Pa. Health Dept. Announces Another Record-Breaking Day With 4,711 New Coronavirus Cases – CBS Pittsburgh

Pa. Health Dept. Announces Another Record-Breaking Day With 4,711 New Coronavirus Cases – CBS Pittsburgh

California Coronavirus Update: 11 Counties Ordered To Impose More Restrictive COVID Measures With Many More Likely; Theaters Must Close Again In 3…

California Coronavirus Update: 11 Counties Ordered To Impose More Restrictive COVID Measures With Many More Likely; Theaters Must Close Again In 3…

November 11, 2020

After Gov. Gavin Newsom warned Monday that some of Californias counties would be falling back in his coronavirus reopening protocols, the states Secretary of Health and Human Services, Dr. Mark Ghaly, announced on Tuesday that nearly a dozen counties are being required to move back to more restrictive measures.

A total of 11 counties, including one of the states most populous, fell back in the governors tiering structure. Sacramento, Stanislaus and San Diego retreated to the most restrictive Purple tier. That means movie theaters in those counties which had been allowed to reopen up to 100 people or 25%, whichever is less in the Red tier must shutter indoor operations again.

Other moves included Amador, Contra Costa, Placer, Santa Cruz and El Doradocounties going from the Orange tier down to the more restrictive Red tier. Modoc, Siskiyu and Trinity moved back to Orange. Yolo County, also at risk of demotion, stayed in the Red tier. No counties moved forward.

Los Angeles now sits firmly within the Purple tier. L.A. County health officials said last week that they do not anticipate the county moving out of the Purple Tier any time soon.

You can view a chart of the tiers and their restrictions in the tweet below.

California reported 5,367 new daily cases on Tuesday, coming close to 1 million milestone at 977,000. The seven-day average now is over 6,000. According to Ghaly, Tuesdays number reflects Sunday data that often is lower.

The state currently has a 3.7% test positivity rate. Ghaly cautioned that the seven-day test positivity is 4.2%. We havent seen test positivity rates above 4 since August, he said.

Hospitalizations due to COVID had increased 3.4% just since Monday. Patients in the ICU due to COVID-19 were up more than 4% vs. Monday. Those are big one-day jumps.

The states number of new cases per 100,000 people was 8.4% as of Tuesday. If taken as a whole, that rate would put the entire state in the most restrictive tier.

Almost all counties in the state are in an upward trajectory, said Ghaly. Even worse: If those trends continue, between this week and next week, he said, more than half of Californias 58 counties will have moved into a more restrictive tier.

To business owners who might be forced to shut down again. Ghaly said, We want to continue to work with all our business owners, big and small, across the state.

On Monday, Disneyland announced that it will be furloughing another group of workers at the park. The bulk of the hit or 67%, the company said will fall on part-time workers.

Also on Monday, Regal Cinemas said it will shutter its 18 locations still open in New York and California, effective Thursday.

The governor said on Monday that, as the numbers increased, the state was being well served by his decision to develop a tiering structure that was more restrictive not based on political whim, but based upon data.

The tier system is working as designed, he asserted, before warning that the state was definitely seeing the second wave of the virus.

I am concerned that we may be over exuberant that we now have a safe vaccine and people may go back to their usual form, said Newsom. The availability to people like you and me is a long way off. Do not take your guard down. First responders, he reminded Californians, will get any vaccine first.

The governor said we likely yet have the worst months of the pandemic before most of us have access to a vaccine. We should see a mass distribution of these vaccines [beginning] in April, he predicted.

Let us double down on the work that we have done together, on non-pharmaceutical interventions like masks and social distancing, he pleaded.


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California Coronavirus Update: 11 Counties Ordered To Impose More Restrictive COVID Measures With Many More Likely; Theaters Must Close Again In 3...
Second Coronavirus Wave Hits Orange CountyVoice – Voice of OC

Second Coronavirus Wave Hits Orange CountyVoice – Voice of OC

November 11, 2020

By Spencer Custodio | 19 hours ago

A second wave of coronavirus infections is beginning to hit Orange County, along with surrounding counties, after hospitalizations and case counts have continued to rise over the past two weeks.

