Did CNN fall on its head? (Or is this a way of kicking the can down the road, making a mandate seem all the more prudent after this toxin has been "proven safe and effective?)
MCM > > > > https://www.cnn.com/2020/09/01/health/eua-coronavirus-vaccine-history/index.html?ref=hvper.com > > Past vaccine disasters show why rushing a coronavirus vaccine now would be > 'colossally stupid' > [image: ATLANTA, GA - OCTOBER 05: A podium with the logo for the Centers > for Disease Control and Prevention at the Tom Harkin Global Communications > Center on October 5, 2014 in Atlanta, Georgia. The first confirmed Ebola > virus patient in the United States was staying with family members at The > Ivy Apartment complex before being treated at Texas Health Presbyterian > Hospital Dallas. State and local officials are working with federal > officials to monitor other individuals that had contact with the confirmed > patient. (Photo by Kevin C. Cox/Getty Images)] > > (CNN) — Vaccine experts are warning the federal government against > rushing out a coronavirus vaccine before testing has shown it's both safe > and effective. Decades of history show why they're right. > > FDA signals vaccine could green light early > > Their concern that the FDA may be moving too quickly heightened when FDA > Commissioner Dr. Steven Hahn told the Financial Times that his agency could > consider an emergency use authorization (EUA) for a Covid-19 vaccine before > late stage clinical trials are complete if the data show strong enough > evidence it would protect people. > [image: Covid-19 vaccine will likely require 2 doses] > Covid-19 vaccine will likely require 2 doses 02:16 > The commissioner has the authority > <https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization> > to allow unapproved medical products to be used in an emergency when there > are no adequate or approved alternatives. An EUA is not the same as full > approval and it can be withdrawn. > That's what happened with hydroxychloroquine and chloroquine. The FDA > granted <https://www.fda.gov/media/136534/download> an EUA to the drugs > -- much praised by President Donald Trump -- on March 28 > <https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-30-2020>. > It subsequently revoked <https://www.fda.gov/media/138946/download> its > EUA in June after studies showed they were not effective and could also > potentially > <https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or>cause > serious heart problems. > > Vaccine approval > > For a vaccine to be FDA approved > <https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Ensuring-the-Safety-of-Vaccines-in-the-United-States.pdf>, > scientists must gather enough data through clinical trials in large numbers > of volunteers to prove it is safe and effective at protecting people > against a disease. Once the data is collected, FDA advisers usually spend > months considering it. > [image: Optimism grows for emergency coronavirus vaccine use in 2020] > Optimism grows for emergency coronavirus vaccine use in 2020 02:14 > An EUA is much quicker. Only once before has the FDA given a vaccine this > lesser standard approval > <https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#anthrax> > of an EUA, but it was in an unusual circumstance. Soldiers had sued, > claiming a mandatory anthrax vaccine made them sick, and a judge put a hold > on the program. The Department of Defense asked for an EUA > <https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#anthrax>that > then overrode the court ruling in 2005, so it could continue vaccinating > military personnel -- this time on a voluntary basis. > > Otherwise, vaccines have had to go through the entire clinical trial > process and FDA approval process, which can take months or years. > > When the vaccine making process has been rushed, there have been bad > outcomes. > > The Cutter incident > > On April 12, 1955 the government announced the first vaccine to protect > kids against polio. Within days, labs had made thousands of lots of the > vaccine. Batches made by one company, Cutter Labs, accidentally contained > live polio virus and it caused an outbreak. > > More than 200,000 children got the polio vaccine, but within days the > government had to abandon the program. > [image: The US just topped 6 million coronavirus cases in about 7 months. > What happens next is up to you, Birx says] > <http:///2020/08/31/health/us-coronavirus-monday/index.html> > > "Forty thousand kids got polio. Some had low levels, a couple hundred were > left with paralysis, and about 10 died," said Dr. Howard Markel, a > pediatrician, distinguished professor, and director of the Center for the > History of Medicine at the University of Michigan. The government suspended > the vaccination program until it could determine what went wrong. > > Monkey trouble > > However, increased oversight failed to discover another problem with the > polio vaccine. > From 1955 to 1963, between 10% and 30% of polio vaccines were contaminated > with simian virus 40 > <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC153983/> (SV40). > > "The way they would grow the virus was on monkey tissues. These rhesus > macaques were imported from India, tens of thousands of them," medical > anthropologist S. Lochlann Jain said. "They were gang caged and in those > conditions, the ones that didn't die on the journey, many got sick, and the > viruses spread quickly," added Jain, who taught a history of vaccines > course at Stanford and is working on a publication about the incident. > Scientists wrongly thought the formaldehyde they used would kill the virus. > "It was being transferred to millions of Americans," Jain said. > [image: Experts call for independent commission separate from FDA to > review Covid-19 vaccines] > <http:///2020/08/30/health/covid-19-vaccine-fda-independent-commission/index.html> > "Many