Vaccine development began with a smallpox inoculation developed in 1796. By the end of the 19th century vaccines had been developed against plague, rabies, cholera, and typhoid. Smallpox has been eradicated. Measles, mumps, chicken pox, and pertussis are rare in the United States where almost all children are vaccinated.
A vaccine is a biological preparation that stimulates immunity to a disease. Made from weakened or killed forms of the microbe, its toxins, or a surface protein, the immune system recognizes the preparation as a foreign agent and seeks to destroy it. It primes the pump so the body is prepared for future encounters.
In 1902, after deaths due to contaminated vaccinations, the U. S. Congress passed the Biologics Control Act establishing the governments right to control how and where vaccines are produced and sold. The U. S. Public Service Act of 1944 mandated licensing.
Development is a long process that can easily take 10 years, sometimes longer. Lab research takes 2-5 years. Researchers use tissue cultures and cell cultures to test viruses and microorganisms, then test on animals using rats, mice, guinea pigs, rabbits, or monkeys.
Phase one clinical trials use 20-100 volunteers and last for a few months. The purpose is to evaluate safety and watch for side effects. Phase two requires several hundred volunteers. This phase can last up to 2 years. Data is analyzed to determine the best composition and number of doses needed and an effective immunization schedule is developed. Phase 3 clinical testing is done on a group of several thousand and lasts for several years. If the product is deemed safe and effective, the company can at last apply to the FDA.
The FDA requires two licenses before production can begin. The content of the product is licensed. Then the production facility is inspected before an establishment license is granted and full scale production can begin. Post licensing, manufacturers must submit samples from each lot to the FDA for testing. All medications are sensitive to environmental factors and must be precisely manufactured and stored to be effective. Each lot is also tested for outside contamination.
The Vaccine Adverse Event Reporting System (VAERS) is a federal government program to monitor adverse effects. Rare side effects and delayed reactions might not be noticed until millions have been vaccinated. In 1990 the CDC established the Vaccine Safety Datalink to link together databases from large medical groups.
Vaccine development today faces economic hurdles. The financial returns are minimal and there are many risks to bringing a new product to market. Since many contagious diseases remain a major threat to life in developing countries, delivery to those in need is a challenge. Research and development is primarily funded by government, universities, and non-profits.
A vaccine is a biological preparation that stimulates immunity to a disease. Made from weakened or killed forms of the microbe, its toxins, or a surface protein, the immune system recognizes the preparation as a foreign agent and seeks to destroy it. It primes the pump so the body is prepared for future encounters.
In 1902, after deaths due to contaminated vaccinations, the U. S. Congress passed the Biologics Control Act establishing the governments right to control how and where vaccines are produced and sold. The U. S. Public Service Act of 1944 mandated licensing.
Development is a long process that can easily take 10 years, sometimes longer. Lab research takes 2-5 years. Researchers use tissue cultures and cell cultures to test viruses and microorganisms, then test on animals using rats, mice, guinea pigs, rabbits, or monkeys.
Phase one clinical trials use 20-100 volunteers and last for a few months. The purpose is to evaluate safety and watch for side effects. Phase two requires several hundred volunteers. This phase can last up to 2 years. Data is analyzed to determine the best composition and number of doses needed and an effective immunization schedule is developed. Phase 3 clinical testing is done on a group of several thousand and lasts for several years. If the product is deemed safe and effective, the company can at last apply to the FDA.
The FDA requires two licenses before production can begin. The content of the product is licensed. Then the production facility is inspected before an establishment license is granted and full scale production can begin. Post licensing, manufacturers must submit samples from each lot to the FDA for testing. All medications are sensitive to environmental factors and must be precisely manufactured and stored to be effective. Each lot is also tested for outside contamination.
The Vaccine Adverse Event Reporting System (VAERS) is a federal government program to monitor adverse effects. Rare side effects and delayed reactions might not be noticed until millions have been vaccinated. In 1990 the CDC established the Vaccine Safety Datalink to link together databases from large medical groups.
Vaccine development today faces economic hurdles. The financial returns are minimal and there are many risks to bringing a new product to market. Since many contagious diseases remain a major threat to life in developing countries, delivery to those in need is a challenge. Research and development is primarily funded by government, universities, and non-profits.
About the Author:
Lucilla Eiche loves blogging about vaccines and cutting edge scientific research. To get further info about vaccine development, or to find about CMO contract manufacturing, please check out the BenchmarkBiolabs.com website now.
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