Pfizer's Covid-19 vaccine receives key FDA panel recommendation
Category: News & Politics
Via: perrie-halpern • 4 years ago • 66 commentsBy: Erika Edwards (NBC News)
S E E D E D C O N T E N T
Dec. 10, 2020, 10:41 PM UTC / Updated Dec. 10, 2020, 11:59 PM UTC By Erika Edwards
An independent panel of experts has overwhelmingly voted to recommend that the Food and Drug Administration authorize Pfizer's Covid-19 vaccine for emergency use in people ages 16 and older.
The vote Thursday afternoon was 17 in favor of the authorization and four against, with one person abstaining.
The members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, were not given an opportunity to explain their votes against recommending authorization. However, there was much discussion before the final vote to recommend authorizing the shots for teenagers 16 and 17 years old. Some experts worried there was not enough data to make an informed decision about the vaccine in adolescents.
One of the members who voted no, Dr. David Kim, director of the vaccines division of the Office of Infectious Disease and HIV/AIDS Policy in the Department of Health and Human Services, told CNBC in an email that he would have voted yes "most enthusiastically" had the vote been limited to recommending authorization to those ages 18 and older.
Although the FDA is not obligated to go along with the panel's recommendation, it is widely expected to authorize the vaccine for emergency use promptly.
"Our plan is to take their recommendations into account for our decision-making and make a decision shortly thereafter," the FDA's commissioner, Dr. Stephen Hahn, said Thursday on NBC's "TODAY" show. "It really depends upon the complexity of the issues discussed, but we intend to act quickly."
Covid-19 vaccine rollout expected to start 24 hours after approval
The United States would be the fourth country to move forward with Pfizer's vaccine. Canada approved the vaccine Wednesday, and the United Kingdom began administering the shots this week. Bahrain has also granted access to the vaccine.
Data so far indicate that the vaccine is safe and 95 percent effective across a variety of age and racial groups and ethnicities when given in two doses, about three weeks apart.
Outside experts have been unusually effusive with praise for Pfizer's vaccine work.
"The trial results are impressive enough to hold up in any conceivable analysis," Dr. Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health, wrote in an editorial published Thursday in the New England Journal of Medicine, where he is editor-in-chief.
"Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year," he wrote. "This is a triumph."
While Thursday's vote is seen as a positive step toward combating the pandemic, it comes as the number of people who dying of Covid-19 is increasing alarmingly. On Wednesday, the number reached a new high, surpassing 3,000 deaths in a single day, according to an NBC News tally.
The shots are known to come with some side effects, including fever, fatigue, headache and muscle and joint pain. Two people in the U.K. were reported to have had severe allergic reactions after getting the shot.
Dr. Paul Offit, a VRBPAC member and vaccine researcher at the Children's Hospital of Philadelphia, urged continued studies to learn more about the potential for allergic reactions to the vaccine and to reassure those who have severe allergies in general.
The matter needs "careful observation to prove that this is not going to be a problem," Offit said. "You've got tens of millions of people who are not going to get this vaccine because of the comments that were made" by health officials in the U.K.
"We need to offer people some solace," he said. "This issue is not going to die until we have better data."
Such reactions are partly why clinical trials of Pfizer's vaccine will continue. Its safety and effectiveness will also continue to be scrutinized, even after shots start going into arms.
During Thursday's meeting, Dr. Nancy Messonnier, director for the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention and head of the agency's work on Covid-19 vaccines, outlined the various tracking platforms and databases that will watch for any potential adverse events or problems that could be related to the vaccine.
"On day one of the Covid-19 vaccine program, systems will be in place to monitor the safety of vaccine recipients," she said. The systems will include tried-and-true monitoring databases, such as the Vaccine Adverse Event Reporting System, as well as a new CDC database called V-SAFE, which uses text messaging and online surveys to check in with people who have been vaccinated to identify potential safety issues.
Another consideration is one of ethics: Should those who participated in clinical trials but received the placebo be offered the real vaccine?
Pfizer has said those participants should be offered the vaccine, but many purists of the scientific process urge the trials to continue as is to collect as much safety and efficacy data as possible.
What's more, experts say, additional information about the vaccine's effects on pregnant women, young children and those who are severely immunocompromised will be needed.
The advisory panel is scheduled to meet again virtually Dec. 17 to consider a similar vaccine, made by Moderna. In November, the company released preliminary results from its Phase 3 trial, which showed that the vaccine is nearly 95 percent at preventing symptomatic illness.
More details from Moderna are expected to be released publicly before next week's meeting.
Elsewhere in the pipeline, vaccine candidates from AstraZeneca and Johnson & Johnson are continuing with Phase 3 trials, with results likely after the New Year.
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Kudos to all involved in the swift development of these safe and efficacious vaccines and other meds, that was achieved under the inspired leadership of the Trump administration, with Pence coordinating the work of the White House Task Force.
