Wednesday, September 20, 2023

Was The Polio Vaccine Fda Approved

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Ten days later, after a careful review of those cases and others, the pause was lifted and immunization with the vaccine resumed, with new guidance for recipients and doctors about what to look for in the way of symptoms and how to treat these extremely rare events.

Polio vaccinations were temporarily halted in 1955 following the Cutter error as well. In both incidents, health officials followed the science. After Cutter’s manufacturing error was pinpointed as the problem, vaccinations restarted within weeks, with renewed quality control efforts and minus any involvement from Cutter Laboratories.

In 1955, mothers and fathers jumped right back in following the Cutter tragedy, once again signing permission slips and lining their kids up to get their polio shot. It was widely understood and accepted that the risks of polio were a much greater threat than the risks of the vaccine.

“I think back then, people were so personally invested in the vaccine,” Stewart says. “They listened to what happened in the Cutter case, and they understood. They continued to trust.”

Because of that trust, the campaign to prevent polio with vaccines â first Jonas Salk’s and then also Albert Sabin’s â was successful, eventually nearly eliminating the disease from the planet. But that also means, says Oshinsky, that people born after the mass vaccination effort don’t have memories of how bad the disease could be.

Koprowski Polio Vaccine Tests

So when was the polio vaccine invented?

In the late 1940s, Dr. Hilary Koprowski of Lederle Laboratories in Philadelphia successfully administered a vaccine for type 2 poliovirus. He chose to test it on himself and his assistant after trying it on chimpanzees. They both drank the vaccine and observed no adverse effects.

The Future Of Vaccine Safety

The importance of vaccine safety will continue to grow throughout the 21st century. The development and licensure of new vaccines will add to the already robust immunization schedule. Scientists could also perfect new ways of administering immunizations, including edible vaccines and needleless injections. However they are formulated or delivered, vaccines will remain the most effective tool we possess for preventing disease and improving public health in the future.

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Early Attempts At A Smallpox Vaccine

In some ways we “owe” vaccination to one particular viral scourge:Smallpox. Caused by the variola virus, smallpox was highly contagious and had about a 30% mortality rate. Many who survived this infectious disease were left with permanent scars, or pockmarks, especially on their faces. Others were left blind. The heavy pale makeup you often see in Medieval and Renaissance paintings was designed to hide smallpox scars.

As horrible as smallpox was, people typically only suffered from it once in a lifetime.

The idea of giving somebody a mild case of smallpox so they would develop immunity appears to have first been put into practical use inChina in the 1500s. Smallpox scabs were dried up and blown into the nostrils of children.

This was not vaccination as we know it today, but an older technique called variolation a controlled exposure to the disease-causing agent. It’s also called inoculation, a term we still use to describe vaccines.

What About The Unvaccinated


“Employers can require that employees be vaccinated. There’s two exceptions to that. The exceptions are if a person has a medical-related issue or if a person has a sincerely held religious belief,” said Robert Shimberg, an attorney with Hill Ward Henderson Law Firm in Tampa and chair of the firms COVID-19 response team. “Some workplaces in the Tampa Bay area have been already. Some places have required vaccinations of their employees with those two exceptions.”

Shimberg said the workers would need a doctors note. As for a religious exception, Shimberg said its typically the honor system or bringing in a note from their religious leader.

“Now that it’s a fully licensed drug, employers who have a rational basis for requiring it, and those are certainly health care employers and front-facing service employees have a stronger legal basis to stand on,” said Dr. Jay Wolfson, a health lawyer and professor with USF Health.

Some places may require unvaccinated people to test all the time. Wolfson said companies could even move a worker to a different position.

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Jenner And The Milkmaids

In the 18th century, the idea of variolation spread to Europe, although Europeans preferred to make a puncture in the skin. Sometimes it worked. Sometimes it killed the patient. Sometimes it even caused an outbreak. But the death rate was under 2%, and many considered this a reasonable risk to take with themselves and their children.

Enter Edward Jenner. Jenner was not the only person to notice that milkmaids seldom caught smallpox, but he was the one who took action. It turned out that milkmaids tended to catch a zoonotic disease called cowpox from their charges. Cowpox produced much milder symptoms. Cavalry officers also enjoyed protection from catching another related disease known as horsepox. It seemed that the two diseases were similar enough that catching one gave you immunity to the other.

The concept of informed consent wasnt widely practiced in the 18th century, so Jenner intentionally exposed a child to cowpox and then tried to infect him with smallpox. It wasnt until 1974 thatproper protection for human subjects was enshrined into law in the United States.

