The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation, CNBC reported.
The move should give even more businesses, schools and universities greater confidence to adopt vaccine mandates.
Up until now, the mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an Emergency Use Authorization that was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention.
Federal health officials had been under mounting pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May. The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up, CNBC reported.
FDA scientists evaluated “hundreds of thousands of pages” of vaccine data, according to the U.S. agency.
Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
Although more than 60% of the total U.S. population has had at least one dose of a Covid vaccine, many Americans say they are still hesitant about getting vaccinated, even as the highly contagious delta variant spreads.
Pfizer’s shot is the first Covid vaccine to receive full regulatory approval in the U.S. Federal regulators had previously said they would work as quickly as possible to clear Pfizer’s vaccines.
Standard vaccine reviews generally take several months to a year or more to determine whether they are safe and effective for use in the general public. But due to the pandemic, which has killed more than 628,000 Americans, the FDA permitted the use of the shots under an EUA.
Can’t wait for all the people who were worried that the vaccine wasn’t FDA approved to rush to get their vaccines now! I hope the clinics can handle the demand!
I mean, they wouldn’t just start moving the goalposts around now, would they?
that that wasn’t the only concern, right? There are also the side effects.
Anyway, though, if you’re so excited about the vaccine, how about showing a little gratitude to Hashem, and to His emissary President Trump for spearheading Operation Warp Speed, that got it developed in record time?
Thank you Hashem for sending your emissary Donald Trump to help get this vaccine developed in record time!
Now let’s show some hakaros hatov and get vaccinated!
I hope this encourages more people to get this vaccine. It was safe from the start but now there’s no excuse not to get it.
The FDA pushed this so fast b/c of political. there is no long term studys on this. Moshiach now
Yup, they were supposed to do studies over 2 years and once again it has been rushed. Please research what the FDA deems “safe and effective”. There’s no way for them to know the long term effects of this shot.
Almost no vaccine, or medication for that matter, is studied for that long before approval. We live life with inherent risks. Every time we get in a car to drive somewhere, there’s a likelihood of a fatal crash, and it’s much higher than the probability of severe adverse events from any currently available vaccine. That said, vaccine research over the years has proven that if there are adverse events, they’re almost certainly going to happen within 6 months of vaccination. We’ve had plenty more than that at this point, and it’s almost certain that with these vaccines, what you see… Read more »
Absolutely true. For example, the risk of a virus for which the death rate is about 0.2% in the USA (and even lower in many other countries), doesn’t really warrant taking a vaccine, especially if you have (as most of us do) natural immunity.
Wrong! 10-14 years on market necessary.
Yeah everything has risks but when you put all your eggs into one basket and then it drops….. Israel just did that to 95% of the Jewish Nation
Where did you get that two-year figure?
According to (https://www.fda.gov/drugs/special-features/frequently-asked-questions-about-fda-drug-approval-process#4):
Q: How long does the drug approval process take?
A: The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review.
Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
Is a drug the same as a vaccine¿
The mRNA study never got past the animal study
Very safe and early treatment saves lives. Trust the long term data and studies
Ivermectin has not been studied for Covid any longer than the vaccine, and the data on its effectiveness is very fuzzy.
What about refua kodem lemaka? The vaccine is the ultimate embodiment of that concept. As the saying also goes, an ounce of prevention is worth a pound of cure!
Except that the it doesn’t really work see all the ppl in the hospitals now who are “fully vaccinated”(especially after 6 months) so don’t forget to line up for your “boosters “
If you are serious, you need help. The fda is advising people not to take this medicine at all. Many people in Mississippi have taken this.gotten very sick. Seems there is a version of this for animals and people ar self medicating. Don’t. Ask your doctor. As the fda says, you are not a cow.