Editors Note: As Orange Countys only nonprofit & nonpartisan newsroom, Voice of OC brings you the best, most comprehensive local Coronavirus news absolutely free. No ads, no paywalls. We need your help. Please, make a tax-deductible donation todayto support your local news.

The second wave has started, but its not baked into the cake how profound it will be, said UC Irvine epidemiologist and public health expert Andrew Noymer.

He said if people dont let their guard down, it may not be as bad as the summer spikes.

It depends on all of the citizens of Orange County to do their part, Noymer said.

Hospitalizations in OC crept up to 224 on Tuesday, the highest number of people hospitalized since Sept. 9, following the June and July case spikes.

At one point in July, over 700 people were hospitalized.

And Orange Countys coronavirus infection rate could be rising to levels that havent seen since the summer wave.

The reproductive rate is used by epidemiologists and public health professionals to predict how many people an infected person could pass the virus to. If the rate reaches 1, that means each infected person can infect another person all of which exponentially can increase the spread.

UC Irvine epidemiologist Daniel Parker said some university researchers have found the infection rate is going up in Orange County.

So back around early June, late May, it (the infection rate) was a little bit above 1 and thats when things were just shooting through the roof, Parker said.

As of late last week, its not real high, but its pretty close to 1. If its 1 or over, thats real bad, Parker said.

Researchers are expected to update the infection rate tomorrow.

But, he added, the data isnt painting what the current picture is in the county.

But theres that lag, right. The cases youre seeing today, those happened almost a month ago, Parker said.

Noymer said he hopes people still follow public health guidance so the infection rate doesnt rise above 1.

So if you have 1.0, then youre just kind of treading water. So each infection is creating a new infection, Noymer said. The problem is when its 1.1 or 1.2, because then youre adding even more cases.

Noymer said hes keeping a close eye on the number of people in intensive care units.

The thing I look at very closely is ICU numbers, Noymer said. The ICUs were in the 150s over the summer but they were down to as low as 42 at one point in September/October. And now theyve been in the 70s consistently for a few days, so that is not pleasing to me or anyone else.

Of the 224 people hospitalized Tuesday, 79 were in intensive care units, according to the Health Care Agency.

Im frankly concerned, Noymer said.

Since the pandemic began in March, the virus has killed 1,512 county residents out of 62,830 confirmed cases, including three new deaths reported Tuesday.

The virus has already killed nearly three times as many people as the flu does on average in Orange County.

For context, OC has averaged around 20,000 deaths a year since 2016, including 543 annual flu deaths, according to state health data.

According to those same statistics, cancer kills over 4,600 people, heart disease kills over 2,800, over 1,400 die from Alzheimers disease and strokes kill over 1,300 people.

Parker said OC may be able to avoid spikes in cases and deaths if people follow the public health protocols, like avoiding gatherings and wearing a mask.

Maybe well be vigilant, but I dont know, Im a bit of a pessimist right now, he said.

Meanwhile, all of the counties surrounding OC are in the most restrictive tier, the Purple Tier, on the states business reopening system because of the positivity rates and new average daily cases. San Diego was moved to the Purple Tier on Tuesday.

For now, Orange County sits in the Red Tier, the second most restrictive tier.

That means retailers, malls, beauty salons, movie theaters, restaurants, gyms and places of worship are open under limited capacity.

Larger entertainment venues, like theme parks, sports stadiums and bowling alleys remain closed.

A move back to the Purple Tier would see movie theaters close, while restaurants and houses of worship would have to move their operations outside. It would also further limit the number of people allowed inside malls and retailers, depending on the specific guidelines for each industry.

The rising cases around California are causing concerns for state and local public health officials, especially since the holiday season is around the corner.

