Emergence of a Deadly Coronavirus
Opening the Floodgates
I read an article this morning that related to the distribution problems associated with the vaccine.
The reason your local grocery store contains relatively fresh food from the other side of the planet is because of something known as the “cold chain,” a series of refrigerated containers that allow perishable food to be shipped without spoiling. Many drugs and especially vaccines require the same thing. However, Pfizer’s vaccine, which consists of an unstable information-containing molecule called RNA encased within an equally unstable bubble of fat, requires storage at -94 F (-70 C). Generally, only research laboratories possess deep freezers that cold; pharmacies and hospitals do not. Pfizer’s solution is to provide special containers that can be packed with dry ice to maintain the requisite temperature, but once the vaccine has been removed and placed inside a regular refrigerator, the shelf life is five days. The Moderna vaccine can be stored and shipped at -4 F and has a shelf-life of 30 days in regulator refrigerators, so it poses a much smaller logistical challenge. AstraZeneca’s vaccine is the easiest to distribute, since it can be shipped at the regular refrigeration temperature of 36-46 F and kept on the shelf for six months.
The question of who gets the vaccine first will play out initially at the international level. Countries that have made purchase orders will be the first to receive them. For example, according to Mint, the European Union has secured 200 million doses (with an option for 100 million more) for Pfizer’s vaccine, Japan 120 million doses, the United States 100 million doses (with an option for 500 million more), and the U.K. 30 million doses. If all options are exercised, Pfizer simply cannot meet that demand even by the end of 2021, which could mean that rich countries will fight among themselves over who gets what batch when. The U.S. already has a tense relationship with Europe, and a fight over vaccine batches would put more stress on a fragile trans-Atlantic relationship, especially since the country that receives the most vaccine doses has a likelier chance of improving its economy the quickest. Because Moderna, AstraZeneca and other companies will also produce vaccines, these tensions can be eased somewhat, though whichever country serves as a company’s “home” likely will be under substantial pressure to deliver vaccines to compatriots first. This latter point is complicated by the fact that some of these companies are multinational entities and have “homes” in several countries around the globe.
While rich countries duke it out, the rest of the world will have to wait. Money doesn’t solve everything. The logistical challenges posed by the cold chain make it nearly impossible to deliver a vaccine to a region with poor infrastructure and unreliable electricity. Gaps in the cold chain – that is, periods in which the vaccine is not stored at the proper temperature – would destroy the vaccine. (This is to say nothing of criminal activity. Everyone is a potential target of criminal enterprises that offer fake vaccines, of course, but poorer countries are most susceptible since delivery of legitimate vaccines may be months if not years away.)
But then the article pointed to what I perceive as the solution.
There are a number of companies around the world working on developing viable vaccines. Some of these race horses will fall by the wayside but others will succeed. It is the cumulative effect of vaccine development that will conquer this threat. So do not put your focus on betting on individual horses but rather bet on the race.
Source: The Geopolitics Of Vaccine Distribution
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Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
The Food and Drug Administration (FDA) is “rapidly” proceeding toward authorizing Pfizer’s Covid-19 vaccine and vaccinations could begin by early next week, Health Secretary Alex Azar predicted Friday, after the shot cleared a key hurdle Thursday when an advisory panel endorsed the vaccine.
2.9 million. That’s the number of doses in the first batch of the Pfizer-BioNTech vaccine that will go out to all 50 states once the vaccine is approved, Good Morning America reported Friday. The company believes it will be able to ship out the entire first batch within 24 hours of the vaccine being authorized.
Once the vaccine rolls out, Azar said Friday there could be 20 million vaccinations “just in the coming weeks,” with “up to 50 million total by the end of January” and 100 million by the end of February.
Source: Covid-19 Vaccinations Could Start ‘Monday Or Tuesday’ As FDA Set To Approve Pfizer Vaccine, HHS Chief Says
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
FDA finalizes Pfizer coronavirus vaccine approval
The U.S. Food and Drug Administration (FDA) on Friday formally granted emergency approval for Pfizer and BioNTech’s coronavirus vaccine candidate, officially paving the way for widespread distribution of the long-awaited vaccine that is recommended to go to health care workers and residents and staff of long-term care facilities first. The move comes just one day after an FDA advisory panel voted to endorse the Pfizer-BioNTech coronavirus vaccine.
In a joint statement released after the vote, FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said the agency will now "rapidly work toward finalization and issuance of an emergency use authorization."
