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Thursday, December 10, 2020

FIRST COVID-19 VACCINES GIVEN. WHAT COULD GO WRONG? FOR STARTERS...

The vaccine officially rolled out in the U.K. on December 8.



The Intercept wrote, 
"Pharmaceutical companies view the coronavirus pandemic as a once-in-a-lifetime business opportunity."


The final aid package not only omitted language that would have limited drug makers’ intellectual property rights, it also left out language that had been in an earlier draft that would have allowed the federal government to take any action if it has concerns that the treatments or vaccines developed with public funds are priced too high.

“Those lobbyists deserve a medal from their pharma clients because they killed that intellectual property provision,” said Gary Posner, author of “Pharma: Greed, Lies, and the Poisoning of America.”
 
He added that the omission of language allowing the government to respond to price gouging was even worse. “To allow them to have this power during a pandemic is outrageous.” 

In 2019, the pharmaceutical industry spent $295 million on lobbying, far more than any other sector in the U.S. That’s almost twice as much as the next biggest spender — the electronics, manufacturing, and equipment sector — and well more than double what oil and gas companies spent on lobbying. The industry also spends lavishly on campaign contributions to both Democratic and Republican lawmakers. Throughout the Democratic primary, Joe Biden has led the pack among recipients of contributions from the health care and pharmaceutical industries.


MANY PHYSICIANS DEMANDED MORE TESTING...WHICH DIDN'T HAPPEN. 

Citing criticism of government agencies and increasing public distrust of vaccines, several prominent physicians and experts are calling for the creation of an independent commission to review data from coronavirus vaccine trials before a vaccine is allowed on the market.  

Dr. Kathryn Stephenson, an assistant professor at Harvard Medical School, said she thought of the idea of an independent panel to increase trust in the vaccine after several colleagues told her they did not want to get a coronavirus vaccine when it becomes available.

“I’m hearing this from my peers, from doctors and nurses. They’re not anti-vaxxers. They’re pro-vaccine. They vaccinated their own children. But they are skeptical about this vaccine,”
said Stephenson, director of the clinical trials unit at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.

Separately from Stephenson, bioethicist Arthur Caplan arrived at the same conclusion. “I think we desperately need an independent national commission.”  

WHERE WOULD WE EVER FIND THOSE "INDEPENDENTS"? 
BOTH POLITICS AND MEDIA ARE HEAVILY "CONTRIBUTED" TO BY "BIG PHARMA"...DRUG COMPANY MONEY FLOWS LIKE RIVERS INTO THE POCKETS OF FAR TOO MANY. 

Since the 1930s, the National Institutes of Health has put some $900 billion into research that drug companies then used to patent brand-name medications, according to Posner’s calculations. Every single drug approved by the Food and Drug Administration between 2010 and 2016 involved science funded with tax dollars through the NIH, according to the advocacy group Patients for Affordable Drugs. Taxpayers spent more than $100 billion on that research.

THINK...WHO ALL IS FUNDED BY THE PHARMACEUTICAL COMPANIES? 

They 'donate' to colleges and federal to local politicians, fund testing/research labs, buy ads in all forms of media, provide 'samples' and 'incentives' to physicians, hospitals, provide vaccines to our military, our school kids are forced to take their vaccines, encouraged to take their drugs for "ADHD", etc...it'd be easier to list who ISN'T touched by the 'Goldfinger' of Big Pharma.  

Their influence is SO GREAT that we TAXPAYERS help pay those injured or killed by their vaccines in "Vaccine Court". 

Former top lobbyists of both Eli Lilly and Gilead now serve on the White House Coronavirus Task Force. Azar served as director of U.S. operations for Eli Lilly and lobbied for the company, while Joe Grogan, now serving as director of the Domestic Policy Council, was the top lobbyist for Gilead Sciences. 
Little Tony Wuhan Fauci is their obedient servant. 

And Birx wants to be. 



