Attributing the approval of a vaccine to Brexit is the most ludicrous claim about Brexit I've ever heard.
- This vaccine was developed by a German company, whose top scientists are Germans of Turkish origin. Pfizer's role is to produce and distribute the vaccine.
- The vaccine is funded by billions of EU public money.
- The vaccine is produced in a plant in Belgium.
- The piece of legislation involved in this emergency approval stems directly form EU law.
If anything, Brexit could make it harder on 1st of January to export this vaccine from Belgium to the UK.
So this is just Boris looking for some distraction from his own shambolic handling of the pandemic and Brexit.
In fact, this show how untrustworthy the UK and its government are. They will do anything to cheat themselves in front of the queue of hard working people. How is the EU, or any other country going to feel confident that the UK will respect the terms of any trade deal they could sign?
3
Trump was one of the most strident anti vaxxers, spreading unfounded conspiracy theories against long established vaccine at cost of children's lives. Now he's trying to take credit for vaccines that are not yet established-- and developed by the scientists he has slandered for years, convincing Americans to ignore their advice. Biden will have a doubly hard task to distribute corona vaccines and convince enough science doubting people to accept them.
1
Trump was one of the most strident anti vaxxers, spreading unfounded conspiracy theories against long established vaccine at cost of children's lives. Now he's trying to take credit for vaccines that are not yet established-- and developed by the scientists he has slandered for years, convincing Americans to ignore their advice. Biden will have a doubly hard task to distribute corona vaccines and convince enough science doubting people to accept them.
Excuse me for being skeptical and I am not an anti vaxer but are Politicians have bungled this from the start and the inconsistency does not instill confidence. Sorry but am I going to believe a process for approval that normally takes years has been reduced to months I’ll wear a mask, keep my distance, and hope I stay healthy. Too many unknowns and too many opportunistic politicians having made a mess of this from day one. If the last four years have taught us anything, it’s that American exceptionalism is a myth Stay safe
14
@Patrick Well said. I'm going to stay safe at home until I see how these new, untried vaccines play out with everyone else who is clamoring to get it.
2
I'm not a anti-vaxxer in any sense of the word. Vaccines have saved humanity several times over and I can't wait to be vaccinated against Covid-19.
That said; when the European Medicines Agency assembles a team of 27 experts (one from each member state) to comb through "tens of thousands" of pages of research papers in order to determine whether the Pfizer vaccine is safe - a process that is not expected to be finished until near the end of the month - one does wonder which corners the British are cutting here...
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"the European Medicines Agency assembles a team of 27 experts (one from each member state)"
You have yourself explained why the process is slower, remembering that most of the agency staff were formerly British before the Euro agency relocated.
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@G Rayns The various teams working on both rolling assessments and final assessments were already appointed months ago, though. That's not what's slowing the process down.
5
@G Rayns What do you mean? The UK, being one member state, contributed one expert to the team of 27.
6
If there is any fault to be given to the US, it is Trump's failure to manage and to guide the US properly, as he should have, but refused, and did not do so.
That is what happens when a world leader intentionally fails to perform, and does not care for anyone in our country other than himself, his personal interests, and those of his wealthy friends that have donated and paid him off!
Again, it was our mistake, by affording him four years of his own lies and personal greed.
73
Three cheers for the scientists. Pharma companies are so often criticized and we forget that it’s their scientists who develop life saving medicines like the vaccines. Thank goodness for them.
1
As I read this article, my mind flashed back to the summer of 1960 when I was pregnant and visiting England. Thousands of women there were taking a medication which reduced nausea but somehow I never felt quite sick enough to take it. A few months later, thousands of babies were born all over Europe with missing arms and legs. Those tragedies did not happen in the US because the relevant authorities were more cautious and did not license thalidomide, in spite of pressure from pharmaceutical companies. Maybe we can wait for a few weeks and carefully examine possible side effects in other countries before beginning mass vaccination here.
1
just one question I haven't found any answer to in any media : what are the possible side effects of the various vaccines that will be available worldwide as of January, 2021 ?
Healthcare colleagues vaccinating their fellow workers - it makes me cry, with joy and relief.
Oh, please let this be the beginning of the end!
1
It is not a cure. It is a treatment to help the immune system fight the virus if you get it. It will still be here to infect everyone and still be transmissible. The virus may weaken summer 2021 return stronger Fall 2021 and perhaps die down finally by the end of 2022. Get the vaccine. Still wear a mask. Socially distance. Do not cross borders. If you do quarantine. Stay vigilant. The Is government should support people to hang on.
FYI, somebody's making billions on this. It's not conspiracy theory: vaccine development takes years, now they've done it in months. Hmm. There's no time to test long-term safety. These are the first mRNA and DNA vaccines. There just happens to be a couple billion guinea pigs waiting to be the first to try it. Here goes humanity again...
BioNtech vaccine, at 95%, is an easy call for UK regulator. The real test will be Oxford Astra-Zeneca, at 62-90%, where the most promising half+one dosage has not even been trialed on over-55s.
UK regulator seems set to approve Oxford/AZN - a highly dubious call if done for all age groups.
1
While I'm sure the UK regulatory authority (MHRA) have done their job thoroughly, the fact is that these first three vaccines - Pfizer, Moderna and AstraZeneca - have tested each vaccine on tens of thousands of people under the glare of unprecedented media interest. If there were any significant issues we'd already know.
For the vulnerable, the front line and particularly the very elderly it's already clear that the risks of Covid outweigh those of the vaccine. While vaccines are often presented as 100% safe that's something we can't truly know for months or years after it is being widely used. What we can and do know already is that it's safe enough to be worth taking in this case now.
2
It is darkest before dawn. While the vaccine rollouts - the logistics of a rollout is as important as the initial date of approval - are immanent, there is still a length period of time, perhaps at least 6 months, before the world's population could achieve some sort of a herd immunity. Letting the guard down now is a huge mistake. Good hygiene practices remain a must and vigilant surveillance of vital importance to minimize wintry contagion.
Additionally, eventual mass vaccination doesn't mean the world should stop supporting the advent of therapeutic research and production. mAbs, remdesivir and dexamethasone are the standard of care now, depending on what COVID phase people are in. Unless everyone has comfortable access to them like Trump and other politicians and big wigs, we are still in a hand-to-hand combat mode with the cunning SARSCoV2 coronavirus. Even if the virus doesn't start its mutating adaptation to the human defenses
I will get this vaccine because it's a vaccine and not a chemical component that is meant to be in the body forever. It self destroys after 72 hours. Vaccines are life savers and enough of this fear mongering.
I just hope the government doesn't mess this up, bit the army is being brought in to help. I wish them all the best.
1
I love my country, but do NOT trust my government. I will NOT be getting one of these shots.
@Ollie Octopus It's noting to do with the government; also don't forget that this vaccine was developed in Germany by two Turkish scientists.
1
it floors me how people on the comments section here after a quick skim are skeptical of the vaccine. people must stop reading fear mongering anti vaxing mommy blogs
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I find it strange that I keep reading here about the "Pfizer Coronavirus Vaccine". I count 18 times "Pfizer", three times "BioNTech" and once "Pfizer-BioNTech".
"BioNTech made a prophetic bet on the technology and joined forces with Pfizer, one of the world’s largest drug companies; they ended up delivering stunning results, on a timeline that was unheard-of before this year."
