Pfizer's vaccine 90% effective for Covid

[HPstache]

The cruise industry has taken a beating by Covid. I wonder if cruise lines are considering documented vaccination as a future requirement for passengers.

I would say that the entire travel industry is considering documented vaccination as a future requirement.

[GuitarStv]

An awful lot of people have been working very hard to ensure that the vaccines are safe . . . and we've done everything possible to ensure safety.  If you're in a high risk group, the odds of the vaccine being less safe than catching coronavirus are vanishingly low.  But to claim that a vaccine of a type never before OK'd for use in humans, with reduced testing can be guaranteed safe because of advances in technology - this is simply false.

Yes, everything in life is risk/reward and there is absolutely no evidence that the cure is worse than the disease in this case.

Agreed.  The lack of the amount of usual testing/evidence is what we need to keep in mind.

[dougules]

An awful lot of people have been working very hard to ensure that the vaccines are safe . . . and we've done everything possible to ensure safety.  If you're in a high risk group, the odds of the vaccine being less safe than catching coronavirus are vanishingly low.  But to claim that a vaccine of a type never before OK'd for use in humans, with reduced testing can be guaranteed safe because of advances in technology - this is simply false.

Yes, everything in life is risk/reward and there is absolutely no evidence that the cure is worse than the disease in this case.

Agreed.  The lack of the amount of usual testing/evidence is what we need to keep in mind.

Yes, and we also need to keep in mind the lack of knowledge as to what the long-term effects of getting COVID are.

[GuitarStv]

An awful lot of people have been working very hard to ensure that the vaccines are safe . . . and we've done everything possible to ensure safety.  If you're in a high risk group, the odds of the vaccine being less safe than catching coronavirus are vanishingly low.  But to claim that a vaccine of a type never before OK'd for use in humans, with reduced testing can be guaranteed safe because of advances in technology - this is simply false.

Yes, everything in life is risk/reward and there is absolutely no evidence that the cure is worse than the disease in this case.

Agreed.  The lack of the amount of usual testing/evidence is what we need to keep in mind.

Yes, and we also need to keep in mind the lack of knowledge as to what the long-term effects of getting COVID are.

I'm not minimizing the risks of covid at all.  It's a weird disease with unknown long term impacts on life, and is a huge problem.  Anyone in a high risk group should absolutely and without hesitation take the vaccine . . . the odds are dramatically slanted towards that decision.

But simply ignoring or minimizing the risks of that the limited testing on the vaccine is a dishonest way to present the situation.  Especially to people in age groups where current data (which is also lacking) seems to show that covid doesn't present much threat at all.  The decision is much less clear cut in these cases.

[Dollar Slice]

The FDA advisory panel just approved it for emergency usage.
Out of 23 members, 17 voted YES, 5 NO and 1 abstain.

I think the panel recommended it, there is still another step for actual approval. It would be interesting to know why some said no.

I read that the no votes were concerned that they were approving it for 16+ age group but it had mainly been tested on 18+, thus not sufficiently testing on 16-17 year olds. I also read they're likely to start studies on kids in January, so by the time the vast majority of 16-17 year olds are offered the vaccine, we'll have a lot more data.

[dougules]

Yes, and we also need to keep in mind the lack of knowledge as to what the long-term effects of getting COVID are.

I'm not minimizing the risks of covid at all.  It's a weird disease with unknown long term impacts on life, and is a huge problem.  Anyone in a high risk group should absolutely and without hesitation take the vaccine . . . the odds are dramatically slanted towards that decision.

But simply ignoring or minimizing the risks of that the limited testing on the vaccine is a dishonest way to present the situation.  Especially to people in age groups where current data (which is also lacking) seems to show that covid doesn't present much threat at all.  The decision is much less clear cut in these cases.

It's only high risk groups they're authorizing the vaccine for right now, anyway (at least in the US).  It's not a full up approval, just an authorization for people who we're pretty sure are at significantly lower risk from the vaccine than from the disease itself.  It's not like there are enough doses right now for a full approval to matter anyway. 