It is clear we are seeing increasing cases, said Dr. Mark Ghaly, secretary of the state Health and Human Services Agency at a Tuesday news conference.

He said more counties will be moving back to more restrictive business reopening tiers next week.

As we look forward to next week and we see which counties may have missed tier thresholds this week, we anticipate over half of Californias counties will have moved into a more restrictive tier, Ghaly said.

No county moved to a less restrictive tier on Tuesday, which is when state public health officials update the business reopening system.

Ghaly, Noymer and Parker all fear new infections stemming from Thanksgiving dinner and other upcoming holiday celebrations.

All three said people should avoid doing Thanksgiving dinner and other celebrations with people they dont live with.

Im really apprehensive about Thanksgiving, Noymer said. People need to really reflect on protecting the elderly and other high-risk groups. And just not use Thanksgiving as this massive springboard into the other holidays.

Heres the latest on the virus numbers across Orange County from county data:

Infections | Hospitalizations & Deaths | City-by-City Data | Demographics


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Second Coronavirus Wave Hits Orange CountyVoice - Voice of OC
NFL coronavirus cases on rise along with nation – ESPN

NFL coronavirus cases on rise along with nation – ESPN

November 11, 2020

The NFL and NFL Players Association reported a big jump in COVID-19 infections for their most recent testing period, a reflection of growing case counts around the country.

A total of 56 employees, including 15 players and 41 staff members, returned confirmed positive tests between Nov. 1 and Nov. 7. That's more than twice the total of any other period (26, from Sept. 27-Oct. 3), the period that accounts for most of the Tennessee Titans outbreak that forced multiple changes to the league's early-season schedule.

1 Related

Since then, the NFL has managed to play its games on schedule after deciding to isolate any high-risk close contacts for five days. But league officials are making contingency plans for future game cancellations, including the possibility of a 16-team playoff field.

The NFL and NFLPA are testing roughly 8,000 different employees during each period.

After deciding last summer against operating in a bubble environment, the league has been focused on preventing spread of inevitable infections. Its chief medical officer, Dr. Allen Sills, has said repeatedly that rising case counts across the country make that job more difficult. Nationwide, more than 100,000 COVID-19 infections have been reported for six consecutive days.


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NFL coronavirus cases on rise along with nation - ESPN
Is a Second Coronavirus Wave Hitting Orange County? – Voice of OC

Is a Second Coronavirus Wave Hitting Orange County? – Voice of OC

November 11, 2020

By Spencer Custodio | November 9, 2020

A second wave of coronavirus infections could be hitting Orange County after a series of upticks over the past week, with over 500 new cases reported Sunday.

The county hasnt seen over 400 new cases reported since early August, when OC was coming out of the summer case spikes. Monday saw an additional 308 cases reported.

All of the counties surrounding OC, except for San Diego, are in the states most restrictive tier of business reopenings because of high positivity rates and daily case rates.

UC Irvine epidemiologist Daniel Parker said new cases could paint a picture of what was happening a couple weeks ago.

The tricky thing is that when the cases start going up, thats probably something thats happened two, three weeks ago. So the transmission thats happening right now, youre not going to see that in cases for two or three weeks. So when they show up in the numbers its too late, Parker said.

Last week, OCs new daily case counts crept above 300 a day before hitting 512 on Sunday.

Parker said the best way to measure how much the virus is spreading in OC is daily new cases, hospitalizations, the positivity rate and new cases per 100,000 residents.

Its good to keep up with the different metrics. Because one metric could shoot up and it could be a statistical blip, Parker said. You could have a bunch of cases reported on the same day.

By Sunday, there were 201 people hospitalized, including 72 people in intensive care units. Thats the highest hospitalizations have been since mid September.

The highest number of hospitalizations happened during the summer virus wave, when over 700 people were hospitalized at one point in July.

Parkers colleague, UC Irvine epidemiologist Andrew Noymer said the number of people in ICUs could indicate a second wave.

When the ICU stays above 70 for a few days in a row, thats when we know the games on, Noymer said. But make no mistake about it, theres going to be a second wave in Orange County and nationwide.

