The U.S. Food and Drug Administration approved a second COVID-19 booster vaccine dose Tuesday for some immunocompromised people as well as all adults over the age of 50.
A second booster dose of either mRNA vaccine will be available for eligible people at least four months after their first booster dose under the FDA’s authorization.
In addition to all adults over age 50, a second booster dose is recommended for people with weakened immune systems from various factors, including organ transplant recipients, those being treated for cancer and people with HIV.
Boosters of the Pfizer-BioNTech vaccine are available to people age 12 and up while booster doses of the Moderna vaccine are only approved for adults.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.
“Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Marks said.
Federal regulators approved initial booster vaccine doses for older and immunocompromised people last summer amid an uptick in COVID cases tied to the delta variant.
Boosters were subsequently approved for most other people in October in anticipation of a wave of cases due to the highly contagious omicron variant.
While both mRNA vaccines and the single-dose Johnson & Johnson vaccine remain highly effective at preventing serious COVID-19 illness and death, public health officials at all levels have argued that preemptively boosting a person’s immune response will maximize protection against existing and potential variants of the virus, which could become more contagious and even circumvent vaccine protections.
Talk of a second booster dose has increased in the wake of the winter omicron surge, as vaccine protection tends to wane over time.
FDA officials said they have yet to determine whether a second booster dose will be recommended for other age groups.
“The data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19,” Marks said. “So, those who have not received their initial booster dose are strongly encouraged to do so.”
35 comments
No thanks…. never.
My wife and I got our 2nd boosters this afternoon at Walmart in Martinez. No issues. That should hold us until an updated version of the vaccine becomes available by this coming fall.
Governments have perfected a method of killing their own citizens using the stupidity and political correctness of the victims friends and family to cover up their murders.
That will hold you till the next experimental version drops all right…Keep up the thinking.
@SAM
… but which group of citizens are being killed by their “stupidity and political correctness of the victims’ friends and family”?
This is a joke, right?
@Sam
Governments have a long history of implementing drastically more efficient means of killing their own citizens.
With all of the practice our government gets via it’s foreign policies, it could easily get much higher domestic numbers, if that was the goal.
However, I haven’t seen much of anyone mentioning the August 23 2021 FDA Approval Letter. https://www.fda.gov/vaccines-blood-biologics/comirnaty
We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of
the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administration of
COMIRNATY.
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis
and pericarditis following administration of COMIRNATY.
6. Study C4591021 substudy to describe the natural history of myocarditis and
pericarditis following administration of COMIRNATY.
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network).
8. Study C4591007 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.
9. Study C4591031 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of a third dose of COMIRNATY in a subset of
participants 16 to 30 years of age.
The soonest submission of any of the studies is Dec 31 2022. The last one is Dec 31st 2026.
First, if you get the vaccine you won’t get COVID, much less transmit it to others. Then it’s simply “safe and effective”. Safety studies still haven’t even been completed yet.
Informed consent my foot!
Nope.
Let me think about it…. Nah…
Scheduled….
The “CLOT SHOT”?
I don’t think so Tim.
The CDC is no longer releasing data comparing vaccinated vs unvaccinated deaths and hospitalizations.
But don’t worry, it’s probably just an oversight.
Each time I’ve got the shot I’ve got sicker, the last time was the worst. Even my doctor said not to get another one. And I won’t. And honestly, what kind of vaccine do you need four doses of? Even flu shots last longer than that. Yet people think this is their ticket to life. Be my guest.
Booster~Booster~Booster
If this was a true vaccine, one shot a year would be enough.
Also, why are people who are vaccinated still getting covid?
Plus, if you caught covid, wouldn’t you have natural immunity now?
Speaking of Covid Roz…How are you doing? All better now and did your hubby get it too?
Hey Simonpure ~
Yes Better!
Test negative & recovered…. just like a head cold….less than 2 weeks.
Hubby didn’t get it, but wanted to, so he could get it behind him.
I think he’s just too tenacious to catch it, even unvaccined…. LOL!
Hope you and the Family are well….. HUGS
Those of you who are continuing to get he boosters might want to research a little something called VAIDS.
@LL Cool J
There’s no such thing as “VAIDS.” It’s just something made up by the anti-vaxxers to try to scare people. Sorry, but it won’t work for me. I hope no one else thinks it’s something that might exist. Again, it doesn’t.
If at first it doesn’t work, try, try again is all well and good when learning to tie your shoes. But if 3 jabs doesn’t do it (and I’ve had 3), perhaps repetition isn’t the best policy.
But then again, Liberals appear to see nothing wrong with doubling down on dumb.
Remember when the Covid vaccine worked?
Yah, no one does.
How about redirecting our efforts to preventing forest fires in California?
Sucking smoke 3 or 4 months of the year has caused me more health problems than the Chinese Flu has.
And when will the people wake up?
Is it the 4th jab/2nd booster?
Is it the 5th? Or the 6th?
I have had all 3 of mine … I believe myself to be well informed and educated.
I do believe this should be OPTIONAL, like the flu shot.
I do believe COVID is real, though not as hyped up as Media and Politicians want us to believe.
I am now believing that we do not know enough about the vaccines as evidenced by the continued boosters being required/suggested at irregular intervals.
@parent, My story is similar to yours. I got the Pfizer vaccines. I though mRNA vaccines were amazing and I couldn’t wait to get them.
I agree that Covid is real (I got it as did many members of my family) but it’s hyped up by the government and the media for some reason. Now that it’s hopelessly tied into politics and sides have been taken (conservatives are Covid nonbelievers and anti-vax while liberals believe Covid is real and are pro-vax) we will never get the truth.
I haven’t gotten any boosters because there are too many questions. What are the side effects? Why do you need so many boosters? Why can you still get it and spread it?
Bottom line is it should be optional like the flu shot.
My Doctor advised per CDC guidelines and not providing TMI, except to say having none of the conditions listed 2nd Booster is advisable for, I would get the shot since all adults over 50 do qualify and I feel better doing it.
I feel better not having caught covid, not taking a jab, a shot or a booster. I don’t trust any of it. Good luck to everyone.
@FPN….One of my doctors asked me why I hadn’t gotten any shots, I told him I was in the “Control Group” for this experiment. He made no comment and stopped hounding me about shots and boosters in subsequent appointments.
Ah yes, government doctors that can’t determine whether someone is a woman or not is recommending a shot.
Pass.
Take your medicine. There is another terrible variant hiding in the shadows. The BA.2 is coming for you. Hurry up and get another jab. Big Pharma is laughing all the way to the bank. Just look at the fear in your people who still wander around outdoors with masks covering their faces.
Chris, if someone wants to wear a mask outdoors, why should that be a concern of yours? Its their decision, not yours, and in no way does it do you any harm.
And where’s Comirnaty? Funny how it never got distributed.
Are the vaxed really protected, and for how long? Saget didn’t last thru through the fall.
“Died suddenly / died unexpectedly”. The new norm.
Tennis Great Rafael Nadal = Done.
Celine Dion = Done
What do you mean these two people are “done”?
Don’t believe the hype…….
Interesting Bloomberg article on why do some people not get covid.
https://tinyurl.com/2frddb7j
Yup, not everyone has a weak immune system. 😉
Simpletons…
Comments are closed.