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Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
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GSK/Sanofi Covid vaccine delayed until end of next year
The drug companies hoped to have regulatory approval for the candidate vaccine in the first half of 2021, but interim results from a phase 1/2 trial showed an “insufficient” response in the over-50s, the age group most vulnerable to severe Covid-19.
The results released on Friday are a stark reminder that despite a flurry of positive results from vaccines produced by Pfizer/BioNTech, NIH/Moderna and Oxford University/AstraZeneca, developing effective vaccines at speed is no simple task.
In those aged 18- to 49-years-old, the GSK/Sanofi vaccine produced an immune response similar to that seen in patients who recovered from Covid-19, but in older adults companies reported a “low immune response … likely due to an insufficient concentration of the antigen”. The antigen is the viral protein that primes the immune system to fight coronavirus.
The companies will now reformulate the vaccine and launch a phase 2 trial in February with an aim to deliver approved shots in the last quarter of 2021, barring any further setbacks.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the results highlighted why many scientists were amazed at the success of the BioNTech, Moderna and Oxford vaccines.
Evans said it was possible that adjustment of doses and constituents of the vaccine could improve responses in elderly people, but that it was not guaranteed.
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Germany to go into national lockdown over Christmas to stem surge in Covid-19 cases
As of next Wednesday, all non-essential shops, services and schools will close until January 10, and Christmas Day gatherings will be reduced from 10 people to only five from two different households.
Germany reported record daily deaths on Friday, with 598 fatalities tallied in a span of 24 hours.
The new measures take aim at traditional festivities: Christmas church services will be subject to prior registration with no singing allowed, alcohol is to be banned from all public spaces and an annual New Year's Eve fireworks display will be canceled. Some states are also implementing additional measures, such as Bavaria, which will have a 9 p.m. curfew.
German Finance Minister Olaf Scholz has pledged economic help for all businesses affected by the lockdown.
On Sunday, Germany recorded 20,200 new coronavirus infections.
In a cabinet meeting on Friday, it was announced the federal state of Thuringia would close retail stories from December 19 and students would shift to online learning from December 21 as part of the new restrictions, while, earlier this week, it was announced German states of Saxony and Bavaria would move to tougher lockdown measures.
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Professionally Identified and joined WP August 26, 2013
DSM 5: Autism Spectrum Disorder, DSM IV: Aspergers Moderate Severity
“My autism is not a superpower. It also isn’t some kind of god-forsaken, endless fountain of suffering inflicted on my family. It’s just part of who I am as a person”. - Sara Luterman
Vaccine is now being shipped
I had an interesting conversation with my daughter today. I had ordered some holiday gift over Amazon and I was pleasantly surprised at how quickly they appeared at my door, even beating their projected delivery dates. She told me that the reason why is because UPS and FedEx had to clear their books in order to handle the upcoming high priority shipments (vaccines).
That was an "Aha moment".
[An Aha moment - a moment of sudden realization, inspiration, insight, recognition, or comprehension The aha moment you experience when you've been trying to remember the name of a song and three hours later it hits you.]
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Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
The first doses of New York’s coronavirus vaccine supply went to a health care worker who spent the last 10 months working the front lines as the illness ripped through the state. The Northwell Health employee, who was the first to receive the vaccine on Monday, was identified as Sandra Lindsay, RN, a critical care nurse at Long Island Jewish Medical Center.
The long-awaited moment comes just one day after workers at a Pfizer plant in Portage, Mich., loaded the first of nearly 3 million doses onto trucks to be distributed across the nation. UPS and FedEx both tweeted that the deliveries were successful.
The vaccines will go to health care workers and residents of long-term care facilities before the country enters the next phases of distribution.
Source: New York gives first coronavirus vaccine to health care worker
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Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
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U.S. Hits 300,000 Covid Deaths, Nearly 1 In Every 1,000 Americans
The U.S. death count reached over 300,000 dead on Dec. 14, according to data from Johns Hopkins University, which added more than 1,300 cases that day.
It was just under a month ago that the country reached 250,000 deaths, making this the quickest amount of time it’s taken between 50,000 death intervals since the start of the pandemic (it took double the time to climb from 200,000 to 250,000 deaths).
Hospitalizations and deaths have increased markedly since the start of November to the point that the daily death toll has begun to hover around—and sometimes surpass—2,977, the number of Americans killed in the Sept. 11 terrorist attacks in 2001.
