Dr. Malone clearly layed out exactly what the FDA did in their two letters, one for Phizer and one for Bio Tech. It's the Bio Tech vax that is on track or final approval. The FDA states they don't have the data to prove anything right now. They also bypassed the typical committee review which has a public comment period stating there were no concerns raised that needed addressing. He also stated he had never seen that happen before for a vaccine approval. Dr. Malone thinks this is a sneaky way for the FDA to shove the burden of mandates onto the government and corporations excluding them from liability. This is exactly what communist countries do.
Ok so it looks like the Dr. is wrong about the two drugs being different, but right about the differing liability / legality of the two different labels, and about the admission of myocarditis pericarditis concerns (and others), and the insanity of full approval while studies have barely begun. Details below:
In the FAQ section, they elaborate:
"The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."
https://www.fda.gov/media/144414/download
So, these are in fact the exact same drug, but with different labels they carry different legal statuses. If you are worried about liability therefore, this is ammunition to avoid the Pfizer and wait for Comirnaty. If you are instead worried about long-term health effects, there is more here...
This same insert notes that adverse effects that were unsolicited (!) were recorded in 4 to 6 months after the second dosing. This means, the only data we have so far after 7 days is both unsolicited, and at a maximum of 6 months.
This insert also mentions:
"The safety and effectiveness of COMIRNATY in individuals younger than 16 years of age have not been established."
So why are many mandating vaccinations in 12+? Because that age group is covered by the EUA, which has no liability and is based on their best guesses (not data).
This insert also mentions there is an ongoing pregnancy study, so no data exists yet on how this will affect birth defects or miscarriage rates.
Safety Study for 12-15 year-olds deferred, scheduled to complete May 2023
Safety Study for 6mos-12 year-olds deferred, scheduled to complete November 2023
Safety Study for 0-6mos-olds deferred, scheduled to complete July 2024
Myocarditis and Pericarditis safety study #C4591009 set to complete June 2025, #C4591021 and #C4591021 in March 2024, and long-term study #C4591036 in Dec 2026. There are many other studies, with the soonest study, #C4591031 completing June 2022.
A pregnancy study #C4591022 won't complete until 2025.
There are more studies that are required to finish and submit reports as conditions of this license......That should really be the huge issue here. How can we have a licensed drug, on the condition that if this licensed drug starts to kill people in 2 to 5 years, they would really like to know about it then.
That all said, I am still suspicious of the phrase "with certain differences that do not impact safety or effectiveness"; what are these differences. I couldn't find anything. But saying they are the same formulation seems to cover the chemical differences, hence why I think they are referring to the legal differences (liability).
I did some more research. Looks like the Doc is wrong on this, but there is still a lot of ammunition in the letters. I made a larger comment about what I found.
Yeh, I hear ya. We need to be kinder to those on our side. I chalk it up to the ever mounting uncertainty of the world as we know it. Have been called out a time or two myself. Hang in there, fren.
Dr. Malone clearly layed out exactly what the FDA did in their two letters, one for Phizer and one for Bio Tech. It's the Bio Tech vax that is on track or final approval. The FDA states they don't have the data to prove anything right now. They also bypassed the typical committee review which has a public comment period stating there were no concerns raised that needed addressing. He also stated he had never seen that happen before for a vaccine approval. Dr. Malone thinks this is a sneaky way for the FDA to shove the burden of mandates onto the government and corporations excluding them from liability. This is exactly what communist countries do.
Pfizer
https://rumble.com/vlmce2-dr.-malone-sounds-alarm-on-liability-coverage-of-pfizer-vax.html
Ok so it looks like the Dr. is wrong about the two drugs being different, but right about the differing liability / legality of the two different labels, and about the admission of myocarditis pericarditis concerns (and others), and the insanity of full approval while studies have barely begun. Details below:
In the FDA site, they state the following: "The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty" https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
In the FAQ section, they elaborate: "The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness." https://www.fda.gov/media/144414/download
So, these are in fact the exact same drug, but with different labels they carry different legal statuses. If you are worried about liability therefore, this is ammunition to avoid the Pfizer and wait for Comirnaty. If you are instead worried about long-term health effects, there is more here...
Cominarty's package insert has charts showing adverse effects and effectiveness studies that encompass just 7-days. https://www.fda.gov/media/151707/download
This same insert notes that adverse effects that were unsolicited (!) were recorded in 4 to 6 months after the second dosing. This means, the only data we have so far after 7 days is both unsolicited, and at a maximum of 6 months.
This insert also mentions: "The safety and effectiveness of COMIRNATY in individuals younger than 16 years of age have not been established." So why are many mandating vaccinations in 12+? Because that age group is covered by the EUA, which has no liability and is based on their best guesses (not data).
This insert also mentions there is an ongoing pregnancy study, so no data exists yet on how this will affect birth defects or miscarriage rates.
Further to the insert, the approval letter itself has lots of ammunition about long-term effects concerns: https://www.fda.gov/media/151710/download
Safety Study for 12-15 year-olds deferred, scheduled to complete May 2023 Safety Study for 6mos-12 year-olds deferred, scheduled to complete November 2023 Safety Study for 0-6mos-olds deferred, scheduled to complete July 2024
Myocarditis and Pericarditis safety study #C4591009 set to complete June 2025, #C4591021 and #C4591021 in March 2024, and long-term study #C4591036 in Dec 2026. There are many other studies, with the soonest study, #C4591031 completing June 2022.
A pregnancy study #C4591022 won't complete until 2025.
There are more studies that are required to finish and submit reports as conditions of this license......That should really be the huge issue here. How can we have a licensed drug, on the condition that if this licensed drug starts to kill people in 2 to 5 years, they would really like to know about it then.
That all said, I am still suspicious of the phrase "with certain differences that do not impact safety or effectiveness"; what are these differences. I couldn't find anything. But saying they are the same formulation seems to cover the chemical differences, hence why I think they are referring to the legal differences (liability).
Fantastic post, Fren. Really makes it a lot clearer.
COMIRNATY is an anagram of ACRONYM IT kek.
This video breakdown complements your analysis. https://www.youtube.com/watch?v=CjVFLzX6Q2s
Annnnd it's been removed!
Great information.
So no approval for Pfizer at all.
Not quite. They got approval for a new vaccine, but not the one being widely administered
GOOD. Now we have fucking destroy their fake news about approval
I did some more research. Looks like the Doc is wrong on this, but there is still a lot of ammunition in the letters. I made a larger comment about what I found.
Dr. Malone did not kill himself.
Only comiRNAty bioNtech is approved Not pfizer. ComiRNAty is not even in manufacture. It is Not available. Per Dr. Robert Malone
No to diminish from this fantastic video, but does anyone else think that Dr. Malone could be related to the Dos Equis guy?
I am so thankful we have such a capable and intelligent man like this in our coalition to explain these things
Good information. What are the implications for those facing mandated vax? Dr. Malone said to hold out. Hold out for what?
Wrong! The video was from today.
https://rumble.com/search/video?q=warroom%20bannon&date=today
Video was from TODAY!
Whatever you say shill. Fuck off.
Really? Why would you think that? The video it speaking directly to the documents released yesterday by the FDA.
Just a familiar looking title. Was an honest mistake.
Thanks for not jumping down my throat about it. Seriously, way too many people way too quick to just shout shill without even explaining anything.
Yeh, I hear ya. We need to be kinder to those on our side. I chalk it up to the ever mounting uncertainty of the world as we know it. Have been called out a time or two myself. Hang in there, fren.
Exactly!