A swift development and a very slow approval - as in still not fully approved
Yeah... In the leadup to yesterday's committee meeting, MSM made it look like this was the approval everybody was waiting for and the vaccine could start to ship after approval. Then after the committee meeting they start to talk about how this was only an advisory committee and the FDA still has to take a couple of days to review and approve. Why were they (the FDA) right in the mix all along so that their approval could follow right away? Why do they have to take a couple more days to review when they should have been doing this work all along? It's not like they require the approval from the advisory committee, that was made quite clear that the FDA does not need to take the recommendations out of the committee. So if it's not needed why bother except for bureaucracy?
The answer to every question is POLITICS.
Politicians were telling people not to trust this vaccine months ago. Now they have to get people to trust it. Many here predicted it.
I yelled at the radio this morning "hurry the hell up, FDA!"
They need to lead, follow, or get the hell out of the way
I don't know what they're waiting for. As far as I'm concerned if the UK and Canada are on board I'm good to go. I trust them more than I trust the FDA.
Same here. I'm ready to roll up my sleeve
As I said a few days back, perhaps they are using the UK, Canada not so much yet, as an extension of their research.......as it turns out the UK did help determine, much by accident, that some people with certain allergies may have a reaction. I, like you, have my sleeve half way up already.
Pfizer was not part of "operation warp speed", so what exactly are you congratulating the Trump administration for?
Facts First : Pfizer's vaccine progress is certainly not solely attributable to the Trump administration's Operation Warp Speed public-private partnership program. But it was not accurate for Pfizer to suggest that it is operating entirely apart from Operation Warp Speed; the company has a major agreement to sell at least 100 million doses of its vaccine to the federal government, and Pfizer acknowledged in a Monday statement to CNN that it is in fact "participating" in Operation Warp Speed through this deal. Also, at least some independent experts say the Trump administration deserves partial credit for Pfizer's progress.
I dont think many people who are not in the Trump cult care who gets the "credit". Trump advocated for a vaccine from the beginning, not necessarily out of concern for the people, but out of concern for his re-election campaign. He would tout anything that helped the stock market stay strong.
But in fairness to him, he did say there would be a vaccine by the end of the year, and that has come true.
I dont care if Trump tries to take credit for the vaccine, he's also going to be blamed for playing the virus down for almost a year.
Then you better take another look at Post 1.2
So, you're implying that they are part of "operation warp speed" simply because they agreed to sell the wealthiest nation in the world some of their product?
Oh, and BTW, YOU are quoting CNN????????? LOL
Trump has been saying that the vaccine is "weeks away" for 10 months. Even a broken clock is eventually going to be right.
Actually I said more than that - they took money from the operation as well.
Oh, and BTW, YOU are quoting CNN?
That's right - Even CNN admitted it!
Didnt he also say Covid would be gone by summer?
And that we should keep schools open.
Even the disgraced NY Times had to agree - he got it right!
Ten months...........approximately 43 weeks. Weeks nonetheless. And therefore, CORRECT. He isn't as stupid as your imagination wants him to be.........or he would have put a number to it. He was trying to instill hope. Your disdain for the man is palpable..........and evidently blinding. Just HAVE to dig for the negative. I feel a little sorry for those with like minds.
Meanwhile, Covid cases continued thru the summer and school had to close again. Is that your idea of getting it right? Looks all wrong to me.
Who closed the schools? Mayors? Governors? The partisan, self serving Teachers Unions?
You are being too kind. My role here is to present the obvious.
Miraculously by Easter, I believe.
So. in your mind , if he'd said the vaccine was minutes away, HE'D STILL BE CORRECT??????
Ten months............approximately 438,000 minutes..
Germany funded the development of Pfizer’s COVID vaccine—not U.S.’s Operation Warp Speed
In July, Pfizer got a $1.95 billion deal with the government’s Operation Warp Speed, the multiagency effort to rush a vaccine to market, to deliver 100 million doses of the vaccine. The arrangement is an advance-purchase agreement, meaning that the company won’t get paid until they deliver the vaccines. Pfizer did not accept federal funding to help develop or manufacture the vaccine, unlike front-runners Moderna and AstraZeneca.
Translation: We paid in advance for the product (vaccine), but did not pay for any development through Operation Warp Drive.
"Facts First"
No such thing(s) as facts coming from the tRump administration or his supporters.
Yup, dumbturd trumpturd said Co-Vid would magically disappear by April.
Don't fucking pretend you know what's in my mind. Your nit picking and digging to argue for argument's sake is crap. Not unexpected but crap just the same. That aside, he wasn't wrong. And your minutes bullshit is just that. Nit picking just to argue bullshit. Bottom line, we should all be happy the vaccine is going into wide distribution.....no matter who said what when.
Your META is so noted
Jim, seriously. If I told you that the midterm elections are weeks away, would you not think I was mistaken? (They are, after all, ~100 weeks away so clearly I am technically correct.) When a duration is two months or more, we use the unit months. When two years or more we use years.
The phrase 'weeks away' informally connotes a duration less than two months.
