Ten Steps to a Vaccine

What takes so long? What if we skip a step!

by Eric Holdeman / May 26, 2020

We have all heard the messages that it might be possible to produce a vaccine in 12-18 months for the coronavirus. Then, we have also been told that most vaccines that are successful take 8-10 years to develop. 

I found these steps to research, test and produce a vaccine. All of these steps come from our national health organizations.

Step 1 — Exploratory Stage: Laboratories conduct research to identify the natural or synthetic antigens that might help prevent or treat the virus. Average duration: 2-4 years

Step 2 — Preclinical Stage: That research is tested in tissue cultures or animal subjects to see how they react, to get an early sense of how humans could react. Average duration: 1-2 years

Step 3 — Investigational New Drug Application: The research has reached a phase where a company or organization applies to the FDA for approval for further testing in humans. Average duration: 30 days

Step 4 — Phase 1 Trials: The first phase of testing includes a small group of human subjects, usually between 20 and 80 adults (even if the drug is intended for children), to first test the safety of the vaccine. Average Duration: Several months, but less than a year

Step 5 — Phase 2 Trials: Vaccines found to be safe are then tested on hundreds of people randomly selected to be in control and placebo groups. Their effectiveness, safety, dosage and delivery methods are studied. Average duration: Several months to two years

Step 6 — Phase 3 Trials: If it passes phase 2, then the vaccine gets tested on a group of thousands to tens of thousands of participants, also randomly placed into control and placebo groups where often neither they nor the researchers know who is in which group. This tests the effectiveness and safety of the vaccine on still-larger groups, while looking for rarer side effects that may not have shown up earlier. Average duration: 1-4 years

Step 7 — Approval and Licensure: So long as a vaccine has passed all three phases of testing, an entity can submit a Biologics License Application to the FDA to approve the product for commercial use. The agency must inspect and approve the factory where it would be made, as well as its product labeling. This can take longer if the FDA responds with questions the applicant must resolve. Average duration: Several months, but less than a year

Step 8 — Manufacturing: Mass production of the vaccine. Average duration: Depends on the product, but in the case of this past flu vaccine season, 174.5 million doses were distributed across the USA between September 2019 and February 2020

Step 9 — Postlicensure Monitoring and Quality Control: The FDA continues to monitor the vaccine's production and manufacturing and has the right to further test the product and conduct facility inspections. Average duration: In perpetuity

Step 10 — Further Testing: The vaccine maker can at any time engage in optional phase 4 testing to further test its safety and efficacy and to look for additional uses to expand its labeling. Average duration: Depends on the product.

Is there a step you think we can eliminate? I see this as the classic logistics issue. There is a time-space continuum that cannot be short cut — unless you don't care about the safety of the product. 

 

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