Since it seems to be obvious that Pfizer gave the money and infrastructure, but BioNtech provided the brains, I find it quite ignorant to call one of the first hopefull solutions to this global misery almost continuous "the Pfizer Coronavirus Vaccine".
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Much of Europe has today criticized the rather “lax approach” (not my phrase) of the British regulatory system for this approval.
Also, as NIH director Francis Collins said today, the FDA approach is the “gold standard” for the world on regulatory oversight of drugs and vaccines. This is needed to convince people that the vaccines which are approved ARE actually safe and effective.
I would say given all the preliminary reports it appears the both the Pfizer-BioNTech and Moderna vaccines are safe, but there are independent and highly qualified scientists tasked with this review. No one’s comment here is going to change that.
The British company GSK’s Pandemrix H1N1 vaccine in 2009 was shown to be associated with narcolepsy in about 1:18,000 people. This is a serious and lifelong disability. That was missed until cases started turning up in Finland and Sweden.
As a scientist, I’m with Francis Collins and Tony Fauci on this.
Remember Thermidolide? The UK approved it, the US did not. How did that turn out?
1
"Rather than accepting the findings of vaccine makers, American regulators validate the results themselves."
And this is how you reach objective conclusions! Scientific Method, people! Peer review. Objectivity!
Remember Russia saying they had a vaccine months ago? ORLY? No they didn't! They lied, cheated, doctored results and did anything they could to go to the front of the pack - all for naught!
Rushing the Polio vaccine killed people. Let's not repeat history's mistakes, ok?
3
It's kind of funny (or ridiculous) that at the 'NYT' it's always the Pfizer vaccine. I read the 'Spiegel' from Germany than it's called the BioNTech & Pfizer vaccine and at 'The Guardian' from England it's called the Pfizer/BioNTech vaccine.
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I trust the FDA and Dr. Fauci. However, it is good to see Trump isn't the first leader to roll out the Vaccine. Once a loser always a loser.
2
It is true that the license is with the vaccine developer, not Pfizer. Pfizer's partner is the developer. However, without Pfizer and its logistical capabilities worldwide the huge challenges of the tests would not have been able to cope with the speed of market readiness for the relatively small Biontech. Therefore, the recognition of both companies for the outstanding great performance.
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Too late for my aunties (80’s) , my mother in law (87), my brother (68) my friend Giu (50) & Nigel (58).
My kids stayed away from elderly grandparents and one granny died in the interim . The other prob will die from loneliness and a broken heart .
Meantime businesses have disappeared along with jobs . We need to get back out there and shore up the economy
& life . We need the vaccine to help NHS . It’s a colossal job no idea if we can . Well done UK & Pzifer .
5
God bless the good old NHS. We have been planning this for months. We have a network of sites and vaccinators literally ready to go. A joined up national health service free at the point of use and funded through central taxation . Now there’s something our American friends could learn from . Socialised medicine is a dignity that all humans deserve . Couldn’t be prouder today . I had a wee tear in my eye as I drove to work this morning and it was announced on the 8am BBC news broadcast .
13
It seems like your approval process isn't as thorough? But okay...
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@Martainn You seem to have overlooked the huge involvement of the private sector in the development of the vaccine.As to the NHS, although akin to a British national religion with politicians on all sides fearful to criticise, it is in fact underperforming compared to its European counterparts including the German system with its many links to the private sector/insurance companies.
1
d
Look at it this way. The Pfizer vaccine is ready to go, and is sitting in freezers instead of being injected into more arms. (Almost 40,000 people have been dosed already in clinical trials, but many more doses are ready.)
The three weeks' delay between the application for approval and the expected date for approval means some lives will be lost. Three weeks in an epidemic is a long time.
The FDA has conducted a rolling review of the Pfizer vaccine for months now. The application was just a formality, and any approval won't stop the review process. It will continue. If any safety issue arises further injections will be stopped.
This whole process has been rushed, and rightly so. Doing a rush job is risky, and is only warranted when people are dying by the thousands every single day. But that's where are.
Bureaucratic delays for no real reason at this point means people will die for nothing. The FDA should approve the vaccine immediately.
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If you will take a couple minutes and read the excellent article next to this onw, you will have some idea at least of what you’re talking about.
This is not “just a formality.” It’s FDA’s best chance to sit down with ALL the data, and look at it from the ground up. And the meeting’s next week, for crying out loud.
As THE ARTICLE WILL TELL YOU, the British reviewers rely on the biopharm companies far more than we do. They have also been increasingly privatized over the last twenty years.
Then there’s Trump, and all the lying, and all the playing around with the science, and all his clowns who go yell at FDA people.
You’re seeing what looks like two reliable vaccines in less than a year, and a third on its way. The FDA review will take what, twenty days?
Anybody with a grain of sense would cheer. Those with an axe stuck someplace about the election simply want to sabotage.
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President Trump did pressure our FDA to expedite the Pfizer vaccine and was chastised for doing so by the press and the Democrats.
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@James
What does the Trump have to do with curbing/pushing back on Corona? The huge spread is heavy on the shoulders of this Donald. Through his criminal behaviour, this has led more and more people into the disease by deliberate deliberate lying and more than 70 million have not understood anything to date, this extraordinary stupidity cannot be surpassed.
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@James Totally agree. I don't understand why people underestimate Trump on this issue.
@Peter Of course Trump has to do with pushing the vaccine.
The U.S. may vet more carefully, but we also have another aspect of this to consider that Brits don't have to think about, and that is how much we ordinary people will be gouged for it.
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@Terrils Just like Covid-19 testing, the federal government will be making sure the vaccine is free of charge to everyone.
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Good luck to Great Britain! God Save the Queen and God Bless the United States of America.
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@Randolph jue
Better you let God out of there, because he forgot to protect yourself from the genius and his disinfectant fantasies.
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This is great news! Can't wait to line up to get my shot. However, the NY Times heading should have also included BioNTech, the German pharma company whose mRNA technology is being used on this vaccine.
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Thank you New York Times for featuring one of our more attractive streets.
5
The U.K followed Science, yes even with their setbacks, including anti-mask protests FAR BETTER than us here in the United States, and why? The United States placed Politics, Ego & Political Parties over Fact, forgetting that we — like our U.K brothers & sisters — were as a Country born out of the Enlightenment, and that without the richness of Science the world we live in today with all the gadgets & conveniences wouldn’t exist. Is the U.K MORE EXCEPTIONAL than the United States of America? In some ways yes, and I say this as someone, who as an American is an Anglophile but also reader & lover of History so I fully understand where we came from. In other ways though the U.K has its own issues but as both countries are Allies, we should LEARN FROM EACH OTHER (capital letters only to emphasize the point), and learning from each other is crucial and in this day and interconnected age absolutely necessary.
Good luck out there.
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So, Pfizer will license the technology to the UK pharma industry and they can produce the vaccines in the UK? I'm sure the EU, particularly Germany, would want to fast track and start producing its own vaccines under license from Pfizer.
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@Phil No, there are no plans to license.
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Whatever the seniors want to do, let them do it at their own risk !
My strong advice to the seniors, please wait for a few months,
Too much politics in the first place,
And too much competition and pressure to roll out this vaccine,
Then, there is the Wall Street...., what do they know about coronavirus and the vaccines ?
Wall Street like to see their graphs going to the heavens.... maybe a bridge for the seniors ?