At the same time, the positivity rate in OC has been hovering around 3.6%, but the average daily new cases is 6 per 100,000 residents a metric thats climbed over the past weeks. A couple weeks ago, OC had an average of 3.5 new cases per 100,000 residents.

If the average daily new cases hits 7 and stays there for a few weeks, that means OC could move back into the Purple Tier on the states reopening system.

For now, Orange County sits in the Red Tier.

That means retailers, malls, beauty salons, movie theaters, restaurants, gyms and places of worship are open under limited capacity.

Larger entertainment venues, like theme parks, sports stadiums and bowling alleys remain closed.

A move back to the Purple Tier would see movie theaters close, while restaurants and houses of worship would have to move their operations outside. It would also further limit the number of people allowed inside malls and retailers, depending on the specific guidelines for each industry.

Certainly the increase in case counts is of a concern, said Dr. Matt Zahn, director of the Communicable Disease Control Division Orange County at the county Health Care Agency, at a Friday news conference.

But its really important at the same time we cant let our guard down, Zahn said. You cant lose sight of the fact that since weve done well in the last two or three months. Thats been a hugely important part, for one, our community to open up and go into the Red Tier, and two, to prevent serious illness and death in our community.

He also said county public health officials have noticed fatigue around OC, meaning people may begin to stop wearing masks and avoid large gatherings or crowding indoors.

By the same token, the virus is not gone. And I think we all know theres COVID fatigue and i think we all feel it, Zahn said, noting the upcoming holidays. We all think of family gatherings, social gatherings, work gatherings. Unfortunately, you have to think about those gatherings differently, because there is a risk there.

Most of the counties surrounding OC Los Angeles, Riverside, San Bernardino sit in the purple tier. San Diego remains in the Red Tier.

Speaking at a Monday news conference, Gov. Gavin Newsom said more counties are expected to move back to the Purple Tier during Tuesdays weekly tier update.

OC is likely to stay in the Red Tier.

State officials are also warning of virus fatigue and a looming second wave.

People are letting their guard down. Theyre taking their masks off, Newsom said. Were starting to see more people mixing so this was anticipated, no one was surprised by it.

Secretary of the state Health and Human Services Agency, Dr. Mark Ghaly, said public health officials across the state are seeing increased virus transmission from people holding parties and other gatherings.

They mention private household gatherings as a major source of spread, Ghaly said at the Monday news conference.

Since the pandemic began in March, the virus has killed 1,509 people, out of 62,563 confirmed OC cases, according to the county Health Care Agency.

For context, Orange County has averaged around 20,000 deaths a year since 2016, according to state health data. Of that number, cancer kills over 4,600 people, heart disease kills over 2,800, over 1,400 die from Alzheimers disease and strokes kill over 1,300 people.

According to those same statistics, the flu kills about 543 OC residents annually.

Hospitalizations continue to creep up also.

As of Monday, 205 people were hospitalized because of the virus, including 76 in intensive care units.

Meanwhile, some Orange County parents are driving their children to Arizona and Nevada so they can play youth sports games like baseball, soccer and softball because current state guidelines only allow for practice and not games.

Zahn said county Health Care Agency officials havent seen any cases stemming from the road trips, but said he worries about increased virus exposure because of what people may do when they get out of state.

Its still unclear when state public health officials will update the guidelines to potentially allow for some games.

Parker said youth sports games are tricky during the pandemic.

I would say something like soccer, if you dont really have a high burden in the community and youre getting around that indoor time with people, that seems like its not a high risk. We all have to find some acceptable levels of risk because we cant just stay indoors forever, Parker said.

Although he said sports like wrestling or indoor basketball is concerning because the virus spreads easier indoors.

The outdoor activities where youre not forced to be in real close proximity to people for a lot of time, that doesnt worry me too much, Parker said. If youre on a soccer field or football field, then youre going to be coming into closer contact with people, Parker said. So its not completely risk free. But being outdoors helps a lot, really.