At least two participants in AstraZeneca's phase 3 trial experienced transverse myelitis, an inflammatory syndrome that affects the spinal cord, after receiving the company's experimental. 


In the U.S., there are four companies that are in the final stage of testing their COVID-19 vaccines: Moderna, Pfizer, AstraZeneca and Johnson & Johnson. All of them have reported side effects in trial participants after giving the shots

Two companies—AstraZeneca and Johnson & Johnson—have paused phase 3 human testing in the U.S. after several volunteers fell so ill that it worried health regulators.  

"People are going to die unnecessarily if we take chances with this," Michael Kinch, a professor of radiation oncology in the school of medicine at Washington University in St. Louis said. "We've got to get this right."

"This could do substantial damage," Kinch said. 

Kinch, who is a patient in one of the vaccine trials himself, said the clinical trial process needs to be followed to the end. A too-early EUA for a vaccine could cause a "nightmare scenario."

[You may be surprised to learn that of the trio of long-awaited coronavirus vaccines, the most promising, Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public.  How...coincidental?] ***


FDA Says Pfizer’s COVID Vaccine Is Safe and Effective. 
But Trial Participants Warn of Intense Symptoms After Second Shot, CNBC reported:

Moderna reported side effects: chills, fevers, headache, shortness of breath, pain in the arm.

Pfizer vaccine: fever, fatigue, chills, redness and swelling

Two trial participants said they experienced “slight flu symptoms” immediately after each of the two shots in August. 

A few volunteers in the younger group reported redness and swelling at the injection site.


NHS Told Not to Give Pfizer Vaccine to Extreme Allergy Sufferers After Two People Have ReactionThe Guardian reported:

“People with a history of significant allergic reactions should not have the COVID vaccine, the medicines regulator has warned, after two NHS workers experienced symptoms on Wednesday."

It’s True: Workers Can Be Fired for Refusing to Get a COVID-19 Vaccine.
WKYC Studios Reported:

“While most Ohioans will still have to wait months to get a coronavirus vaccine, what if you don’t want one? 

Could you even be fired from your job if you refuse?

“Legal experts say yes.

“’Employers can require their at-will employees to get a vaccine. That’s already law,’ said Rema Ina, employment attorney at Cleveland’s Gallagher Sharp law firm, adding that many hospitals already require health care workers to get flu vaccinations as a condition of employment.”

BIDEN MISSPEAKS...AGAIN.

“'This team will help get at least 100 million COVID-19 vaccine shots into the arms of Americans in 100 days,’" the president-elect said in a speech on Tuesday.
A transition team official clarified afterward that 50 million Americans would be vaccinated — because the two most promising early vaccines require two shots per person.”

[IT'S OKAY, JOE; WE EXPECT YOU TO SAY THE WRONG THING EVERY TIME YOU TALK.] 


THOSE ON THE FRONT LINES DON'T WANT THE VACCINE. 

55% of FDNY Firefighters Would NOT Get a COVID-19 Vaccine If Offered by Department, Poll Finds.

“Despite research that shows firefighters were 15 times more likely to be infected, a majority of those who took the poll declined the offer of a vaccine."
Over 1,100 firefighters, or 54.7%, said they would not get the vaccine while 929, or 45.3%, said they would."
But many other people, including doctors and scientists, have raised a multitude of concerns about the safety of the leading COVID vaccine candidates. In fact, polls consistently show that more people than not, including healthcare workers, won’t sign up, at least not right away, for the vaccines. 


Whistleblower: FDA Failed to Address ‘Biohazard Nightmare’ at Merck Vaccine Plant

A former FDA employee-turned-whistleblower says the agency downgraded his report on safety violations at a Merck vaccine plant. The allegation raises questions about how the FDA will monitor safety of COVID vaccine manufacturers.

