Who decides the vaccination schedule?

A child receiving an intramuscular vaccination in the thigh. Courtesy of: CDC/Judy Schmidt

A child receiving an intramuscular vaccination in the thigh. Courtesy of: CDC/Judy Schmidt

It’s come to my attention that there seems to be a misunderstanding circulating of who exactly determines our children’s vaccination schedule. It seems that some are under the impression that it is the pharmaceutical companies that determine when the vaccinations have to be given. This is actually not the case, pharmaceutical companies don’t determine the vaccinations schedule.

Who determines the vaccination schedule?

Every year the vaccination schedule is looked at and updated depending on the latest research. Let’s take the 2015 recommended childhood and adolescent immunization schedule in the U.S. as our example. It was decided on and approved by:

  1. The American Academy of Pediatrics (AAP). It has 62,000 primary care pediatricians, pediatric medical sub-specialists and pediatric surgical specialists dedicated to the health, safety, and well being of infants, children, adolescents and young adults.
  2. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (ACIP). It consists of 15 experts chosen by the United States Secretary of Health and Human Services.
  3. The American Academy of Family Physicians (AAFP). It is one of the largest medical organisations with more than 115,900 family doctors across the U.S.
  4. The American College of Obstetricians and Gynecologists (ACOG). It has 58,000 members focused primarily on healthcare for women. 1 2
The official vaccination schedule by ACIP in 1983. Courtesy of: CDC

The official vaccination schedule by ACIP in 1983. Courtesy of: CDC

The schedule is given to the Center for Disease Control and Prevention who publish it. These are four highly professional organisations that are made up of and represent the doctors and experts that daily help to keep the U.S. healthy. They are very experienced and competent in deciding what the vaccination schedule should be, based on the latest scientific research and newly available vaccines. The ACIP was first formed in 1964 by the U.S. Surgeon General to provide expert advice and guidance on vaccination in the U.S. population. To avoid any conflicts of interest the 15 voting members must undergo a stringent screening process to maintain the integrity of the ACIP.3 It was in 1995 that the AAP and AAFP joined the ACIP in the approval process of an official vaccination schedule and it has remained that way to this day.4 For a more detailed look at the history of the immunisation schedule from the year 1914 until the present time I recommend this article from The Children’s Hospital of Philadelphia.

Find the 2016 vaccination schedule here

You can find the 2016 vaccination schedule and catch-up schedules here at the AAP’s website or the CDC’s website. Both contain downloadable schedules and the CDC website contains links to an app and online program to personalise and print your child’s schedule. These can also be used by doctors for their patients. The Spanish version of the vaccination schedule for children from birth to 6 years old can be seen here and the English version here. As always please consult with your family doctor for the most recent vaccination advice.

What part do the pharmaceutical companies play?

As far as deciding the vaccination schedule they don’t play a part, however, they are required to provide scientific data on their vaccine which will be taken into consideration during the decision. When a pharmaceutical company develops a vaccine it has to go through a very strict testing process to demonstrate its safety, any side effects and its efficiency at protecting against the disease. All vaccines in the U.S. are highly regulated by the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). So what does the process look like? 5

Vaccine development – Stage 1 & 2

Vaccine research can take a considerable amount of time and investment.

Vaccine research can take a considerable amount of time and investment. Courtesy of: CDC/Hsi Liu, Ph.D., MBA, James Gathany

This process can take years or decades of research and a substantial investment of money. Vaccines for some viruses like HIV are still being worked on despite decades of research. The vaccine is first developed in the laboratory and undergoes animal testing for safety and potential effectiveness.

The company developing the vaccine then has to meet a strict set of requirements to get a FDA Investigational New Drug (IND) Application approved to allow it to begin testing in humans. This includes:

  1. Animal toxicology reports to prove it’s safe for human testing and its effectiveness as a vaccine.
  2. Manufacturing information proving sterility and quality controls.
  3. Clinical protocols for the studies and qualifications of the investigators.6

Vaccine development – Stage 3

If approval is given then the vaccine begins clinical trials (that is to say testing in humans), this is known as Pre-licensure vaccine clinical trials. The FDA monitors each phase and gives (or denies) permission to carry on to the next. This whole process is highly monitored and controlled. The FDA can also request additional studies should they have any concerns. The clinical trials follow this route:

  1. Phase 1: Small groups of people consent to receive the trial vaccine and are monitored. If safety and efficiency requirements are met it enters the next phase.
  2. Phase 2: The group being tested is increased to include the ages of person that the vaccine is intended for – again this can only happen with consent. If all safety and other requirements are met it continues to the next phase.
  3. Phase 3: The group is increased to thousands of individuals and the vaccine’s efficiency and safety data is collected. 7

Some may remember that an Ebola vaccine trial by Merck and NewLink was temporarily suspended in December 2014 after 4 patients complained of joint pain.8 This is an example of how detailed and strict the clinical trials are. Safety is the utmost priority.