Because of the ever-changing situation with the virus, Parker said people will have to constantly do risk assessments before trying to resume pre-pandemic activities.

Youre not going to completely stop living, youre just going to balance out risky behaviors. Like, how important is it for me to drink a beer in a bar tonight, which is a really risky thing to do. Or go to the park to play catch, which is less risky, Parker said. We just have to find ways to balance these things out.

Heres the latest on the virus numbers across Orange County from county data:

Infections | Hospitalizations & Deaths | City-by-City Data | Demographics


See the article here: Is a Second Coronavirus Wave Hitting Orange County? - Voice of OC
This is how fast Ohios coronavirus cases have been increasing – cleveland.com

This is how fast Ohios coronavirus cases have been increasing – cleveland.com

November 11, 2020

CLEVELAND, Ohio - It took 112 days from the first known coronavirus cases in Ohio for the state to reach 50,000 in late June. But over just 13 days recently, the state went from 200,000 to 250,000 cases, with no end for the recent spike in sight.

This illustrates how quickly the case totals have been adding up.

Ohios first three cases were confirmed on March 9. It wasnt until June 28 - three and a half months later - that Ohio reported case No. 50,000.

Then things accelerated, in part because more testing was able to confirm more cases, but more so because of an increasing spread, especially over the last several weeks.

* It took 42 days for Ohio to go from 50,000 cases to 100,000 on Aug. 8.

* It took 48 days to go from 100,000 to 150,000 on Sept. 26.

* It took 30 days to go from 150,000 to 200,000 on Oct. 26.

* And it took just 13 days to go from 200,000 to 250,000 on Sunday, Nov. 8.

After adding 4,706 cases on Monday and 6,508 more on Tuesday, Ohios case total now stands at 261,482, according to the Ohio Department of Health.

Read related coverage

Mapping Ohios coronavirus cases, updates, trends; deaths now reported in all 88 counties

Ohio Gov. Mike DeWine cancels Tuesdays coronavirus briefing for a statewide broadcast Wednesday evening

Ohio reports 6,508 new coronavirus cases - 959 above previous record: Tuesday update


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This is how fast Ohios coronavirus cases have been increasing - cleveland.com
Pfizer Says COVID-19 Vaccine 90% Effective Against Virus …

Pfizer Says COVID-19 Vaccine 90% Effective Against Virus …

November 11, 2020

Pharmaceutical giant Pfizer has announced that its COVID-19 vaccine successfully prevented 90% of disease compared to a placebo, a more positive result than experts expected.

The analysis is based on 94 cases of infection with SARS-CoV-2, the virus that causes COVID-19, among both the vaccinated and placebo groups. Experts had set a minimum threshold of 60% effectiveness for vaccines to be considered for emergency authorization or approval. The results included data from 38,955 of the total 43,538 volunteers who enrolled.

Immediately, as with much of the U.S.s pandemic response, the results were quickly thrown into the political blender of opinion, with President Donald Trump and his team taking to social media to tout the government support that made the promising results possible. In fact, Pfizer did not receive federal funding from the Operation Warp Speed (OWS) program that supported development of some of the vaccines currently in late stage testing. The company also plans to pack, ship and distribute its vaccine using its own system and not the network being built by OWS. In July, the company signed a contract with the government to provide 100 million doses of vaccine with a potential for several million more if the vaccine is authorized for distribution by the Food and Drug Administration.

Pfizer is the first company to release results from its COVID-19 vaccine, part of a planned interim analysis by an independent data safety monitoring board that is reviewing all of the handful of vaccine candidates from different companies that are currently being tested in people. The findings represent results collected seven days after the second of Pfizers two-shot regimen.

Pfizer, which developed and is testing its vaccine with German company BioNTech, said in a release that it will continue following study participants for a couple more weeks, until the middle of November, when everyone in the study will have been followed for at least two months. Thats the timeframe the Food and Drug Administration is requiring for COVID-19 vaccines before considering them for emergency authorization or approval, and also when the data safety review boards next scheduled analysis of the data will occur.