The number of people killed by Covid-19 in the U.S. is now a hundred times the death toll of 9/11, six times that of the Vietnam War, more than twice that of World War I, and slightly above the country’s combat deaths in World War II, but is still below the 675,000 believed to have been killed by the 1918 influenza pandemic.
In other words, the coronavirus pandemic has shaved off 0.01% of the U.S. population of roughly 328.2 million Americans, claiming the lives of nearly 1 in every 1,000 residents.
The worst-hit state to date per capita is New Jersey, where 1 in every 500 residents has been killed by Covid-19, with the rate even higher among the state’s Black population.
North and South Dakota, where infections are currently rampant, are fast approaching New Jersey’s mortality rate, with roughly 1 of every 650 and 1 of every 700 residents dead, respectively.
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London is going into lockdown tonight as the numbers have shot up, but the British Govt has told us all we are having a 5 day relaxation of the rules from this time next week.
A lot of sciencey types outraged at the Govt and demanding they do (yet another) u-turn on this policy so people can't mix freely over Christmas
New Variant of Coronavirus
“We are aware of this genetic variant reported in about 1,000 individuals in England,” Mike Ryan, chief of WHO’s emergency program, told a news briefing Monday. “Authorities in the UK are looking at its significance. We have seen many variants, this virus evolves and changes over time.”
Professor Nick Loman from the COVID-19 Genomics U.K. Consortium told the BBC that the variant has several surprising mutations. "It has a surprisingly large number of mutations, more than we would expect, and a few look interesting," Loman said, per the outlet — which also reported the mutation is most prevalent in areas with the highest burden of cases. The professor said there are “two notable sets of mutation,” both situated in the spike protein, which the virus uses to bind to healthy cells.
It’s too early to make any conclusions.
Source: Officials assessing UK new coronavirus strain, significance
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
Moderna Vaccine
This week the FDA will take a vote on recommending/not recommending the Moderna Vaccine. The FDA has just released a briefing document. Here is a link: FDA Briefing Document - Moderna COVID-19 Vaccine
A Food and Drug Administration committee review of Moderna’s coronavirus vaccine emergency use authorization application found “no specific safety concerns” in subgroup analyses by age, race, ethnicity, medical comorbidities or prior SARS-CoV-2 infection, potentially paving the way for a second COVID-19 jab to enter the scene.
In documents posted ahead of Thursday’s Vaccines and Related Biological Products Advisory Committee meeting, the panel also found that the vaccine reduced the risk of confirmed COVID-19 – including severe cases – occurring at least 14 days after the second dose.
Not unlike Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adverse reactions such as pain at injection site, fatigue, headache, muscle pain, joint pain and chills. The reactions were characterized as generally mild to moderate.
The FDA did consider three serious adverse reactions as related to the vaccine, including nausea and vomiting, and facial swelling. An incident of Bell’s palsy also occurred in a vaccine recipient, “for which a causal relationship to vaccination cannot be concluded at this time.”
Source: FDA committee documents on Moderna's COVID-19 vaccine find 'no specific safety concerns'
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
Most Likely Coronavirus Spreader
A new meta-analysis found that there is one household member, in particular, who is most likely to give you COVID-19: Your spouse.
In a meta-analysis of 54 studies that involved a total of more than 77,700 participants across 20 countries, researchers concluded that an estimated 37.8% of COVID-19 patients passed the virus to their spouses.
The review comes after a Centers for Disease Control and Prevention study in November found that 53% of people who lived with someone who was positive for the novel virus also contracted it, “with approximately 75% of infections identified within 5 days of the index patient’s illness onset,” the health agency wrote at the time.
Source: Coronavirus infection most likely to come from this person: study
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
Vaccine Side Effects
A Food and Drug Administration advisory panel is set to review the safety and efficacy of Moderna’s experimental vaccine on Thursday. The company released data Tuesday that showed that its shot is 94.1% effective at preventing Covid-19 with certain symptoms. The data also show that after the second of two doses, about twice as many trial volunteers aged 18 to 64 who received the vaccine experienced side effects compared with those injected with a placebo. About 17% got a fever compared with less than 1% of the placebo group, and 48% got chills versus 6% of placebo recipients. Fatigue and headaches were also more common among vaccine recipients.