Vaccine development – Stage 4

Once the clinical trials have been successfully completed the pharmaceutical company will submit a Biologics License Application (BLA). During this application process a team from the FDA consisting of medical officers, microbiologists, chemists and biostatisticians among others, review all the data from the trials and studies. They perform a risk to benefit analysis and study the effectiveness of the vaccine at preventing the disease. The manufacturing facilities are also checked in great detail at this stage in what is known as a pre-approval inspection. 9

Vaccine development – Stage 5

The FluMist Quadrivalent influenza vaccine for the 2014-2015 season. It is shown alongside its approved packaging. It is in the vaccination schedule.

The FluMist Quadrivalent influenza vaccine for the 2014-2015 season. It is shown alongside its approved packaging. Courtesy of: CDC/ Heather Richmond, MedImmune

Once the FDA’s review is completed there is a second review by an non-FDA team, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This team consists of 12 voting members who are known authorities in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology and biochemistry. They also assess all of the data and vote on whether the vaccine should be granted the license. 10

Finally before approval the product labelling is verified to make sure it contains all the relevant information for doctors, side effect details and frequencies and finally all relevant information that the public needs.

Post development monitoring

Once approved the verification process does not end. As long as the manufacturer has the license for the vaccine the FDA carries out vaccine batch testing and facility inspection to ensure the highest standards are maintained. Very often, after approval, manufacturers will also carry out a phase 4 clinical trial where they monitor any adverse effects in the wider population.11 These typically include very rare side effects that affect 1 person in 100,000 or a million. The government also has a monitoring system in the form of the Vaccine Adverse Event Reporting System (VAERS).12

Conclusion

All of this data on the vaccine that the pharmaceutical company had to produce during the approval process is examined by the organisations when they decide the vaccination schedule. If you think about it, prior to this data arriving with them, it has had to pass through the initial FDA approval for human testing, all the monitoring during the clinical trials, a review by the FDA, an independent review by a panel of 12 experts and continual monitoring after licensing. That is a lot of very qualified people considered authorities in their areas looking at the vaccine data and either approving or rejecting it. Then it still has to be approved by the organisations mentioned above representing the doctors and experts looking after the health of the country before it enters your vaccination schedule. So I hope this goes some way to shed light on what exactly happens in the process and that as a result you feel more confident that the vaccination schedule is one that you can trust. After all, it’s made and checked by some of the best minds in the country.


Further Reading

Unsafe thimerosal or mercury in vaccines?

A look at thimerosal and mercury content in vaccinations. Should you be worried?

My name is David Hamilton and I’m from Northern Ireland but currently living in Puerto Rico. I have a degree in Biochemistry and a M.Phil in molecular virology from Queen’s University Belfast. I write on some of my interests which range from virology, astronomy and science related subjects to history. Thanks for your interest!

References

  1. American Academy of Pediatrics.2015. Recommended Childhood and Adolescent Immunization Schedule— United States, 2015.
  2. CDC. 2013. The Advisory Committee on Immunization Practices (ACIP).
  3. Smith J.C., Snider D.E. and Pickering L.K.. 2009. Immunization Policy Development in the United States: The Role of the Advisory Committee on Immunization Practices. Ann Intern Med. 150:45-49.
  4. ACIP. Past immunization schedules.
  5. Center for Biologics Evaluation and Research. Development and Approval Process.
  6. FDA. Investigational New Drug Application.
  7. FDA. Vaccine testing and the approval process.
  8. Reuters. 2014. Ebola vaccine trial halted temporarily after joint pains: Geneva hospital.
  9. CBER. Biologics License Applications (BLA) Process.
  10. FDA.Vaccines and Related Biological Products Advisory Committee.
  11. FDA. Vaccine product approval process.
  12. Vaccine Adverse Event Reporting System (VAERS)

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