According to Vanity Fair, “the unprecedented effort to actually make the more than 300 million doses that a successful national vaccination effort will require has gotten less attention” than issues related to the safety and efficacy of the actual vaccines themselves.

“Vital questions about the FDA’s inspections of vaccine plants have slipped under the radar,” the magazine reported.

Vanity Fair, the first to report on the whistleblower complaint, focused on concerns related exclusively to the manufacturing process.

Merck isn’t the only drugmaker whose manufacturing operations have been called into question.

 Eli Lilly, which has been working on a COVID therapeutic drug, recently had a run-in with the FDA over problems with one of its manufacturing plants. Reuters reported that the FDA had cited “serious quality control problems” at an Eli Lilly plant working on an antibody therapy.

A former associate counsel at the FDA told Reuters the violations were “serious enough and have a significant enough impact on the public health that something needs to be fixed.”

In an interview after her article was published, Vanity Fair reporter Katherine Eba told PBS NewsHour the “last thing she wanted to do” was contribute to “vaccine hesitancy.”

“You know, the issues we raised in this story have nothing to do with the anti-vaxxer position. They have to do with whether the FDA is doing the job it is supposed to do, which is ensuring that all these manufacturing plants follow good manufacturing practices.”

Researchers from the University of California Los Angeles’ Karin Fielding School of Public Health surveyed healthcare personnel working in the Los Angeles metropolitan area.

As the Washington Post reported, they found that two thirds (66.5%) of healthcare workers “intend to delay vaccination,” meaning they do not intend to get the COVID vaccine when it becomes available. They plan instead on reviewing the data once it’s widely administered and proven safe.
Seventy-six percent of the vaccine-hesitant healthcare workers cited the “fast-tracked vaccine development” as a primary reason for their concerns.


BLACKS AND LATINOS PASS ON TAKING VACCINE
A new collaborative survey project by the National Association for the Advancement of Colored People and Langer Research found that Black and Latinx Americans are overwhelmingly concerned about the coming COVID vaccine.

The survey, as reported in the Washington post, claims to be “one of the largest and most rigorous conducted on this topic to date.” It found that only 14% of Black Americans trust that a vaccine will be safe, while only 34% of Latinx Americans trust it will be safe.

The survey also found, in the context of COVID, only 19% percent of Black Americans trust drug companies, while less than a third trust the U.S. Food and Drug Administration to “look after their interests.”

According to the Advisory Committee on Immunization Practices, a group of medical experts who advise the Centers for Disease Control and Prevention (CDC), fears surrounding the painful or harmful side-effects of the COVID vaccine are rooted in reality.

According to CNBC, during a virtual Advisory Committee on Immunization Practices’ meeting on Nov. 23, Dr. Sandra Fryhofer told fellow CDC officials that patients need to be aware that the side effects from the COVID vaccines “will not be a walk in the park.” Fryhofer acknowledged that side effects from the vaccines have been reported to mimic symptoms of a mild case of COVID, including muscle pain, fever, chills and headache.

Fryhofer, who explained that both Pfizer’s and Moderna’s COVID vaccines require two doses, worries that her patients might not come back for a second dose after experiencing potentially unpleasant side effects after the first shot.

As a participant of the Moderna vaccine trials noted “it was the sickest I’ve ever been.”

Typically, vaccines take between 8 to 10 years to develop, Dr. Emily Erbelding, an infectious disease expert at National Institute of Allergy and Infectious Diseases, told CNN in an article titled, “The timetable for a coronavirus vaccine is 18 months. 
Experts say that’s risky.”

Susan Bailey, president of the American Medical Association, said in a video that the number of physicians expressing hesitancy was “unprecedented” and “posed a real risk” to public confidence in vaccines. 

When it comes to COVID vaccines, Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, told Vanity Fair, “There is not a lot of room for error on a COVID vaccine.”