Pfizer’s vaccine, which uses technology similar to Moderna’s, showed similar side effects, according to data released last week. Among its volunteers aged 18 to 55 receiving their second dose, 15.8% got a fever, compared with 0.5% of the placebo group; 35% got chills versus 4% of placebo recipients; and they also got more headaches and were more fatigued than those who got the placebo. Volunteers in both trials who received the vaccine also reported pain at the injection site more frequently than placebo recipients.
While the data show that some Moderna and Pfizer trial volunteers experienced side effects, even those who had harsh reactions recommend the shots.
Source: COVID-19 vaccine trial volunteers note occasional harsh side effects
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Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
I read an interesting article covering several points:
With a winter storm almost upon the East Coast, one might wonder if it will impact delivery of the vaccine! Despite a fast-approaching nor'easter across the Northeast, Secretary of Health and Human Services Alex Azar said FedEx and UPS are prepared and federal officials are keeping a close watch on shipments of doses. We literally know where every truck is, we know where every box is, we track all of that.” “This is FedEx, this is UPS Express Shipping, they know how to deal with snow and bad weather but we are on it and following it,” he continued. The first shipments of nearly 3 million doses were previously said to arrive in 145 distribution centers Monday across 50 states, with an additional 425 sites getting shipments Tuesday and the remaining 66 on Wednesday.
Moderna Vaccine - Azar reiterated his hope for likely authorization of Moderna’s vaccine candidate by federal regulators this week. If a Food and Drug Administration (FDA) independent advisory committee votes to endorse the product, and the commissioner upholds the vote, Americans could see nearly 6 million Moderna doses shipped out next week.
Projections for Inoculations - He projected 20 million Americans vaccinated against COVID-19 by the end of 2020, up to 50 million vaccinated by end of January and 100 million shots administered between first-dose and booster shots by the end of February.
What to do in the interim if you get COVID - Azar again advised coronavirus-positive individuals over 65 and those under 65 at risk for serious COVID-19 disease to promptly ask health care workers about Regeneron or Eli Lilly’s monoclonal antibody treatments. He said these drugs work best early on the disease, and staff at MedStar Georgetown University Hospital was reportedly setting up related systems in the community to avoid overstressing the health system. "We have supplies, they're not getting used," Azar reiterated. "You don't want to use it when somebody shows up in the emergency room, you want to use it when they're first diagnosed so you keep that viral load down, you reverse the disease, pushing it back and you keep out of the hospital hopefully."
Source: Pfizer COVID-19 vaccine shipments under close watch amid upcoming snowy weather, Azar says
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
Moderna Vaccine
The Moderna Vaccine is currently undergoing review by the FDA. This review is posted live in real time.
An expert panel is meeting Thursday to consider whether the Food and Drug Administration should issue a second emergency use authorization for a Covid-19 vaccine, this one made by Moderna.
It is almost a foregone conclusion that it will. But the hearing still promises to tell us more about the vaccine and its use.
The FDA gave Moderna’s vaccine a favorable review in the leadup to the meeting, all but guaranteeing the Vaccines and Related Biological Products Advisory Committee will recommend an EUA be granted. It’s also widely expected the FDA will issue the EUA on Friday.
Source: Tracking an FDA advisory panel’s review of the Moderna Covid-19 vaccine
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."
Signs of Optimism in the Air
The first signs of "Life Returning Back to Normal" has begun to sprout like a flower rising out of the snow in Springtime. This is despite the rising infections and death rates.
The travel industry has been beaten badly by the coronavirus.
After news of the FDA's first COVID-19 vaccine approval, the number of hotel bookings at properties across websites for hotels such as Hyatt, Marriott and Best Western and booking platforms like Kayak, Hotwire and Priceline saw the largest jump in daily bookings since March, when the pandemic became widespread in the U.S. The company, which runs bookings for the travel websites, saw 9,512 transactions processed in the U.S. on Dec. 11, the day when the FDA approved the Pfizer and BioNTech COVID vaccine, perhaps suggesting that Americans are hopeful for safe future travel. To compare, sales between November and December a year earlier, before the pandemic hit, generated between 8,500 to 10,000 bookings per day, RateGain data shows.
The travel industry has gained some momentum following COVID-19 vaccine trials in the U.K. British budget airline EasyJet has had a 50% increase in bookings.
Source: Hotel bookings surge following news of COVID-19 vaccine approval
_________________
Author of Practical Preparations for a Coronavirus Pandemic.
A very unique plan. As Dr. Paul Thompson wrote, "This is the very best paper on the virus I have ever seen."