5
Article cites FDA Regulators “re-analyzing thousands of pages of raw data.” That snails pace will ensure the deaths of thousands of innocent people. If this weren’t a pandemic, then academic exercises in futility at the FDA would be harmless. However, the term “emergency” means that even the FDA must use common sense, and get on with the approval. Why is the FDA meeting not being held until December 10? This week would be fine, there are no holidays.
5
"a requirement that Britain said on Wednesday that it would initially restrict vaccinations to a network of 50 hospitals." Suggestion: drop the superfluous "that it"....
2
If no one "smells a rat" (that is the political, profiteering, fame-glory type) then someone is getting rich, someone is getting duped and no one knows if we are assured of protection.
There seems to be much skepticism in the general populace with some offsetting due to impatience-induced "virus fatigue".
5
You have to correct in this report that the storage is 5 days at refrigerator temperature, according to Dr.Ugur Sahin chief of Biontec company founder . A very crucial point for logistics.
4
It is so very sad that due to politics that delayed the Vaccine in the US many lives will be lost. Who can we blame? Perhaps Joe Biden. Based on comments he makes I have the impression that he would like to take credit for this vaccine just like he blames Trump for every death. Joe sleeps while people die.
5
Splendid!
Now no innocent white mice will be experimented on.
Now we have over dressed, British schoolchildren, with London accents, to experiment on.
1
Are you smoking that Colorado “ Rocky Mountain” buds, because children are not being vaccinated at this stage....
2
It's always some $ shakedown with us Americans. Can't we just get a vaccine approval to save lives? Are we really this much a cheesy business?
3
I'm not surprised that the UK has beat us to the punch. It's my understanding that the UK's approval process runs parallel, i.e. data is studied as it is generated, saving time. Conversely, the FDA (and most bureaucratic agencies in the US) function linearly, which is frustratingly slow. The first step has to be completed 100% before it goes to step 2. Anyone that's dealt with a government agency in the US knows exactly what I mean.
3
We are going to have to have an accessible national database that identifies everyone who has been vaccinated.
People should be allowed to refuse to be in the database, but nobody should be allowed to board a plane or enter a school that is not in the database.
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It is not because the FDA is "too careful" or bureaucratic that we are behind in approval. We don't have the FDA we had 20 years ago before draconian budget cuts have progressively restricted staffing and increasingly forced reliance on outsider consultants. And swelling the ranks of political appointees at the expense of seasoned professionals does not help anything.
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I sure hope that the first wave of people on the vaccination list (front line medical workers and the most at risk of the elderly) are already being contacted to set up their first vaccine appointment. I also hope that the process is already in place to distribute the vaccine to the various medical centers that will vaccinate this first group. I assume we already have a national process for getting this done starting as early as next week; although I’m not holding my breath.
6
Great Britain did the right thing here. While the rest of Europe is waiting for the EU meeting on 29 Dec, then several days after for inputs, people are dying needlessly. In this case, for it to be the right thing, it must be done promptly. If it is not done promptly, regardless of any other quality, it becomes the wrong thing.
Bless the British for not letting rancorous politics, self-sustaining bureaucracy, and Euro-ennui stand in the way of their doing the right thing.
The opposition press in the United States has fostered distrust of everything our government does (oh, don't deny it, you sure do). So there is little doubt that atop the tragedy of Trump's ineptitude will be piled additional avoidable tragedy due to this opposition reflex. I wonder if Governor Cuomo is going to stick by his threat to conduct his own trials after a vaccine is belatedly approved by the FDA.
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@Charles Becker, well said. Your statement, “Belatedly approved by the FDA” is correct. Amazing that the British NHS, famous for bureaucracy, has correctly bypassed bureaucracy, and immediately and correctly approved the Pfizer vaccine, which will save thousands of lives. Meanwhile, in the US, where the vaccine was, in part, developed, the FDA is busy rediscovering the wheel, one week at a time.
7
Sigh.
Please read the accompanying article. For one thing, the NHS isn’t the approving agency.
For another, our FDA goes back to the raw data, crunches its own numbers, and makes its own analysis. The Brits look for anomalies, but bascially take the biopharm company’s word.
And, the English reviewing agency has besn more and more privatized/linked to corporations since 1999.
By the way, the Euro agency is more like ours, and won’t de deciding until the end of this month.
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@Charles Becker
Personally, I'm happier to wait for scientists to do their peer reviews instead of relying on what little data Pfizers have released. Just last Friday, the British Medical Journal published an article about the lack of data received from any of the potential vaccine candidates and yet the regulator pushes ahead with approval.
Putting trust in the British government which has failed time & time again during the pandemic is a recipe for disaster.
I really hope that there are no hiccups and the Pfizer/BioNTech vaccine is a game changer but I also want their product to be thoroughly vetted because lives are at stake!
5
There's a lesson in all of this; we never know which bit of science we'll need next. Only a couple of decades ago, the technology that's now saving the world's human population was a curiosity for manipulating the lives of fruit flies. I hope that future administrations will recognise that lawyers, legislation and even the military don't stop events like this one. Science and scientists should be heeded, funded and nourished. The only thing we know for sure is that the future will need them.
9
I believe that the FDA has made a major misstep with this process. Data should have been analyzed in parallel with a larger team and done with a true sense of urgency. While they seem to be operating quickly by past history, this is not nearly appropriate for the situation of the current day. I hope that they realize that a ten day delay compared to the UK will cost more than 20,000 American lives at our current death rate, and it may be worse than that.
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JohnP
I agree that the system the British use of doing a concurrent evaluation of the pieces of the data were a very plausible solution, but don’t you think that social pressure, especially from people like Cuomo from NY and The VP elect, Harris, butting in to add doubt to the efficacy of the vaccine were perhaps an issue.
1
These vaccines are two-dose vaccines. You get your two shots on Dec. 11, immunity fully kicks by roughly Feb. 1.
1
It feels like there’s some light at the end of a long, dark and deadly year. As a high risk senior, I look forward to being vaccinated and returning to a more normal way of life. I hope the various vaccines used throughout the world will be safe and protect us from this terrible virus.
8
The FDA has been doing a rolling review of the paperwork for this vaccine for months now, just like in the UK. The application was just a formality. The FDA advisory committee meeting is just a formality too.
There is no good reason the application was not approved immediately. It's just politics, resulting in a 3-week delay and the lost lives that will cost.
7
Wasn't this the least-effective vaccine? Is it charity for Pfizer?
1
@Pank No, the least effective was the UK's own Oxford-AstraZeneca vaccine. Pfizer and Moderna have stellar numbers (so far).
5
Britain jumped ahead of America. It would never have happend if Trump was president. Will America still get it's share like we already paid for? There's two types of bad pay. One is when you pay too late and the other's when you pay too early. We were supposed to get it before anybody else.Everybody else was supposed to get what we didn't want or need. Doesn't the rest of the world know by now how important we really are?
1
You might Want To Reread You’re First Sentence Carefully
2
Speed against safety....... And the referee is...greed.
5
How do you come to that conclusion? No one in the Government or regulatory agency stands to gain financially. Someone has to be first and the NHS does have a National database and organisation that will allow efficient distribution. Why can’t people just be happy that scientists all over the world have cooperated to make this breakthrough?
4
The US agencies are funny. It reminds me of the HIV/AIDS epidemic in the 1980's when Americans would fly to the UK to get drug called AZT because the American agencies said they needed more studies for another year and half before you could get it there. One of my friends said you could be on your death bed with doctors telling you there is nothing more they can do, you have 2-3 weeks to live, and the American FDA told him he could not have the AZT on a compassionate use basis because it has not been approved from a safety standpoint yet. He came here and got AZT and lived another 2 years, who knows how long he could have lived if he started sooner. I hope American media keeps Americans informed and you guys have got to lighten up on the political partisanship and start thinking clearly.