Actually one person was hospitalized. It is one of the safest drugs on the market snd the only reason they resorted to the veterinarian one is because the government has stopped access to it. If I were you I would question why a government vaccinated people after less than a year claiming safety but is withholding a 60 year old drug which has thousands of testimonies of being affective. If you believe e that it’s all Hashem than you rely on Hashem and know even Ivermectin is from him and Hashem in his infinite kindness wouldn’t deny sick people a… Read more »
Ivermectin is literally for sheep (and other livestock). Then they accuse mask wearers of being sheep.
Ivermectin’s been FDA-approved and safely used on humans for parasites for over 30 years.
What about Refua Kodem Lemaka???
Maybe think abt that- with the vaccine.
Maybe think about that indeed.
How about hydroxy/zinc vit d within the first 5days of symptoms?
That came before the clotshot.
But that’s ok, you do yours.
Gotta love the comments and debates on col.
Sorry, no one else was able to get his results that he claims. That suggests it does. It work.
If you think your regulatory agencies are still looking out for you and are not captured by industry, you might want to follow the money and the narrative. We were very disturbed to hear that no public hearings occurred on the wake of tens of thousands of reports to the Vaccine Adverse Events Reporting System over the last nine months. Public hearings and open data examination are imperative in building trust, but again our agencies are silent as they lord over citizens with advice instead of transparency.
If you were hesitant about getting the vaccine, here is your proof that it is safe and it works.
Go get vaccinated!!
See:
https://www.israelnationalnews.com/News/News.aspx/312235
I hope this works and can be repeated by others and studied. Nevertheless, a vaccine is better. Prevention is better that a cure.
COVID vax is not a cure; most recent hospitalizations for COVID are from the fully vaccinated (even CNN reported this).
Best prevention is using either the hydroxychloroquine prophelactic protocol or the ivermectin prophelactic protocol. Most world leaders and many doctors and nurses have been using these protocols since the beginning of the pandemic.
First they forced vaccination on the Healthcare Workers, and I did not speak out – Because I was not a Healthcare Worker.Then they forced vaccination on the Teachers, and I did not speak out – Because I was not a Teacher.Then they forced vaccination on the children, and I did not speak out – Because I did not have children.And then they forced vaccination on me – and there was no one left to speak for me.
Rally City Hall 4pm
The FDA only reissued emergency use authorization. They did not fully approve it. Collive should fix this mistake. Here’s the document so you can see for yourself. https://www.fda.gov/media/150386/download.
Better read this document and revise the article instead of copying info from propaganda media
A perfect example of why the general public’s interpretation of medical documentation should be disregarded. Yes, it was fully approved for use for those 16 and older. IN ADDITION, the previous emergency approval was extended for other uses not included in this approval. “On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. …. the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and… Read more »
The quote shows that BioNTech COMIRNATY is now Fda approved. This is not the pfizer vaccine. This is a different vaccine that was not released yet. The Pfizer vaccine is still not FDA approved and therefor is still protected from any liability.
Meet Janet Woodcock the head of the FDA. She’s the one who presided over one of the worst regulatory agency failures in U.S. history. She had a big part in America’s opioid crisis including approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years old. And now she approved the Pfizer V regardless that the placebo control group was given the V months ago, the safety trials skipped important steps and there is no… Read more »
Will the clotshot now become the next dependency drug everyone must get a ‘fix’ for every 6m for a virus with a 99% recovery rate and zero risk for the young? Unbelievable. Oh how science had evolved!
This should not be mandated for anyone! New V A E R S (Adverse Events Reporting System) New report is in (as of August 13, 2021): 13,068 Deaths 54,142 Hospitalizations 72,699 Urgent Care 98,761 Office Visits 5,617 Anaphylaxis 4,681 Bells Palsy 1,607 Miscarriages 5,882 Heart Attacks 4,861 Myocarditis/Pericarditis 17,228 Permanently Disabled 2,738 Thrombocytopenia/low platelet 13,812 Life-Threatening 25,169 Severe Allergic Reactions 7,080 Shingles Deaths went up by 7,277 since August 6th These are just the officially reported reactions. There are MANY more that go unreported. It does not prevent infection or transmission and comes with these risks. We don’t know what… Read more »
This proves how complete the corruption at the FDA is. There are no long term studies because that would be impossible, since it’s so new. If you still the the government has your best interests at heart..nebach!
Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide
updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to
update language regarding warnings and precautions related to myocarditis and pericarditis.
Your rights to bodily autonomy, to informed consent and to be free from religious discrimination remain unchanged regardless of any change in status of the thingy.
Do not be daunted. Faith isn’t supposed to be easy.
I have been a family practice PA for 21 years and this is truly breaking my heart. I have work throughout the pandemic and I have know first hand this is handled totally wrong. But I have never feared it. Never have clinicians and medical staff been told to not touch a patient who is sick. Or not do CPR on a cardiac arrest patient. Hospitals have mandates and protocols but in primary care we have to diagnose and treat based on what we know to be true. This is a virus and it’s not going away because its hosts… Read more »
I don’t need to be a biologist or medical expert to know that the vaccine isn’t safe. Next time I have a medical problem, I am going to go to Tucker Carlson for help, not some liberal, atheist, evolutionary scientists who probably didn’t vote for Trump anyways!
You want to bring Trump into this? Well, FYI,
who made the most vigorous and financial
effort to develop this vaccine in “Warp” time?
This is faster than the speed of light (186,000
miles per second – yeah, talk about “Trekies”).
None other than Donald Trump. See his urging
all to vaccinate:
https://www.youtube.com/watch?v=eA306aNtvmk
This was one of the responses to his interview with a Rabbinical court in Yerushalayim: https://rumble.com/vkrdx6-dr.-zelenko-speaks-to-a-rabbinical-court-in-jerusalem.html?fbclid=IwAR0wUs8KJarAkO8Lrnyl4QyiHTzz17Zoa3-4KWYQkXov8ggEQ4RBGAubojU ______________________________________________________________ Jonathan Sarfati, Ph.D. said… I debated Dr Zelenko on Just the Truth with Jenna Ellis. I used his own figures to show that the vax was far safer than catching the disease and treating with his protocol. Zelenko claimed 0.5% mortality after his protocol of HCQ, Zn, Azith. His figures are highly suspect (see of HCQ claims, including Zelenko’s, by Christian Ph.D. geneticist Kristen Panthagani, in her last year of medical training). But let’s grant them arguendo. Assume all VAERS reports are true (which VAERS explicitly says that reports are… Read more »
” 200,000 American death. This is out of 166,861,912 fully vaxed people, so 0.12%. Still 4× safer than catching the disease” NOT to address an illness with a 99.7% recovery rate. The 4x “safer” does not apply to MOST people especially CHILDREN! The risks of severe vaccine injury and death from this injection FAR outweigh the risk of acquiring covid! We don’t weight a human life by “statistics” . You are CLEARLY admitting there were indeed tens of thousands of deaths, many to young healthy people who would have or have had recovered from covid without incident but dismissed these people… Read more »
Stop getting your info from mainstream n cdc. Theyve been bought off handsomely. At least look at vaers! Do sime research and question: so many unanswered questions!! Once the passports are in your privacy. Yes PRIVACY is over. Lets see if this is published.
https://www.nih.gov/news-events/news-releases/nih-begins-study-covid-19-vaccination-during-pregnancy-postpartum
Now that thousands of pregnant women have taken the vaccine we can start researching about its safety
This is how they conduct research
“Tens of thousands of pregnant and breastfeeding people in the United States have chosen to receive the COVID-19 vaccines available under emergency use authorization. However, we lack robust, prospective clinical data on vaccination in these populations,” said NIAID Director Anthony S. Fauci, M.D., “The results of this study will fill gaps in our knowledge and help inform policy recommendations and personal decision-making on COVID-19 vaccination during pregnancy and in the postpartum period.”