The Food and Drug Administration (FDA) will decide on whether to fully approve the use of the Pfizer Covid vaccine in the U.S. for those aged 16 and over no later than January 2022, it has been announced. The vaccine is currently only authorised for emergency use in Americans aged 12 and over and has been given to millions of people across the world. The MailOnline has the story.
According to a press release from the [Pfizer and BioNTech] on Friday, the federal health agency’s goal date for a decision is by January 2022.
If approved, the vaccine will be the first fully approved Covid shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval.
As of Friday, more than 186.5 million shots of the vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention (CDC).
Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.
Additionally, emergency use authorisation requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.
The designation is also intended to be temporary.
If and when the shot is fully approved, companies and schools may feel more comfortable requiring employees and students to get it.
The decision would also allow the vaccine makers to market their shots directly to the general public.
According to the press release, Pfizer and BioNTech completed the rolling submission of data to the FDA in May 2021.
It includes data from the Phase III trial completed last year and six months of follow-up data rather than two months.
Although the shot is currently approved for use in teenagers and adults, the full approval would only be for those aged 16 and older because emergency authorization for Americans aged 12 to 15 only occurred in May.
The companies plan to apply for full approval in teens as well, but only after six months of follow-up data is available, the press release states. …
Moderna Inc has also filed for full approval from FDA for its Covid vaccine, announcing the news on June 1st. …
The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.
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Not worth reading in full.
The Pfizer vaccine is only for natural immunity deniers who have a death wish
Doctors urge teachers to reject Covid vaccination for children
https://www.conservativewoman.co.uk/doctors-urge-teachers-to-reject-covid-vaccination-for-children/
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“emergency use authorisation requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.”
madness!
Evil.
I just don’t understand it. 2 months safety data and then inject the entire world population including children?
has one ever heard of long term risks?
They have other agendas Steve, they laugh at you for suggesting this has anything to do with long term safety
See my post above for the views of Dr Jobst Landgrebe
What’s the point? It’s so far down the road that almost everyone (me excluded) will have had the jab.
And the medical world has brought itself into such disrepute that I wouldn’t believe their findings anyway. If by some miracle they disapprove, it’ll be a case of shutting the barndoor after the horse has bolted.
The point is that with FDA approval they can actually mandate the death shot, they can actually force people to take it, whereas now they’re coercing people but these coercions have no legal force, because it’s an experimental treatment with only emergency use authorisation
Your point is well made. Hopefully by January, we will all have found a way to avoid this. Personally, right now, I’m selling up my house while the market is hot (before the inevitable crash) and will look to move to safest place out of the state’s reach. That’s how seriously I’m taking this.
I’ve been trying to think of somewhere – any tips?
Romania. Not joking
Thanks – I’ll research it.
North Pole
No need for a bedroom, any crypt will offer you a coffin.
If still in the UK, a location as isolated as possible while still in reach of ‘civilisation’ – and off-grid. I’ve been learning horticulture over the last year to try and make up for the likelihood I’ll be denied access to shops to buy food.
This will sound tin-hat stuff to any normie (ordinarily identified as covidians these days), but if we’ve learned one thing over the last 16 months it’s that things have continued to get worse from the beginning and the outlook is far more bleak.
Prepare for the worst, hope for the best.
Thanks – I have been researching islands in the UK and there are some possibilities. Good luck in your quest.
I know a man called John. He has a gulch…
Where might that be? Having early such thoughts myself
They can try, but if they do mandate them, there will be more than vaccine deaths to worry about.
I’m guessing that to actually force people to be injected, they would have to section them first under the mental health act. Good luck there.
I read a paper at the beginning of all this written by three psychologists suggesting that a diagnosis of temporary insanity would do very nicely to allow people to be forcibly injected. I reckon they have it all worked out.
So compulsory “vaccination” from next year then. Will any country escape? and what fate awaits refuseniks?
A more positive thought – if it no longer requires emergency authorisation maybe they can look into permitting the likes of Ivermectin. Unlikely I know but a lot of the pressure against treatments is that they would interfere with the emergency use clause
The medical community has dug itself into a hole so deep now they can feel the heat from hell underneath them, and they will never gain that credibility back. Hard to see how society can move forward at this point without some drastic restructuring.
They are restructuring society. It’s been going on for 16 months now.
There’s no going back to normal I mean, things do have to change in a big way, just pray it doesn’t happen via their great reset agenda.
Dr Peter McCullough’s recent comments on this are interesting – his view is that there will be a deluge of lawsuits against the vaccine manufacturers if the vaccines are formally approved for use in the USA. The current ’emergency’ use authorisation is arguably more advantageous to the manufacturers
Depends on what your aim is. I don’t think they’re worried about lawsuits, the manufacturers are immune from civil suit and the corrupt courts will never allow a suit against the FDA to proceed.
Meanwhile, the US Military has said that as soon as the shots are FDA approved every soldier will be required to take them
The US forces recruit heavily from Dixie, and they are going to find it harder to recruit than before.
Yes – I have been terrified of this for a while now, but after listening to Peter M twice, I feel better about it. I think that the approval will hopefully be the undoing of it. Let’s hope so.
The Oxford trial of Ivermectin is constructed to fail. That should reach its conclusions in a good enough time frame to get this FDA approval of injecting our 16 year olds.
So mandating this for our kids will start in high schools with a vengeance in 2022.
Dark days.
Oh like the rigged vitamin D trials?
On the plus side, does this mean that they can stop pretending ivermectin etc. don’t work?
It should take the pressure off them. But, seeing how safe and effective alternatives are, it would still be a bad selling point.
