DETROIT – There is positive news about one of the COVID vaccine candidates currently undergoing phase three human trials.
Here is a look at what it means and doesn’t mean for the possibility of a vaccine in the near future.
Today’s announcement came from the independent data monitoring committee that’s tasked with periodically evaluating data on the joint Pfizer and BioNTech vaccine.
The news the vaccine has a 90 percent efficacy meaning those who had two doses of the Pfizer vaccine three weeks apart had 90 percent fewer cases of symptomatic COVID-19 compared to individuals who received the placebo far better than the 50 percent minimum the FDA set.
Meanwhile, the vaccine is one of two m-RNA vaccines currently under investigation, the other is from Moderna. The m-RNA vaccines are the most high tech being tested, using small bits of genetically engineered viral RNA that allow our cells to make the viral spike proteins that we then become immune to.
The joint Pfizer BioNTech vaccine trial has so far enrolled over 43,000 participants from around the world representing diverse racial and ethnic backgrounds.
The data monitoring committee uses pre-determined triggers that say when to look at the data for safety and effectiveness.
In this case the trigger for the first analysis was after 94 COVID cases had took place in study participants. The final analysis will occur after 164 confirmed cases.
Pfizer still has to wait before it can apply for an emergency use authorization until a safety analysis can be done.
The trigger for the safety analysis will occur when at least half of the participants have had both doses of the vaccine for at least two months that’s expected to occur during the third week in November.
If both safety and effectiveness milestones have been reached Pfizer is expected to file for an emergency use authorization to distribute its vaccine.
Although this is very promising questions still remain. We don’t know how long any immunity would last, does it prevent asymptomatic disease, and can it decrease the risk of severe disease?
The number of confirmed cases of the coronavirus (COVID-19) in Michigan has risen to 216,804 as of Monday, including 7,640 deaths, state officials report.
Monday’s update represents 9,010 new cases and 62 additional deaths over the last two days. On Saturday, the state reported 207,794 total cases and 7,578 deaths.