believe this issue wasn't adequately pursued," Jain said. Some > studies showed a possible link between the virus and cancer. The US Centers > for Disease Control website, however, > <https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html>said > most studies <https://onlinelibrary.wiley.com/doi/full/10.1002/ijc.22425> > are "reassuring" and find no link. > > No current vaccines contain SV40 virus, the CDC says, and there's no > evidence the contamination harmed anyone. > > The epidemic that never was > > In 1976, scientists predicted a pandemic of a new strain of influenza > called swine flu. More than 40 years later, some historians call it "flu > epidemic that never was." > > "President Ford was basically told by his advisers, that look, we have a > pandemic flu coming called swine flu that may be as bad as Spanish flu," > said Michael Kinch, a professor of radiation oncology in the school of > medicine at Washington University in St. Louis. His latest book, "Between > Hope and Fear," explores the history of vaccines. > [image: What you need to know about coronavirus on Monday, August 31] > <http:///2020/08/31/world/coronavirus-newsletter-08-31-20-intl/index.html> > > "Ford was being cajoled to put forward a vaccine that was hastily put > together. When you have a brand new strain situation like that, they had to > do it on the fly," Kinch said. > > Ford made the decision to make the immunization compulsory. > > The government launched the program in about seven months and 40 million > people got vaccinated against swine flu, according to the CDC. That > vaccination campaign was later linked to cases of a neurological disorder > called Guillain-Barre syndrome, which can develop after an infection or, > rarely, after vaccination with a live vaccine. > "Unfortunately, due to that vaccine, and the fact that it was done so > hastily, there were a few hundred cases of Guillain-Barre > <https://www.mayoclinic.org/diseases-conditions/guillain-barre-syndrome/symptoms-causes/syc-20362793>, > although it's not definitive that they were linked," Kinch said. > [image: We're only just beginning to learn how Covid-19 affects the > brain] > <http:///2020/07/29/health/covid-19-brain-effects-wellness/index.html> > The CDC said > <https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html> the > increased risk was about 1 additional case of Gullain-Barre for every > 100,000 people who got the swine flu vaccine. Due to this small > association, the government stopped the program to investigate. > > "It was kind of a fiasco," Markel said. "The good news is that there never > was an epidemic of swine flu. So we were safe, but that shows you what > could happen." > > Growing distrust in the US > > It took several incidents for people to start distrusting vaccines. Even > after thousands of kids got sick from the first polio vaccine in 1955, when > the program restarted, parents made sure their children got vaccinated. > They had clear memories of epidemics that paralyzed between 13,000 and > 20,000 children every year. Some were so profoundly paralyzed that they > could not even breathe easily on their own, and relied on machines called > iron lungs to help them breathe. > > "Parents were pushing their kids to get to the head of the line to get the > polio vaccine, because they had seen epidemics every summer for years, and > saw kids in iron lungs and they were terrified," Markel said. > [image: He signed up for a coronavirus vaccine trial using a method > that's never been used in humans. Here's why.] > <http:///2020/04/24/health/coronavirus-vaccine-speed-sanjay-gupta/index.html> > > Markel said people's attitudes started to change between 1955 and the > problematic 1976 swine flu vaccination project. > > "You've got civil rights, when people see the cops beating the hell out of > people on TV. You've got the Vietnam War where people start to get > disgusted with the killing. You've got Watergate when the president is > literally lying through his teeth," Markel said. "That led to a real > distrust of authorities and federal government, and it extended to doctors > and scientists. And, that's only progressed as time has gone along." > > A 'colossally stupid' move > > [image: Trump claims 'political reasons' held up convalescent > plasma emergency authorization] > <http:///2020/08/23/politics/coronavirus-trump-fda-convalescent-plasma-emergency-authorization/index.html> > > Markel said people's mistrust of the system makes the idea that the FDA > would rush this process before late stage clinical trials are complete > "colossally > stupid." > > "This is one of the most ridiculous things I've heard this administration > say," Markel said. "All it takes is one bad side effect to basically botch > a vaccine program that we desperately need against this virus. It's a > prescription for disaster." > > FDA Commissioner Hahn said that the vaccine decision will be based on > data, not politics, but Kinch shares Markel's concern. > Get CNN Health's weekly newsletter > > "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," for a few reasons. > > One, the vaccine may not be safe. Two, if it is not safe, people will lose > faith in vaccines. Three, if a vaccine doesn't offer complete protection, > people will have a false sense of security and increase their risk. Four, > if a substandard vaccine gets an EUA, a better vaccine may never get > approval, because people would be reluctant to enroll in trials and risk > getting a placebo instead of a vaccine. > > "People are going to die unnecessarily if we take chances with this," > Kinch said. "We've got to get this right." > > CNN Health's Jamie Gumbrecht contributed to this story > > --- Support News from Underground: http://bit.ly/NFUSupport You received this email because you are subscribed to News from Underground. 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