The encouraging results were revealed to Pfizer officials yesterday, on Nov. 8, by the five-member data safety monitoring board. They were incredibly poker-faced, right up until they reported the results, says Bill Gruber, head of clinical vaccine research and development at Pfizer. I have been in vaccine development for more than 35 years, and in my most optimistic moment did not expect efficacy of 90%. My most optimistic expectation was 75% or 80%, so this is a remarkable outcome.

Its important to note what that effectiveness means. The results do not reflect complete or so-called sterilizing immunity against infection, but rather protection against COVID-19 illness and its serious consequences once someone has been infected. In fact, the study was not set up to test people regularly and compare those who were negative versus those who were positive in each of the vaccine and placebo groups. Instead, all of the participants were asked to report any symptoms of COVID-19 they experienced, including fever, shortness of breath, sore throats and intestinal problems. Once they reported symptoms, they were tested for SARS-CoV-2, either by requesting a swab to take a sample themselves, or by reporting to their trial site for a test. Researchers then looked at those who were confirmed to be infected, and compared disease outcomes among those getting the vaccine and those getting a placebo in this group.

Gruber says its possible, however, that the vaccine is also protecting against infection, because many people experience COVID-19 without any symptoms. The full set of data will investigate other important questions such as whether the vaccine can protect people from getting infected in the first place. Before I began the study, I wasnt particularly optimistic that there would be high level protection against infection, he says. Now, given the high level of protection [we see] for relatively mild disease, suggests to me that there is a chance to protect against infection as well. But we wont know the answer to that until the end of the trial. Additional data may also reveal how contagious people who are infected but asymptomatic might be, which is an important public health question and critical to containing the pandemic.

So far, however, the results represent good news for not only for public health but for science as well. The companies vaccine is based on a new technology that relies on a genetic material known as mRNA. No mRNA-based vaccines have received approval from the FDA yet, although several are being tested for other diseases. The results are a testament to the benefits of the platformusing mRNA speeds up development of a vaccine since the process does not require growing vast amounts of virus.

Instead, vaccine developers only needed the genetic sequence of SARS-CoV-2, which became available in January, to start building a vaccine. Other companies, including Massachusetts-based Moderna, and vaccine giant Sanofi, are also testing mRNA COVID-19 vaccines.

This is a developing story and will be updated throughout the day.

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Read this article: Pfizer Says COVID-19 Vaccine 90% Effective Against Virus ...
Coronavirus: Pfizer COVID-19 vaccine found to be 90% …

Coronavirus: Pfizer COVID-19 vaccine found to be 90% …

November 11, 2020

The coronavirus vaccine being developed by Pfizer and BioNTech has been found to be 90% effective in preventing people from getting the virus.

Phase 3 of Pfizer's trial involved 43,538 participants from six countries. They received two doses of either the immunisation or a placebo, with 90% protected from the virus within 28 days of having their jabs.

Only 94 people who took part in the trial developed coronavirus and no serious safety concerns were reported, the US pharmaceutical firm said.

"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," said Pfizer chairman and chief executive Dr Albert Bourla.

"With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.

The news saw stock markets surge, with the FTSE 100 jumping by 5.5% - adding 82bn to the value of its shares and resulting in its best trading day since March.

Pfizer and BioNTech's vaccine is one of around 12 worldwide in the final stages of testing, but it is the first to produce any results.

The US and German companies say they can supply 50 million doses by the end of 2020 and 1.3 billion by the end of 2021.

The UK government has secured around 40 million doses - enough for 20 million people - and could roll out 10 million by the end of the year if they are approved for use in time.

Pfizer says that it will apply to the US healthcare regulator - the Food and Drug Administration - by the end of this month for emergency approval to use the vaccine.

A UK government spokesman said it is "optimistic about a breakthrough" but urged people to remember "there are no guarantees".

