Post by icemandios on Feb 11, 2022 20:09:58 GMT
BREAKING: FDA postpones next week's adcomm for Pfizer's Covid-19 vaccine for the youngest age group
Zachary Brennan
Senior Editor
The FDA on Friday afternoon said it’s no longer moving forward with its plan to authorize two doses (while waiting for data on a third dose) of Pfizer’s Covid-19 vaccine for the youngest group of children, from 6 months through 4 years of age.
“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” FDA’s top vaccine official Peter Marks and acting FDA commissioner Janet Woodcock said in a statement while announcing that next week’s VRBPAC meeting would be delayed.
Marks said the data, some of which was “late-breaking,” are coming in very rapidly because of the large number of cases of Omicron and “at this time it makes sense to wait for the third dose before taking action.
“The data we saw made us realize we need to see a third dose in order to proceed with an authorization,” he added.
The extension allows the FDA time to receive updated data on the two and three-dose regimen, Pfizer said, while conducting a thorough evaluation of it.
The company had initially said in December that it would test a third dose of its Covid-19 vaccine in the trial after announcing that non-inferiority was not met for children between the ages of two and five when compared to older teenagers in the current trial. But for the youngest group, from 6 months to 2-years-old, non-inferiority was met.
Pfizer plans to study a third shot for its Covid-19 vaccine in the youngest kids, pushing back its timeline farther
But Marks said it was a “safe assumption” that the efficacy decision would be based on clinical data from Pfizer.
Pfizer said in a statement that in these children, data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
“The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and support a potential three-dose regimen,” Pfizer added.
Some public health experts said they thought FDA was correct in pressing the pause button.
Reasonable decision for Pfizer to pull application for FDA authorization of its COVID vaccine for kids under 5.https://t.co/OnsEm18dx6
2 doses of Pfizer's COVID vaccine is SAFE in kids 6 months to 5 years old
but kids 2-5 years old probably need 3 doses for adequate protection
— Céline Gounder, MD, ScM, FIDSA (@celinegounder) February 11, 2022
This is a good idea as the 2-dose data for children < age 5 would not have likely been endorsed by @us_FDA as a promissory dataset. Let's see final results in April. t.co/IIas6AioWs
— Eric Topol (@erictopol) February 11, 2022
I know this will so disappoint parents of kids under 5
But this is good science in action
If we don't yet have clear evidence of effectiveness, postponing a decision is the right thing to do
I'm glad to see @us_FDA making this call
Better to wait and get it right t.co/eiTKCO86th
— Ashish K. Jha, MD, MPH (@ashishkjha) February 11, 2022
Zachary Brennan
Senior Editor
The FDA on Friday afternoon said it’s no longer moving forward with its plan to authorize two doses (while waiting for data on a third dose) of Pfizer’s Covid-19 vaccine for the youngest group of children, from 6 months through 4 years of age.
“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” FDA’s top vaccine official Peter Marks and acting FDA commissioner Janet Woodcock said in a statement while announcing that next week’s VRBPAC meeting would be delayed.
Marks said the data, some of which was “late-breaking,” are coming in very rapidly because of the large number of cases of Omicron and “at this time it makes sense to wait for the third dose before taking action.
“The data we saw made us realize we need to see a third dose in order to proceed with an authorization,” he added.
The extension allows the FDA time to receive updated data on the two and three-dose regimen, Pfizer said, while conducting a thorough evaluation of it.
The company had initially said in December that it would test a third dose of its Covid-19 vaccine in the trial after announcing that non-inferiority was not met for children between the ages of two and five when compared to older teenagers in the current trial. But for the youngest group, from 6 months to 2-years-old, non-inferiority was met.
Pfizer plans to study a third shot for its Covid-19 vaccine in the youngest kids, pushing back its timeline farther
But Marks said it was a “safe assumption” that the efficacy decision would be based on clinical data from Pfizer.
Pfizer said in a statement that in these children, data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
“The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and support a potential three-dose regimen,” Pfizer added.
Some public health experts said they thought FDA was correct in pressing the pause button.
Reasonable decision for Pfizer to pull application for FDA authorization of its COVID vaccine for kids under 5.https://t.co/OnsEm18dx6
2 doses of Pfizer's COVID vaccine is SAFE in kids 6 months to 5 years old
but kids 2-5 years old probably need 3 doses for adequate protection
— Céline Gounder, MD, ScM, FIDSA (@celinegounder) February 11, 2022
This is a good idea as the 2-dose data for children < age 5 would not have likely been endorsed by @us_FDA as a promissory dataset. Let's see final results in April. t.co/IIas6AioWs
— Eric Topol (@erictopol) February 11, 2022
I know this will so disappoint parents of kids under 5
But this is good science in action
If we don't yet have clear evidence of effectiveness, postponing a decision is the right thing to do
I'm glad to see @us_FDA making this call
Better to wait and get it right t.co/eiTKCO86th
— Ashish K. Jha, MD, MPH (@ashishkjha) February 11, 2022