Jenners approach was clearly unethical, but it worked, and intentional cowpox infection became the standard for protecting people from smallpox. By 1801, 100,000 people had been vaccinated. Initially, vaccination was performed by getting a cowpox victim to donate pustule from their sores, but later the vaccine was grown in cows.

Polio Vaccine Trial Announcement

“Safe, effective, and potent.”

With these words on April 12, 1955, Dr. Thomas Francis Jr., director of the Poliomyelitis Vaccine Evaluation Center at the University of Michigan School of Public Health, announced to the world that the Salk polio vaccine was up to 90% effective in preventing paralytic polio.

Dr. Francis made the announcement to a crowd of scientists and reporters at the University of Michigan’s Rackham Auditorium, concluding his two-year national field trials of the poliomyelitis vaccine developed by his former student, Jonas Salk. Francis was chair of the School of Public Health Department of Epidemiology where Salk did postgraduate training.

Over 1,800,000 children participated in the field trials, which were unprecedented in magnitude.

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`safe Potent And Effective

In the late 1940s and early 1950s, Jonas Salk made a polio vaccine by growing the virus in monkey kidney cells, purifying it, and inactivating it with the chemical formaldehyde. He tested his vaccine in about 700 children in the Pittsburgh area, finding it to be safe and highly immunogenic. But he hadnt yet proved that it worked. To do that, Thomas Francis at the University of Michigan conducted the largest clinical trial of a medical product in history. The trial broke Salks heart. He couldnt accept withholding his vaccine knowing that polio paralyzed as many as 30,000 children every year in the United States and killed 1,500.

Between 1954 and 1955, 420,000 first and second graders were given Salks polio vaccine, 200,000 were given a placebo vaccine, and 1.2 million served as observed, uninoculated controls. When the trial ended, in April 1955, Francis stepped to the lectern in Rackham Hall at the University of Michigan and said four words that became a headline in every newspaper in the country: safe, potent, and effective.

How did Francis know that Salks vaccine was effective? He knew it because 16 children died from polio during the study all in the placebo group. And he knew it because 36 children were paralyzed during the study 34 in the placebo group. But for the flip of a coin, most if not all these children could have lived long, healthy lives. Such was the price of knowledge.

What Does Full Fda Approval Of A Covid

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Review for full FDA approval is a normal step in the process of making a vaccine available for the public. One of the COVID-19 vaccines has full approval, and the FDA may grant full approval for others in the future.

Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities. After many months of studies and more than 165 million people having received a COVID-19 vaccine, the FDA has a lot of information on how safe and effective the COVID-19 vaccines are in protecting people, how well they work to prevent severe coronavirus disease, and how the vaccines are safely and consistently manufactured.

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Development Of A Vaccine Schedule

Physicians began recommending some childhood vaccines, including diphtheria, tetanus and pertussis , as early as the 1940s. However, it wasnt until 1995 that the medical community officially endorsed a vaccine schedule for children beginning at infancy. The Advisory Committee on Immunization Practices, American Academy of Pediatrics and the American Academy of Family Physicians approved these guidelines and continues to review them annually.

The current schedule, updated in 2014, recommends a dozen different vaccinations, including the DTaP and another combined vaccine for measles, mumps and rubella

The Cutter Incident: How America’s First Polio Vaccine Led To A Growing Vaccine Crisis

In April 1955 more than 200 000 children in five Western and mid-Western USA states received a polio vaccine in which the process of inactivating the live virus proved to be defective. Within days there were reports of paralysis and within a month the first mass vaccination programme against polio had to be abandoned. Subsequent investigations revealed that the vaccine, manufactured by the California-based family firm of Cutter Laboratories, had caused 40 000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.

Paul Offit, paediatrician and prominent advocate of vaccination, sets the `Cutter incident’ in the context of the struggle of medical science against polio and other infectious diseases over the course of the 20th century. He reminds us that, within a decade of Karl Landsteiner’s identification of the polio virus in 1908, an epidemic in New York killed 2400 people and left thousands more with a life-long disability. In the 1950s, summer outbreaks in the USA caused tens of thousands of cases, leaving hundreds paralysed or dead. `Second only to the atomic bomb’, polio was `the thing that Americans feared the most’.

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The Vaccine Life Cycle: Safety At Every Phase

Safety is a Priority During Vaccine Development and Approval

Before vaccines are licensed by the FDA, they are tested extensively in the laboratory and with human subjects to ensure their safety. First, researchers use computers to predict how the vaccine will interact with the human immune system. Then researchers test the vaccine on animals including mice, guinea pigs, rabbits, and monkeys.

Vaccine development and approval follows the same general pathway as for drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application to FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release. Also included are information about the vaccines safety and ability to elicit a protective immune response in animal testing, as well as a proposed plan for testing the drug on humans.

