There seems to be some hope in sight for an effective vaccine….possibly as soon as Spring, 2021. For that to even be remotely possible this quickly is astounding. Vaccine development is a very long and complex process usually taking 10-15 years! Prior to 1902 when the Biologics Control Act was passed by Congress no regulation of vaccine production existed. Smallpox, rabies, plague, cholera, and typhoid vaccines were all developed prior to that. Throughout the 20th century there were many revisions to this Act as there were several vaccine “accidents” such as the Cutter incident which involved the polio vaccine. In the U.S. vaccine development follows several steps. The Exploratory phase which involves basic laboratory research and often lasts 2-4 years where scientists identify natural or synthetic antigens that might help prevent or treat a disease. Next is the Pre-Clinical Stage where tissue-culture or cell-culture systems and animal testing are done to explore the safety and activity of the vaccine. Many candidate vaccines never progress beyond this stage because they fail to produce the desired immune response. The pre-clinical stages often lasts 1-2 years and usually involves researchers in private industry. If the new vaccine passes this stage they then apply for Investigational New Drug (IND) status from the FDA (Food and Drug Administration). If approved, the vaccine enters 3 phases of clinical trials with HUMAN subjects. Phase I trials are in humans. A small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. The participants in these studies are carefully monitored and conditions are carefully controlled. If results are safe and promising the vaccine or drug goes to Phase II in which larger groups of several hundred individuals participate. These trials are randomized and well controlled, and include a placebo group. Next will be Phase III Vaccine Trials involving thousands to tens of thousands of people. Phase III tests are randomized and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance). Vaccine safety and efficacy are both looked at very closely. I used to be a Clinical Trial Researcher and did extensive work on antibiotics and analgesics for Merck, Eli-Lily, Parke-Davis and others. These trials are extremely detailed with weekly patient visits, patient logs, weekly labwork and literally hundreds of pages of data to be collected on each patient. Patients are excluded for as little as being one day late for a scheduled blood sample draw! If the vaccine makes it through this phase it is eligible for Licensing. Production facilities are investigated, labeling is approved and after licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity.
NOW before you all start writing to me about vaccine impurities and side effects, YES I get it and DO agree that there are so many areas of this procedure that COULD be manipulated for greed and profit and cutting corners. YES it has happened as we’ve seen over recent years with influenza vaccine production facilities, effectiveness, etc. YES there are claims that vaccines cause a multiple of chronic problems such as autism, Guillan Barre Syndrome and lots more. I’m NOT going to get into that in this particular post….maybe another day when I have INFINITE energy. BTW…..there are also Phase IV trials where the manufacturer may continue to test the vaccine for safety, efficacy and other potential uses. I also conducted many of these…..for instance using Preparation H as a topical wound ointment. As an aside, the Prep H was INCREDIBLY effective! I’ll tell you about that sometime soon too.
So what does Small Pox have to do with this? Smallpox is believed to have first infected humans around the time of the earliest agricultural settlements some 12,000 years ago. Historians speculate that smallpox caused the devastating Plague of Athens in 430 B.C. and the Antonine Plague of A.D. 165 to 180, the later of which killed an estimated 3.5 million to 7 million people, including Emperor Marcus Aurelius, and hastened the decline of the Roman Empire. In the Old World it killed about 30% of it’s victims. The effects were even worse in the Americas which had no exposure to the virus prior to the arrival of Spanish and Portuguese conquistadors. Historians believe that smallpox and other European diseases reduced the indigenous population of North and South America by up to 90 percent ! It also was probably the first BIOLOGICAL WEAPON! Lord Jeffrey Amherst, the commander-in-chief of British forces in North America during the French and Indian War, even advocated handing out smallpox-infected blankets to his Native American foes in 1763!!!
As for early treatments, one prominent 17th-century English doctor realized that those who COULD afford care actually seemed to be dying at a HIGHER rate than those who couldn’t. He reportedly told patients to “leave the windows open, only cover yourself to the waist and drink profuse amounts of beer”!! Hmmmm…….what time is happy hour for YOU? I know I’ve been participating in the last recommendation! Far more effective was inoculation, also called variolation, which involved taking pus or powdered scabs from patients with a mild case of the disease and inserting them into the skin or nose of susceptible, healthy people. Ideally, the healthy people would suffer only a slight infection this way and, in so doing, would develop immunity to future outbreaks. This became the practice through the 1600’s and throughout Europe and eventually to The New World (America). Despite this, in Europe alone, an estimated 400,000 commoners were succumbing to smallpox annually. Finally, in 1796, English doctor Edward Jenner performed an experiment. By inserting pus from a milkmaid with cowpox, a disease closely related to smallpox, into the arms of a healthy 8-year-old boy and then variolating him to no effect, Jenner was able to conclude that a person could be protected from smallpox without having to be directly exposed to it. This was the world’s first successful vaccine, a term that Jenner himself coined. He tried to get his results published by the prestigious Royal Society, only to be told not to “promulgate such a wild idea if he valued his reputation.” Because the vaccine originally had to be transferred from arm to arm, its use spread slowly. Nonetheless, one country after another managed to rid itself of the disease. The last reported U.S. case came in 1949.
