Pfizer Vaccine News

[MisterPenguin]

Pfizer readies 'Herculean effort' to distribute coronavirus vaccine

“With 1,000 people dying every day in the U.S., there’s no time to lose,” Pfizer's CEO said.

www.nbcnews.com

Why Pfizerâs COVID-19 vaccine will be a nightmare to distribute

Pfizer’s promising new COVID-19 vaccine could become a logistical nightmare to distribute to Americans — all because of the ultra-cold temperatures in which it must be stored, experts s…

nypost.com

 

[MisterPenguin]

Of note in the Coronavirus thread...

Update to the vaccine timeline outline in red. In this update: Pfizer's updated timeline...

Reading about the status of various vaccines have left me confused as to which vaccines are which and where they are in development and who's saying what about how far along they are. So, I made an outline...


Monderna/NIH

Type: mRNA (requires ultra-cold storage, -20C, and 2 doses)​

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Warp Speed: $2.5B, for 100M doses​

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Phase 3: Started Jul 27, 30K people, enrollment completes in September​

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Earliest according to CDC: “Vaccine B” – local health departments, prepare for Oct (just in case, if all goes very well). Late Oct or Nov. 1M doses by Oct, 10M by Nov, 15M by Dec.​

​

Earliest according to manufacturer: by the end of 2020. It's *possible* that interim results in November can lead to Federal emergency use approval in December, otherwise, beginning of 2021.​

Biontech/Pfizer/Fosun

Type: mRNA (requires ultra-cold storage, -70C, and 2 doses)​

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Phase 3: Started Jul 27, 30K people​

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Warp Speed:​

• $1.9B for 100M doses (by Dec?)
• Though Warp Speed will pay for the vaccine and the CDC will guide distribution, Pfizer has not accepted any money in advance and they have set up their own distribution operations

​

Earliest according to CDC:​

• “Vaccine A” – local health departments, prepare for Oct (just in case, if all goes very well).
• Late Oct or Nov.
• 2M doses by end of Oct, 10-20M doses by Nov, 20-30M dosed by Dec.

​

Earliest according to manufacturer: ​

• Regulatory review in Oct. which could theoretically lead to early end of Phase 3.
• Now, not going to happen until Thanksgiving the earliest.
• Likely to get the governmental review before Thanksgiving which will show 90% effectiveness and completely safe (on the populations they tested)

AstraZeneca/Oxford

​

Type: altered chimp adenovirus​

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Warp Speed: $1.2B​

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Phase 3: in progress, recently started, study paused due to unexplained illness. Restarted in Europe, still on hold in the US. Restarted in the U.S. too.​

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Earliest according to CDC: Doses can be delivered by Oct.​

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Earliest according to manufacturer: Doses available by the end of 2020.​

Johnson & Johnson / Beth Israel

Type: altered adenovirus (the one they used for an Ebola vaccine) [1 dose, only refrigeration to store]​

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Warp Speed: $456M (+$1B if proven successful for 100M doses)​

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Phase 3: just started, but will use a much larger test group (60k people), could be done by the end of 2020, enrollment now on a temporary pause due to one subject's unexplained illness. Enrollment restarted (the illness was in the placebo group).​

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Earliest according to CDC: Nothing from CDC yet about this vaccine.​

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Earliest according to manufacturer: Beginning of 2021. Plan to make a billion doses.​

Novavax

Type: sticking proteins on microscopic particles​

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Warp Speed: $1.6B​

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Phase 3: just started, could be done by the beginning of 2021​

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Earliest according to CDC: Nothing from CDC yet about this vaccine.​

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Earliest according to manufacturer: Plan to make 100M doses by 1st Q of 2021.​

Phase 3:

Final phase of trials. A large number of people are given either the vaccine or placebo, double blind​

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Wait to see if there are negative reactions to the vaccine. If there are, vaccine is scrubbed.​

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Wait to see how much more the vaccinated group is protected compared to the placebo. To be effective, people should be at least 50% more protected.​

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If early results show extraordinarily good results, then this Phase can end early, because it would be unethical to leave those who received the placebo to be unprotected by an effective vaccine – this is what leads to an “October vaccine,” which, is only a result of extraordinarily good results.​

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An independent review board evaluates the effectiveness. The FDA will not approve (or, is not supposed to approve) a vaccine without the board's go-ahead.​

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In addition to governmental approval (or "fast-tracking"), the manufacturers themselves can decide not to release the vaccine until what they consider are appropriate evaluations are made. And, in fact, have pledged to "follow the science" and not release the vaccine until large trials and the science show that it is both safe and effective.​

In short, as Dr. Fauci has said, an October vaccine is not impossible, just very unlikely... and unlikely it was.

