Pfizer COVID-19 vaccine gets full FDA clearance
(CNS): The US Food and Drug Administration has given full approval of the Pfizer-BioNTech COVID-19 vaccine for everyone aged 16 years and older after the agency completed its full review of the quality, safety and effectiveness of the vaccine which has been under Emergency Use Authorization (EUA) since the end of last year. In a press release Monday, the US government agency said it was a milestone in the battle against the pandemic.
Acting FDA Commissioner Dr Janet Woodcock said the vaccine had met the FDA’s rigorous scientific standards for emergency use and the public could be confident in the safety, effectiveness, and manufacturing quality.
“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. Today’s milestone puts us one step closer to altering the course of this pandemic,” she added.
The public health authorities in Cayman have almost exclusively used the Pfizer vaccine since it began the national vaccination programme at the beginning of the year thanks to the help of the UK government, which has supplied the nearly 100,000 doses for these islands. Only around 100 people have received the Oxford-AstraZeneca shots.
This additional stamp of approval for the Pfizer vaccine, which will now be marketed as Comirnaty, will mean that some people may feel more comfortable taking up the vaccine but it also means that mandating people to be vaccinated in certain circumstance will be easier. However, no local official statement has yet been made on this FDA approval.
Figures released on Monday showed that just 239 people received their fist shot of the vaccine over the weekend. Since there must be a gap of at least three weeks between the two vaccination shots, it is now certain that government cannot exceed a rate of 72% of the population being fully vaccinated by 9 September, the date when the borders were due to reopen to commercial air traffic.
Meanwhile, as vaccination numbers stall, five more travellers tested positive over the weekend for the coronavirus. There are now 12 active cases among the 864 people in quarantine and isolation. Three people have symptoms of COVID-19 but have not required hospital treatment.
How much of an impact the FDA approval will have on the local vaccination rate remains to be seen, but currently less than 51,000 people aged 12 and over have had at least one dose. The hope is that the FDA approval will see the numbers increase and remove one of the barriers holding some people back.
Dr Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said the scientific and medical experts at the FDA conducted an incredibly thorough and thoughtful evaluation of the vaccine.
“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of (the vaccine’s) safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” he said. “We have not lost sight that the COVID-19 public health crisis continues… The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US.”
Monday’s approval by the FDA was supported by updated data from the clinical trial, which supported the EUA and included a longer duration of follow-up in a larger clinical trial population, which was also peer reviewed, Pfizer said in a release.
Data from around 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose was used to analyze the safety and effectiveness. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received the Pfizer vaccine were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalisation and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorisation safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose.
The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes.
The FDA said there are monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination.
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Category: Health, Medical Health
CNS you need to retract this.
The Pfizer vaccine wasn’t approved by the FDA. They approved the new BioNTech vaccine called Comirnaty. Clearly stated in the letter on page 2.
https://www.fda.gov/media/150386/download
“Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA
(modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid
particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the PfizerBioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech
COVID-19 Vaccine to provide the COVID-19 vaccination series.8”
You should have read the letter first.
CNS: Please stop posting this. My head is exploding. How can you not understand “is the same formulation” and “can be used interchangeably”? It’s just a name change of the same product for marketing purposes.
There is a difference this new one won’t have the liability exemption for Pfizer that the emergency use one has.
The FDA approval is based on outdated data as they clearly state it was based on the 6 month Pfizer study that didn’t include Delta cases and the pathetic vaccine record over the past month. This is not something worth celebrating. And the FDA is not your friend, they got the back of American pharma companies first and foremost.
Why do my comments keep getting rejected, CNS? Is this an open platform or not?
CNS: Your posts tend to be anti-vaxx conspiracy theory junk. I post them when I have time to fact check – and if you look, I have just posted several of them. Sometimes they are deleted because the nonsense is tiring. Honestly, if you think that Robert F. Kennedy, Jr. is a reliable source, you’re probably beyond help. Those people dying in hospital begging for the vaccine when it’s too late probably also thought he was a brave truth seeker, rather than the bottom feeder he actually is.
CNS is under no obligation to publish your tedious anti vax drivel. Do everyone a favour and go back to facebook.
Even if only half of one percent of our population is infected, Cayman would need 350 ICU beds and associated equipment/ ventilators/ doctors and nurses.
Cayman can’t cope with a mass infection situation…keep the borders closed until you know how you’re going to deal with what’s ahead.
US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”
XXX
CNS: The info-demic: stopping the spread of false information
No, COVID mRNA Vaccine Won’t Cause Alzheimer’s or Prion Disease
“Among the most pernicious myths is one that claims the mRNA vaccines made by Pfizer/BioNTech and Moderna are a form of genetic engineering, a lie that is being perpetuated by none other than fraud doctor Andrew Wakefield.