In 1967 The World Health Organization set out to rid the planet of Small Pox. That year, there were 10 million to 15 million cases of smallpox and 2 million deaths. Within 10 years the disease was eradicated. Except for one lab accident with Small Pox which killed a worker in England in 1978. Today, guarded laboratories in Atlanta and Moscow hold the only known stores of the virus. Some experts say these should be destroyed, whereas others believe they should be kept around for research purposes just in case smallpox somehow remerges.
SO…….what’s the point of this LONG post? From seemingly everywhere I hear people ask “will you take a vaccine?” and so many that say “I’ll never take it, it’s part of the plan of the New World Order” or “I’ll let someone else take it first” or “it’s Bill Gates plan to microchip all of us!”. Listen…..YES I have my qualms about a Covid vaccine. MANY of the above steps that were in place for safety have been reduced and/or removed. I DON’T think the FDA has done a good job of regulating and inspecting the production of vaccines particularly flu vaccine. Will I “take the vaccine”…….probably if the risk/benefit adds up that way. And the World is MORE than a little “nuts” right now. We’re trying to correct century old racism, save an economy that’s crushed, decide if the next generation should go back to school and on and on. We have ineffective government to put it mildly with the alternative party is not being any better! They ARE NOT! So don’t go on and on to me about a “dumpster” being a better alternative. STOP THE INSANITY. The MAJORITY of us think pretty much the same as each other when it comes to agreeing this is craziness and NO ONE IS AT THE CONTROLS. Small Pox was a virus that decimated entire civilizations and in the Aztecs made them extinct. MAYBE Covid isn’t as “serious”….we unfortunately shall see. Right now to me as a physician and scientist it’s pretty formidable and has done more harm than 9/11. If Covid miraculously is tamed either by a vaccine or sheer fate that would be amazing. BUT……Covid could be the “trial run” for a new era of pandemics that makes “global warming” a picnic. We need government that is PREPARED, has a UNIFIED MESSAGE and the SCIENCE to back up decisions that MAY affect the survival of our civilization as we know it………that is if the terrorist….yes TERRORIST organizations that want to tear down AMERICA each day are allowed to continue as a MINORITY unabated. Nuf said for today. Feel free to comment and share as always!
OK, another question, since you brought up vaccines. It was reported today that scientists are seeing 6 different types of Covid:
…….”Six distinct types of coronavirus have been identified by scientists in a breakthrough that promises to save lives by flagging the highest-risk patients.”
https://news.yahoo.com/scientists-identify-six-different-types-185531392.html
So, since this virus is a RNA virus, and seems to continue to mutate, unlike the Smallpox, which was stable and a DNA virus, how will a vaccine ever be created for this moving “target”?
There’s never been a vaccine for other coronavirus (common cold, SARS, MERS), how will a vaccine be created THIS time? After decades of the flu virus, they still can’t get it right, and the flu vaccine has been less than 50% effective the last decade,
It seems like we’re putting too much hope and faith in vaccine development for Covid…
I read the article. I don’t think they are talking about 6 different “viruses”….rather 6 different “reactions” to contracting the virus and thus different “tolerance” to it. Maybe AS to RNA vaccines here’s the problem. RNA viruses generally have very high mutation rates compared to DNA viruses, because viral RNA polymerases lack the proofreading ability of DNA polymerases. This is one reason why it is difficult to make effective vaccines to prevent diseases caused by RNA viruses—diversity is their strength. THIS coronavirus is mutating but very slowly. Mutations are not only a bad thing….sometimes they weaken a virus. IF they get a vaccine it will likely be active even if there are some small mutations. The flu virus on the other hand mutates “very fast” and thus the need for YEARLY changes in the vaccine. Dr. Mark Schleiss, a pediatric infectious disease specialist and investigator with the Institute for Molecular Virology at the University of Minnesota believes the worst-case scenario is that we’ll see some breakthrough infections, but we wouldn’t have breakthrough life-threatening disease.