We're not really able to say there are any groups of people who are truly at low risk from COVID.  The number of young previously-healthy people who are showing long-term symptoms similar to myalgic encephalomyelitis alone is worrisome.  That can be a debilitating life-long disease.  With that in mind, will it really take that much testing just to say that the vaccine is less risky than the disease itself for your average young person?  Then you've got the fact that lower-risk people still spread the virus to people that are high-risk.  Maybe it is very slightly dishonest to downplay the risk from the vaccine when it's fully approved, but most people are pretty bad at risk management.  It is very important right now to manage people's cognitive biases. 

[GuitarStv]

Yes, and we also need to keep in mind the lack of knowledge as to what the long-term effects of getting COVID are.

I'm not minimizing the risks of covid at all.  It's a weird disease with unknown long term impacts on life, and is a huge problem.  Anyone in a high risk group should absolutely and without hesitation take the vaccine . . . the odds are dramatically slanted towards that decision.

But simply ignoring or minimizing the risks of that the limited testing on the vaccine is a dishonest way to present the situation.  Especially to people in age groups where current data (which is also lacking) seems to show that covid doesn't present much threat at all.  The decision is much less clear cut in these cases.

It's only high risk groups they're authorizing the vaccine for right now, anyway (at least in the US).  It's not a full up approval, just an authorization for people who we're pretty sure are at significantly lower risk from the vaccine than from the disease itself.  It's not like there are enough doses right now for a full approval to matter anyway. 

We're not really able to say there are any groups of people who are truly at low risk from COVID.  The number of young previously-healthy people who are showing long-term symptoms similar to myalgic encephalomyelitis alone is worrisome.  That can be a debilitating life-long disease.  With that in mind, will it really take that much testing just to say that the vaccine is less risky than the disease itself for your average young person?  Then you've got the fact that lower-risk people still spread the virus to people that are high-risk.  Maybe it is very slightly dishonest to downplay the risk from the vaccine when it's fully approved, but most people are pretty bad at risk management.  It is very important right now to manage people's cognitive biases.

As tempting as it can be (and you can couch it in softer terms like 'managing people's cognitive bias'), I don't believe that lying about the truth because you're afraid that people are too stupid to handle it is a valid response to this situation.  Either facts and the truth matter, or they don't.

[dougules]

As tempting as it can be (and you can couch it in softer terms like 'managing people's cognitive bias'), I don't believe that lying about the truth because you're afraid that people are too stupid to handle it is a valid response to this situation.  Either facts and the truth matter, or they don't.

Call it what you want, but is telling people the truth really telling people the truth when you know that the truth isn't what they're going to take away from the truth that's actually told?

[GuitarStv]

As tempting as it can be (and you can couch it in softer terms like 'managing people's cognitive bias'), I don't believe that lying about the truth because you're afraid that people are too stupid to handle it is a valid response to this situation.  Either facts and the truth matter, or they don't.

Call it what you want, but is telling people the truth really telling people the truth when you know that the truth isn't what they're going to take away from the truth that's actually told?

The line of reasoning that argues that people can't handle the truth and make their own decisions based on facts and evidence is repugnant to me.

Are there willfully stupid people who will (intentionally or otherwise) misunderstand reality?  Yes.  Absolutely.  Wholesale misinformation campaigns are not a reasonable response to this problem though.  Such an action would destroy any shred of trust in the perpetrating groups and lead to a situation where it's impossible to believe anything anyone says.

As hard as it is, we need to release the truth and then have faith that people will act in their own self interest based upon it.

[EvenSteven]

As tempting as it can be (and you can couch it in softer terms like 'managing people's cognitive bias'), I don't believe that lying about the truth because you're afraid that people are too stupid to handle it is a valid response to this situation.  Either facts and the truth matter, or they don't.

Call it what you want, but is telling people the truth really telling people the truth when you know that the truth isn't what they're going to take away from the truth that's actually told?

The line of reasoning that argues that people can't handle the truth and make their own decisions based on facts and evidence is repugnant to me.

Are there willfully stupid people who will (intentionally or otherwise) misunderstand reality?  Yes.  Absolutely.  Wholesale misinformation campaigns are not a reasonable response to this problem though.  Such an action would destroy any shred of trust in the perpetrating groups and lead to a situation where it's impossible to believe anything anyone says.

