0:00 MEG TIRRELL [reporter based in New York for CNBC] Pfizer and Moderna getting Emergency Use Authorization, EUA, for their vaccines down to 6 months of age, but the youngest
age group yet eligible, the only one yet so far has not had access to the vaccine, yet eligible for vaccination. The
only
“A with all vaccines for any population, when authorizing COVID-19
vaccines intended for pediatric age groups, the FDA ensures that our evaluation
and analysis of the data is rigorous and thorough.” Peter Marks, M.D., Ph.D., Director of the FDA’s
Center for Biologics Evaluation & Research, June 17, 2022.
0:16 Sonia Elijah interviews Dr. David Wiseman on the FDA’s
controversial decision to authorize Moderna & Pfizer-BioNTech’s COVID-19
vaccines for children as young as 6 months old, based on a unanimous vote by
VRBPAC, the FDA’s expert advisory committee, during the June 14-15 virtual
meeting.
David Wiseman, thank you so much for talking with me again.
WISEMAN: . . . the FDA, so that the data on the third vaccine dose
data is “imprecise, it’s unstable.” We have
no idea what the efficacy is for Pfizer in the third dose. If you have no idea what the efficacy is,
then you cannot begin to calculate a risk-benefit ratio. FDA believes that the drug “may be effective”
and that the benefits outweigh the risks.
If you don’t know what the benefits are, if you don’t know what the efficacy
is, how can you calculate what the risk-benefit ratio is?
[Here is the full interview with David Wiseman.]
The Consumer Representative on the FDA Committee, Dr. Jay Portnoy, asked
probably the most important question I’ve seen asked in any of these vaccine
meetings.
1:15 I’m confused about the
dosing in terms of micrograms, because
Dr. Jay Portnoy, M.D.
Consumer Rep on the FDA’s VRBPAC (Vaccine & Related Biological
Products Advisory Committee) He asked
the most important question that I’d see anybody ask in these hearings. You’re dosing is 3mcg. Moderna’s dosing is 25 mcg. Clearly, we’re thinking of micrograms the way
that we would think of proteins, a way of inducing an immune response. Purpose of mRNA is to induce protein
production. So is your mRNA more
efficient at making cells produce protein, or how shall we think of micrograms “in
terms of the amount of spike protein that’s produced by the cells?” Can you
kind of clarify that?
Dr. William Gruber, Pfizer’s VP of vaccine clinical R &
D.
1:50 Yeah, I’ll leave it to
Moderna to describe how they address their vaccine dosage. But I think . . . “Obviously, we don’t have a
complete understanding of the nature of the way the vaccine works.” In producing
an immune results. You have to go by the results!
“But have you ever measured the amount of protein that’s produced
as a result of the mRNA?” And how many
cells are producing in it and how persistent that production is for a given
microgram of mRNA?
That’s a pretty broad question.
A fundamental scientific question is avoided.
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