14
Nytimes: "Britain beating the United States to authorization — on a vaccine co-developed by the American pharmaceutical giant Pfizer, no less — may intensify pressure on U.S. regulators, who are already under fire from the White House..."
For journalists to pitch the vaccine approval process like a nationalistic race-- and many news organizations are already, just as in this story -- only serves to intensify needless pressure on authorities to get this death-defying decision right. It's bad enough that our democratic elections are presented as Kentucky Derby days. American journalism has done more and harder work to expose the cons in this presidential election than almost any other element of society. Maybe more than any, since U.S. Justice has largely taken a powder under William Barr. Please apply those spectacular journalistic standards to everything else of such import.
8
Good luck to Britain.
8
Can we just day that this is fantastic news. 5 months ago no one thought there would be a vaccine ready this early. Let's just appreciate the extremely hard work done by these companies and all the upcoming ones. Technology today is simply amazing. This is step one on the long road back to normalcy.
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President Trump thought and often said a vaccine would be ready by the end of the year and even by the election but Pfizer’s CEO held back the data until after the election.
Holding back the data was clearly political and a disregard for the lives of the general public.
2
@MDCOOKS8 If Pfizer held back their data a few days to help Trump get the boot, the on balance they will save many lives. Good judgement call, Pfizer!
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@MDCOOKS8 Trump said a lot, very little with basic authority or understanding and most of it false.
Given his irresponsibility from the beginning, he can't really redeem himself now. Too many human beings died virtually at his hands.
2
Yes, this may be a welcome distraction from Brexit for Boris, but it is the MHRA (Britain's medicines regulator) I have confidence in, not the politicians. The MHRA has approved this vaccine and, trusting the science, I will be waiting for my turn in the queue, sleeve rolled up and ready. The stalwart National Health Service, 1.4 million strong, is gearing up for the biggest mass inoculation program in UK history; from setting up large vaccination sites to coordinating GP surgeries and roving teams to visit care homes and the housebound, I am hopeful that we've got this.
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@Sidaleaf why are they calling it "inoculation," when it's a vaccine? Should be "vaccination" then. The two are not the same. Similar, but not the same. When discussing specific medical procedures, accuracy is important.
2
I can sympathize with the view that nursing homes/extended healthcare facilities recieve the first doses, but it seems to me obvious that (especially since these people also care for the hursing home patients, as well) healthcare providers on the front lines fighting the pandemic should get the first vaccinations.
That said, I agree; it's complicated!
2
Health service workers are being given first priority. In fact they will probably get it before care homes because the logistics of keeping this particular vaccine cool enough are more suited to a hospital environment. First shots in hospitals planned for next Monday I believe.
3
The USA somehow dodged thalidomide, mostly. Let's hope there's no serious long term side effect lurking in a vaccine that is set to be administered to millions. It's puzzling that my home country, and others in the West, could be so reluctant to endorse preventative measures like masks, which have nearly no cost and utterly no risk, while pulling out all the stops to roll out new technologies that come with considerable long term unknowns. As yet, I've seen no explanation for the disconnect, but the upshot is that much of the Far East has had the pandemic under control by applying old tech without delay - while vaccines appear to be the only hope for an out of control situation in the West.
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@Michael Cooke Personally, I would take the vaccine as soon as it is available, simply based on my own situation and on weighing known risk and known benefit _at this time_. But there is inevitably a lot on both sides that we don't know and cannot know for some months, possibly years, down the road. This is true for all new drugs and vaccines, especially ones used by an enormous number of people. Our best hope is that politics doesn't corrupt the process so that we'll at least have the best shot at success (pun intended).
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@Michael Cooke The US dodged thalidomide because of the brilliant Frances Oldham Kelsey, who withstood pressure from the manufacturer and refused to approve the drug for use in the United States. She was a dual citizen of Canada and the USA.
20
@Peggy is right. Th U.S. distributor of thalidomide, which was a liquor company, also successfully lobbied a number of politicians and FDA officials and Kelsey almost didn't succeed. Also important that this was before FDA had new drug review in any way resembling what happened later, partly as a result of the thalidomide disaster. So the bullet was not entirely dodged. Docs in the U.S were able to distribute "samples" to patients at will, with little or no regulation or record-keeping. Thousands of such samples were distributed in the U.S. While the resulting disaster was on a smaller scale than in Europe--especially in the UK and Germany--it was not trivial here. Thalidomide led the passage of the Kefauver-Harris amendments which are the foundation of modern FDA drug review. In the 90s, Gingrich and Company--especially with help from big tobacco--tried to undo Kefauver-Harris and return us to the pre-thalidomide FDA. That "deregulatory" impulse has clearly not gone away. It is part of the wider political pandemic in which we are living.
20
1. It’s not the speed of approval that’s critical, it will be the speed and efficiency of the national distribution and mass inoculation efforts that matters. We are almost at the starting line on that, so watch this space.
2. Trump needs to stay out of all of this - everything he touches he undermines and corrupts. Him putting any pressure on the FDA will have the effect of undermining public confidence, already shaky with a large chunk of the population thanks to misinformation, and this will get worse.
Hats off to the scientists in the US, UK, Germany and elsewhere for their amazing, lifesaving, efforts.
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@Vavoter. Odd that so many people are criticizing Donald Trump for pushing vaccines, as he has been doing for months now and which helped us get to this point, while also criticizing him for not doing enough to fight the pandemic.
The vaccines are the only way to end the epidemic. The sooner they are in arms instead of freezers, the better. The FDA's 3-week delay in approval will literally cost lives.
4
‘Medicines and Healthcare Products Regulatory Agency (MHRA) fast-tracked a review of the Pfizer vaccine.’
This is what ‘fast-track’ means: Supposing you have to wait for the results of an exam before you can act. You can:
a) Wait until the whole exam is finished and then start marking.
b) Start marking each question as the examinee finishes it.
What do you think is the faster approach?
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One recalls the Thalidomide approval process to justify extra scrutiny the FDA uses in reviewing raw data independently.
2
It‘s not the Pfizer Coronavirus vaccine. The vaccine has been developed by Biontec since January. Pfizer joined in March.
6
everything is pushed hurriedly! pharm companies are free to push their vaccine without any liability with govt. help. I know it is needed for the well being of the public but is it good for the consumer not making drug companies liable for long term side effects?
2
Let's not forget the political motivation. The European Medicines Agency (EME) is the one that would normally have to approve this. This is one more gesture to sell the new "autonomy" that Brexit brings. But, oh my friend, they are getting what is essentially a German vaccine, that will most likely will be shipped on special refrigerated containers. I hope it does not escape the brexiters radar the irony of what could be happening after Dec when strong customs get reinstated.
3
I live in the U.K. and am adamantly opposed to Brexit. However I don’t see it being sold as benefit of Brexit - which would be stupid anyway as EU rules allow for exceptions in an emergency and, of course, we are subject to EU rules at the moment anyway.
4
@O Paco
The UK has the AstraZeneca vaccine that is waiting for approval. It might not be quite as effective as the pfizer vaccine but it will be approved if it is effective enough. Easier to produce and in larger quantities, no deep freezing required, no special handling or logistics or storage. The EU and the US have orders for this Brexit or not.