Now, a new myth has reared its ugly head. A paper written by a well-known anti-vaxxer named J. Bart Classen and published in a scientific journal — if we can even call it that (because it’s not indexed in PubMed) — claims that the mRNA vaccines that target coronavirus could cause prion diseases like Alzheimer’s. It’s total garbage.”
31 fully vaccinated people have died in Tennessee, health department says.
https://www.google.com/amp/s/fox17.com/amp/news/local/24-fully-vaccinated-people-have-died-in-tennessee-health-department-says-breakthrough-case-virus-coronavirus-
CNS: Which may discourage those who are incredibly bad at percentages and otherwise not very bright from taking the vaccine. From this same article: “TDH says right now, 96% of all new cases in Tennessee are among unvaccinated individuals and 96.9% of all COVID-19 deaths were among unvaccinated individuals.”
31 out of a crap-ton of persons! My guess is all of those were not in good health anyway prior to catching Covid.
The VAST majority of deaths in Tennessee (and everywhere else for that matter!) are in the UNvaccinated!
In the news lately is a report that a shipment of 30 doses of the Sinopharm vaccine was imported into the Cayman Islands. Does anyone reading this know who imported it and who will be receiving that vaccine?
I and family and several people I have been in contact with will not be taking the Pfizer vaccine but we would take the jabs of Sinopharm or Coronavac/Sinovac. They use old school, reliable, time/proven and very well known inactivated virus technology. This is the same vaccine technology that defeated Polio. The Cayman Islands government should be looking into offering people a choice of vaccines and not just one.
Are you seriously saying you wlkld take a Chinese vaccine over Pfizer? This must be the craziest thing I’ve heard since Covid 19 first broke out in wuhan, China. The Chinese vaccines are half as effective and not fda approved, you must be mad.
Why not take Oxford AstraZeneca is this is your wharped rationale?
Time to get serious with those too selfish/stupid/gullible to take the vaccine Mr Panton. Even if they don’t want to play a proper part in society they shouldn’t be allowed to stop the rest of us living normal lives any longer:
https://www.theguardian.com/world/2021/aug/24/greece-announces-bars-and-clubs-off-limits-for-unvaccinated
🤔 7 fully vaccinated Florida COVID-19 patients die in what doctors say is extremely rare situation.
https://www.wfla.com/community/health/coronavirus/7-fully-vaccinated-covid-19-patients-die-in-what-doctors-say-is-extremely-rare-situation/
Masks are quickly becoming badges of ignorance for the unvaccinated. Good thing these anti-vaxers weren’t around for Polio.
Masks are recommended in the US for everyone in public indoor settings, regardless of vaccination status.
Only about half of those in Florida wear masks indoors, it’s not a rule, just a recommendation
11:11am, masks do NOT necessarily mean a person is unvaccinated. I’m fully vaccinated but wear mine in certain scenarios.
Most of the anti-vaxxers are also anti-maskers.
Can we get the Pfizer Booster Shot here please? I had my vaccine so long ago that my immunity dipping now…
I am ready to travel…
Jeez you people need to stay off facebook
Which people?
Few months ago all the conspiracists were saying “It na FDA approved so I na taking it”
Now that it’s approved, you hear “I still na taking it”
And all you idiots were saying “it’s a conspiracy that it is not approved”.
I didden say dat.
Approved for emergency use, not full approval.
CNS: This comment is beyond stupid. Actually read the article or one of the thousands online about the Pfizer vaccine getting full approval.
Well said CNS.
LOL at the original poster. Dear god.
Another brilliant graduate of YouTube University I see.
It’s called, “Freedom of choice”.
Abortion? I agree
The vaccine is presenting the virus with only one hurdle in the global population once it clears this it will wreak mayhem. The best defence was vaccinating the elderly and keeping quarantines for travellers. Governments worldwide failed to do this.
One cannot for the world understand why some who cannot behave or will not comply with Covid 19 regulations in their own home countries are so damn eager to come here with their friggin drama, and are hell bent to open this place to spread it here. Why in light of the clear news and dangers now overseas in certain neighboring countries and these same countries some in our leadership are 1 entertaining this foolish notion that Cayman is some how immune to these very same dire circumstances and situations we see elsewhere. 2 why are we Lessening quarantine restrictions for those coming here when we know they work and understand that these Covid variants pose a significant threat to our vulnerable and are clearly dangerous to even our vaccinated population . Why are we listening to those who clearly got terribly wrong in their own countries just because they appear to be now suffering great inconveniences in their selfish little lives. Has Cayman not giving them enough ?? Or should we sacrifice our lives now too so they can get on with some level of normalcy which clearly no longer exists for all of us !