Learn more about how vaccine safety works in the United States.

Vaccine licensing is a lengthy process that can take 10 years or longer. The FDA requires that vaccines undergo three phases of clinical trials with human subjects before they can be licensed for use in the general public:

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While its true that vaccine development can take a lot longer for some diseases we still dont have an effective vaccine for HIV, for instance it can happen much more quickly for other illnesses.

For example, we understand the vaccine technology very well for influenza, said Dr. Benjamin Bates, a professor of health communication at Ohio University, which is how were able to develop new vaccines to different strains of influenza annually. That helps expedite the process.

In the case of the SARS-CoV-2 virus that causes COVID-19, Bates said, we were fortunate because scientists began studying SARS viruses extensively after the SARS and MERS outbreaks of the early 2000s.

By the time COVID-19 was identified, we had done a lot of the homework over the previous two decades, he said. That previous knowledge allowed manufacturers to quickly develop laboratory and computer modeling tests for potential vaccines. It also helped them to perform early tests for safety and efficacy in real people to be ready to meet the FDAs standards for authorization and approval.

Dr. Leana Wen, an emergency physician and public health professor at George Washington University, said that no shortcuts were taken in the research or authorization process of any of the COVID-19 vaccines and that getting them out to Americans more quickly though the emergency use authorization saved countless lives.

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Next Steps: Approval And Licensure

After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA. Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.

After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturers tests of lots of vaccines for potency, safety and purity. The FDA has the right to conduct its own testing of manufacturers vaccines.

Post-Licensure Monitoring of Vaccines

A variety of systems monitor vaccines after they have been approved. They include Phase IV trials, the Vaccine Adverse Event Reporting System, and the Vaccine Safety Datalink.

Phase IV Trials

Phase IV trial are optional studies that drug companies may conduct after a vaccine is released. The manufacturer may continue to test the vaccine for safety, efficacy, and other potential uses.


The CDC and FDA established The Vaccine Adverse Event Reporting System in 1990. The goal of VAERS, according to the CDC, is to detect possible signals of adverse events associated with vaccines. About 30,000 events are reported each year to VAERS. Between 10% and 15% of these reports describe serious medical events that result in hospitalization, life-threatening illness, disability, or death.

The CDC states that they monitor VAERS data to

VAERS has successfully identified several rare adverse events related to vaccination. Among them are

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It had taken the worlds top medical minds more than two centuries to progress from recognizing a disease to testing vaccines. Even after identifying the virus that caused polio, it took another 40 years to get vaccine trials up and running. But in 2020, the first human clinical trials for vaccines against SARS-CoV-2 are already underway just 3 to 4 months after the first people were infected. Moderna started a Phase I clinical trial of a potential vaccine on March 20, and Inovio announced a Phase I trial on April 6.

After the initial Pittsburgh trial, Thomas Francis at the University of Michigan organized a massive trial spanning 3 countries and 1.8 million children. The Francis Trial was the largest clinical trial ever conducted at the time, and one of the first double blind trials, in which neither the patients nor the researchers administering the drugs and monitoring the patients knew who was getting a placebo and who was getting the real vaccine . Francis announced on April 12, 1955 that the vaccine had proven 80% to 90% effective at preventing the worst, paralyzing form of polio.

But were not likely to see another Jonas Salk or Albert Sabin modern science isnt done by lone heroes, but by huge teams of people all working together, often in relative anonymity. The future of the fight against COVID-19 depends not just on principal investigators or pharmaceutical CEOs, but on interns, lab techs, and janitorial crews.

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Challenges For The 21st Century

The discovery of DNA opened the door to a new science – human gene therapy. With the publication of Watson and Crick’s pioneering work in 1953 came new hope for sufferers of genetic diseases. The structure that they proposed, the double helix, is the DNA molecule in a human cell that contains genetic information. Understanding DNA allows researchers to manipulate genes and potentially cure inherited diseases. The discovery of recombinant DNA methods led the way to the development of biotechnology. An early outgrowth of biotechnology was the first recombinant DNA vaccine, Hepatitis B , licensed in 1986. Says Philip Noguchi, MD, Director, Division of Cellular and Gene Therapies for CBER, “Gene therapy is either very complicated or very simple. It is a means by which you can actually alter the genetic makeup of a cell. Instead of giving a person interferon – which is a protein used to treat certain cancers and other diseases – why not give the person the gene and then his own body will actually start to make the protein, and might never have to replace it again? That’s one of the very intriguing theories of gene therapy.”

New vaccines are being developed and modified as new discoveries teach us more about the human immune system. New allergenic products provide relief for Americans who suffer from allergies. Infectious diseases, both new and old, create an urgent demand for the hastened availability of new drugs.

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