4
Hmmm. Will California still do an independent review or will the British approval suffice?
5
Just as well that we see how it goes elsewhere first
Trump voters have been taught to distrust science so won't be eager to be in line to get a vaccine while nobody else trusts s any recommendations coming out of one of Trump's agencies
5
1. Stop yelling at FDA already. Their job is to provide an independent analysis, and that is in fact what they are doing. At warp speed, you should pardon the expression. And if you find this stuff simple to do, that is because you have no idea whatsoever of what’s involved.
2. I hate to break this to folks, but ALL medications require us to balance risk against benefit. There is no way around that. There’s probably a bit more risk involved in these first two vaccines—new tech—but whoop-de-do.
3. FDA and CDC have to think about the whole country, not just what you want or need. They need to figure out how to get as many vaccinated as they can, as fast as possible. Considering all the yacking out there, all the conspiracy theories, all the anti-vaxxing, and Trump’s screaming demonstrations of his utter untrustworthiness on ANYTHING having to do with science, why is it the worst thing in the world that their review takes a big, big twenty days?
10
I have had great confidence in Biontec since I read about it carefully.
The two company founders Dr.Ugur Sahin and his wife are scientists with heart and soul. The company has fewer than 2000 employees but a larger market value than Deutsche Lufthansa. And yet the family does not own a car, both still ride their bicycle from their rental apartment in Mainz to the nearby company.
The boss of the partner company Pfizer, Albert Bourla, says that he has had great trust and friendship with Ugur since the years of cooperation. At Dr.Sahin, science always comes first, then the business contracts.
17
I'm perplexed by Britain's decision to vaccinate nursing home residents first, over the National Health Care Service. If this is a war, medical workers are the foxhole canon fodder.
In this pandemic, no group or entity has shown more heroism - even amid their confessed fears and open tears -- than health care workers all over this globe. They deserve to be Time magazine's "Person off the Year" cessation but I'm betting most on the Nobel Peace Prize.
People in long-term care are suffering and dying in unimaginable numbers but medical workers are healing multiples of the most sick, and as each patient recovers and departs, another comes rushing in on a gurney or relative's shoulder. As each patient dies, their hand-holding and breath-giving has to stand in for their spouses and children.
To me it was a given. If we can bang our pots, we all can stand aside while they get some personal assurance they won't sicken the healthy, nor their own families.
4
@Peggy Rogers From local commentary here in the UK.. on paper there maybe a hierarchy but in reality most of first phase will be in parallel with a few days separating the groups in phase 1 - NHS my get it first because of ease of storage at hospital sites, which care homes do not have
9
@Peggy Rogers. The reason behind vaccinating nursing home residents first is to save lives. In the US the residents of nursing homes are 0.6% of the population but over 40% of the deaths.
One can argue that old and sick people are soon going to die anyway, and there are lots of other things to consider. But that risk of death disparity is a pretty strong reason to go with the older people over the young for the first doses.
3
The logic is that nursing home folks—who by the way, are NOT all elderly—are at the greatest risk of dying, and that it is impossible to keep the virus out of these homes because workers have to go in and out.
7
In the trial, the doses were given three weeks apart, not four, according to Pfizer. It's also said that the vaccine can be kept at between 2-8C in a normal fridge for five days.
4
Pfizer says their vaccine requires storage at -70 degrees Celsius, not 4-8 degrees for any length of time.
2
The Utah Department of Health sends its vaccine rollout plans to CDC this week and House Speaker Brad Wilson is already asking his colleagues for their opinions on who should get it first. Although it appears UDOH, not the legislature, will decide, lawmaker comments the Salt Lake Tribune has shared thus far pit health care workers, teachers and nursing home residents in just the struggle of interests I feared we might see. Legislators’ power to set the budget for UDOH makes them capable of exerting pressure without official authority over distribution.
The CDC’s Advisory Committee on Immunization Practices ethical principles document helped set the stage for what may become a political fracas by including too many groups in its priority list, which covers more than half the US population in a plethora of rationales. This negated the simplicity of definition the committee said it wanted.
3
@Jesse Baker There are no easy answers. While there appear to be differing views on who should get the vaccine first, the main thing is to get started. The initial doses are very limited but the sooner someone is vaccinated the better for everybody. As the number of people with immunity increases, the curve of infections flattens and the epidemic ends.
6
What is taking the US so long, are the fDA and outside experts taking weekends off and Thanksgiving breaks? Lives are at stake, this is ridiculous! We have a meeting on December 10, what is everyone doing until then?
8
@Helen they are reviewing the hundreds (maybe thousands ) of documents of the data . Yes , speed is of the essence , but so is safety.
23
@Diane - I had Helen's same question, the FDA or media should be describing the efforts taking place now. It does seem like nothing is happening. How did the UK pore over the same quantity of material faster than the FDA?
1
@Diane and @G, I agree completely. There is no good reason why the FDA did not approve this vaccine within 24 hours of the application being made.
The FDA has been working with Pfizer for many months now and has had the data all along as it came in. The advisory committee meeting will add nothing of significance and could as easily be done after approval as before.
Approval means little as a practical matter since the initial doses are very limited in number. If any safety questions arise the vaccinations can be stopped.
This is bureaucracy at its worst, and it's refreshing to see that in the UK sense won out over the urge to cover one's bureaucratic backside. Would that Stephen Hahn and his minions had had the same courage.
6
What do they say about a hare and a tortoise.
Let's remember it is this same British givernment that almost approved the Oxford dosage - is it half full or half empty.
Also,spent millions in buying Wuhan tests from China or South Korea on a website.
And let's not also forget that 4 years later - it is this same government that still cannot define Brexit.
So, no problems FDA taking time.
I am 71 and am eagerly waiting for a vaccine
But I have resigned myself to getting vaccinated about April at the earliest.
17
@Neil it’s not the British government who approves the vaccines but our independent drugs regulator. They’ve just given a press conference explaining how they did it so quick. They've been working on it since June, expanding their team and capacity, working alongside the drug companies for months, reviewing evidence as it became available with multiple workstreams going on in parallel. Working nights and weekends. All safety protocols have been followed to the letter. The U.K. drugs regulator is totally independent of government, is respected worldwide and is a leader in Europe. I trust them and hope to have my vaccinations in the next couple of months
23
@Neil I worked for years in the Semiconductor Industry. If designers weren't working weekends where needed to speed the timeline on an urgent chip expletives would be uttered, and career arcs would be altered. Why? Because in the that industry the company that is second is very often dead. When talking about thousands of human lives per day rather than the death of a company, it would be shocking to me if the FDA wasn't working nights and weekends on this. If they aren't, and doing so could speed approval and distribution - I find that tremendously callous.
2
And yet they based their approval on the “analysis” by Pfizer of the incidence of COVID in a fraction of one percent (170) of more than 43,000 test subjects. No honest scientist would ever try to claim definitive results from a fraction of one percent of his sample just because those results are what he wanted.
2
Like Trump, Johnson tends to toxify the ordinary with ulterior political motivations, the wise-heads of SAGE have seemed anything but, and nobody really knows if this authorization is Project Super-Duper-Whoopee-Warp Speed or a responsible regulatory step.
6
It's going to be interesting to see widespread lipid nanoparticle reactogenicity. I wonder how it will play out?
2
@Mary That is an interesting question. The aches and fevers won't do any lasting harm, but in these days of Twitter and Facebook, those who are predisposed by politics to look wary at a vaccine will have another excuse.