So what exactly are you trying to say? Hide under blanket forever?
Just take vaccine, if you can and didn’t do it yet.
Next…
While it is wonderful that we do not have to wear masks in our little utopia.
Many Caymanians are suffering greatly due to the economic downturn, rise in inflation and underemployment.
Not to mention the limited and expensive flights to the states for basic needs like Medical treatment and taking our kids to school.
So we have to do a cost/benefit analysis and recognize that staying this closed forever will have devastating consequences on our future generations.
We need to continue with the safe and staged border reopening. Keep 5 day quarantine, but add daily flights for everyone!
If it means the island reopens and people can have their livelihoods back, I’d glad put my mask back on. Small price to pay for the thousands of Caymanians suffering in this current economy.
Same. I’m sure the majority of people I’m cayman are happy with social distancing measures and mask wearing to open up. Zero covid is not a realistic strategy – let’s get in the real world.
Get rid of the quarantine or no one will want to holiday there.
Open up with a 14 day quarantine for all. Vaccination does not eliminate transmission possibility.
Many caymanians are also doing better as the reduction in work permits has seen opportunities and wages rise. Cayman needs to pivot away from low wage tourism.
Second paragraph:
“ Acting FDA Commissioner Dr Janet Woodcock said the vaccine had met the FDA’s rigorous scientific standards for emergency [!!!] use and the public could be confident in the safety, effectiveness, and manufacturing quality.”
Does that mean the approval is only for re-issue of authority to be used per EUA and It has NOT been approved for standard use?
No.
The FDA’s official definition of “approval,” as opposed to emergency authorization, is that “data on the drug’s effects have been reviewed by the Center for Drug Evaluation and Research,” which rules on whether the drug’s provided benefits “outweigh its known and potential risks for the intended population.” According to Dr. Allison Arwady, commissioner for the Chicago Department of Public Health, “The difference between authorization and approval does not have anything to do with new studies, it has to do with making sure that people have been followed for a long enough time.”
“..it has to do with making sure that people have been followed for a long enough time…”
A long enough time for what?
8.5 years is an average time NOT 4-6 months.
We don’t have 8.5 years. The world can’t stay like this for that long. If it was just you, sure, everyone else gets vaccinated and that protects you and you choose to wait 8.5 years. The problem is there are way too many of you, and the consequence of all of you acting stupid is that we can’t get the world going again. So we are all locked down so you don’t have to wear a mask because you won’t take a vaccine. Well, you can wear your mask for 8.5 years because we are not waiting for you.
Okay, anti-vaxxers what’s next on the agenda..Should we try to Ivermectin FDA approved for people rather than horses?
Probably something about mercury in the vaccine.
Ah, well I suggest people who eat a lot of seafood should be scared of that too then.
there is more mercury in the fish you are eating
Ivermectin is approved for people.
It won the Nobel prize in 2015.
XXXX
CNS: Do not self-medicate. Leave decisions about treatment to your doctor. The Nobel Prize was for its original intended use.
Mississippi officials warn against using anti-parasite drug to treat COVID amid uptick in calls to poison control
FDA: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
Note, there are studies underway about the use of ivermectin in patients who are already sick with covid. They are not yet conclusive. This is not a big cover-up, this is social media warriors jumping the gun.
CNS, bless you for trying to inform the horde of uninformed and misinformed that comment here!
There are some real fools among us.
Yawns and moves on to other news…
won’t make a bit of difference at this stage.
time to bring in vaccine passport for people who want to socialise in public……like most other countries.
friggin idiot 10.53pm
Que the anti-vaxxers..It’s no longer experimental but we are under reporting the deaths and people are having heart palpitations…more of the same old crap.
We can only hope that by looking at New Zealand over the last few days, the cayman government finally realize that a zero Covid policy is naive and unrealistic. We are waiting time here. We will get community spread eventually and Covid is not going away, the cayman vaccination rate is extremely high and our hospitals can surely cope with the projected death rate among the remaining unvaccinated, so open up with a a quarantine and testing policy now. Why wait – nothing is going to change in a years time so why not just open now?
2nd pension fund withdrawal from those grossly underperforming overcharging 1.5% MER pensions to incentivize the unvaccinated to get the vaccine is the solution for reopening. Stick it to those multimillionaire owners of those pensions that a blatantly ripped off pensioners for decades.