But as Vanity Fair and Bloomberg pointed out, if the FDA, as it’s expected to, grants emergency use authorization for a COVID-19 vaccine, “it is not even clear whether the FDA will require full inspections of manufacturing plants” because transparency has been “notably absent in Operation Warp Speed,” the public-private partnership launched by the Trump administration to rapidly develop and distribute a COVID-19 vaccine.

BIDEN IS IN A BIGGER RUSH.
SAME PLAN, BASICALLY AS TRUMP'S...ROLL OUT THE VACCINE AT "WARP SPEED". 


JUST ANOTHER PSYCHOLOGICAL OPERATION 

Despite all this, officials at the forefront of the COVID response plan to combat vaccine safety concerns and hesitancy using, what some are calling, questionable psychological techniques.

For example, the WHO, which named “vaccine hesitancy” as the top global public health threat, has hired the PR firm Hill + Knowlton to identify micro-influencers, macro-influencers and “hidden heroes” on social media who could covertly promote the organization’s image as a COVID authority in order to “ensure WHO’s advice and guidance is followed.”

Cass Sunstein, the chairman of WHO’s Technical Advisory Group on Behavioral Insights, recently wrote an article in Bloomberg in which he promoted the use of popular celebrities, athletes and actors as tools for vaccine persuasion against those who “lack vaccine confidence.”

“Trusted politicians, athletes or actors — thought to be ‘one of us’ rather than ‘one of them’ — might explicitly endorse vaccination and report that they themselves have gotten the vaccine,” Sunstein wrote.

Sunstein, founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School, will chair the advisory group, which was created in July.


In 2008, Sunstein wrote a paper proposing that governments employ teams of covert agents to “cognitively infiltrate” online dissident groups and websites which advocate “false conspiracy theories” about the government. In the paper, Sunstein and his co-authors wrote:

“Our principal claim here involves the potential value of cognitive infiltration of extremist groups, designed to introduce informational diversity into such groups and to expose indefensible conspiracy theories as such.”

Some of this would be accomplished by sending undercover agents, or government-paid third parties, into “online social networks or even real space groups.”

Sunstein also advocated in 2008 that the government pay “independent experts” to publicly advocate on the government’s behalf, whether on television or social media. 
He says this is effective because people don’t trust the government as much as they trust people they believe are “independent.”

ARE PAID 'INDEPENDENT EXPERTS' REALLY 'INDEPENDENT'?
OF COURSE NOT. 


'SALON' took issue with Sunstein in 2010...

Obama confidant's spine-chilling proposal   
Cass Sunstein, one of Barack Obama's closest confidants wants the government to "cognitively infiltrate" anti-government groups, 
sending covert agents into "chat rooms, online social networks, or even real-space groups." 

The paper's abstract can be read, and the full paper downloaded, here.
[See more in my end notes ** below.]

Then there’s the “Guide to COVID-19 Vaccine Communications,” developed by the University of Florida and the United Nations that aims to help governments improve COVID vaccine uptake. 

The authors of that guide promote the tactic of covertly using trusted community leaders to help with pro-vaccine information.

Citing vaccine hesitancy among the African American community, the guide suggests that barber shops and hair salons in predominantly black neighborhoods might be tapped to help disseminate approved vaccine messaging.

[THAT'S LIKE MARGARET SANGER USING BLACK MINISTERS TO HELP CONVINCE BLACK WOMEN TO USE PLANNED PARENTHOOD.] 

If WHO were to adopt such a strategy, and use it to convince hesitant populations to take a COVID vaccine, it would raise questions of legality.

As put forward in a report by the Congressional Research Service, illegal “publicity or propaganda” is defined by the U.S. Government Accountability Office (GAO) to mean either (1) self-aggrandizement by public officials; (2) purely partisan activity; or (3) “covert propaganda.” 

By covert propaganda, GAO means information which originates from the government but is unattributed and made to appear as though it came from a third party.

Because WHO is a multinational organization and not a U.S. Government agency, covert “cognitive infiltration” policies could fall into a gray area, or even be considered legal.

