The race to develop an Ebola vaccine: Understanding FDA and Pharma roles

Healthcare, News, Politics

There are few epidemics as harrowing as the recent breakout of Ebola, which is ravaging West Africa and slowly making strides here in the United States. People are understandably concerned.

But if it is possible to pinpoint a bright spot in this all-consuming global healthcare crisis, it would be the efficacy, dedication and urgency espoused by the selfless workers tasked with not only managing this deadly viral strain, but also comforting afflicted patients.

Along with the treatment workers, volunteers and healthcare professionals are drug companies chomping at the bit to be the first to create and market the cure-all Ebola vaccine. According to the Centers for Disease Control and Prevention, there is no antidote or preventative vaccine currently available to treat an Ebola outbreak.

However, Big Pharma – never afraid of a challenge – has committed to stockpiling anti-Ebola vaccines as early as the end of 2015, relying heavily on the Food and Drug Administration’s fast-track approval process in the wake of an outbreak.

Status of experimental Ebola drugs

Johnson & Johnson, a leader in pharmaceutical products and prescription drugs, plans to begin its first round of safety testing on an Ebola vaccine in January 2015, with large clinical trials scheduled for May 2015. The company quickly licensed the vaccine from a Danish company and has reportedly spent over $200 million to expedite the testing procedures.

Comparable pharmaceutical kingpin GlaxoSmithKline PLC has partnered with the U.S. National Institutes of Health to develop its own Ebola vaccine, of which it plans to manufacture about 1 million doses per month by the end of 2015.

Other smaller pharmaceutical companies in the U.S. and abroad have also ramped up efforts to develop and test Ebola vaccines, all with the hopes of shipping as much as necessary to residents of affected West African nations with the greatest needs.

FDA approval in the midst of an outbreak

From the laboratory to the pharmacy shelf, the typical timeline for approval of a mass-market prescription or over-the-counter drug is approximately 12 years, including 3 ½ years of clinical testing. In the midst of an outbreak like Ebola, 12 years is too long to wait.

Fortunately, the FDA has implemented a system to fast-track the experimentation and sale of certain life-saving drugs known as Emergency Investigational New Drugs. Physicians facing an outbreak may request to use an EIND to treat a dying patient if the following criteria are met:

  • the need is urgent and the patient’s life is in danger;
  • there is no satisfactory alternative therapy available, and;
  • the patient cannot receive the product through any current clinical trials.

Moreover, under its emergency use authorization, the FDA may allow physicians to treat a patient with an unapproved vaccine or treatment when there are no “adequate, available and approved” alternatives.

On Oct. 10, 2014, the FDA issued authorization for unapproved Ebola diagnostic and detection procedures, thereby allowing medical professionals to use the “Ebola Zaire Test” to diagnose the presence of the virus.

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