Federal regulators issued their full approval Monday of the Moderna COVID-19 vaccine, the second approval of a COVID vaccine outside of its emergency use authorization.
The FDA issued its full approval of the vaccine after considering data from roughly 14,000 vaccine recipients and 14,000 placebo recipients. In the more than 28,000 adults sampled, the two-dose vaccine was 93 percent effective at preventing COVID-19 infection and 98 percent effective at preventing serious illness.
The FDA also determined that the vaccine is safe to receive after analyzing data from a pool of more than 30,000 vaccine recipients and placebo recipients, with the most common reported side effects including fatigue, headache, redness and swelling at the injection site and fever.
“While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
The vaccine has been available to adults under emergency use approval since December 2020, along with the similar mRNA vaccine developed by Pfizer-BioNTech.
Since then, the FDA has expanded its emergency use authorization for the Moderna vaccine to include its use as a booster dose for people who completed their initial vaccine series at least five months prior.
With Monday’s announcement, Moderna’s vaccine will now be marketed as Spikevax.
“Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”
41 comments
Abolish all 3 letter agencies.
They’re all corrupt. If you don’t think they are, how nice to be naive.
“Spikevax” huh?
93% effective? Then why does anyone get covid?
Also, why are some other countries limiting its use?
Face the real facts. They haven’t created a vaccine yet that works and all but nine states have dropped their mandates. Mayors and above are also in the exempt class. (See game photos of Newsom)
93% effective against serious disease/death.
Other countries liniting it’s use? Harder to store, need their own data.
The vaccines work.
93% effective is the relative risk not the absolute risk.
An example of relative risk; 1000 people in the placebo group got covid and 500 people in the vaccine group got covid. they could say the vaccine is 100% effective because 1000 is 100% more than 500.
There are lies, damn lies, and statistics.
It is so easy to manipulate data to get the result you want.
@ just me
quite creative your math, but that’s not how efficacy is calculated. If the vaccine group and the placebo group have the same number of people and there are 1000 infections in the placebo group and 500 infections in the vaccine group the relative efficacy is 50%.
When I went to the County’s vaccination site at DVC last winter, I got the shot and then learned that it was the Moderna version. At first, I was a bit disappointed, since all of the talk up until then had been about Pfizer’s version. As more research came out over the summer, it became clear that Moderna’s vaccine kept its effectiveness better as time passed. Now that I have the booster to go with the first two shots, I should be good through spring and into summer.
How do you know you didn’t get a placebo?
So, you let them inject it into you and THEN asked what it was?
You’re not very observant.
Survival rate of COVID is over 99%. Why would you let someone inject you with an unproven experimental gene therapy for that? It’s not a vaccine and it’s all over the news where triple vaxxed are testing positive.
Doesn’t something seem wrong to you about this?
Maybe the story I linked below will jar your thinking cap. Think for crying out loud. Think.
https://www.thegatewaypundit.com/2022/01/37-year-old-man-suffers-severe-brain-rupture-cardiac-arrest-receiving-booster-shot-moderna-vaccine-life-support-removed/
I’m like observer… I was disappointed that they gave me the moderna when everyone was hyping about Pfizer. Ends up now that moderna was the best one.. and yes, we knew what was going into us but it wasn’t until we showed up at the clinic that they told us which vaccine they were using that day. We didn’t have to take it that day and could have come back. But I’m glad I didn’t.
Perfect timing. This is in today’s headline!
“37-Year-Old Man Suffers Severe Brain Rupture and Cardiac Arrest After Receiving Booster Shot of Moderna Vaccine- Life Support to be Removed“
https://www.thegatewaypundit.com/2022/01/37-year-old-man-suffers-severe-brain-rupture-cardiac-arrest-receiving-booster-shot-moderna-vaccine-life-support-removed/
People are far more likely to die of Covid than from any of the vaccines. And, no, I don’t go to The Gateway Pundit or the Epoch Times for news.
The most recent numbers from the County Health Department show that unvaccinated people are nearly eight times as likely to be admitted to the hospital for Covid as people who have been vaccinated and boosted. I have pretty good health insurance, but I still don’t want to have to go to the hospital if I can do something that sharply reduces my chances of having to go there.
That’s my point. You’re not very observant. Attack the source rather than the facts
Classic
Hey Patriot. Other then a single tweet from his sister, which indicates a considerable time lapse between his booster dose and what seems an undiagnosed, unforseen heart failure, can you provide any evidence that links what happened to Om Prakash Mohapatra to the vaccination? I don’t mean casual correlation, I mean solid, causal evidence that show directly that the vaccine booster was the ultimate cause of Oms heart failure?