I'm more worried about lawsuits about something like Guillain-Barré syndrome. With the 1976 flu shot fiasco plaintiffs' lawyers made a bundle from those lawsuits. Expect even more of a feeding frenzy this time around. And the American taxpayer will be paying for it all.
2
Speaking of the prioritization of who gets the vaccine, and of nursing home residents, *of course* those residents in far-flung rural areas won’t get the Pfizer vaccine, given its requirement for sub-zero temperatures. They will almost certainly have to wait for another vaccine with friendlier storage requirements. (That includes my mom.) It’s hard enough getting adequate testing to these areas.
4
@Joanne - Pfizer designed a cooler that can keep its vaccine packed up to 15 days with ordinary dry ice, long enough to reach anywhere in the US with a mobile vaccination setup. Clinicians will prefer the Astra-Zeneca and Moderna products for large-scale use in rural areas because of easier storage, but the temperature requirement alone won't stop them if Pfizer remains the only option.
4
You fail to understand the logistics of manufacturing enough coolers and dry ice to safely store and transport tens of millions of vaccine doses.
1
@Jesse Baker - True but it appears that we have a shortage of dry ice at this point in time much like a shortage of N95 masks or toilet paper.
3
Pfizer is first to market. It is unlikely to be the best due to the difficulty of distributing it in ultra-cold conditions. It matters little if distribution in the USA starts a week or two later. It matters much more that the FDA maintains its integrity - what’s left of it - from political influence by the Trump administration. But as Fauci has said, it’s important that we have multiple vaccines. Pfizer’s will play a role in settings where it can be safely stored.
The more interesting question to me is how the long term safety and efficacy turn out. I’m not reluctant to take a vaccine, but I’m fully aware that I will essentially be part of a very large next stage trial, along with millions of others. We will be hearing about the duration of immunity in the coming months and years, and maybe about unanticipated and unfortunate adverse effects that will need to be investigated. We should all hope that in the final analysis, the benefits greatly outweigh the deficits. Nothing in life is without risk.
18
The U.K. was one of the first states to heavily invest in Pfizer, Trump did Not. Plus invested very eaily on in 100 million shots of the cheaper ($4) easily transported Oxford/AZ vaccine. Plus 20 million of Moderna as back up. Any excess stuck the UK gov't had committed to distribute to poorer nations. 1st in the queue are NHS workers, care homes....
The U.S. will follow quickly now Biden has the reins...
15
@Bilbo Your comment misleads. Pfizer could have received federal funds for vaccine development, but chose not to. The US did place an order for Pfizer vaccines back in July, which was a big help, and has supported the vaccine throughout.
Operation Warp Speed in the US has several aspects to it, and it has helped get these vaccines to market. Joe Biden couldn't have done it any better, and probably would have done worse.
3
@Bilbo Your comments mislead. The vaccine has been developed by the BioNTech-Pfizer alliance and is the result of BioNTech’s proprietary technology. In the beginning of the Corona-crisis, Germany’s BioNTech received 375mn Euro from the German government in order to support this development. As by public information from Pfizer, Pfizer has chosen not to be part of the US fast-track-program.
Later GB has (pre-) ordered 40 mn doses, like other countries (including EU and Germany) have preordered as well.
As by a recent statement of the German minister for health, the original intention of the current approval phase was to give the European authorities the chance to check and approve this vaccine in a way that all European citizens can receive the vaccine at the same date. GB authorities have chosen to follow a different timeline.
Obviously GB is not the first to invest. It is just the first to approve this vaccine.
4
@John Smithson, you write:
"The US did place an order for Pfizer vaccine
back in July, which was a big help, and has supported the vaccine throughout."
To clarify this statement, the order that the U.S. placed for Pfizer vaccine is payable upon delivery of the vaccine, so no monetary support for vaccine development.
"Operation Warp Speed in the US has several aspects to it, and it has helped get these vaccines to market. Joe Biden couldn't have done it any better, and probably would have done worse."
I don't understand this comment. How exactly has Operation Warp Speed helped get "these vaccines" to market, since, for example, the Pfizer is not expected to be approved until Dec 10 or 11 and none has been shipped to U.S.? And the other (western) vaccine candidates have not yet been approved by any country.
2
Please, F.D.A., absolute integrity. If we’re going to have a vaccine, please only approve what clearly passes your proper standards. Respiratory epidemics with rapid and widespread transmission in our current century, like SARS and MERS, along with a host of Emerging And Re-Emerging respiratory diseases may, along with Covid-19, be signaling us that we’re about to enter “The Time of Pandemics.” Conditions are perfect: extreme population of eight billion drains upon the environments of the Earth; disruptions in the production of food crops caused by Global Warming, caused by Man’s conquest of Nature; pernicious political inability to address the measurable aspects of this pandemic; and a polarized polity that gridlocks almost everything we’ll need, in order to get through this.
So, please show us the kind of integrity and strength of character that stands for the best America ever was, to help us all make a new America the best America there ever was.
10
The UK does not have 'emergency authorization'!
The MHRA has recommended the vaccine for use in the UK -period.
Why is everything always reported in terms of what the US does? There is a large world out there and believe it not, the US is not the centre of the universe.
45
@Sallie very well said!
8
@Sallie We might not ever have been the “center “ but we were certainly leaders in the world . We aren’t anymore thanks to the hapless incompetence of the Trump years .
11
@Sallie Historically, England has considered itself the center of the Universe .
3
The emphasis in this article on rivalry is ridiculous--"The specter of Britain beating the United States to approval..." etc. Why "specter"? Why not "prospect"? Instead let's welcome this huge step toward ending the pandemic, wherever that step is taken.
40
@JMS In the UK our health secretary has credited Brexit (the UK leaving Europe) as a reason behind the quick move to license the vaccine. Its very sad that something so important and developed by experts and not politicians is used by politicians to glorify themselves. Apparently one upmanship and political point scoring now seem to be the currency of the day.
17
@Margaret
My very thoughts indeed.
3
Every vaccine rollout should include accommodation for poorer countries. This is a global pandemic- we need to realize global solutions. Let’s also make sure the prison populations are on the priority list for vaccination where the risk of community spread both in and then out of prison is still among the highest even if seldom mentioned.
6
@Jerr, there are international activities into this direction as well: Most countries back the Covax initiative that was carried forward by the WHO. The EU has invested 400 mn Euro into this initiative, and other countries have invested as well (i.e. Germany 500 mn Euro). In the last G20-Meeting Germany’s chancellor Merkel asked further countries to join, and to support the WHO as well.
The USA and other few are not supporting this WHO-initiative.
9
While good news the British vaccine developed in Oxford might be the better one as it can be stored at normal fridge temparatures and costs a lot less,100 million doses have been ordered and could be in use before xmas either way lets hope they work.
11
Lets hope this works and hope also for the vaccine made in the U.K which costs a lot less and can be stored in normal fridge temps.
8
The chance that the FDA refuses approval is precisely zero. They should just approve it today. Enough already.
8
A Brexit benefit. Britain by going it alone has more vaccines doses on order from 7 companies than what is available for all of Europe. EU solidarity is likely to be frayed as they argue how to allocate their order between the various EU countries.
8
A Brexit deficit: an incompetent right-wing government under an incompetent right-wing leader arguing over how to allocate their order between various British classes.
