Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.

[PeteS in CA]

Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration’s (FDA) has authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA). Delivery to the U.S. Government will begin immediately. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. I also want to thank the Moderna team, our suppliers and our partners for their tireless work across research, development and manufacturing of our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants. It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

[bigheadfred]

NO TO ANY COVID VAX.

I will not comply.

[jmyrlefuller]

NO TO ANY COVID VAX.

I will not comply.

You have any better ideas to get us back to living normal lives again? Because nothing else so far has worked.

[bigheadfred]

You have any better ideas to get us back to living normal lives again? Because nothing else so far has worked.

Yeah. I call HIM GOD.

Or give me my Neutron Bombs.

[jmyrlefuller]

Yeah. I call HIM GOD.

Or give me my Neutron Bombs.

Let's not go there.

[thackney]

Moderna's timeline is incredible for the vaccine.  It was figured out two days after the virus was genetically sequenced.  The first clinical batch of mRNA-1273 was completed, a total of 25 days from sequence selection to vaccine manufacture.  It has been in testing and trials since then.

https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19

[catfish1957]

Moderna's timeline is incredible for the vaccine.  It was figured out two days after the virus was genetically sequenced.  The first clinical batch of mRNA-1273 was completed, a total of 25 days from sequence selection to vaccine manufacture.  It has been in testing and trials since then.

https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19

2 days?  That's the proverbial finding a needle in a hay stack in the 1st 2 minutes. 

[libertybele]

You have any better ideas to get us back to living normal lives again? Because nothing else so far has worked.

So everyone jumping on board this bogus, rushed through vaccine train that is getting people sick that weren't sick before they got the vaccine is your answer?

What are the restrictions that you are under??

I know it's cold outside, but getting out and grabbing a breath of fresh air and some sunshine is healthier than sitting inside allowing them to keep you locked up inside.

[bigheadfred]

2 days?  That's the proverbial finding a needle in a hay stack in the 1st 2 minutes.

They have a vaccine for the first one. Never used it. Shelved it.

Maybe this gave them a solid base to design a new vaccine. A jump start.

[thackney]

They have a vaccine for the first one. Never used it. Shelved it.

Maybe this gave them a solid base to design a new vaccine. A jump start.

I suspect the studies from the first SARS gave them a jump start.  But both of today's vaccine for Covid are messenger RNA types and the previous SARS vaccine was virus based.

What about a SARS vaccine? Vaccine studies for SARS-CoV-1 were started and tested in animal models. An inactivated whole virus was used in ferrets, nonhuman primates and mice. All of the vaccines resulted in protective immunity, but there were complications; the vaccines resulted in an immune disease in animals. No human studies were done, nor were the vaccine studies taken further because the virus disappeared. Many factors were involved in the end of SARS-CoV-1, perhaps including summer weather, and certainly strict quarantine of all those who had contact with infected individuals, but we don’t really know why the epidemic ended. Viruses are like that, unpredictable!

https://theconversation.com/the-mysterious-disappearance-of-the-first-sars-virus-and-why-we-need-a-vaccine-for-the-current-one-but-didnt-for-the-other-137583

[bigheadfred]

I suspect the studies from the first SARS gave them a jump start.  But both of today's vaccine for Covid are messenger RNA types and the previous SARS vaccine was virus based.

https://theconversation.com/the-mysterious-disappearance-of-the-first-sars-virus-and-why-we-need-a-vaccine-for-the-current-one-but-didnt-for-the-other-137583

 Interesting. If I can I'll dig out the article I read that claimed they had a successful human tested vaccine.

[PeteS in CA]

I suspect the studies from the first SARS gave them a jump start.  But both of today's vaccine for Covid are messenger RNA types and the previous SARS vaccine was virus based.

https://theconversation.com/the-mysterious-disappearance-of-the-first-sars-virus-and-why-we-need-a-vaccine-for-the-current-one-but-didnt-for-the-other-137583

Traditional vaccines use a weakened variant of the target virus. The recipient is infected by it and his/her immune system fight it off. Their immune system "remembers how to fight the target virus.

The Pfizer and Moderna vaccines both use mRNA, and the AstraZeneca (and others) use the same technique as gene splicing therapy. Both techniques hinge on knowing the DNA sequence of the target virus. That is why BioNTech (Pfizer), Moderna, and Oxford University (AstraZeneca) were able to develop their vaccines so quickly.

The monoclonal antibody treatments from AbCellera/Eli Lilly and Regeneron (and more are coming) also use knowledge of the target virus' DNA sequence to develop antibodies against that virus. AbCellera had been part of a DARPA program to develop a replicable technique for developing  treatments for new disease outbreaks - which is what they did for Covid. Regeneron had been involved in HHS efforts to develop treatments for Ebola. The Trump Administration leveraged those relationships.

Covid-19 will prove to be what spurred new advances in vaccine and disease treatment development.

[thackney]

Traditional vaccines use a weakened variant of the target virus. The recipient is infected by it and his/her immune system fight it off. Their immune system "remembers how to fight the target virus.

The Pfizer and Moderna vaccines both use mRNA, and the AstraZeneca (and others) use the same technique as gene splicing therapy. Both techniques hinge on knowing the DNA sequence of the target virus. That is why BioNTech (Pfizer), Moderna, and Oxford University (AstraZeneca) were able to develop their vaccines so quickly.

The monoclonal antibody treatments from AbCellera/Eli Lilly and Regeneron (and more are coming) also use knowledge of the target virus' DNA sequence to develop antibodies against that virus. AbCellera had been part of a DARPA program to develop a replicable technique for developing  treatments for new disease outbreaks - which is what they did for Covid. Regeneron had been involved in HHS efforts to develop treatments for Ebola. The Trump Administration leveraged those relationships.

Covid-19 will prove to be what spurred new advances in vaccine and disease treatment development.

My understanding is the vaccine is not based upon the whole virus DNA sequence.  It just replicates the spike protein to get the body to produce the correct antibodies prior to an infection.

mRNA can most easily be described as instructions for the cell on how to make a piece of the “spike protein” that is unique to SARS-CoV-2. Since only part of the protein is made, it does not do any harm to the person vaccinated but it is antigenic.

After the piece of the spike protein is made, the cell breaks down the mRNA strand and disposes of them using enzymes in the cell. It is important to note that the mRNA strand never enters the cell’s nucleus or affects genetic material. This information helps counter misinformation about how mRNA vaccines alter or modify someone’s genetic makeup.

Once displayed on the cell surface, the protein or antigen causes the immune system to begin producing antibodies and activating T-cells to fight off what it thinks is an infection. These antibodies are specific to the SARS-CoV-2 virus, which means the immune system is primed to protect against future infection.

https://www.cdc.gov/vaccines/covid-19/hcp/mrna-vaccine-basics.html

Also a significant benefit is the production does not require a culture to be grown in.  This results in much faster production times in large quantities.