CORONA FDA Grants Moderna Full Approval to its COVID-19 Vaccine

Macgyver

Macgyver

Has No Life - Lives on TB
www.thegatewaypundit.com

FDA Grants Moderna Full Approval to its COVID-19 Vaccine

The Food and Drug Administration has granted Moderna’s Covid-19 vaccine full approval for use in people aged 18 and older on Monday. Moderna’s COVID-19 vaccine was available in the U.S. under Emergency Use Authorization (EUA) from December 18, 2020. Moderna company announces in a press release...
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FDA Grants Moderna Full Approval to its COVID-19 Vaccine
JIM HOFT

4 - 6 minutes

moderna-vaccine-shot-vax-1.jpg

The Food and Drug Administration has granted Moderna’s Covid-19 vaccine full approval for use in people aged 18 and older on Monday. Moderna’s COVID-19 vaccine was available in the U.S. under Emergency Use Authorization (EUA) from December 18, 2020.
Moderna company announces in a press release, “Today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.”
Moderna is the second to be granted full approval for use in the United States.
The approval was “based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose,” according to the announcement.

Read the press release below:
“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”
The FDA based its decision on the totality of scientific evidence shared by the Company in its submission package, which included follow-up data from the Phase 3 COVE study showing high efficacy and favorable safety approximately six months after the second dose. Moderna also submitted manufacturing and facilities data required by the FDA for licensure. SPIKEVAX has received approval by regulators in more than 70 countries.
Moderna’s COVID-19 vaccine was available under Emergency Use Authorization (EUA) in the U.S. from December 18, 2020. Under an EUA, the FDA has the authority to allow medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives. A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the U.S. under EUA for adults 18 years and older. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
INDICATION (U.S.)
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
Click to expand...
The FDA published a revised “VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS about SPIKEVAX (COVID-19 VACCINE, mRNA) on Monday.
“This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.”
According to this fact sheet information, people who are planning to receive this vaccine should tell the vaccination provider about all of their medical conditions, including:
  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection
 
Tom McDowell

Tom McDowell

BAMN
Macgyver said:
www.thegatewaypundit.com

FDA Grants Moderna Full Approval to its COVID-19 Vaccine

The Food and Drug Administration has granted Moderna’s Covid-19 vaccine full approval for use in people aged 18 and older on Monday. Moderna’s COVID-19 vaccine was available in the U.S. under Emergency Use Authorization (EUA) from December 18, 2020. Moderna company announces in a press release...
www.thegatewaypundit.com www.thegatewaypundit.com

FDA Grants Moderna Full Approval to its COVID-19 Vaccine
JIM HOFT

4 - 6 minutes

moderna-vaccine-shot-vax-1.jpg

The Food and Drug Administration has granted Moderna’s Covid-19 vaccine full approval for use in people aged 18 and older on Monday. Moderna’s COVID-19 vaccine was available in the U.S. under Emergency Use Authorization (EUA) from December 18, 2020.
Moderna company announces in a press release, “Today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.”
Moderna is the second to be granted full approval for use in the United States.
The approval was “based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose,” according to the announcement.

Read the press release below:

The FDA published a revised “VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS about SPIKEVAX (COVID-19 VACCINE, mRNA) on Monday.
“This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.”
According to this fact sheet information, people who are planning to receive this vaccine should tell the vaccination provider about all of their medical conditions, including:
  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection
Click to expand...

Long past time to gut the FDA and CDC.

Perhaps in 2023. In the meanwhile they'll do everything possible to funnel all the power to the machine.

CDC/FDA => Big Pharma $$ => MSM$$ => Death and misery => Larger Profits => .gov controls/$$ - - repeat.

FJB!

===
.
 
bw

bw

Fringe Ranger
If this is approved in the US it would be the first, not the second. It would also stop the EUA usage of others. What are the odds laws will still govern? Anyone? Anyone? Bueller?
 
T

TFergeson

Non Solum Simul Stare
Hfcomms said:
So now you can sue Moderna for vaccine injuries now that it's fully approved and deemed 'safe' by the FDA?
Click to expand...