 

[NelleBelle]

This vaccine being 90% effective is good news. However if enough people don’t get it then it’s not going to matter. For the sake of the economy everyone who is able should consider getting it. If you don’t want to get it then you have no excuse to complain about continued unemployment or businesses closed or masks and distancing. We have a way to get back to normalcy much faster if people follow through, but you can’t just rely on your neighbors to get it. We need as many people as possible to get stuck.

For people worried about safety, wait until the trial results are published and see for yourself. The vast majority of severe adverse reactions to vaccines occur in the first 2-3 months after vaccination. By The time we get a shot at this thing the trial will be much further along. It should be possible to review and see the risks. Don‘t just assume because this was done fast that it’s somehow flawed.

So true! I have family that are nervous to take the vaccine, some being both nurses and high-risk. I have to tell them that the very first time I took my first flue shot almost 15 years ago when I was pregnant, I had an extremely rare allergic side-effect, one that my trauma-center's employee health had never even heard of occurring and had to report it to the CDC. I spent the next 9-months in and out of multiple infectious disease specialists and ENT offices when I had a lymph node in my neck swell up with-in 24hrs of getting the flu vaccine and it continue to get larger and larger. I even had work-ups done to ensure I didn't have lymphoma, just to be ruled-out. It was finally determined that I had a bizarre reaction and to never have a flu vaccine again out of fear of what might happen on the 2nd exposure.

So even with that horrible experience, I am definitely taking this vaccine as soon as distribution plans for high-risk individuals are in place and my endocrinologist can order it. I figure I've recently had boosters to my MMR, had boosters to my hepatitis B series, etc all with no issues.

 

[FeelsSoGoodToBeBad]

My husband has systemic diffuse scleroderma with lung fibrosis and pulmonary arterial hypertension as a result. He is chomping at the bit to get this vaccine. We have 3 teenagers in school (all on a hybrid plan in two different districts), one of which has asthma, as do I. While I work out side the home in a county government office, my husband has had the blessing of being able to work from home. We've had one date night since March and that was for a brief dinner outdoors at a place I was confident followed or exceeded all recommended COVID guidelines. My kids haven't been able to visit with their friends outside of a few outdoor activities while wearing masks for what feel like forever. We'll be skipping Thanksgiving and Christmas family gatherings in a neighboring state because I don't trust that part of the family is doing everything they can to protect themselves, and thereby us, from being infected.

Getting this vaccine will mean more than just being able to take the WDW trip we have scheduled. It will mean lower stress levels for all of us on a daily basis and hopefully getting to visit with family again in the Spring and Summer. While I'm a bit nervous about getting it, you better believe I'll be lining up as soon I'm eligible.

 

[DisneyTransport]

This will likely not be the only vaccine that gets approval. The Moderna vaccine, which also is mRNA-based, is expected to pass their trials soon which will also help with production numbers.

Unclear why you would not give vaccine to front-line workers first (ie nurses—or any other healthcare worker who daily works with COVID)? As someone who worked in healthcare, I have many family and friends who put their lives on the line to work with patients with COVID, some of whom are in the ER and don’t know a person even HAS it until they have tested positive for it. My mom took cate of a pt in the ER 2-was ago that was there for something intelated to COVID (surgical complications) but because they needed to admit him, they ran a COVID test and it came back positive. He was 25. My mom had PPE on but not COVID PPE, which they only don if they know someone is positive or suspect has it. She herself is at high risk. Healthcare workers like her and her colleagues are who I think of when they say “front-line” workers and my old colleagues in the ICU who are taking care of these pts. If hospitals run out of beds, they can make more “ beds out of field hospitals—but they can’t manufacture physicians, nurses, respiratory therapists, custodians/housekeepers, etc when there is a huge surge.

