Regulations Keep Some Life-Saving Vaccines on the Shelf

Sept. 18, 2018   

As the Ebola virus crisis created panic in Dallas in 2014 and the virus killed thousands of people in Africa, two vaccines that could have prevented the epidemic sat on a shelf, unused. Prototype vaccines that potentially could save lives are either sitting on a shelf or nowhere near completion because of red tape. So-called “orphan” vaccines are delayed from helping people because of stringent regulations leading to expensive development costs. Orphan vaccines already exist for Zika, chikungunya, West Nile virus, and several other vector-borne illnesses present in Texas, but the deployment of those vaccines is delayed too, reports September’s Texas Medicine magazine. And four years ago this month, when a Liberian man arrived in a Dallas hospital suffering from a hemorrhagic fever, panic over the Ebola virus spread across Texas and the United States; yet two Ebola vaccines existed. One of the vaccines had been under development for more than a decade prior to the 2014 outbreak. However, neither vaccine was used until the end of the epidemic in 2016. By then, Ebola killed the man in Dallas and 11,325 West Africans.

Experts say orphan vaccine delays are not uncommon. “There’s not a lot of interest, I would say, in orphan vaccines in the same way that we’ve developed interest in [orphan] drugs that are for very rare conditions,” said Trish Perl, MD, chief of the division of infectious diseases at UT Southwestern Medical School in Dallas and a member of the Texas Medical Association’s Committee on Infectious Diseases.

Why? Vaccines are extensively tested, and doing so is expensive.

U.S. and European governments require extensive laboratory and clinical testing. In the United States, the approval process is not complete until the vaccine goes through several rounds of tests, then receives a license from the Food and Drug Administration (FDA). The licensing process ensures patient safety but also increases the vaccine’s cost. Pharmaceutical companies are also required to test their vaccines on humans during the Phase 3 stage of development, a process that frequently slows down approval. “That’s where it tends to become very challenging,” said Scott Weaver, PhD, principal investigator for the Western Gulf Center of Excellence for Vector-Borne Diseases and director of the Institute for Human Infections and Immunity at The University of Texas Medical Branch at Galveston.

Phase 3 trials carry enormous price tags — easily hundreds of millions of dollars. For the most part, only two institutions can afford vaccine testing: large pharmaceutical companies and the U.S. government. “Even if a big pharma company does an analysis and thinks there’s a big potential market for a vaccine, if they don’t know how much it’s going to cost [because it’s so hard to find the right test population] to successfully complete a Phase 3 trial, that uncertainty makes it very difficult to invest,” Dr. Weaver said. The U.S. government does not fund the full cost of product and clinical development, including Phase 3 trials, unless the vaccine is a national defense issue.

Catherine Eppes, MD, another member of TMA’s Committee on Infectious Diseases, said there are limits on funding from any source, including the government. But to avoid wasting the life-saving potential of new vaccines, physicians, pharmaceutical companies, and public health and medical officials need to find more creative funding sources — like nonprofits — and pressure the government for more support. “It will require dedicated [public] funding and attention,” Dr. Eppes said, “and a lot of motivated people making sure it reaches the right priorities.”

Stages of Vaccine Development 

Exploratory stage — Basic laboratory research to investigate vaccine candidates
Preclinical stage — Use of tissue and cell cultures and animal testing to gauge the safety of a potential vaccine as well as its ability to provoke an immune response

Clinical development

  • Phase 1 — Small groups of people receive the trial vaccine to test its safety.
  • Phase 2 — The vaccine is given to a larger group of people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
  • Phase 3 — The vaccine is given to thousands of people to test its efficacy and safety

Regulatory review and approval — The drugmaker submits a license application, and FDA inspects the factory where the vaccine will be made.

Manufacturing and quality control — FDA and the Centers for Disease Control and Prevention continue to monitor the production of the vaccine

Sources: Centers for Disease Control and Prevention; Western Gulf Center of Excellence for Vector-Borne Diseases at The University of Texas Medical Branch at Galveston; The College of Physicians of Philadelphia 

TMA is the largest state medical society in the nation, representing more than 51,000 physician and medical student members. It is located in Austin and has 110 component county medical societies around the state. TMA’s key objective since 1853 is to improve the health of all Texans. TMA actively works to improve immunization rates in Texas through its Be Wise — Immunize program. Be Wise works with local communities to give free and low-cost shots to Texans, and educate people about the importance of vaccination. More than 277,000 shots have been given to Texas children, adolescents, and adults through the Be Wise program since 2004.

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Be Wise — Immunize is a service mark of the Texas Medical Association.

Brent Annear
phone: (512) 370-1381
cell: (512) 656-7320

 Marcus Cooper
phone: (512) 370-1382
cell: (512) 650-5336

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Last Updated On

February 13, 2020