USA – Novel vaccines typically take 8 years of clinical development: Study

As the U.S. Food and Drug Administration (FDA) prepares to evaluate the first of the COVID-19 vaccine candidates, a group of researchers found that the traditional evaluation of novel vaccines has taken about 12 months and, in most cases, was based on at least two pivotal efficacy trials.

Those trials enrolled a median of about 5,000 patients who were followed for 6 months to determine safety, the researchers found.

“Given the urgency of developing a COVID-19 vaccine, trials will need to be larger than those supporting prior vaccine approvals and include sufficient follow-up time for emergence of adverse effects,” Jeremy Puthumana, MD, of Yale School of Medicine in New Haven, CT., and colleagues at Yale-New Haven Hospital and Duke University School of Medicine in Durham, NC, wrote in a research letter in JAMA Internal Medicine.

The researchers analyzed original biologics licensing applications (BLAs) for vaccines approved by the FDA between January 2010 and June 2020, leaving out any supplemental approvals of existing vaccines…