1) if you read the bottom, I clearly state that is not what i would do. I was capturing the ethical viewpoint one person was making with an example. What i was trying to get at is that one could (not that i would) make an argument that the first wave of vaccines shouldnt go to critical workers where if there is some sort of problem, they would be unable to perform their work. (Ie problem with mass production, side effects, etc)

2) yes, a lot of us are related to and have friends in healthcare. I have many friends and family in that industry was well. Its a huge industry. 90% of my family are nurses with someone close to me a director of the surgical floor for over 25 years now.

 

[unmitigated disaster]

Not being a conspiracy person and not being an anti-vaccine person, I know theres a lot of parents who link their childrens cause of autism to vaccines.

Except those parents are wrong. It's been disproven over and over.

 

[Seanual757]

Where did you hear fall/winter of 2021 and early 2022?

Yesterday I do not recall which doctor they had on but what it came down to is the states missed the deadline to prepare and are scrambling. The issue is the shelf life of the vaccine and the dry ice and facilities needed to store the vaccines.

Pfizer's ultra-cold vaccine, a 'very complex' distribution plan and an exploding head emoji | CNN

As Molly Howell, a state health official in North Dakota, watched a webinar on how to distribute what's expected to be the first Covid-19 vaccine, her head began to spin.

www.cnn.com

The Dr said he could see fall of 2021 and maybe into 2022 if states cannot get the necessary resources to store and distribute this vaccine.

 

[Goofyernmost]

I can't imagine things ever going back to just the way they were, but I'll be in line to get that vaccine as soon as available.

I agree! In spite of the horrendous political climate we are dealing with currently, at some point we stop listening to people that have no knowledge and only opinion and start to pay attention to those whose life has been dedicated to disease prevention. We didn't know anything about the polio vaccine, but some very serious science went into creating that vaccine. We lined up for blocks to get vaccinated because a minor reaction was far better then a life in an iron lung. (yesterdays equivalent to todays respirator) What I know for sure is no matter who tries to take credit for it, I can assure you that politics had nothing to do with it. Most of the politicians couldn't successfully apply a band aid!

 

[muddyrivers]

I can't wait to get the vaccine and am going to get it as soon as it is available for me. My family has had to reschedule a vacation twice due to this virus and we decided that as soon as we get the vaccine, we'll be hopping on a plane and going to Hawaii to visit Aulani

 

[Goofyernmost]

Yep. First they tell you not to take the drug if you’re allergic to it (how do you know that until you take it?), then the first-mentioned side effect is the thing you’re trying to cure. “Anti-depressants have been known to cause suicidal thoughts . . .”

Allowing drug companies to advertise on TV is one of the worst decisions ever.

I think we can safely say that those commercials are nowhere near as affective as they might think. If people actually listened to the list of possible side affects no one would ever ask. Ask your doctor if "such and such" is right for you. If he/she thought it was he/she would probably have prescribed it for you already.

 

[Kamikaze]

Look into............the definition of statistics.
Sure.
I dont even know why I come here anymore.
A 40 000 person pool of data over a few months is nothing like 1 billion over years.

Thats exactly how statistics work. You extrapolate a data pool over X to apply it to Y.

 

[Seanual757]

I said if you do not vaccinate. Twist words all you like but all vaccines go through trials like this. I took 2 shots and lived to tell the tale. It baffles me that anyone is anything but happy about a 90% effective vaccine that has few side effects. If you are against all vaccines then yes, you are someone who denies science. If you are against this one because of some crazy conspiracy theory then that's just as bad. They took no shortcuts. I'm personally thrilled to have been a part of the trial but I like science

Yep the flu vaccine is maybe 30% effective but 90% is like gold.

 

[John park hopper]

When the vaccine is available I will consult with my physician as I have some medical issue if he gives the go ahead I will get it no problem. As a kid of the 50's I've been vaccinated numerous times and entering the service I have no idea what I was vaccinated for prior to shipping out to Nam

 

[marni1971]

2021 for the majority won’t be anywhere near normal.

Here’s to 2022.

 

[DisneyTransport]

2021 for the majority won’t be anywhere near normal.

Here’s to 2022.

My motto has been "here's to today since who the heck knows what tomorrow will bring!"

 

[correcaminos]

2021 for the majority won’t be anywhere near normal.