When the NHS is ready to roll out the vaccine, people who live and work in care homes will be top priority, followed by the elderly and the clinically vulnerable, they added.

Chief medical officer Professor Chris Whitty described it as "a reason for optimism for 2021".

But Brendan Wren, a professor of microbial pathogenesis at the London School of Hygiene and Tropical Medicine, suggested it may prove difficult for GPs to store the vaccines as they must be kept at -80C temperatures.

He told Sky News: "You can certainly make a lot of it but whether you could get it to everybody that needs it is another issue and that's why it's good that there are other vaccines available."

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Sky News science correspondent Thomas Moore said the results "exceed the expectations of many scientists".

Peter Horby, professor of emerging diseases and global health at the University of Oxford, described the development as a "watershed moment".

He said: "This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general."

Michael Head, senior research fellow in global health at the University of Southampton, commented: "This cautiously sounds like an excellent result from the Phase 3, but we should remain a little cautious - the study is ongoing.

"However, if the final results show an effectiveness of anywhere near 90% with response in elderly and ethnic minority populations, that is an excellent result for a first generation vaccine."

William Schaffner, infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee, added: "The efficacy data is really impressive.

"This is better than most of us anticipated. I would have been delighted with efficacy of 70% or 75%, 90% is very impressive for any vaccine. The study isn't completed yet, but nonetheless the data looks very solid."


See original here: Coronavirus: Pfizer COVID-19 vaccine found to be 90% ...
Q&A: Where are we in the COVID-19 vaccine race?

Q&A: Where are we in the COVID-19 vaccine race?

November 11, 2020

By Carl O'Donnell

NEW YORK(Reuters) - Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway. Some companies had suggested early trial data could be ready for release in October, but have since pushed that back to November and December.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, and U.S. biotech Moderna Inc could have early data in November. Britain-based AstraZeneca Plc, in conjunction with University of Oxford, and Johnson & Johnson say they are on track to deliver data for their vaccines this year.

What happens in these trials?

The companies are testing their vaccines against a placebo - typically saline solution - in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why are data reports delayed beyond original predictions?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer, for instance, believes it may know if its vaccine works once 32 people contract COVID-19 in the 44,000-person trial, as long as the overwhelming majority of those infected had received the placebo.

But drugmakers have said an insufficient number of infections prior to the recent spikes in cases slowed their ability to present data earlier. Pfizer in October said it did not expect to have usable trial data until late November due to slow infection rates. It had previously suggested that would happen in October.

Story continues

AstraZeneca said a slowdown in infections during the summer delayed its UK trial and that it expected to have results by the end of the year. Its timeline was also extended by a pause to investigate an illness in a UK trial participant.

After a slowing of infections in late summer and early autumn, COVID-19 cases were rampant again in October and early November, setting daily records in the United States and Europe as the weather cooled and people moved indoors. Experts have suggested that trial participants may also have been more careful to avoid contracting COVID-19 than the general population knowing they may have received a placebo.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Some regulators have said that vaccines must demonstrate at least 50% efficacy - meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

When will regulators decide?

Regulators will review the vaccines after the companies have enough data to submit applications seeking emergency use authorization (EUA) or formal approval. The earliest they could decide is in December because Moderna and Pfizer/BioNtech do not expect to have enough safety data until the second half of November. U.S. regulators have asked that participants be watched for side effects for two months after receiving a final vaccine dose. AstraZeneca could provide a look at late-stage data by the end of the year. UK officials said there is a slight possibility they could decide on that vaccine in late December.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to do speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

Could these be the first approved coronavirus vaccines?

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia's Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data in November. Russia has also given the vaccine to at least hundreds of "high-risk" members of the general population.