As hard as it is, we need to release the truth and then have faith that people will act in their own self interest based upon it.

I sympathize with this view. However, effective communication requires the communicator to take into consideration how their message will be received, so that they can effectively communicate accurate facts. People who are not themselves anti-vaxers still participate in spreading anti-vax misinformation, like that these trials show evidence that the vaccine causes Bell's palsy, even while they wax poetic about Truth and Facts.

[zygote]

But simply ignoring or minimizing the risks of that the limited testing on the vaccine is a dishonest way to present the situation.

Can you expand on your point about limited testing? My understanding is that the vaccines have all been through every traditional trial stage. The vaccine has only been "rushed" in the sense that the other, more bureaucratic steps have been minimized.

Since so much money has been shoveled into this problem, companies have not had to take time to raise money. They were able to examine multiple leads at once, rather than sequentially. They have built on previously tested vaccine mechanisms, only switching out the particular genetic material for this virus. They were allowed to start the next trial phases before all the previous ones were finalized, but not before preliminary data came in (and the early trials were still continued to make sure nothing unexpected came up). It took no time to recruit volunteers for the trials, and covid is so rampant now it didn't take as long as usual for a critical mass of trial volunteers to contract the disease and allow for the data analysis. And, of course, much of the FDA red tape has been minimized.

That's not to say that it's impossible for longer-term or more rare effects to arise in the future, but that is true of every vaccine introduced to the market that has undergone the same trial stages with the same number of participants. Some things just aren't going to show up until you have the numbers of the general public involved. But the vaccine has undergone the same level of testing as every other vaccine. The corners haven't been cut in the science, just in all the other barriers.

I admittedly have the perspective of a young, healthy person who had covid in March, is still dealing with lung issues when I exercise, and would have happily volunteered in a vaccine trial if my prior covid case weren't disqualifying. So perhaps I just have a different risk analysis.

[GuitarStv]

But simply ignoring or minimizing the risks of that the limited testing on the vaccine is a dishonest way to present the situation.

Can you expand on your point about limited testing? My understanding is that the vaccines have all been through every traditional trial stage. The vaccine has only been "rushed" in the sense that the other, more bureaucratic steps have been minimized.

Since so much money has been shoveled into this problem, companies have not had to take time to raise money. They were able to examine multiple leads at once, rather than sequentially. They have built on previously tested vaccine mechanisms, only switching out the particular genetic material for this virus. They were allowed to start the next trial phases before all the previous ones were finalized, but not before preliminary data came in (and the early trials were still continued to make sure nothing unexpected came up). It took no time to recruit volunteers for the trials, and covid is so rampant now it didn't take as long as usual for a critical mass of trial volunteers to contract the disease and allow for the data analysis. And, of course, much of the FDA red tape has been minimized.

That's not to say that it's impossible for longer-term or more rare effects to arise in the future, but that is true of every vaccine introduced to the market that has undergone the same trial stages with the same number of participants. Some things just aren't going to show up until you have the numbers of the general public involved. But the vaccine has undergone the same level of testing as every other vaccine. The corners haven't been cut in the science, just in all the other barriers.

I admittedly have the perspective of a young, healthy person who had covid in March, is still dealing with lung issues when I exercise, and would have happily volunteered in a vaccine trial if my prior covid case weren't disqualifying. So perhaps I just have a different risk analysis.

This has been mentioned several times in the thread.

No other vaccine has before been developed and released for general use in under four years.  No covid candidate vaccine has received even a single year of testing.  The covid vaccines have not undergone the same level of testing as other vaccines and all have considerably less data gathered regarding longer term effects/potential problems than is usual.  Cutting this corner was unavoidable to produce a vaccine quickly, but it leads to greater risk than usual.

[dougules]

- No other vaccine has had anything close to as many resources thrown at it as these.
- No other vaccine has benefitted as much from existing research and development.
- No other vaccine has been able to command analysts' and reviewers' immediate attention, and not have its data sit in someone's queue for months at a time.
- The vaccines will still have a year of testing by the time most young healthy people have access to them.
- No other vaccine has had to be weighed against a threat as urgent.  It's misleading to talk about risks from vaccines in isolation without comparing it to the risks presented by the disease it prevents.