Here’s to 2022.

Maybe not majority. At least in the US they are looking at wide spread distribution by April or so. Vaccine is effective within a week after 2nd dose. That could mean starting spring we'll see improvements and massive ones by summer. For all the negative speculation articles people have posted, there are many more positive ones. They have been working on ways to overcome some issues with transport even by creating their own coolers for travel.

Yep the flu vaccine is maybe 30% effective but 90% is like gold.

More like 40-70% usually but yes, 90% is fantastic. They wanted at least 60% from what I recall from Dr. Fauci

When the vaccine is available I will consult with my physician as I have some medical issue if he gives the go ahead I will get it no problem. As a kid of the 50's I've been vaccinated numerous times and entering the service I have no idea what I was vaccinated for prior to shipping out to Nam

Even if you cannot, that's why everyone who can, should get the vaccine. It's to help prevent it in all. By the way, thank you for your service. I hope you have a good Veterans day.

 

[Gojira ゴジラ]

You should also know that the flu shot is around 40% effective each year. Sometimes a little more, sometimes less. Even if this 90% number is actually 75%, thats extremely good news.

I'm not an expert but I was curious about this too so I asked a nurse during my flu shot. She said that there are a lot of flu strains out there and a flu vaccine only carries 4 or so strains for a reason I can't remember. It is determined by a projection of strains that would likely be attacking that season. Hence why if you still got a flu after the shot, perhaps the flu you got is more likely from a different strain.

 

[Trackmaster]

Even if you cannot, that's why everyone who can, should get the vaccine. It's to help prevent it in all. By the way, thank you for your service. I hope you have a good Veterans day.

Moreso than that, we need the government and businesses to step up to the plate too. Once the vaccine is reasonably well distributed where anybody who wants one can get one, Biden needs to get to work passing some bills, and businesses need to jump on board too and comply. Vaccine certifications required to enter offices and places of work, vaccine certifications required to enter theme parks, certifications required to enter airports and fly, etc. No more kidding around on this. We may not legally be allowed to pin people down and shove a needle in their arms, but we can take away their ability to keep this bug circulating around from idiots who think that their rights to be idiots supersede everybody else's rights to be safe and get back to life as normal.

I'm perfectly fine with anti-vaxxers staying at home the rest of their lives on their own dime (maybe they're independently wealthy or can work from home 100%). Couldn't care less. They just better not act as vectors to keep this thing going.

 

[correcaminos]

Moreso than that, we need the government and businesses to step up to the plate too. Once the vaccine is reasonably well distributed where anybody who wants one can get one, Biden needs to get to work passing some bills, and businesses need to jump on board too and comply. Vaccine certifications required to enter offices and places of work, vaccine certifications required to enter theme parks, certifications required to enter airports and fly, etc. No more kidding around on this. We may not legally be allowed to pin people down and shove a needle in their arms, but we can take away their ability to keep this bug circulating around from idiots who think that their rights to be idiots supersede everybody else's rights to be safe and get back to life as normal.

I'm perfectly fine with anti-vaxxers staying at home the rest of their lives on their own dime (maybe they're independently wealthy or can work from home 100%). Couldn't care less. They just better not act as vectors to keep this thing going.

Both administrations need to be on it before it becomes a need for the new president. Timeline is all healthcare, first responders, and high risk people in extended care facilities by January. Then they need to work together to make the time during transition smooth as well for this. The generic government should do everything in their power to get all who can be vaccinated to be vaccinated.

I am 100% understanding of those with real and true medical exceptions. I don't want to punish them, but no real care for those who are anti-vaxxers. How one group can believe a proven falsified report so many years later is appalling to me. I don't care if they have limited abilities to move around because of a choice. Call me callous but I am sick of people denying sciences lately.

 

[GoofGoof]

This trial has been around longer than 2-3 months where I am at least I'm 2.5 months out from first shot and I was 2nd wave of people to be done due to a scheduling conflict they had. Otherwise I would have had my first shot in early August. I was 3 weeks waiting after that

Yeah, next week marks the point where over 50% of the participants received their 2nd dose in the Pfizer trial. Many had it before that and some after, but by the time the general public gets the vaccine most or maybe all of the expanded participants will have had the 2nd shot a few months earlier.