(Reporting by Carl O'Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer and Bill Berkrot)


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Q&A: Where are we in the COVID-19 vaccine race?
Knox County is prepping for a COVID-19 vaccine, but most of us won’t get it first – Knoxville News Sentinel

Knox County is prepping for a COVID-19 vaccine, but most of us won’t get it first – Knoxville News Sentinel

November 11, 2020

Pfizer and BioNTech released early study results indicating that their vaccine prevented more than 90% of infections with the virus that causes COVID-19. USA TODAY

The Knox County Health Department is gathering supplies and preparing staff to administer the first batch of COVID-19 vaccines as soon as they're ready, perhaps as soon as the end of the year.

But for almost all of us, don't expect to be among the first to get the shot.

Guidelines from the Centers for Disease Control and Prevention and the Tennessee Department of Health dictate that the vaccine be given to groups based on priority with medical providers and first responders at the front of the line, Health Department Director Dr. Martha Buchanan told the county commission Monday night.

From there, she said, the vaccine will be given to long-term care providers and others who provide services that put them at risk of getting COVID-19. Next up will be people categorized as susceptible because of age or medical conditions.

(Photo: Getty Images)

Children will not be eligible for the first vaccine, Buchanan said, because it has been tested only on adults and children have a higher immunity to the virus.

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The health department has been told to be ready to distribute a vaccine by late November or early December, though theres no guarantee it is ready that quickly. There's been a buzz of anticipation after the drug company Pfizer and its partner, the German company BioNTech announced test results that showed its vaccine was 90% effective in preliminary trials.

Experts do not think the vaccine will be available with the speed and in quantities to do much at all in the next several months to mitigate the pandemic.

Im just being really honest and transparent. I think distribution will go slowly, Buchanan said.

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There were 75 people hospitalized in Knox County with the virus Monday, and 119 people have died here since the pandemic arrived early this year. Most of those deaths have occurred since June 30 the virus has killed 114 people in the past 132 days.

Public health officials are warning the disease is likely to surge again worldwide as winter approaches and people are indoors more often, and as people gather with friends and family for the holidays.

Pfizer is the first drug company to release data from a large, Phase 3 trial as it and several other companies are working to produce a COVID-19 vaccine that is safe and effective.

Like other vaccines, Buchanan said, the health department wont be the only (or largest) distributor. Local hospitals and doctors offices, among others, will administer the treatment as well.

Knox County Health Department Director Dr. Martha Buchanan speaks during a news conference at the City County Building in downtown Knoxville on April 27, 2020.(Photo: Brianna Paciorka/News Sentinel )

This particular vaccine is expected to come in 975-dose batches, Buchanan said. It is unclear how many batches the county can acquire at one time, but whatever the number is, Buchanan said she doesnt want to hoard supplies that might get better use in other parts of the country.

We will make sure we get adequate supplies based on our demand, but weve also learned from 13 years of in-school vaccinations that vaccine uptake (the percentage of those who agree to get the vaccine) varies and we dont want to waste such valuable resources by having too much on hand and having too much discarding, she said.

The vaccine is expected to require two doses, likely 21-28 days apart, Buchanan said. This gives your immune system a chance to produce antibodies and makes it less likely to get COVID-19, she said.

Pfizers vaccine is unique in that it must be stored at about negative-97-degrees Fahrenheit, requiring either rotating amounts of dry ice or an ultra-cold freezer.

A shot is prepared as part of a possible COVID-19 vaccine developed by the National Institutes of Health and Moderna Inc. in Binghamton N.Y.(Photo: Hans Pennink)

Funding for the supplies needed for this vaccine will come from the $7.1 million in CARES Act funding the county commission allotted the health department earlier this year.

There are other vaccines coming down the pipe and because this one has such rigorous storage requirements that Id imagine when others that are easier to store become available, well get those as well, she said.

So, I dont want to put too much money in the super-cold storage, but I want to have adequate storage so we can meet the demand.

USA TODAY contributed to this report.

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Knox County is prepping for a COVID-19 vaccine, but most of us won't get it first - Knoxville News Sentinel
Counties plan for first round of COVID-19 vaccine; most will have to wait until 2021 – WKRC TV Cincinnati