Pfizer Covid Vaccine Given Full FDA Approval
[Updated] The U.S. Food and Drug Administration has now officially approved the Pfizer-BioNTech Covid-19 vaccine, amending the prior emergency use authorization to a full approval.
The FDA website said, “Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty [koe-mir’-na-tee], for the prevention of COVID-19 disease in individuals 16 years of age and older.
“The vaccine also continues to be available under emergency use authorization [EUA], including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D.
“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 in the U.S.”
The FDA added, “Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
“EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Dr Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.
“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. 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 U.S.”
You can read the full statement here on FDA website.
Update 4.16pm: MP Michael Dunkley said, “The One Bermuda Alliance is today pleased to learn that the Federal Drug Agency has approved the Pfizer-BioNTech Covid-19 vaccine, the first full approval.
“This approval, for persons aged 16 and older, signifies a key public health achievement. Emergency approval still applies to those between 12-15.
“The FDA said today upon notification of the approval ‘the FDA approval of a vaccine may now instill additional confidence to get vaccinated.’
“We hope this proves true in Bermuda as we still have not reached the desired vaccination rates. Those who have some hesitancy should take comfort in this major announcement as we continue to tackle the impact of the virus on our community.
“This vaccines offers significant protection in the ongoing battle to tackle Covid 19 and the announcement by the FDA today is a clear indicator of the confidence people can have in it.”
You can find more information on the links below and also on our dedicated website BermudaCovid.com, which is the most comprehensive resource and historic record available of Bermuda’s handling of the pandemic.
- All: Our coverage of the Covid-19 pandemic here
- Bermuda Stats: Chart of testing stats here
- Vaccinations: Data covering vaccinations here
Well, there goes one of the key arguments for the anti vax muppets.
Now, make it law.
@ sandgrownan your stupider than I though. Make it law to take a medicine? Pharma lobbyists would love you. What you do not believe in “my body my choice” huh. How could that possibly return to bite you in the arse.
LOL you are a supremist, fascist and a disgusting excuse for a human. Enjoy your life your welcome to stay here as long as you leave our politics to us.
There’s a global pandemic, people are dying for lack of a vaccine. Mass mandatory vaccination programs are nothing new.
Grow up and get the jab.
at the start of all of this we were told that it was killing “millions around the world everyday” right? times a million by 365. does it add up to the total of deaths world wide? no it doesnt. ask your self why Dr’s and nurses havent been dropping like flies if the virus is so deadly and they havent been double jabbed? they have dealing with covid since it came out but they are ok. and to top it all off if you are double jabbed then you are safe right? no because you can still catch it and pass it on to others without even knowing. remember this virus is so deadly you need to take a test to know you have it.
That is the most stupid thing I’ve read all day.
Grow up. Get vaccinated.
Thanks for letting me know how delusional you are….have a nice day.
7 day average for deaths is around 9,000. 4.4m deaths to dates. The peak in January was 15,000 a week, but it appears to be oscillating between 9,000 and 12,000 so far this year.
The point your conspiracy theory addled brain cell fails to understand, is that the death rate is much lower than originally forecast because of travel restrictions, quarantines, lockdowns to get this thing in check while vaccines were developed and rolled out.
Reading the FDA Aug 23 press release, you have to wonder why the efficacy numbers are so out of date, and why they are based on data compiled prior to March 13. Peter Doshi, Senior Editor of the BMJ, has been asking excellent questions about it. I don’t know why the FDA would not want to publish up-to-date efficacy figures, but they haven’t.
Yes it is the stupidest and make believe comment I’ve ever read on Bernews. Jesus help us.
Now now everyone is entitled to their opinion.
Dude I’m from here and completely support his/ her comments on the matter.
You have a right to make decisions regarding your body BUT not when they negatively impact others. Texas awaits you!
FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of cigarettes. Cigarettes are responsible for 7 million deaths per year, that is 70 million dead worldwide since 2011, 4,000,000 Americans and around 2,000,000 from second hand smoke exposure.
Yes, of course, they are a regulatory authority, i.e. a law states they are the ones to regulate a certain industry or industries, they also regulate many foods, all types of medicines, tobacco etc.
Elected politicians as government make the laws and the government agencies such as the FDA are regulators/enforcers of legal compliance of that law, which hopefully aligns with good practice. However its the politicians in elected positions that make the laws. SMH.
This was the Great Argument from anti-vaccers. Now watch the hasty moving of goalposts.
Just trying to make sure we are on the same field and shooting at the same goal post Fauci and the CDC/FDA have constantly moved since 2016.
LOL
“Since 2016”. You have no idea what you’re talking about, do you.
The FDA does not guarantee safety. THE FDA is financed by Big Pharmaceutical which creates a conflict of interest. The FDA agency is focused on approving drugs to appease Big Pharmaceutical and it lacks the proper authority and funding to protect the public.
So take a wild guess who is the 4th largest pharmaceutical company in the world…….you guessed it, Pfizer is.
Oh, and the FDA has reversed their decisions on numerous occasions after they found that the drugs they approved ended up causing harm and illness. Look up Vioxx, Zelnorm and Palladone. Look at these FDA messes, just to name a few.
