FDA Advisory Panel Rejects Pfizer Booster Shots


Posted originally on the conservative tree house September 17, 2021 | Sundance | 526 Comments

The Food and Drug Administration (FDA) advisory group who evaluate the efficacy and safety of vaccines have rejected the request for Pfizer booster shots.  However, the White House – desperately trying to push as many needle jabs as possible – was already on track to begin giving booster shots this month.  The implication here is that the White House was not following the recommendations of the FDA or the science.

WASHINGTON DC – A U.S. Food and Drug Administration (FDA) advisory panel voted Friday against approval of Pfizer (PFE)/BioNTech’s (BNTX) third dose for the U.S.

The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for.

Dr. Peter Marks, the FDA’s leading expert on vaccines, touched on the controversy in his introductory remarks. “We know that there may be differing opinions of the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex, and evolving,” Marks said.

He added the meeting focused on almost real-time analyses compared to what is happening in the world, and the goal remains slowing the spread of COVID-19, which is killing almost 2,000 Americans daily.

The question the advisory panel was given to consider only used the U.S. data, a small dataset, despite the presentations including data from the U.K. and Israel.

Marks instructed the panel to consider all the data, noting, “This is not a legal proceeding, this is a science proceeding, so you can take all the data into account.”

The meeting precedes a September 20 start date for additional doses, announced last month by the White House COVID-19 Response Team, despite U.S. Centers for Disease Control and Prevention (CDC) data showing some Americans are already receiving third doses. Last month, the CDC recommended additional doses for immunocompromised people.

A CDC advisory panel will meet next week to discuss recommendations for who should receive a booster dose. (read more)

This happens on the same day the CDC announces a study [Data Here] showing the Moderna vaccine remained stronger in protecting against hospitalization compared to Pfizer and Johnson & Johnson (JNJ).

Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%).  (link)

However, Moderna has now highlighted their own diminished benefit study [DATA HERE] showing the vaccine effectiveness wanes after 8 months:

[…] “In the analysis, 88 breakthrough cases of COVID-19 occurred in the more recently vaccinated group (49.0 cases per 1000 person-years) compared to 162 cases in the group vaccinated last year (77.1 cases per 1000 person-years). The reduction in incidence rates for participants vaccinated more recently compared to participants vaccinated last year was 36% (95% CI: 17-52%). A Cox proportional hazards model showed similar results after adjusting for age and risk factors for severe COVID-19. Fortunately, only 19 severe cases were observed. While not significant, there was a numerical trend towards a lower rate of severe cases in the group vaccinated more recently (3.3 per 1000 person-years) compared to the group vaccinated last year (6.2 per 1000 person-years).” (read more)

Once you get locked in the vaccine roller coaster, you ain’t getting off until the ride’s over…

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