Dr. Margaret Chan, former general-director of WHO, once stated that the organization’s policies are “driven by what [she called] donor interests.”

According to a 2012 article in Foreign Affairs, “few policy initiatives or normative standards set by the WHO are announced before they have been casually, unofficially vetted by Gates Foundation staff.” 

Or, as other sources told Politico in 2017, “Gates’ priorities have become the WHO’s.”

If, as Politico put it, “Gates priorities have become the WHO’s,” and if WHO’s policies are driven by “donor interests,” this raises questions as to what online groups, people and websites would be targeted by such covert programs.

The idea of government agents carrying out psychological operations on social media is not far fetched. 

Earlier this year the head of editorial for Twitter’s Middle East and Africa office was outed as an active officer in the British Army’s psychological warfare unit, known as the 77th brigade, which specializes in online behavioral change operations.


WHAT COULD GO WRONG WITH THE NEW COVID-19 VACCINES?  





It could make Wadi al-Salam seem small.





_____________________

END NOTES: 

-- ** The G.W. Bush Pentagon employed teams of former Generals to pose as "independent analysts" in the media while secretly coordinating their talking points and messaging about wars and detention policies with the Pentagon. Bush officials secretly paid supposedly "independent" voices, such as Armstrong Williams and Maggie Gallagher, to advocate pro-Bush policies while failing to disclose their contracts. 
 In Iraq, the Bush Pentagon hired a company, Lincoln Park, which paid newspapers to plant pro-U.S. articles while pretending it came from Iraqi citizens. In response to all of this, Democrats typically accused the Bush administration of engaging in government-sponsored propaganda -- and when it was done domestically, suggested this was illegal propaganda.

Consider the recent revelation that the Obama administration has been making very large, undisclosed payments to MIT Professor Jonathan Gruber to provide consultation on the President's health care plan. With this lucrative arrangement in place, Gruber spent the entire year offering public justifications for Obama's health care plan, typically without disclosing these payments, and far worse, was repeatedly held out by the White House -- falsely -- as an "independent" or "objective" authority.

Obama allies in the media constantly cited Gruber's analysis to support their defenses of the President's plan, and the White House, in turn, then cited those media reports as proof that their plan would succeed. This created an infinite "feedback loop" in favor of Obama's health care plan which -- unbeknownst to the public -- was all being generated by someone who was receiving hundreds of thousands of dollars in secret from the administration (read this to see exactly how it worked).

In other words, this arrangement was quite similar to the Armstrong Williams and Maggie Gallagher scandals which Democrats, in virtual lockstep, condemned. 

 Paul Krugman, for instance, in 2005 angrily lambasted right-wing pundits and policy analysts who received secret, undisclosed payments, and said they lack "intellectual integrity"; he specifically cited the Armstrong Williams case. Yet the very same Paul Krugman last week attacked Marcy Wheeler for helping to uncover the Gruber payments by accusing her of being "just like the right-wingers with their endless supply of fake scandals." 
 What is one key difference? 
 Unlike Williams and Gallagher, Jonathan Gruber is a Good, Well-Intentioned Person with Good Views -- he favors health care -- and so massive, undisclosed payments from the same administration he's defending are dismissed as a "fake scandal."

-- *** Could things have moved faster from design to deployment of the vaccine? 
Given the grim prospects for winter, it is tempting to wonder. Perhaps, in the future, we will. But given existing vaccine infrastructure, probably not. Already, as Baylor’s Peter Hotez pointed out to me, “Operation Warp Speed” meant running clinical trials simultaneously rather than sequentially, manufacturing the vaccine at the same time, and authorizing the vaccine under “emergency use” in December based only on preliminary data that doesn’t track the long-term durability of protection or even measure the vaccine’s effect on transmission (only how much it protects against disease). And as Georgetown virologist 

