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The Highwire with Del Bigtree

FDA PANEL PUSHES RISKY RSV SHOT FOR PREGNANT MOTHERS

The Highwire with Del Bigtree

The Highwire with Del Bigtree

News, Society & Culture, Health & Fitness

4.93.4K Ratings

🗓️ 4 June 2023

⏱️ 9 minutes

🧾️ Download transcript

Summary

An advisory panel to the FDA has recently voted in favor of a vaccine for RSV. Despite some safety signals of fetal demise, the advisors green-lit the new shot for pregnant women, taking a wait and see approach for safety monitoring. #RSV #Myocarditis #FDA

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Transcript

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0:00.0

Right now the FDA is in the middle of approving a whole new class of vaccines and that's the RSV vaccine.

0:07.6

And if you remember we reported on this just a couple of years ago there was an RSV as a respiratory

0:12.6

sensitional virus. It usually comes during the winter time. It's a respiratory virus and it was

0:19.2

coming off season. So the people with the COVID shots were out and people were locked down and you

0:25.6

have this you had this virus that was spreading in the summer instead of during the winter where

0:30.7

it usually spreads. Here's the headlines from that time. Why the respiratory disease RSV is

0:34.0

having an off season surge. One of the first in several years and people were saying well you

0:38.8

know it's the immunity gap. People were locked down. They didn't develop the immunity against this

0:42.6

and then when we were you know when the lockdowns were released in certain areas then people

0:46.7

were just getting this but they noticed that other diseases, respiratory disease like the flu

0:50.6

were not surging. So people were kind of scratching their head but no one in the media except us really

0:55.4

was reporting on the fact that in modernist COVID trials from the six-year-old to six-month-old

1:02.0

to five-year-olds we're having increased RSV cases when they were in these trials compared to the

1:06.9

placebo arms. No one talked about that. So now we fast forward to current currently this month.

1:13.1

60 and up was approved. So FDA approves world's first RSV vaccine a shot for adults ages 60 and up

1:21.2

and that brings us to this headline. Vaccinating this is their next kind of venture. Vaccinating

1:27.9

pregnant women against RSV helps prevent severe illness and newborns study shows. This is a

1:32.3

Matisse trial. This was fully funded by Pfizer and then published in the New England Journal of Medicine.

1:37.8

The FDA, the Verpat committee spoke about this. This is their by-valent protein-based vaccine

1:43.9

and we go into the article here to talk about this and the article is kind of just like a press release

1:48.6

from Pfizer. There were no major safety concerns with the vaccine. Although 5.6% of pregnancies in

1:54.7

the vaccine group ended in premature delivery compared to 4.7% in the placebo group. That's kind

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