The FDA was pressured to approve this vaccine:
https://www.wsj.com/amp/articles/fda-under-pressure-to-grant-full-approval-to-covid-19-vaccines-11627810202
These lot are part of the problem they except anything. The road to hell is paved with good intentions. Ultimately if the rights of the individual are not protected then no one has rights at all. Like I said in the beginning I’ll keep and maintain your stuff while you all self isolate see you once the virus is exterminated……
LOL
You do know how mistakenly using the work ‘except’ instead of ‘accept’ makes a post utter nonsense ?
Oh , but it don’t matter , it’s only the internet . lol
Do you have anything of substance to add or are you an editor?
I think the nail in the coffin for those of us waiting to get the vaccine will be when Biden makes it mandatory that all travelers from overseas will have to be vaccinated to enter the country. It will be the only way he will open the borders. It’s only a matter of time before all countries will do this. And I for one will not be able to spend the rest of my life in tiny ole Bermuda. I need to travel and this will be why I end up getting the jab.
Go get it now.
Why have you been waiting to get the vaccine?
There are countries around the world who are downgrading the severity of covid…no more masks, no mandatory testing, no vaccines, no social distancing, etc. They are classifying it as a mild version of the flu. What research are those countries reading that other countries seem to be ignoring?
Name one.
Just to name one Singapore. I admit they do a pack over there but I named one.
LOL
Singapore has tried to pivot away from its initial “closed border” stance which has, not surprisingly, resulted in an increase in cases.
So, no, not downplaying it all, just doing what everyone is, cautiously trying to “re-open” without overwhelming the health system.
Try again.
DENMARK
Denmark
A very quick and cursory internet search, looking at a variety of sources, shows Denmark isn’t treating COVID any different from many other countries.
In fact, your statement contains flat out lies unless, of course, you’re misinformed.
Try again.
NMS, You are way out of date on Denmark. – As of Aug 23rd: face coverings mandated in all public spaces, workplace closings required for some, school closures recommended, public gatherings cancelled and more.
Source:https://ourworldindata.org/covid-face-coverings
Like everywhere else, except some ‘rogue’ US States, mitigation measures are generally ramped up if cases rise. Why? Because they are proving to work. Not 100% individually, as its a combination of safety precautions, or mitigations that reduce public health risks overall.
@Truth – You lie. That is categorically 100% untrue. NO country is downplaying the severity of this virus. You’re just saying stuff off the top of your head just to argue. COVID is NOT a mild version of the flu. If that was the case, people would not be getting in line to get tested at Bulls Head.
Bernews, I think a disclaimer on COVID facts needs to apply to some people’s posts on here.
Now you want to censor stuff you don’t like or do not know if it is true or not!!! Bernews and the media are here reporting the news not being arbiters of the truth. Last I checked they are not doctors and would most likely need help to sort out the science. Something the scientist can’t seem to do it either as things change(get it things change as the science changes AKA we don’t know either yet). Stupidest thing written on here yet.
Just for reference he was not wrong just a news cycle time lag maybe.
https://www.news.com.au/national/singapore-shifting-covid19-to-seasonal-flu/video/49d9a15a3ad6a302a3a90c9d77e34653
However since the announcement they have reinstituted restrictions as cases blew up out of no where. I am for full disclosure after all.
@LOL well I’m not calling you a liar but if you side with one….
Don’t you side with Fuaci?
LOL guess your in the same boat!!!
Yet you side with Fuaci a proven liar ….
Bet you wear two masks LOL
Time lag is correct, your posted reference is from July 1st.
At that time Singapore had a high level of vaccination (60% of entire popln. in your ref. above) and was restricting flights from affected countries, together with restricting numbers at public events and having them only attended by vaccinated persons. i.e. more stringent than our Safe key, and that was before their more recent rise in cases and fallback to earlier levels of increased mitigations.
It was an interesting article BTW.
Denmark
Truth might have a point. I have not looked to see how Angola or Ethiopia or Eritrea or Burundi or South Sudan or the Central African Republic have portrayed the COVID-19 virus.
And before anyone breaks out the racist accusations, I named countries that are currently in civil war and have greater problems. I intentionally did not name Nigeria or Zimbabwe or Zaire or other African countries not in civil war. You can check the BBC website to see how those other countries are portraying the COVID-19 pandemic.
Science follows the virus as new research, discoveries and data reveal more detail and help us try to keep up as the virus evolves with new variants and so on.
In that, it is not a fixed group of facts, but an evolving series of facts at different points in time and with different variables, so yes, health advice will change according to conditions in that location at a certain time. This is how science works. So when we learn more or something different, we have to change or amend our approach.
You or others may have heard the new buzz word/cliche’- ‘pivot’ to describe these changes in policy.
Just that yesterdays “conspiracy” seems to be reality. Lab Leak anyone. Think about the nonstop censorship on this one point. Censorship by private entities working the Government, see Jenn Pskai briefing. This is what stopped people from obtaining crucial information that could have saved many in the beginning of this. Then the cover up came hence the hesitancy. Has nothing to do with the vaccine itself. Has to do to the lack of transparency.
LOL All you point out is that science gets it wrong sometimes. We know that to be true.
“In that, it is not a fixed group of facts, but an evolving series of facts at different points in time and with different variables, so yes, health advice will change according to conditions in that location at a certain time. This is how science works. So when we learn more or something different, we have to change or amend our approach.”