2
@Ruth Bennett Search for the article „Brexit Britain just approved a European vaccine, German health minister says“ by Reuters and read it. Today, the German minister for health has put your comment about the „Brexit benefit“ into perspective. Among others he mentioned that Biontech is a European development, from the EU. „The fact that this EU product is so good that Britain approved it so quickly shows that in this crisis European and international cooperation are best,” he said.“
3
First to approve is not always the best thing. Remember thalidomide. Francis Kelsey, a medical reviewer for the FDA about 1960, refused to approve the drug in the US, in spite of pressures from the company who developed it. She stood tall and insisted on more evidence. They approved it in the UK, with tragic consequences. I understand the situation is different with Covid, and I understand how people have suffered from this terrible virus. Nevertheless, the thalidmide case does point to the value of using our own experts to determine the efficacy and safety of the vaccines.
45
@AlaskaTom Agree. But the MHRA is very cautious and will not have approved the vaccine unless they were satisfied. Britain got into vaccine research very early and committed resources to many companies. I shall be first in the queue when my age cohort is 'called up' for the vaccine.
24
@AlaskaTom - Cutter Incident. After that, the polio vaccination program was put on hold here in the U.S. for a while.
Then you are volunteering to be a lab rat. Apparently neither you, nor the MHRA appreciate the slimness of the supposed evidence being used to declare efficacy of the three vaccines. All three companies base their wild claims of virtually unheard of levels efficacy on the random occurrence of COVID-19 in a fraction of one percent of their test subjects by the end of phase three trials. The politicized rapid rollout of unproven vaccines is a recipe for disaster.
1
Congratulations to BioNTech and Pfizer on this vaccine. It is really a great day for science and international research cooperation.
That said I am a little bit skeptical how the British agency could make this decision so fast. There might have been some political agenda behind it.
I think the FDA and EMA are doing it the right way. Don't procrastinate, but also don't rush. The EMA already said it might take about two weeks to review everything (currently focusing on Moderna, because they were the first to apply), even with the rolling review already speeding things up a lot. Two weeks of proper procedure are a good price to pay, to increase the chances of catching a major caveats.
Then again, the UK probably also had the rolling review data. And if the numbers hold up to what the press releases promised, chances probably far outweigh risks and this approval is a nobrainer.
4
@Andreas
The UK Approval agency has worked with the various candidates for months, and in some of the research, years. The UK is also one, if not the leading Country, when it comes to Infectious Diseases Research and has contributed significantly to our understanding of CV19, including, unfortunately, the likely fatality rate.. It is very likely the EMA will use UK data in their approval process.
18
@Andreas the answer is simple the UK is Not in the EU! Free of over burdensome bureaucracy for overs paid politicos.... U.K. had a get out clause early on, knowing how bad the EU is. It really is that simple. Plus being one of the first nations to heavily invest in bioNtec/ Pfizer.
Germany could have been first but is stuck in its own created EU export market.....
5
@Andreas Another way to look at the UK "early" approval, is that Fauci, who is defiantly not a fan of Trump or the likely outgoing administration won't likely be able to "engineer" a delay in the U.S. approval until after December 14, when the next president will have been selected.
"
Funny how the NYTimes reporting of China's vaccines emphasizes the words "untested" and "rushed approval" and "possible side-effects", somehow omitting the fact that it has a higher success rate than Pfizer or Moderna and uses a proven method. Yet here we see nothing but hagiography for a US-backed vaccine based on an experimental model that has yet to complete its phase III trials, and whose side effects are entirely unknown.
As if biased language could actually shape reality. It's not hard to see why COVID has decimated the US so.
31
@Mary - I don't believe that China has released efficacy data, but would you trust them and take it even if they did? I'll take the Pfizer or Moderna in a hearbeat because the risks, when compared to Covid-19, appear to be minimal at worst.
5
@Mary I would take a vaccine made in Germany, the UK, or the USA, but never China.
5
@Mary Exactly. I am much more open to the vaccines from China, as they used a method that has been employed for decades. We know much more about the potential risks. We know almost nothing about mRNA vaccines. Eight weeks of testing is not good enough for me.
3
How about some of that Warp Speed, FDA?
1
The FDA’s job is to ensure the safety and efficacy of drugs before they are approved, not to allow companies to use the American public as uncompensated guinea pigs.
34
So now it’s a competition to see who approves the vaccines the fastest? It should be about approving them correctly and properly, not the fastest. The two countries should have even been cooperating on such approval to speed up all these processes, I think. It simply shows the mediocrity of Trump’s go it alone approach. The vaccines have been done fast, but would have probably been even faster had the US had better leadership. Instead you had an incompetent demagogue turning the problem into another opportunity to display his ignorance. He can’t leave fast enough!!
21
A big caveat - US Warp Speed Act to fast track vaccine for covid, has no liabilities attached now and forever more? Buyers' emptor.
7
i am 72 and live in the US. Health care workers first. First responders next. All the rest of us will get it soon enough.
20
@Mabel - I agree. I can continue hiding in my apartment but I can't intubate you or even start an I.V.
I don't even have a driver's license anymore so I can't even drive one to the hospital.
Just drop some groceries and a big bag of weed along with a copy of "The Diary of Ann Frank" at my doorstep and tell me to be patriotic. Oh, and tell Judge Judy she can't retire yet - its her patriotic duty!
1
We in the UK are pretty good at this sort of thing. At 69, I am looking forward to my first jab in the next 3-4 weeks.
28
@Mark hear, hear, I'm 68, it can't can't come fast enough.
7
I took Redux in the mid-90s, FDA apprived for weight loss. Shortly after, reports of serious, fatal side effects occurred. I had to endure a full cardiac evaluation. I dodged the immediate complications, but years later developed a cardiac arrhythmia. Related? Who knows. Im staying socially distanced, masked, and away from gatherings until a conventional vaccine is vetted and available.
14
Let the FDA do its review without outside interference. The difference in time to decide on approval is about 10 days from the UK. The consequences of approval (or disapproval) affect hundreds of millions of people, and should not be further rushed.
67
@Krishna Myneni Look at it this way. The Pfizer vaccine is ready to go, and is sitting in freezers instead of being injected into more arms. (Almost 40,000 people have been dosed already in clinical trials.)
The three weeks' delay between the application for approval and the expected date for approval means some lives will be lost. Three weeks in an epidemic is a long time.
The FDA has conducted a rolling review of the Pfizer vaccine for months now. The application was just a formality, and any approval won't stop the review process. It will continue. If any safety issue arises further injections will be stopped.
This whole process has been rushed, and rightly so. Doing a rush job is risky, and is only warranted when people are dying by the thousands every single day. But that's where are. Bureaucratic delays for no real reason at this point means people will die for nothing. The FDA should approve the vaccine immediately.
2
This is smug Joe in the UK!! In terms of safety, the London Times reports "The vaccine has been tested on 43,500 in six countries, and no safety concerns were raised." So I'll be in line when offered to the over 70s.
21
@Joe No "safety concerns" were raised for thalidomide, either, until babies were born without limbs.
The question is whether a few months is long enough to access the LONG-TERM safety/side-effects of the vaccine. Given that a decade is typically needed to make this assessment, it is possible to be rationally wary of the vaccine.
28
But the thing is, the normal 10 year period of time to research and approve a vaccine is not that long because of the large amount of tests that are done, but more because of the bureaucracy and lack of funding. The COVID-19 pandemic is a huge problem, which is why there is much more funding available and the authorities are focused on the approval of a vaccine.
You can’t compare this process now to the process of making vaccines, that aren’t that urgent.
