As the year ends…

Happy Tuesday, Friends.

I hope you all had a very happy holidays – whether with your family or virtually.

One question I was asked recently was:

“What about the people who received placebo during the clinical trials for the two vaccines that have been recently approved?”

 

Background – as everyone knows the Food and Drug Administration (FDA) has granted Emergency Use Authorization to two vaccines – made by Pfizer and Moderna, respectively.  The Clinical efficacy trials are still in progress as they continue to follow patients who received the vaccine.  But this raises a somewhat delicate question – what to do about those people who received the placebo (inactive vaccine)?

The vaccine manufactures do have plan(s).  Pfizer has already asked FDA for permission to unblind the study and offer volunteers who received a placebo its active two-dose vaccine.  However, due to the limited supply of vaccine, authorities have said they would first provide it to groups most at risk of contracting the virus, such as front-line health care workers or people living in nursing homes.

Moderna prefers an approach where their trial is unblinded and the company offers everyone in the placebo group the vaccine regardless of eligibility in their location.

Another plan proposed is a “blinded crossover” option.  In that approach, all trial volunteers would receive an additional pair of shots, with placebo recipients getting the vaccine and the vaccinated getting placebos.   But the volunteers wouldn’t be told which arm they were in for some period of time.

This has the advantage of keeping the trial going so that researchers can collect unbiased data longer on just how long the vaccine lasts.

Only time will tell which approaches will be taken.

Which approach would you prefer?

1 Comment

  1. Jean De Muzio

    I’d like to see the unblinded approach used because there would be a higher percentage of individuals to follow for side effects and to see how long immunity lasts. Better results with more people involved.

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