@ 7:33pm If they were to offer a second pension withdrawal to incentivize taking the vaccine, then I’d likely take it for at least half of what I have left in there. Even with full FDA approval, they still did not remove the liability clause and that’s my major issue with it. What if a person has some really adverse effects or even dies?? I’m surprised this light bulb has not gone off for any of the new Government. Money motivates most people to do things they don’t even want to do.
So you are not going to take a vaccine because in the highly unlikely and rare circumstances in which you have a serious allergic reaction to it you wont be able to sue Pfizer? Instead you will do without the vaccine that is highly likely to prevent you from being seriously ill or dying from covid, when you will be unable to sue anyone? SMH. Think your scale of priorities is way off my friend. You are not going to wear a safety belt because there is a tiny chance that it may injure you and you wont be able to sue the manufacturer, so you are going to drive without one and see how that goes.
10:19 Try a new excuse! EVERY vaccine you’ve ever taken has a liability clause! I’ve signed one for every vaccine my children have gotten…..including MMR, chicken pox, tetanus, etc.
Excellent news.
Hopefully this will encourage the very last holdouts on island to get vaccinated and protect themselves from severe infection when they will invetibly be exposed.
We should also prepare Mono Clonal Antibodies treatment for when the Island soon reopens. This can help reduce Covid complications when taken immediately at the start of the first symptoms of infection.
Nothing will let them change their mind..Not even their holy Leader Trump will they listen to anymore.
https://www.nbcnews.com/politics/donald-trump/trump-booed-alabama-rally-after-telling-supporters-get-vaccinated-n1277404
I say leave them be and lets starts culling the herd.. once we get community spread they will be the first ones to go and with them goen we will have herd immunity. Sick and tired of their foolishness keeping us from any sense of normalcy.
Nope. I’ll give it 5 more years ….
Doubt you will make it to 5 years
I am fine Living in Florida you are so terrified of. No one I know has died. Few got sick, but fully recovered on their own. New treatments have been introduced this month.
Before you start spewing insults, I have GBR after 2015 flu vaccination that was a requirement for a nursing school enrollment.
Based on the tone of your comment, end of the world can’t come soon enough. People have permanently lost their minds. We need to start from a scratch.
Not 5:32 AM,
You do realize that in Florida as of today, is the only state where more people are dying of COVID than ever before.
249 deaths today.
What went wrong?
Believe you are delusional about Florida today. Certainly would not want you as my nurse as you are obviously the nurse from hell.
Florida COVID update:
726 deaths in last 2 days
42,143 new cases in last 2 days
Visiting Florida may be hazardous to your health.
They are safe. Oh wait… just a bit of risk for males under 40…
I’m sorry I don’t understand your very stupid comment, please elaborate and show your work.
You will soon understand.
As per the article…
“The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age”
Read the article trough the end to find out whose comment is stupid!!
🤦♂️
I believe an apology is in order!
READ the article or take your ADD pills if you can’t finish reading the entire article.
What risks? Article said within 7 days of second jab… none of the thousands of males under 40 in cayman had any issues months in? Grow up and get jabbed. Pathetic to not be fvaxed by now and so selfish
That isn’t how medicine works. Pretty much anything a doctor gives you can have negative side effects, but this is weighed against the risks of doing nothing. Theoretically my seat belt could choke me to death when I drive down the road, but I know getting in an accident while not wearing a seat belt WILL lead to a much worse outcome.
Seat belt isn’t permanently attached to your body.
mRNA is naturally degraded in the body also. It does not replicate nor can the vaccines modify your DNA.
They train cells like giving a boy a ball to train to play football.
I can see, feel and touch that my seat belt is not attached to my body, but I have to take someone’s word about “…mRNA is naturally degraded in the body…”?
• What do you mean by “naturally”? How does it happen?
• What do you mean by “degraded”? How does it happen in a human body?
Common! Come up with something other than parroting what someone had said. In fact, I don’t think anyone knows. But you probably know, since you’ve made such a statement. Share your knowledge, please.
At this point, 6 months is not a “long term” to make any conclusions about covid jabs.
Sorry but this person is just explaining how vaccines work. This is common knowledge and you can easily find this out for yourself. To say “come up with something other than parroting what someone had said” is ridiculous. Obviously people should be following medical advice because they are not able or capable of doing the actual research themselves. Unless you are planning to go back to school for a long time and then spend a significant portion of your life in a lab.
Apparently the drugs and alcohol you took in your youth never naturally degraded as you cannot form a coherent and legitimate arguement. And you have the balls (maybe) to call the pro-vaxxers parrots….
Just be aware that COVID-19 has a significantly higher chance of causing more severe myocarditis in the same age groups, in addition to it’s other risks.