21
@Lex The company knew about the side effects and didn't disclose the data. There is plenty of evidence pertaining to this.
4
These vaccines are great news of course.
For the safety of the public though, I prefer the American regulatory approval process where a group of independent scientists carefully examine the raw data for the drug or vaccine’s safety and effectiveness. This is akin to peer review for publication and adds another layer of protection so that effectiveness and any risks are well known to the public. In this case, Pfizer says that headache and muscle soreness are the most common side effects for the mRNA vaccine. Very good. But with other drugs side effects could be more severe and the benefit not quite what is claimed.
23
@Michael as someone who knows the system in the UK I know they are very strict on what gets approved. I would have no reservations about taking the vaccine.
45
@ Michael
Several versions of this vaccine (BNT162) have been trialed here (California) and in Germany for months with over 30,000 participants. Some received 1 dose, others: 2; some received a placebo.
The trials also happened in China (in March) with both Fosun and Pfizer using BioNTech’s identical earlier research on mRNA.
Pfizer did not participate in Warp because the paperwork (NIH, CDC) was too onerous. With SARS-CoV-2 following the earlier SARS, Ebola... perhaps there’s a lesson we should learn from the UK about speed in a crisis.
Well done UK!
35
@Sue
Exactly!
Hope.
9
Praying that there are no negative side effects, and I am surprised they are willing to be the guinea pigs for this.
10
instead of praying, which has zero efficacy, we could read the data already collected about side effects and live in an evidence based existence.
37
there were already 46,000 guinea pigs.
11
@Here
Evidence based existence? Take a look around. Why start now? it seems lonely.
Either way, it would be nice if long term negative side-effects do not arise, from what I have seen of the data and in consultation with those educated in field, it appears to not be as thorough of a process as is normal with this sort of thing.
Don't worry, I am not anti-vaccine, I am anti-politicized race to inject millions of people with hastily concocted panacea to cover up widespread political ineptitude and greed.
@G Rayns its only been 10 months since the virus was sequenced.
6
I am 30 years old and recently had a heart episode which landed me in the hospital. Now I'm out and recovering, and am at a enormous risk of complications if I catch this virus. I cannot wait for this vaccine, it truly cannot be approved by the EMA soon enough!
Let's also remember that this was a global effort, not Pfizer or the United States' alone. BioNTech, the German company that developed its technology, deserves the most credit. To state otherwise would be like saying China is responsible for the iPhone simply because it manufactures it en masse.
110
@S Yes, absolutely! And the German couple who developed the vaccine (and owns BioNTech) are children of Turkish immigrants to Germany.
45
@S I do agree with your assessment, but I would not cut Pfizer's contribution short. Yes, BioNTech developed the vaccine, but Pfizer brought the resources for quick large scale clinical trials a small company like BioNTech does not have. It was really a great match.
But of course I also need to acknowledge, that the US federal governments "Operation Warpspeed" and Moderna developed another great result.
I think what we can see is, that a collaborative effort on all fronts is the way to go. We should always remember: the enemy is the virus.
22
@S - Just to add for the sake of a correct attribution: The so-called „Pfizer-vaccine“ has been developed by the BioNTech - Pfizer alliance. BioNtech received a 375mn Euro grant from the German government to support this development. Since it’s formation in 2008, BioNtech received further regular financial support from the Government (ministry of science).
Core part of the so-called „Pfizer-vaccine“ is BioNTech‘s proprietary mRNA technology.
Pfizer and BioNtech are partnering since 2018 in order to develop a flu-vaccine. This particular partnership was extended into the Covid-partnership that now let to the new vaccine. Therefore, the so-called „Pfizer-vaccine“ is clearly the result of an international private and governmental initiative. For more information see public information issued by all of the mentioned parties.
12
Hoping that this is truly the beginning of global recovery! However - as richer nations begin to vaccinate their residents - two questions loom: 1) What, if any, will be the specific plan for poorer countries to have *equal, sustained* access to vaccines?; 2) What will those individuals who had flouted science (no masks, no social distancing) ethically decide, as to their irresponsible "roll of the dice" having actually contributed to infections and death? I'd like to be wrong, yet I remain distressed that the answer for both will be: "This is not important."
16
@Mildred Pierce
To start with ´poor countries’ handled the pandemic better then the developped world. (Much lower mortality)
Some vaccines will be cheap, AZ 2-3 $ an not 20$ range for the others. Some Chinees and maybe Indian or Morocco and Senegal made will be cheap and targeted at these marketd
5
Hopefully this is good news for us, I guess we’ll see how the deployment goes. The fact I’m learning this from the NYT is a bit of a shock to me.
7
@Russ but it’s all over the press here, and was within minutes of the announcement.
19
it has also been widely announced in the UK media.
17
@Russ This news is available in all the main UK media. I live in Portugal and first saw it in The Guardian.....
8
What a great achievement for science!
36
Only time will tell if this vaccine will put this terrible pandemic to an end. I will be watching Britain carefully and meanwhile continue to act responsibly until this pandemic ends in the United States.
28
Apparently our agency was talking to the drugs companies during development so they had oversight from the off.
14
It is inevitable that many on the right will blame FDA for "over-caution" relative to other regulatory agencies. Mark Meadows has already started that drumbeat. This is an old canard among conservatives. The reality is that FDA approves more drugs sooner than any agency in the developed world. There are also converse cases. The diet drug fen-phen was withdrawn in the UK because of its lethality and minimum benefit. Political pressure, however, induced FDA approval _after_ withdrawal in the UK. That decision cost thousand of lives and the end of the drug company Wyeth, one of fen-phen's manufacturers. The lesson is that we should back off, let the FDA do its job, and be grateful that it does.
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I’ll take the FDA over the Johnson regime anyday
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I’d take the Johnson regime any day over the Trump regime. And the FDA hasn’t shown itself to be immune from Trump influence.
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@Henry Greenspan
That the fool in the WH kept saying that the virus would somehow "dissapear, just dissapear, you know. One day. It will be like a miracle"
(Duh?)
Or have people already forgotten?
Certainly did not make things easier for the US and the FDA..
It has proven costly to the US AND the world to give soo much power to such a damaging individual.
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OK, so Baby Trump, aka Boris Johnson, wants to be the "First" western country to use a vaccine. At least, that is what he says today; his wishy-washy, today this, tomorrow that style in the last several months should not give anyone false hope that Britain's scourge (that he fomented) is over. If anything, given his track record, were I to be living in Brexit-land (remember the great promises he had for that?), I would be extremely skeptical.
I read a suggestion somewhere that "the people" should demand that the politicians take the first jabs. If they survive, then "we" can. If not, at least "we" will know that it was not all it was cracked up to be, and perhaps the next lot of politicians will be more careful with the lives of their "subjects".
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A perfect example of sour grapes!
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@Helen
If that is aimed at me, I'm not inclined to drink British wine anyway. Also, as a double, high-risk individual, I am very hard pressed to think of any country in the world I would rather be living in now than Germany. Check out the stats.
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@Helen Why sour grapes? Even though the article says this vaccine was developed by (the US giant) Pfizer with (the much smaller German firm) BioNTech, it *really* was developed i.e., ‘invented’ by the power scientist couple who owns BioNTech in Mainz, Germany! What’s more, the couple are children of... Turkish immigrants to Germany. Thus I hardly think “The Lone Protester” in Frankfurt would be guilty of sour grapes, especially since Mainz is only a short train ride away!
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