History of Vaccine Safety

The first documented method of vaccination came from Edward Jenner in 1796. With virtually no safety precautions or oversight, Jenner injected puss from the blister of someone infected with cowpox into someone who had yet to come in contact with the virus, succeeding in immunizing the first individual against smallpox.

From this time, scientists continued to research vaccine medicine, motivated by high mortality rates that followed epidemics such as Diphtheria, Pertussis, and Polio. Today, the list of vaccine preventable diseases has grown from one to 24, limiting the prevalence of some infectious diseases, and completely eradicating others. As the number of available vaccines grew, so too did the necessity for tracking their effects.

Today, the Center for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) work hand in hand to continuously monitor the effectiveness and safety of vaccines. Vaccines are required to pass a battery of tests prior to obtaining licensed approval. For most common questions about vaccine safety, the FDA has a FAQ page.

Pre-Licensure Vaccine Safety

In order for the FDA to approve a license for a vaccine, the vaccine must pass a series of tests established to ensure its efficacy and safety. Before beginning live tests, researchers first model how a vaccine might interact with a human’s immune system using computers. Once safety concerns have been addressed, the vaccine moves to animal testing, which can involve mice, guinea pigs, rabbits, and monkeys.

If animal testing is successful, the FDA approves clinical testing on human subjects. Clinical trials happen in three phases:

• Phase one happens over a period of months in small groups (20-100 volunteers) to assess basic safety and common reactions;
• Phase two determines the composition of the vaccine, dosing regimen, and reaction profile through the observation of several hundred participants for up to two years;
• Phase three typically spans several years as researchers assess vaccine reactions of up to several thousand study participants.

With the successful completion of all three clinical trial phases, vaccine manufacturers apply for both a product license and an establishment license from the FDA. At this point the FDA reviews proposed product labels, data from clinical trials, and manufacturing protocols. Once the FDA has determined the vaccine is safe and effective, it may award a license for use in the general population.

Post-Licensure Vaccine Safety

Safety monitoring does not stop with licensure, it continues well beyond. The FDA requires samples of each vaccine lot prior to release, along with test results for safety, potency, and purity. Because vaccines are sensitive to environmental factors, every lot must be tested before receiving approval for use.

As part of the National Childhood Vaccine Injury Act of 1986 (NCVIA), health professionals and vaccine manufacturers are required to report specific adverse events that occur following a routine vaccine injection. In response, the CDC and the FDA created the Vaccine Adverse Event Reporting System (VAERS) in 1990 as a means for tracking reported adverse events.

Monitored by both the FDA and CDC, the VAERS program offers supplementary safety information of rare side effects that may not have been identified in clinical trials. This aids in identifying emerging safety concerns, working to ensure that the benefits of vaccines continue to outweigh the risks.

Improvements to Vaccine Safety

VAERS reports have successfully allowed the CDC and FDA to remove high risk vaccines from the US market, like with RotaShield in 1999. After increased reports of intussusception following vaccination, the CDC’s validation studies recommended suspending use and eventually discontinuing production of the vaccine.

Similarly, studies pointing to safety concerns associated with DTP vaccine influenced the recommendation for the DTaP vaccine, which featured a more purified acellular pertussis as opposed to whole cell pertussis, as well as a change to the polio vaccination schedule in response to vaccine-associated paralytic polio (VAPP).

The CDC makes vaccine data available to researchers through the Vaccine Safety Datalink (VSD) to aid in studies that seek to investigate links between vaccines and the side effects reported through the VAERS program. This allows researchers the ability to track past correlations between vaccines and reported side effects, as well as use Rapid Cycle Analysis (RCA) to look at data related to reported health conditions among vaccinated populations in real time.

The CDC and the FDA continually work to regulate vaccine safety, making changes when necessary. Because of their research, beginning in 2018 all providers of Vaccines for Children (VFC) must comply with new requirements on vaccine storage. The new guidelines outline requirements for temperature monitoring devices and primary and back up thermometers.

National Vaccine Injury Compensation Program

Vaccines are an important part of public health, working to save lives by preventing disease. Most of the time, vaccines are administered without any serious problems. Like with any medication, however, there is a risk of side effects, ranging from mild to serious.

For this reason, the US government created the National Vaccine Injury Compensation Program (NVICP), a “no-fault” alternative to the traditional legal system. Petitions can be filed by any individual, at any age, after developing an injury believed to be a result of a covered vaccine, if jurisdictional requirements are met.

Conway Homer, P.C. is the most experienced vaccine injury law firm in the United States. We represent clients from all 50 states and have advocated for landmark cases that have shaped the Vaccine Program and made it friendlier and more generous to individuals who suffer from vaccine injuries. To get in touch with our dedicated team, click here for a free consultation.