Angela Rasmussen told me, the name itself may have needlessly risked the trust of Americans already concerned about the safety of this, or any, vaccine. 
Indeed, it would have been difficult in May to find a single credentialed epidemiologist, vaccine researcher, or public-health official recommending a rapid vaccine rollout — though, it’s worth noting, as early as July the MIT Technology Review reported that a group of 70 scientists in the orbit of Harvard and MIT, including “celebrity geneticist” George Church, were taking a totally DIY nasal-spray vaccine, never even intended to be tested, and developed by a personal genomics entrepreneur named Preston Estep (also the author of a self-help-slash-life-extension book called The Mindspan Diet). 

China began administering a vaccine to its military in June. Russia approved its version in August. And while most American scientists worried about the speed of those rollouts, and the risks they implied, our approach to the pandemic here raises questions, too, about the strange, complicated, often contradictory ways we approach matters of risk and uncertainty during a pandemic — and how, perhaps, we might think about doing things differently next time. 

That a vaccine was available for the entire brutal duration may be, to future generations trying to draw lessons from our death and suffering, the most tragic, and ironic, feature of this plague.


For all of modern medical history, Christakis writes in Apollo’s Arrow, vaccines and cures for infectious disease have typically arrived, if they arrive, only in the end stage of the disease, once most of the damage had already been done and the death rate had dramatically declined. For measles, for scarlet fever, for tuberculosis, for typhoid, the miracle drugs didn’t bring rampant disease to a sudden end — they shut the door for good on outbreaks that had largely died out already. 

This phenomenon is called the McKeown hypothesis — that medical interventions tend to play only a small role compared to public-health measures, socioeconomic advances, and the natural dynamics of the disease as it spreads through a population. 

The new coronavirus vaccines have arrived at what counts as warp speed, but not in time to prevent what CDC director Robert Redfield predicts will be “the most difficult time in the public-health history of this nation,” and do not necessarily represent a reversal of the McKeown hypothesis: The country may still reach herd immunity through natural disease spread, Christakis says, at roughly the same time as the rollout of vaccines is completed. 

Redfield believes there may be 200,000 more American deaths to come. 

[THAT'S DOWN FROM MILLIONS, ISN'T IT. REDFIELD? YES, THE PREDICTION BY FAUCI, ET AL, WAS ORIGINALLY FOR MILLIONS TO DIE IN THE U.S. FROM LITTLE COVID. SORT OF LIKE ZIKA, SWINE FLU, SARS1, MERS.] 

This would mean what Christakis calls a “once-in-a-century calamity” had unfolded start-to-finish between the time the solution had been found and the time we felt comfortable administering it. A half a million American lives would have been lost in the interim. Around the world, considerably more.

In weighing other risks and uncertainties, Americans have been much less cautious, and not just in the case of marching maskless into Wal-Marts. 

The treatment dilemmas facing physicians and patients in the early stages of a novel pandemic are, of course, not the same as the dilemma of rushing a new vaccine to a still-healthy population — we defer to the judgment of desperate patients, with physicians inclined to try to help them, but not to the desires of vaccine candidates, no matter how desperate. An unsafe vaccine, like the one for polio that killed ten and paralyzed 200 in 1955, could cause medical disaster and public-health backlash — though, as Balloux points out, since none of the new coronavirus vaccines use real viral material, that kind of accident, which affected one in a thousand recipients, would be impossible. (These days, one adverse impact in a million is the rule-of-thumb threshold of acceptability.)

 An ineffective vaccine could also give false security to those receiving it, thereby helping spread the disease by providing population-scale license to irresponsible behavior (indoor parties, say, or masklessness). But on other matters of population-level guidance, our messaging about risk has been erratic all year, too. In February and March, we were warned against the use of masks, in part on the grounds that a false sense of security would lead to irresponsible behavior — on balance, perhaps the most consequential public-health mistake in the whole horrid pandemic. In April, with schools already shut, we closed playgrounds. In May, beaches — unable or unwilling to live with even the very-close-to-zero risk of socializing outside (often shaming those who gathered there anyway). But in September, we opened bars and restaurants and gyms, inviting pandemic spread even as we knew the seasonality of the disease would make everything much riskier in the fall. The whole time, we also knew that the Moderna vaccine was essentially safe. We were just waiting to know for sure that it worked, too.