Do stop this verbatim quotation without caveats of text that is full of dodgy assertions.
It won’t get my approval.
Neither will anyone who knocks on my door with syringe in hand.
Watch and weep!
https://www.bitchute.com/video/b87VjAYDXS0g/
How can Pfizer or any of these drug companies provide full safety and effectiveness data (ignoring the laughable claim that 6 months’ follow-up data is sufficient)? It’s my understanding that the trials were spoiled months ago by being unblinded, and the unvaccinated group being offered the so-called vaccine. So there is no control group, which makes a mockery of the trials. They’re not even trying to hide the motive here, which is to mandate the injections. Nothing to do with safety or effectiveness.
Yes, can confirm the Moderna trial was unmasked within months.
a mandate is not a law , never give in . they are evil. we will win
Yes. And totally inadequate structure of the rollout to the public in that any adverse reactions are by self-reporting (either directly or to a doctor), both situations which suffer from selection bias. All post vaccination adverse events should be reported, so that it is the statisticians, not the injected person or their doctor, who can identify whether or not there is a pattern.
As a result of which the sane, logical position is to reject the results by default.
‘Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.’
What a load of shite. Couldn’t be bothered to read any further let alone ‘in full’.
I didn’t get further than the headline.
6 month data instead of 2, that’s truly comforting.
I suggest you and Tom Chivers sign up as sales reps with Pfizer.
Oh yes. Tom Chivers. I’ve tried to be open-minded but now whenever I see something is written by him, I pass it by. He could do well working for the DT’s Global “Health” Security team.
Interviewer:
“Covid misinformation – what’s your message to platforms like Facebook?
Senile old man usurping the President’s office:
“They’re killing people…..Look, the only pandemic we have is among the unvaccinated. And they’re killing people.”
The most powerful politician in the world – a senile old dodderer repeating dangerous lies, falsely scapegoating dissenters with a blood libel.
This isn’t likely to end well.
https://twitter.com/LozzaFox/status/1416130103122276361
There were some sceptics chortling with delight about the Democrats’ big tech and big media accomplices rigging the election to get rid of Trump. They’re not laughing now, if they’ve got any sense.
It wuill be a big relief to know Pfizer is safe for everybody. Good scientific work.
Hilarious. Are you here all week?
I assume irony.
As reported earlier the UK has decided that the vaxed cannot get their hols in France after all, well not without quarantine. The reason they have stated is that they are worried about the increases in the Beta variant in France and that the vaccines especially the AZ one doesn’t appear to do too well against it. I previously looked into this and realised the UK experts didn’t realise that the French numbers included ‘cases’ from their global empire of small islands, including Reunion a volcanic island in the Indian Ocean. Reunion is significant because 100% of its cases are beta variant. So I found the attached graph which shows cases by variants, I have tried very very hard to see the problem that the UK experts have, without success. Further investigation into French numbers led me to look at a couple of graphs I haven’t bothered to look at recently. Firstly the INSEAD reported all causes deaths compared with previous years. Up to 17 March it was following the pattern of 2019 almost identically. Now INSEAD have stopped reporting it. Fishy I thought, so I referred to EUROMOMO graph for France. And there was the reason. The excess death… Read more »
I am actually bored of data analysis now. They are lying, we know they are lying, they know we know they are lying, and it changes nothing.
So am I. Fucking tired beyond words of this shit show pantomime.
None of these news items seem particularly sceptical do they?
Today’s news items are all just repeating what is in other newspapers without much questioning if any.
How about some actual scepticism? Is there really no news of any pushback anywhere in the world?
Twitter has blocked Alex Berenson – no doubt for saying the “vaccines” don’t work for long.
The extreme censorship has been proof of the Faucist conspiracy all along.
Alex B is on Substack though,
The lies are looking more and more desperate.
And they will approve them. And then enforce them. Marchons, citoyens.
Marchons? Aux armes more like. Their blood’ll certainly be impure if Manual Chevron has his way. As I say, liberty and equality now!
CNN is saying the decision will be in the next two months
https://edition.cnn.com/2021/07/16/health/pfizer-covid-19-vaccine-fda-priority-review/index.html
People like Dr Jobst Landgrebe need to be heard. https://odysee.com/@voicesforfreedom:6/couragous-convos-dr-jobst:b?r=CGu4pMrhgVUyuG84fs2kQLUrkT9ywh3Z
9,000 deaths and counting in USA post vaccines (cdc vaers) and the USA is considering approving Pfizer? A grave concern.
Just must add a further 2000 in yesterdays new figures.Almost 2000 more in one week added(they have an enormous backlog)
Doctors urge teachers to reject Covid vaccination for children
https://www.conservativewoman.co.uk/doctors-urge-teachers-to-reject-covid-vaccination-for-children/
Stand in South Hill Park Bracknell every Sunday from 10am meet fellow anti lockdown freedom lovers, keep yourself sane, make new friends and have a laugh.
Join our Stand in the Park – Bracknell – Telegram Group
http://t.me/astandintheparkbracknell
Home Schooling – Ex-Primary School Teacher on Resistance GB YouTube Channel:
https://www.youtube.com/watch?v=kZ5oS2ejye0
https://www.hopesussex.co.uk/our-mission
So why don’t they even mention the numbers of people that have been killed or maimed by this experimental procedure? Surely that is an important statistic?
Shush! Do you want to be disappeared?
Covid JabID has been dounle vaxxed and has now come down with covid. How could that possibly happen???
Its illegal to keep calling it a vaccine…its a medical treatment.