Clinical

Two Months Time

On Tuesday, the US Food and Drug Administrations clearly stated that they want two months of follow-up data of a possible vaccine before officially calling it one. 

Originally, scientists collected follow-up data for around six weeks to three months before a vaccine is official. “We picked two months as something that was reasonably aggressive, yet also somewhat, kind of in the middle,” said Marks “Not too aggressive, not too conservative — in the middle.” 

This two month period should not be a surprise to anyone. “We’ve made it clear that we want to see a median of about two months of follow up for any of the vaccines that come in, and while it would be nice to have much more, we have to balance the safety we get upfront with the need to try to save lives with a vaccine that’s helping to prevent a virus that’s killing 1,000 or more people a day in the United States,” Marks supported in a YouTube interview on Monday.

Trump, whose goal was to have a vaccine by Election Day responded by, “Why would they do this, when we come back with great results…”. Many differ in thoughts and see reason in the follow-up. Dr. Hahn adds that “science will guide our decisions. FDA will not permit any pressure from anyone to change that.” The Health and Human Services Secretary firmly stated, “politics play no role whatsoever in the approval of a vaccine.”

“We don’t need an election vaccine, we need a safe, effective, and trustworthy vaccine.” With all of the 10 candidates for a Covid-19 vaccine, none will be FDA approved by November 3rd, Election Day. 

https://www.cnn.com/2020/10/06/health/fda-covid-vaccine-safety-data-bn/index.html

https://www.usatoday.com/story/news/2020/10/16/pfizer-ceo-letter-makes-thanksgiving-earliest-date-covid-19-vaccine/3685200001/

Categories: Clinical