Before you trust in any anecdotal stories from one biased person, you should try to verify them
https://healthfeedback.org/authors/jim-hoft/
My neighbor got the booster and quickly had heart arrythmia. Days later she had such severe heart arrythmia she said she really thought she was going to die right then and there. By my posting this, some readers here will immediate think I am biased, and if I posted it on a major social media site (I don’t participate in those) I assume I would be censored as spreading misinformation. George Orwell was right to warn us about control of the media and some here are more than happy to be the foot soldiers for those who are lying to us for reasons we don’t understand.
Well, once again attack the source. BTW, there was no Russian Collision. Where have you been ?
So, I guess we wait for the autopsy. In the meantime, this guy DID have an autopsy and died from the vaccine. Here’s an excerpt and a link to the article.
“When the pathologist looked at the 22 segments of Joseph’s heart, it showed the vaccine inflamed and attacked his entire heart. There was so much damage … to the heart. It was full multi-focal myocarditis, and it wasn’t just affecting one part of his heart, it was attacking his whole septum and ventricles.”
https://childrenshealthdefense.org/defender/joseph-keating-autopsy-death-myocarditis-pfizer-covid-vaccine/
That’s great, but I hate the Spikevax name.
Ivermectin … cheap, safe, effective … nuff said
VAERS.
And stop LYING by saying it’s not monitored.
If you truly trust the ‘science’ = You would want feedback from ALL OF THE ADVERSE REACTIONS.
Ignoring something doesn’t make it cease to exist.
Every COVID vax they’ve come out with has ended up way less effective than they initially advertised. This will be the same, just watch. Then they’ll have another vax or booster, wash-rinse-repeat.
Federal regulators…
I don’t believe anything they say or do.
They lie just like politicians, with every word.
Approved or not, it still doesn’t prevent you from getting or spreading this supposed virus! Plandemic Scamdemic!!
Check who has a piece of the patent pie, initials AF, and those who are jabbed are more susceptible to Omnicom. It is troubling. I feel bad for our servicemen and women who don’t have a choice. the vax injury and adverse effects have skyrocketed for them.
Remember the good old days when vaccines used to require vigorous trials, extensive and vigilant monitoring and reporting, and would take SEVERAL YEARS to be approved?
Current covid jabs are the fast food of vaccines and people seriously trust them? And for a virus with a 99% recovery rate? Mind boggling!
Deb,
I would suggest you do some reading on this topic. Most trails last for years because the disease level is low and its hard to collect the amount of data needed. It is not the length of time that is the standard its the amount of data. This is exactly why the Chinese vaccine trials took longer than in the US. We had more spread which made it easier to collect the data.
The other is money. I would also suggest your 99% recovery rate is a bit off. Knowledge is power.
My ML received the Moderna and had several heart attacks with no heart problems and with clear arteries.
It’s refreshing to know many of the people who claimed to be waiting until the FDA approved will just shift into any excuse imaginable to continue to avoid a vaccine.
You’re not taking it seriously and so there’s no reason to take any of you seriously.
Noone takes the FDA seriously.
Too many cancer causing drugs and dangerous side effect drugs approved by these fools. wake up Chuq and smelll the money making fraud.
Shifting like when Biden Harris and Pelosi said they would never take the vaccine, right?
Sadly we will never know what the end game is for the deep state for another 75 years. Until then tell your grandkids to warn their grandkids (when they are born) of what is to come. Its coming its here….
“Truth is the vaccine wasn’t what was promised and people who got it are furious and want mandates to validate their choice.”
Show me one person who loves to admit they were wrong.
Also I would suggest you surround yourself with people that admit when they are wrong. It’s called growth and those are the best people to know.
Either the vaccines work, and people don’t need to wear masks,
or else the vaccines don’t work and you need to wear a mask,
or else masks don’t work so why wear one,
or else the government wants to keep you scared and confused.
Any bets on the right answer?
D…all of the above
I thought that we were told that the original trials of this Experimental jab were to last until 2023.
Funny how everyone forgot.
Anon, Science changes with new information.
The science changes depending on who’s paying for it.
Dancing nurses time? My favorite one was the Hillary look alike!
Big Joey gonna give a speech soon ? There are still unvaccinated people corrupting and insurging against their democracy! What about all black doctors in a sing along ….
Just a commercial away….
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