine for seven days before the gathering and receive a negative COVID-19 test result no more than 48 hours prior.

New measures will also take effect in Oregon Wednesday, when the state will go into a "Two-Week Freeze." Social gatherings will be limited to no more than six people total from a maximum of two households and restaurants will be limited to delivery and takeout only, among other measures.

As the Thanksgiving holiday nears, Connecticut Gov. Ned Lamont issued guidance on Monday for out-of-state college students who are planning on returning home to the state for Thanksgiving.

Lamont asked the returning students to self-quarantine for 14 days before or after returning home, get tested for the virus both before leaving school and after getting home, not attend parties or reunions and not quarantine with any elderly or high-risk family members.

"We can't enforce this," he said. "I'm going to have to depend upon your good judgment ... that you follow the protocols, you follow the quarantine, and you follow the testing."

Public health officials and state leaders have repeatedly emphasized how critical the upcoming holidays are and have expressed concern that family and friend gatherings will help fuel an already rampant spread.

"Separation should be the norm," this year, Schaffner also previously urged.

"Less is more this Thanksgiving," he said. "It is the COVID Thanksgiving. We don't want to give the virus while we're giving thanks."

See more here:

Encouraging data from COVID-19 vaccines won't prevent dangerous stretch of rising cases, experts warn - WXII The Triad

Health care workers are likely to receive the first coronavirus vaccines when supplies are limited, but a decision on who gets the first shots has not been made. An expert panel advising the U.S. Centers for Disease Control and Prevention is also considering giving high priority to workers in essential industries, people with certain medical conditions and people 65 and older. To make its recommendations to the CDC, the panel will consult trial data on side effects and how people of different ages, ethnicities and health statuses responded. State officials distributing the vaccines are expected to follow the CDCs guidance.

The rest is here:

Who will be the first to get COVID-19 vaccines? - WBNG-TV

Jodi Doering says some of her patients, including those who die from the coronavirus, insist there must be another reason.

A South Dakota nurse's plea for people to take COVID-19 seriously went viral over the weekend after she said she's had extremely ill patients who still didn't believe they were infected with the coronavirus. Her state is facing a death rate that has risen to the highest in the nation this month.

Jodi Doering tweeted about it Saturday night, describing it as a "horror movie that never ends" because it's something that keeps repeating itself.

"The (patients) that stick out are those who still dont believe the virus is real," Doering tweeted. "They tell you there must be another reason they are sick," she added, noting that they are "screaming" for a "magic medicine."

She said the yelling stops when the patient's condition gets so bad, they have to be intubated.

"The reason I tweeted what I did is it wasn't one particular patient. It's just a culmination of so many people. And their last, dying words are, 'This can't be happening. It's not real.' And when they should be spending time Facetiming their families, they're filled with anger and hatred and it just made me really sad the other night," Doering told CNN. "I just can't believe that those are going to be their last thoughts and words."

That's not to say all her patients think that way. Doering notes there are many who accept they have COVID-19 and are thankful for the care they are receiving.

South Dakota Gov. Kristi Noem on Monday showed no sign of budging from her hands-off approach to the pandemic, despite finding herself among a dwindling number of Midwest governors holding out against mask mandates.

South Dakota has reported 219 deaths in November about a third of all its deaths over the course of the entire pandemic. The COVID-19 deaths have sent the state to the top of the nation in deaths per capita during November, with nearly 25 deaths per 100,000 people, according to data from The COVID Tracking Project.

South Dakota currently has the nations second-worst rate of new cases per capita, according to Johns Hopkins researchers. There were 2,047 new cases per 100,000 people, meaning that roughly one out of every 49 people has tested positive in the last two weeks.

The only state where new cases per capita are worse, North Dakota, moved to require masks and limit the size of gatherings on Friday. The situation there has grown so desperate that hospitals are preparing to ask medical workers with coronavirus infections but no symptoms to staff COVID wards.

But Noem has no plans to issue mask requirements. The governors spokeswoman Maggie Seidel pushed back against arguments by public health experts that a mask mandate would dramatically reduce the spread of the virus, pointing out that states like Illinois, Minnesota and Wisconsin have also experienced significant virus waves despite having strict mandates to wear face coverings.

Read more from the original source:

Nurses' tweets, about severely ill COVID-19 patients who insist they aren't infected, go viral - ABC10.com KXTV

Clark County is in the midst of a COVID-19 explosion, according to its highest-ranking health official.

Case counts, infection rates and hospitalization numbers for coronavirus in Clark County have hit new heights, two weeks before Thanksgiving and about seven weeks before Christmas.

Clark County Public Health Officer Dr. Alan Melnick said that eight weeks ago, the county was averaging 28 new cases per day. Last week, it averaged more than 120 new cases per day. On Monday, Clark County added 310 new virus cases, the highest total from a weekend since COVID-19 was officially spotted in March in Clark County.

During a Monday press briefing, Melnick and local health care leaders called on the public to take responsibility in stopping the spread of COVID-19.

The COVID-19 case numbers are exploding, said Clark County Public Health Officer Dr. Alan Melnick. They are going up at an alarming rate.

The upcoming holidays, which are known for gatherings, have local health officials and experts worried hospital capacity and resources will be overwhelmed before the end of the year or by early 2021.

Small gatherings have been Clark Countys second-biggest spreader of COVID-19, behind household transmission.

Dr. Ray Lee, the chief of medical staff at PeaceHealth Southwest Medical Center, said in the press briefing that the stakes of our personal decisions before us right now cannot be higher.

Dr. Hoa Ly, the medical director at Legacy Salmon Creek Medical Center, said his hospital is cutting some elective procedures to increase its bed capacity for an expected surge.

The county currently has 50 people hospitalized for COVID-19, close to double the highest numbers from early spring.

Nearly 9 percent of hospital beds are taken by COVID-19 patients, barely below the 10 percent threshold the state wants counties to remain under. And 76 percent of licensed hospital beds are occupied, just four percent below the states desired 80 percent target.

Ly said everyone can wear masks in public, stay distanced and skip in-person gatherings this holiday season to stop spread of the virus. He explained a virus cant spread itself to others without a host.

We are fully capable of making sacrifices for a higher calling. We are capable of making difference for ourselves and our loved ones, Ly said. The virus can only do what we allow it to do. This is in our power to defeat this virus if we choose to work together.

Vancouver Clinic Chief Medical Officer Dr. Alfred Seekamp said there remains a COVID-19 testing materials shortage, although testing ability has improved since the early spring.

Vancouver Clinic is seeing a 20 percent increase in testing demand, week over week, Seekamp said. Vancouver Clinic is testing around 2,700 people per week, and Seekamp said the goal is to be at 10,000 tests per week by December. It is recommended you get a test if you have COVID-19 symptoms or close contact with someone confirmed to have the virus.

Seekamp also asked people to stay home this holiday season. Gov. Jay Inslee has banned indoor gatherings, unless you can quarantine for two weeks ahead of the gathering or can quarantine for one week before the gathering and receive a negative COVID-19 test result no more than two days before the gathering.

Health officials recommend outdoor gatherings if you must host one, and ask that there is no sharing of food, utensils or drinks. Outdoor gatherings need to be limited to five or fewer people from outside your household, and everyone must be spaced at least 6 feet apart.

Melnick said people need to take action now. They cant wait until that hospital capacity is overwhelmed to start being more diligent.

Then its like turning the Titanic around, he said.

Read the original post:

Melnick: Clark County in midst of COVID-19 'explosion' - The Columbian