[RetiredAt63]

- No other vaccine has had anything close to as many resources thrown at it as these.
- No other vaccine has benefitted as much from existing research and development.
- No other vaccine has been able to command analysts' and reviewers' immediate attention, and not have its data sit in someone's queue for months at a time.
- The vaccines will still have a year of testing by the time most young healthy people have access to them.
- No other vaccine has had to be weighed against a threat as urgent.  It's misleading to talk about risks from vaccines in isolation without comparing it to the risks presented by the disease it prevents.

And they were building on vaccine research from SARS-1.  That vaccine never finished development because SARS-1 was controlled so quickly.

[GuitarStv]

- No other vaccine has had anything close to as many resources thrown at it as these.

- No other vaccine has been able to command analysts' and reviewers' immediate attention, and not have its data sit in someone's queue for months at a time.

Yep, agreed on both counts.

- No other vaccine has benefitted as much from existing research and development.

Not sure that I understand what you mean by this.  Can you elaborate?  Being incremental development, existing r&d is normally used to create something new in medicine.  (Our knowledge is higher today than it was yesterday, and higher yesterday than the day before, so I guess you could argue that the statement is true for every new vaccine ever developed - but that seems a bit facile.)

- The vaccines will still have a year of testing by the time most young healthy people have access to them.

A year of testing is 1/4 of the longevity testing that the fastest previously developed/released vaccine had (and most have longer than that - typical is 6 years).  Absolutely better than nothing . . . but not all that comforting.

- No other vaccine has had to be weighed against a threat as urgent.  It's misleading to talk about risks from vaccines in isolation without comparing it to the risks presented by the disease it prevents.

I've tried really hard not to talk about the risk of the vaccine without also being very clear about covid.  Coronavirus is bad news.  I've mentioned several times that for higher risk people, there should be no question at all about taking the vaccine.  I plan to take the vaccine myself when it's available - but am doing it with my eyes open, and not based on half truths and outright falsehoods about it.

[zygote]

No other vaccine has before been developed and released for general use in under four years.  No covid candidate vaccine has received even a single year of testing.  The covid vaccines have not undergone the same level of testing as other vaccines and all have considerably less data gathered regarding longer term effects/potential problems than is usual.  Cutting this corner was unavoidable to produce a vaccine quickly, but it leads to greater risk than usual.

Right, but my point was that the traditional time to approval you cite is due to red tape, not due to the level of testing protocol. The FDA's recommendation for a phase III vaccine trial (from pre-covid) is to track participants for 6 months. They extend the time to a year for vaccines with novel adjuvants/delivery methods. Completing a phase III trial in 6 months to a year is absolutely normal. As with any newly released vaccine, the FDA/CDC will certainly continue to collect data about any effects that may occur after the fact through the Vaccine Adverse Event Reporting System (VAERS), but that is considered after-market surveillance, not part of the testing protocol. I do understand your point that a longer period of time between a phase III trial ending and approval will give such adverse events (if any) more of a chance to crop up and be reported. But the actual formal testing has not been sacrificed. I don't think it is a falsehood to be saying this, even if there is some nuance about the additional post-testing time other vaccines have had before release.

This blog post compiles a lot of sources on all this, if you're interested: https://www.deplatformdisease.com/blog/long-term-effects-of-covid-19-vaccines-should-you-be-worried

[GuitarStv]

No other vaccine has before been developed and released for general use in under four years.  No covid candidate vaccine has received even a single year of testing.  The covid vaccines have not undergone the same level of testing as other vaccines and all have considerably less data gathered regarding longer term effects/potential problems than is usual.  Cutting this corner was unavoidable to produce a vaccine quickly, but it leads to greater risk than usual.

Right, but my point was that the traditional time to approval you cite is due to red tape, not due to the level of testing protocol.

This is a popular talking point, but it is untrue.  This has nothing to do with red tape.  It is not possible to compress long term symptom testing into a shorter period of time.  Testing protocols related to long term impacts for the covid vaccine could not be performed.