None of the scientists I spoke to for this story were at all surprised by either outcome — all said they expected the vaccines were safe and effective all along. Which has made a number of them wonder whether, in the future, at least, we might find a way to do things differently — without even thinking in terms of trade-offs. Rethinking our approach to vaccine development, they told me, could mean moving faster without moving any more recklessly. A layperson might look at the 2020 timelines and question whether, in the case of an onrushing pandemic, a lengthy Phase III trial — which tests for efficacy — is necessary. But the scientists I spoke to about the way this pandemic may reshape future vaccine development were more focused on how to accelerate or skip Phase I, which tests for safety. More precisely, they thought it would be possible to do all the research, development, preclinical testing, and Phase I trials for new viral pandemics before those new viruses had even emerged — to have those vaccines sitting on the shelf and ready to go when they did. They also thought it was possible to do this for nearly the entire universe of potential future viral pandemics — at least 90 percent of them, one of them told me, and likely more.

As Hotez explained to me, the major reason this vaccine timeline has shrunk is that much of the research and preclinical animal testing was done in the aftermath of the 2003 SARS pandemic (that is, for instance, how we knew to target the spike protein). This would be the model. Scientists have a very clear sense of which virus families have pandemic potential, and given the resemblance of those viruses, can develop not only vaccines for all of them but also ones that could easily be tweaked to respond to new variants within those families.

“We do this every year for influenza,” Rasmussen says. “We don’t know which influenza viruses are going to be circulating, so we make our best guess. And then we formulate that into a vaccine using essentially the same technology platform that all the other influenza vaccines are based on.” The whole process takes a few months, and utilizes a “platform” that we already know is basically safe. With enough funding, you could do the same for viral pandemics, and indeed conduct Phase I trials for the entire set of possible future outbreaks before any of them made themselves known to the public. In the case of a pandemic produced by a new strain in these families, you might want to do some limited additional safety testing, but because the most consequential adverse effects take place in the days right after the vaccine is given, that additional diligence could be almost immediate.

According to Florian Krammer, a vaccine scientist at Mount Sinai, you could do all of this at a cost of about $20 million to $30 million per vaccine and, ideally, would do so for between 50 and 100 different viruses — enough, he says, to functionally cover all the phylogenies that could give rise to pandemic strains in the future. (“It’s extremely unlikely that there is something out there that doesn’t belong to one of the known families, that would have been flying under the radar,” he says. “I wouldn’t be worried about that.”) In total, he estimates, the research and clinical trials necessary to do this would cost between $1 billion and $3 billion. So far this year, the U.S. government has spent more than $4 trillion on pandemic relief. Functionally, it’s a drop in the bucket, though Krammer predicts our attention, and the funding, will move on once this pandemic is behind us, leaving us no more prepared for the next one. When he compares the cost of such a project to the Pentagon’s F-35 — you could build vaccines for five potential pandemics for the cost of a single plane, and vaccines for all of them for a fraction of the cost of that fighter-jet program as a whole — he isn’t signaling confidence it will happen, but the opposite.

Krammer spent the early months of the pandemic focused on serological testing — it was his lab that gave New York City its first clear picture of just how far the pandemic had spread through the five boroughs in the spring— but recently, he has turned his attention to how to accelerate the timeline of vaccine delivery. In a just-published paper in Cell, he suggests it isn’t just that Phase I clinical work and the larger, longer Phase II safety trials which could be done preemptively, entirely before the arrival of new pandemics. Some Phase III efficacy testing, he says, could be done then, as well — especially for existing rather than novel strains. “To look for immunogenicity”—whether scientists can provoke the right immune response — “you don’t even have to develop the vaccine,” he says. “You can make antigens in the research center and just test it — that’s pretty inexpensive.” And if a Phase III trial were deemed necessary, it could start just weeks after the disease was identified and conclude in as soon as ten weeks.

