Sumary of Global quest underway to speed up COVID-19 vaccine trials:
- CHICAGO – Scientists are working on a benchmark for COVID-19 vaccine efficacy that would allow drugmakers to conduct smaller, speedier human trials to get them to market and address a huge global vaccine shortage.
- Researchers are trying to determine just what level of COVID-19 antibodies a vaccine must produce to provide protection against the illness.
- Regulators already use such benchmarks — known as correlates of protection — to evaluate flu vaccines without requiring large, lengthy clinical trials.
- “You could use it to predict efficacy from a vaccine, which will be more important as we are less able to conduct placebo-controlled trials,” said Stanley Plotkin, inventor of the Rubella vaccine and an expert on correlates of protection.
- ” An established benchmark for COVID-19 would allow drugmakers to conduct vaccine trials in just a few thousand people, about one-tenth the size of the studies conducted to gain authorization for currently widely-used coronavirus shots, researchers and drugmakers said.
- Those studies, involving tens of thousands of volunteers, compared the rate of COVID-19 infections in people who received the shot with the rate in participants who got a placebo.
- Such randomized, controlled trials may no longer be considered ethical in some countries, as researchers cannot give a dummy shot to people where an effective vaccine is widely available.
- In addition, many of the new shots are being developed by small companies that may not be able to conduct very large trials without government funding or a partner with deep pockets.