The blog post you linked agrees with this (while arguing that we should ignore those risks because of fear of covid):

The pertinent question to ask when considering the risks from these kinds of adverse consequences is how they compare to the risks of no vaccine i.e. the risks of getting the disease. VAPP is far rarer than paralytic poliomyelitis from poliovirus infection. The numbers for intussusception are less clear, but ACIP deemed that the increased risk was too low to warrant withdrawal of the vaccine (though history of intussusception is a contraindication for this vaccine). So regarding this kind of long term-effect- it’s possible that this will be missed if it is very, very rare and will then show up in post-marketing surveillance. But the question then is “How relevant is that to your decision-making calculus if it’s truly that rare?” Consider the ever-expanding litany of long-term consequences we are tracing to COVID-19 infection- consequences which are not uncommon.

Again, I'm not saying that you shouldn't get the vaccine.  I'm not saying the risks of reduced testing for the vaccine outweight the risks of covid.  All I'm saying is, don't pretend that the safety testing was the same and as in-depth as that for regular vaccine development.  It was not.

[Dollar Slice]

- The vaccines will still have a year of testing by the time most young healthy people have access to them.

A year of testing is 1/4 of the longevity testing that the fastest previously developed/released vaccine had (and most have longer than that - typical is 6 years).  Absolutely better than nothing . . . but not all that comforting.

Maybe this will comfort you a bit: https://youtu.be/-UJFZttdp-8?t=1279

It's a long video so I cued it up right before the relevant part. Dr. Fauci was taking questions about the vaccine roll-out at the Mailman School of Public Health (they are all about things like vaccine roll-outs there, I know someone who works there and that's one of the things he works on). He said that the vast majority of vaccine side effects, historically speaking, happen in a short time after the vaccine being given. Like within a month or so, at most. So they're not particularly worried about stuff coming up many months (or years) down the road. And I've read elsewhere that mRNA vaccines are specifically designed to be safer in part because they don't last very long in the body, so there should be even less of a chance with them to have long-term problems.

[zygote]

No other vaccine has before been developed and released for general use in under four years.  No covid candidate vaccine has received even a single year of testing.  The covid vaccines have not undergone the same level of testing as other vaccines and all have considerably less data gathered regarding longer term effects/potential problems than is usual.  Cutting this corner was unavoidable to produce a vaccine quickly, but it leads to greater risk than usual.

Right, but my point was that the traditional time to approval you cite is due to red tape, not due to the level of testing protocol.

This is a popular talking point, but it is untrue.  This has nothing to do with red tape.  It is not possible to compress long term symptom testing into a shorter period of time.  Testing protocols related to long term impacts for the covid vaccine could not be performed.

The blog post you linked agrees with this (while arguing that we should ignore those risks because of fear of covid):

The pertinent question to ask when considering the risks from these kinds of adverse consequences is how they compare to the risks of no vaccine i.e. the risks of getting the disease. VAPP is far rarer than paralytic poliomyelitis from poliovirus infection. The numbers for intussusception are less clear, but ACIP deemed that the increased risk was too low to warrant withdrawal of the vaccine (though history of intussusception is a contraindication for this vaccine). So regarding this kind of long term-effect- it’s possible that this will be missed if it is very, very rare and will then show up in post-marketing surveillance. But the question then is “How relevant is that to your decision-making calculus if it’s truly that rare?” Consider the ever-expanding litany of long-term consequences we are tracing to COVID-19 infection- consequences which are not uncommon.

Again, I'm not saying that you shouldn't get the vaccine.  I'm not saying the risks of reduced testing for the vaccine outweight the risks of covid.  All I'm saying is, don't pretend that the safety testing was the same and as in-depth as that for regular vaccine development.  It was not.

I don't think that's what that particular paragraph is saying, though, unless I'm misreading. For context, the section leading up to it:

Firstly, we need to be clear about our terminology here. When we say long-term effect from a vaccine, we can mean one of two things:

1. An effect of the vaccine that arises soon after its receipt and has long-term consequences on the vaccine.

2. An effect of the vaccine that arises years after the initial vaccination (I would prefer to call this a latent adverse event following immunization (LAEFI) but this is what many are calling a long-term effect so I’ll be consistent with their language).

