As more Covid-19 vaccines become available in the U.S., it is getting tougher to run large clinical trials to test a new vaccine’s ability to prevent disease because people are less willing to take a placebo—forcing drugmakers and researchers to look for workarounds as they vet the next generation of shots and test new uses for authorized ones. One potential workaround would be to determine what level of immune response a vaccine has to trigger to protect people from the coronavirus, as measured in blood samples, and to use that information to create smaller, faster and less-expensive clinical trials.
Instead of requiring tens of thousands of volunteers and costing several hundred million dollars, such trials could involve only hundreds of people at a fraction of the cost. They could be used to speed the availability of new vaccines targeting emerging variants. Moderna Inc., Pfizer and its partner BioNTech SE , and a federally funded network of researchers are conducting analyses to learn what immune response is necessary for protection with current vaccines, known as an immune correlate of protection. They say it could come in handy for new studies of already-authorized vaccines—such as testing the shots in children or whether reduced doses are effective—as well as for trials of the next generation of shots, including those targeting new coronavirus strains. Over time, such knowledge could also help determine how long protection from the vaccines lasts.
FDA Greenlights Visby Medical’s Single-use, Portable PCR Test for COVID-19
Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point of care. The entire test is contained on a small, palm-sized device that plugs into a power outlet. After a patient’s swab sample is mixed with reagents and diluted in a test tube, the fluid is placed into the reader. It’s designed to deliver a result three buttons and 30 minutes later. The portable diagnostic was first granted an FDA green light last September, as the San Jose, California-based company exited stealth mode; the latest authorization allows the test to be used outside of the laboratory setting and by healthcare professionals on the front lines of the pandemic.
By miniaturizing PCR technology, Visby hopes to provide a gold-standard molecular test for COVID-19, but in an accessible form factor similar to rapid antigen tests that may have lower sensitivity. “Medical professionals and the communities they serve have been forced to abide by the idea that accuracy comes at the cost of speed,” said Visby’s founder and CEO, Adam de la Zerda. “Even in the face of an available vaccine, a rapid PCR test is an important tool to create COVID-free zones and establish operational continuity for businesses and critical infrastructure,” de la Zerda added. The company also said it is developing the diagnostic for testing combined pools of samples simultaneously.