If we do all that, he says, the entire timeline could be compressed to as few as three months. The production and distribution of a vaccine adds considerable cost, bureaucracy, and even some chaos, as we’re likely about to see. But three months from the design of the Moderna vaccine was April 13. The second and third surges, the return to school and the long-dreaded fall, 225,000 more deaths and 50 million more infections — all of that still lay ahead. 
Shave another month off somehow and you’re at March 13, the day the very first person in New York City died.

TIME WILL TELL. 
IF IT'S ALLOWED TO. 




//WW

4 comments:

  1. Back in August, FORBES imagined what could go wrong with a hasty vaccine.
    They wrote:"Immunologists have observed that the virus has exhibited no major or concerning mutations since reaching U.S. shores. But, theoretically, it could. And a virus that mutates significantly over time could render an approved vaccine ineffective."
    PSST, Forbes, there were about 8-10 mutations/different strains as of March 2020.
    HOW DID YOU MISS THAT FACT IN AUGUST?
    WHY DIDN'T YOU REPORT THE MUTATIONS IN MARCH?
    BUT, THERE ARE ALSO OVER 40,000 "variants' (46,508) & 12 "clades" as of today in just the USA. Go see the mutation tracking map?
    On that map, left click for selections menus. Pick one, see for yourself.
    https://www.cbrc.kaust.edu.sa/covmt/index.php?p=maps#

    From March:
    The good news is that the 8 mutations are not more lethal, said Trevor Bedford, whose website NextStrain.org is tracking the virus’s genome from samples provided to him from throughout the world.
    “In the literal sense of ‘is it changing genetically?’ the answer is absolutely yes,” Harvard University infectious disease epidemiologist Marc Lipsitch told NPR.
    “What is in question is whether there’s been any change that’s important to the course of disease or the transmissibility or other things that we as humans care about.”
    The strains emerging are only slightly tweaked, with no variations in lethality, experts said."
    https://www.news.com.au/lifestyle/health/health-problems/covid19-mutating-coronavirus-now-has-eight-strains/news-story/e70752f70f7e623c24aa02fbad16c705



    ReplyDelete
  2. Fri Dec 11, 2020...French infectious disease expert shocked by the number of adverse reactions to COVID-19 vaccine
    'I have never read such a high frequency' of side effects from an injection," the head of the infectious and tropical disease department at a Paris hospital observed.
    53 pages of side effects. 53 pages.
    Caumes complained earlier about the lack of available scientific data from their results and side effects, saying he would never take an RNA vaccine, nor blindly trust the vaccine industry merely on their press releases. “I'm surprised because these adverse reactions are not listed in the U.S. drug agency document, which is my only source," he said. "This confirms that we should not rush.”
    https://www.lifesitenews.com/news/french-infectious-disease-expert-shocked-by-the-number-of-adverse-reactions-to-covid-19-vaccine

    ReplyDelete
  3. Vaccine Rollout Hits First U.S. Snags With Delays, Allergic Case

    https://www.bloomberg.com/news/articles/2020-12-16/first-hiccups-seen-in-u-s-push-to-deliver-covid-19-vaccine

    ReplyDelete
  4. Dec. 16 (UPI) -- United Airlines said Wednesday it has started a COVID-19 contact tracing program that will collect key health information from passengers on all domestic and international flights.

    https://www.upi.com/Top_News/US/2020/12/16/United-Airlines-works-with-CDC-to-start-COVID-19-contact-tracing-on-all-flights/6331608091925/

    ReplyDelete