Sumary of Testing timeline: What’s ahead for coronavirus vaccines? Everything you need to know:
- Pfizer’s surprising news that its COVID-19 vaccine might offer more protection than anticipated — an announcement right after a fraught US presidential election campaign — is raising questions about exactly how the different shots will make it to market..
- and the maker of the other leading US vaccine candidate, Moderna Inc., have been cautioning for weeks that the earliest they could seek regulatory approval for wider use of their shots would be late November..
- While COVID-19 vaccines are being developed at record speeds in hope of ending the pandemic, when they’re ready for prime time depends on a long list of research steps including how many study volunteers wind up getting the coronavirus — something scientists cannot control..
- How the studies work Pfizer and its German partner BioNTech have enrolled nearly 44,000 people in final testing of their vaccine..
- Late-stage testing of other vaccine candidates is similar, varying slightly in the number of volunteers and timing..
- How to tell shots work Every vaccine study is overseen by an independent “data and safety monitoring board,”.
- Before a study is complete, only the DSMB has the power to unlock the code of who got real vaccine and who got placebo, and to recommend if the shots are working well enough to stop testing early..
- Those boards take sneak peeks at pre-determined times agreed to by the manufacturer and the Food and Drug Administration..
- The company reported its data monitors had counted 94 infections so far — and that among those initial cases, the vaccine appeared 90 percent effective….