Posted 10 November 2020 | By
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.
In total, the agency approved 21 novel vaccines during that time period, with four vaccines receiving accelerated approval. There were five vaccines approved for influenza, five approved for meningococcus, two approved for diphtheria, tetanus and acellular pertussis (DTaP), and nine approved for other indications.
The median premarket clinical development period – from investigational new drug submission to FDA approval – was 8.1 years. That development period included a median FDA review period of 12 months.
Each approval was supported by a median of seven clinical trials, including two pivotal efficacy trials and one trial to establish lot-to-lot consistency, the study found. Across all approved vaccines, 17 vaccines had at least one pivotal efficacy trial that used masking, 20 vaccines had trials that used an active or placebo comparator group, and eight vaccines were approved based on trials that used a clinical primary endpoint.
The median number of patients included in the prelicensure safety database was 6,710 and the median follow-up for serious adverse events was 6 months. The median aggregated number of patients enrolled among all pivotal efficacy trials supporting vaccine approval was 4,961. The median efficacy for approved vaccines was 91.9%, the researchers reported.
The research comes just a day after Pfizer and BioNTech announced interim results from their phase 3 trial of an mRNA vaccine candidate for COVID-19. Those initial results showed a vaccine efficacy of more than 90%, without significant adverse events. The phase 3 trial has an estimated enrollment of nearly 44,000 individuals and the companies are expecting to have a median of two months of safety data by the end of November.
Jason Schwartz, PhD, one of the research letter’s co-authors and an assistant professor of health policy at the Yale School of Public Health, said that level of enrollment and safety follow-up should give the public confidence that the FDA will have sufficient evidence to determine safety of the vaccine.
He noted that the 2-month safety follow-up, which matches the minimum duration spelled out in the FDA’s guidance for Emergency Use Authorization for COVID-19 vaccines, provides a good window for determining safety since most vaccine-related adverse events are known within 6 weeks.
The piece that’s left out when vaccines are moved forward so quickly, Schwartz said, is that researchers will not know right away when immunity will wane. The length of immunity – and the potential need for booster doses – will need to be monitored in real time, he said.
“That’s the balancing act,” Schwartz said.
JAMA Internal Medicine
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November 11, 2020 at 04:04AM
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Novel vaccines typically take 8 years of clinical development: Study - Regulatory Focus
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