If you take Spikevax yes, but spikevax, just like Comirnaty, is not available. Bw is also correct above that if any of these "approved" vaxes like comirnaty or spikevax were to hit the market then the EUA money train and liability shield would be over. So, just like comirnaty which cannot be produced here until 2024, I do not expect to see spikevax anytime soon
 
Sherrynboo

Sherrynboo

Veteran Member
If it is really appproved then it CAN be legally mandated, right? Seems I have read that along the line somewhere.
 
P

Profit of Doom

Dismember
Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series. Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine.
 
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TammyinWI

TammyinWI

Talk is cheap
They will all suffer in hell, but I hope it comes back around to all of them now, in the form of "you reap what you sow."

That Johnny Cash song comes to mind, something about God striking people down.
 
C

Crusty Echo 7

Veteran Member
TFergeson said:
If you take Spikevax yes, but spikevax, just like Comirnaty, is not available. Bw is also correct above that if any of these "approved" vaxes like comirnaty or spikevax were to hit the market then the EUA money train and liability shield would be over. So, just like comirnaty which cannot be produced here until 2024, I do not expect to see spikevax anytime soon
Click to expand...

Just like the Pfizer one they will say it’s medically interchangeable with Spikevax but is not legally interchangeable meaning that it’s experimental with no liability for the makers.

The only immunity in any of these “vaccines” is for the companies from lawsuits. Seriously, who uses the name Spikevax? Only Dracula would be interested in that.
 
BUBBAHOTEPT

BUBBAHOTEPT

Veteran Member
OK, WIZARDS OF SMART, where pray tell do I go to get the MODERNA SPIKEVAX? :lkick: :lkick: :lkick: :lkick: :lkick: :lkick: :lkick: :lkick:
I want FULL APPROVAL from the Jab designed for something that has morphed into something else….:bhd:
 

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jed turtle

jed turtle

a brother in the Lord
Thinking some atoll out in the South Pacific May be far enough away, as long as it doesn’t have tourists and a government trying to help...
 
end game

end game

Veteran Member
Approval is a function of shorts and puts and those who benefited from the transactions. Their names usually start with Senator, Congressman or woman, Secretary, as well as president and vice president. Their masters are Blackrock, Vanguard, State Street and a select few others.
 
Lone_Hawk

Lone_Hawk

Resident Spook
Profit of Doom said:
Haven’t found “legally distinct” yet.
Click to expand...

In both cases the FDA has approved a vax under a specific trade name. They are saying the formulation and manufacture is the same. But courts have ruled that the name on the bottle matters. That is where the legally distinct comes in and why the approved vaxs are not available.

You would think that they would just start producing with a new label if they were the same. Maybe chemically they are the same. But legally they are not.
 
P

Profit of Doom

Dismember
Lone_Hawk said:
In both cases the FDA has approved a vax under a specific trade name. They are saying the formulation and manufacture is the same. But courts have ruled that the name on the bottle matters. That is where the legally distinct comes in and why the approved vaxs are not available.

You would think that they would just start producing with a new label if they were the same. Maybe chemically they are the same. But legally they are not.
Click to expand...
Apparently what they are doing works on most of the public. Having a go-round on Twitter with some entity that says Pfizer and Moderna are approved, safe, and effective. Oh, and IVM doesn’t work on humans.
 
BUBBAHOTEPT

BUBBAHOTEPT

Veteran Member
Lone_Hawk said:
You would think that they would just start producing with a new label if they were the same. Maybe chemically they are the same. But legally they are not.
Click to expand...
That's why they keep the EUA, they want that legal shield while saying fully approved. Same crap we have been putting up with all along. Can’t have other therapeutics -like IVM- and keep your EUA status… I think this is the best example in the world of having your cake and eating it too…:hmm:

On interesting side note, NOVAVAX has asked for FDA approval 2 days ago. Since I have no Covid antibodies I find this highly compelling. Any bets on whether the FDA will approve emergency use?
I didn’t think so…. :whistle:
 
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