Did FDA Panel Reject Pfizer Booster Dose Over Myocarditis?

Did FDA Panel Reject Pfizer Booster Dose Over Myocarditis?

Did the US FDA panel reject the Pfizer booster dose for those who are 16-65 years old over increased risk of myocarditis / pericarditis?

Take a look at the viral claim, and find out what the FACTS really are!

 

Gateway Pundit : FDA Panel Rejected Pfizer Booster Dose Over Myocarditis!

The notorious fake news website, The Gateway Pundit, is at it again, this time posting fake news that the FDA panel rejected the Pfizer booster dose for those who are 16-65 years old over increased risk of myocarditis / pericarditis.

Originally posted on 17 September 2021, this piece of fake news has been repetitively shared on WhatsApp and Facebook.

What The Gateway Pundit posted is a long read, so just skip to the next section for the FACTS…

On Friday, Biden’s vaccination plan hit a major roadblock after an FDA advisory panel declined to endorse authorization the Pfizer-BioNTech Covid booster shot for people aged 16 or older.

The 18 member group of influential experts was tasked with deciding if Pfizer’s latest clinical trials had provided adequate results that demonstrate the safety and effectiveness of their booster shot.

Unsurprisingly, the results did not make the cut, not even close.

The panel voted 16-2 to reject extra doses of experimental vaccine, citing insufficient data from incomplete clinical trials and the potential risk of heart inflammation – especially among young men. 

 

FDA Panel Rejected Pfizer Booster Dose Because It Was Not Needed Yet

The truth is – the FDA panel rejected the Pfizer booster dose, because they felt that the Pfizer vaccine was still effective and a booster was NOT NEEDED YET.

Here are the facts, and the reasons why it’s just fake news by The Gateway Pundit…

Fact #1 : The Gateway Pundit Is Notorious For Fake News

The Gateway Pundit is notorious for creating and propagating fake news and conspiracy theories.

The Gateway Pundit has been identified by the Harvard Journal of Law & Technology as a website that “primarily propagates fake news“.

CNN calls it “prone to peddling conspiracy theories“, while Newsweek straight up calls it “a fake news website“.

Even though it started out as a far-right political website, The Gateway Pundit joined LifeSiteNews and Natural News in peddling health-related fake news to cash in on the COVID-19 pandemic.

Everything that The Gateway Pundit posts should be regarded as FAKE NEWS, until proven otherwise.

Fact #2 : Higher Risk Of Myocarditis With COVID-19 Infection

What The Gateway Pundit knew but did not mention was the fact that there is a MUCH HIGHER RISK of getting myocarditis with a COVID-19 infection, than with the Pfizer vaccine.

The Gateway Pundit article even used this ultrasound image that was clearly labelled “Myocarditis Heart Failure From COVID-19” as their feature image!

For a better perspective of the risk of developing myocarditis, here is a comparison table that I created :

Myocarditis Risk Per Million People Difference
COVID-19 Patient 450 +2208%
Pfizer Vaccine
(Adult Dose)
20 +2.6%
Normal Population 19.5 Baseline

As you can see, the risk of developing myocarditis is MUCH higher if you get infected with COVID-19, compared to getting the Pfizer vaccine.

There is no doubt that The Gateway Pundit is fully aware of that fact. They just don’t care about the truth, or your life. They are only interested in spreading misinformation.

Fact #3 : FDA Panel Rejected Pfizer Booster Dose Because It Was Not Needed Yet

On 17 September 2021, the FDA Vaccines and Related Biological Products Advisory Committee met to discuss the data on the Pfizer booster dose.

They voted 16-2 not to recommend the blanket use of Pfizer booster dose for individuals age 16 years or older because :

  • the primary series of 2 vaccine doses is still effective against COVID-19.

The panel said that the US and Israel calculate COVID-19 illness differently, and the Israeli data showed that the vaccine’s protection against serious illness remained strong after six months.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

  • it was more important to focus on vaccinating the unvaccinated.

Dr. Amanda Cohn of the CDC said, “At this moment it is clear that the unvaccinated are driving transmission in the United States.”

  • they wanted more safety data, especially on the risk of heart inflammation in younger men.

Dr. Paul Offit of the Children’s Hospital of Philadelphia said that he “wanted to see more data on the risk of heart inflammation in younger men”.

Myocarditis / pericarditis is a rare side effect of the mRNA vaccines that is associated mostly with young males; but not of older adults.

Fact #4 : FDA Panel Recommended Pfizer Booster Dose For Selected Groups

The FDA panel was not particularly worried about the safety of the Pfizer booster dose, as claimed by The Gateway Pundit.

In the same meeting, they unanimously voted 18-0 to recommend the Pfizer booster dose for people who are at “high risk” of severe COVID-19.

  • individuals 65 years and older
  • individuals with co-morbidities or compromised immune systems
  • healthcare workers and other people whose jobs put them at high risk of being exposed to the coronavirus

They would not have done so, if they felt that the Pfizer booster dose posed significant risks. As stated in Fact #4, they were of the opinion that a booster dose was not needed at the moment.

Fact #5 : FDA Approved Pfizer Booster Dose For 18 And Older

On 22 September 2021, the FDA approved the Pfizer booster dose for :

  • individuals 65 years of age and older;
  • individuals 18 through 64 years of age at high risk of severe COVID-19; and
  • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The booster dose is the same formulation and dosage as the first two doses of the Pfizer COMIRNATY vaccine.

With that approval, the Pfizer booster dose can be given to any of those individuals, at any point after at least six months following the completion of their primary series vaccination.

 

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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