YOUR interpretation is noted....................and why in the holy hell would ANYONE say the primaries are weeks away knowing full well that is not for almost two years? (and no I wouldn't think you were mistaken. that would be your thoughts on how to convey) The vaccine arrived as predicted, prior to year end. Perhaps he should have said months. "‘What difference, at this point, does it make?" None to those with an open mind and damned happy it's here. Why argue semantics?
As an aside, are you going to get the vaccine when available to you?
Well, that is my point. Using weeks when we are talking months is not colloquial English. So when Trump speaks of a vaccine being "weeks away" that will normally be understood as 'between 2 and 8 weeks'.
The point, I suspect, is that this is yet another example of Trump misrepresenting the truth (or, possibly, just talking out of his ass). Either way, this is not what a PotUS should do. Obama failed when he claimed that people could keep their doctors; you no doubt saw that as either a lie or a mistake from ignorance. Why do you not recognize this claim by Trump similarly?
Yes. Unless we see indications that would dissuade me from doing so.
Maybe in your circles. But in mine, it's more of a wait and see. Reality
Frankly didn't really care...........considering he was building a legacy and it was no skin off my nose either way.
Because I, again, consider the source and the desire for optimism and not panic. And again, I am of the belief that sooner or later, the majority of citizens in the US will more than likely contract the disease at some time or another. I had resigned myself to that fact months ago and abra cadabra, my wife and I both got it.........even following the guidelines to the best or our ability. Her father was soon to die and she got it in the process of flying up to see him in his last days. She lost taste and smell only (besides a little fatigue but i think a lot of that may have been mental due to the situation unfolding). I, otoh, was asymptomatic. 20 YO son never got it. Was tested twice.
So in your circle, if I said that we will reach herd immunity in a matter of weeks, you would consider me correct even if herd immunity does not occur until June, 2021?
A lie by the PotUS should bother you no matter who it is.
People smart enough and caring enough to take steps to contain viral spread.
Is that supposed to be some kind of rationalization? Covid cases and deaths are still occurring on a daily basis.
As previously stated, if you said that and were in a position of authority, would mean I would adopt a wait and see attitude. Believe none of what you hear and less than half or what you see.
Not where this is concerned. Every theory, no matter who, is just a theory and I don't need anyone telling me what I am to take as gospel and believe their prediction(s). Hell we couldn't even listen to Dr. Fauci. Early on he, to a much lesser degree, downplayed it slightly and then changed as things unfolded. We didn't know. And he nor his colleagues knew for certain either. They were theorizing what may happen using their "expertise". SWAG method because nothing was certain and we were, and are now, not privy to what and when the Chinese knew anything for sure.
Which is what?
When you go to the store to buy a loaf of bread, do you claim that you have funded the growing of that particular loaf of bread?
So you have gone in circles and are back to:
If he'd said the vaccine was minutes away, in your mind, HE'D STILL BE CORRECT??????
Ten months............approximately 438,000 minutes..
It's really sad that you are still in denial. Post 1.2.1 There it is!
Ya, FACTS!
Trump did it! He got us a vaccine within a year!
Well, we're only a few weeks past that, you know /s
Nope, no facts.
No, actual scientists and pharmaceutical companies did that. They deserve the credit.
Post 1.2.1
Read
They naturally get their share of the credit, but it was Donald J Trump that got us a vaccine in world record time.
And that is why the ever confused Joe Biden won't have to preside over about 1 Million covid deaths.
Still no facts found.
Hard to see when that blind eye is turned to them!
EPIC FAIL................................AGAIN
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Then in post 1.2.26 he reversed his earlier statement.
There it is!!
1 - How can it be world record time? UK got it first.
2 - Exactly how did Trump create or get us the vaccine personally? Pfizer was not part of Operation Warp Speed.
No they didn't. The US purchased a product, they did not fund any of the research.
And yet you are claiming the US funded a product by simply buying it.
As previously explained, you would then hold an atypical meaning for the phrase 'within weeks'.
Why? A lie by a PotUS regarding healthcare coverage or availability of a vaccine is an important thing, right?
Not sure what this ⇡ is supposed to mean.
It amazes me that several people keep returning to Fauci's comment on masks and do not give the man credit for the 10 months afterwards and the years prior. It is as if some just want to discredit the man and keep hammering endlessly on one point.
Nothing in the real world is ever certain. And for a unique pandemic, your bar is ridiculously too high. To not realize that the entire planet was learning about COVID-19 in real time and thus would have sketchy early information if just plain naive. By now, everyone should be well aware of what happened and thus should be able to understand why reports have varied over time.
What is with this continued movement to try to discredit science and the spokespersons of same?
No, they deserve ALL of the credit. And rightfully so!
It shall be remembered as the "Trump vaccine."
That is the perfunctory action. What happens during a president's term of office is typically attached to same — good and bad.
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If I understand what you are saying, you do not consider 300K deaths to have gone wrong?
Well Good for US
Found this quite interesting...............
Guess they didn't take enough precautions and NOW look where we are.