The former would be caught by the clinical trials process unless it were very rare (Phase III trials include tens of thousands of people at least and compared the incidence of the infection in the vaccinated vs. unvaccinated groups and their outcomes from infection). Examples of such phenomena include vaccine-associated paralytic polio (VAPP) which occurs very, very rarely from the oral polio vaccine (OPV) and not at all from inactivated polio vaccine (IPV) (nOPV2 is a polio vaccine that has additional mutations to prevent the reversion to neurovirulence that causes VAPP) or intussusception from the rotavirus vaccines (also very rare, and largely determined by when the vaccine is given which is why it is given on the schedule before the risk for intussusception peaks). Basically this sort of thing is exactly what clinical trials are examining right now, and as long as the event isn’t very, very rare like the previously mentioned, there’s no reason that these would be missed by clinical trials (in biostatistics there is a rule of three which when extrapolated to clinical trials means that for a trial of n people, if an event does not occur, the 95% confidence interval for the event in the population is (0, 3/n) e.g. for a trial of 30,000 people, if a given event does not occur then the 95% confidence interval for the population is (0, 3/30,000) which means we can be 95% confident that the true risk of the event occurring is between 0 and 1 in 10,000 times within the population; this is only an approximation and not rigorous but can help you determine appropriate sample sizes in a study).

The paragraph you quoted is still discussing these "type 1" long-term effects, where you see an immediate reaction that lingers long term. Those kinds of immediate reactions would indeed show up in the phase III trials that have been conducted, unless they are exceedingly rare. That's true of every vaccine; phase III trials can only be so big. I would certainly be curious to see the data on whether any participants for these covid vaccines had adverse reactions still lingering at the 6-month or one-year mark, with the potential to turn into a longer-term issue.

I'm not arguing that you should or shouldn't get the vaccine either, and I'm also not arguing that there are guaranteed to be no unexpected effects of the vaccine down the road. But the phase III trials done for this vaccine are absolutely as rigorous as they have been for other vaccines.

[Abe]

From Pfizer's briefing to the FDA for emergency use:

In Phase I trials (n=150 between the two):
Within 1 month:
one patient had a migraine (had history of migraines)
one patient had muscle spasms (had the vaccine)
one patient had nerve pain (but got the placebo)
At 4 months:
pain from an needle stick for blood draw (hit a superficial nerve)

Phase 2/3 studies (n=37,796)
- all reactions were least common in >55yo patients at Dose 1 (low end of figures), and highest in <55 at Dose 2 (high end of figures)
Mild-moderate pain at injection: 66-83% (depending on age)
Redness at injection: 4.5-7.2%
Swelling: 5.8-7.5%
Fatigue: 34-59%
Headache: 25-52%
muscle pain: 14-37%
chills: 6-35%
Joint pain: 9-22%
Fever: 1-16%
High fever (>39C): 0.1-0.2%
Vomiting: same as placebo (1-2%)
Diarrhea: same as placebo (8-12%)

Severe adverse events were same in placebo and vaccine groups (0.3%) in patients with >2 month follow-up.

The most common serious adverse events NUMBERS (not percents). None were significantly more common in vaccine groups:
Cardiac arrhythmia: 4/18,801 vaccine, 5/18,785 placebo
Other cardiac events: 10 and 7
Neurologic (strokes): 15 and 13
Random infections (appendicitis, diverticulitis, urinary tract infections, skin infections): 25 and 14

Six deaths were reported between the two arms:
Vaccine arms:
A >55yo had a stroke and died 3 days after Dose 1
Another had a cardiac arrest 60 days after Dose 2

Placebo arms:
Two <55yo died of unknown causes
One >55yo had hemorrhagic stroke 15 days after Dose 2
One >55yo had a heart attack 16 days after Dose 1

Final analysis of efficacy submitted to the FDA:
After Dose 1:
50 in vaccine arm
275 in placebo arm
Efficacy 82.0%

After Dose 2 (planned primary endpoint):
8 COVID-19 cases in the vaccine arm
162 COVID-19 cases in the placebo arm
Efficacy 94.8% (95% CI: 89.9-97.5%)

Severe COVID-19 (leading to ARDS):
After Dose 1:
1 in vaccine arm
9 in placebo arm

After Dose 2:
1 in vaccine arm
3 in placebo arm

There was no difference in efficacy between age groups, ethnicities or genders.

The FDA approval is contingent on monthly updates of adverse events reported from the vaccine, and distribution as directed by the CDC (they cannot sell doses outside the CDC's distribution plan).

[stoaX]

From Pfizer's briefing to the FDA for emergency use:

In Phase I trials (n=150 between the two):
Within 1 month:
one patient had a migraine (had history of migraines)
one patient had muscle spasms (had the vaccine)
one patient had nerve pain (but got the placebo)
At 4 months:
pain from an needle stick for blood draw (hit a superficial nerve)

Phase 2/3 studies (n=37,796)
- all reactions were least common in >55yo patients at Dose 1 (low end of figures), and highest in <55 at Dose 2 (high end of figures)
Mild-moderate pain at injection: 66-83% (depending on age)
Redness at injection: 4.5-7.2%
Swelling: 5.8-7.5%
Fatigue: 34-59%
Headache: 25-52%
muscle pain: 14-37%
chills: 6-35%
Joint pain: 9-22%
Fever: 1-16%
High fever (>39C): 0.1-0.2%
Vomiting: same as placebo (1-2%)
Diarrhea: same as placebo (8-12%)

Severe adverse events were same in placebo and vaccine groups (0.3%) in patients with >2 month follow-up.

The most common serious adverse events NUMBERS (not percents). None were significantly more common in vaccine groups:
Cardiac arrhythmia: 4/18,801 vaccine, 5/18,785 placebo
Other cardiac events: 10 and 7
Neurologic (strokes): 15 and 13
Random infections (appendicitis, diverticulitis, urinary tract infections, skin infections): 25 and 14

Six deaths were reported between the two arms:
Vaccine arms:
A >55yo had a stroke and died 3 days after Dose 1
Another had a cardiac arrest 60 days after Dose 2

Placebo arms:
Two <55yo died of unknown causes
One >55yo had hemorrhagic stroke 15 days after Dose 2
One >55yo had a heart attack 16 days after Dose 1

Final analysis of efficacy submitted to the FDA:
After Dose 1:
50 in vaccine arm
275 in placebo arm
Efficacy 82.0%

After Dose 2 (planned primary endpoint):
8 COVID-19 cases in the vaccine arm
162 COVID-19 cases in the placebo arm
Efficacy 94.8% (95% CI: 89.9-97.5%)

Severe COVID-19 (leading to ARDS):
After Dose 1:
1 in vaccine arm
9 in placebo arm

After Dose 2:
1 in vaccine arm
3 in placebo arm

There was no difference in efficacy between age groups, ethnicities or genders.

The FDA approval is contingent on monthly updates of adverse events reported from the vaccine, and distribution as directed by the CDC (they cannot sell doses outside the CDC's distribution plan).

Interesting stuff...thanks for taking the time to share it with us. 

[Kris]

From Pfizer's briefing to the FDA for emergency use:

In Phase I trials (n=150 between the two):
Within 1 month:
one patient had a migraine (had history of migraines)
one patient had muscle spasms (had the vaccine)
one patient had nerve pain (but got the placebo)
At 4 months:
pain from an needle stick for blood draw (hit a superficial nerve)

Phase 2/3 studies (n=37,796)
- all reactions were least common in >55yo patients at Dose 1 (low end of figures), and highest in <55 at Dose 2 (high end of figures)
Mild-moderate pain at injection: 66-83% (depending on age)
Redness at injection: 4.5-7.2%
Swelling: 5.8-7.5%
Fatigue: 34-59%
Headache: 25-52%
muscle pain: 14-37%
chills: 6-35%
Joint pain: 9-22%
Fever: 1-16%
High fever (>39C): 0.1-0.2%
Vomiting: same as placebo (1-2%)
Diarrhea: same as placebo (8-12%)

Severe adverse events were same in placebo and vaccine groups (0.3%) in patients with >2 month follow-up.

The most common serious adverse events NUMBERS (not percents). None were significantly more common in vaccine groups:
Cardiac arrhythmia: 4/18,801 vaccine, 5/18,785 placebo
Other cardiac events: 10 and 7
Neurologic (strokes): 15 and 13
Random infections (appendicitis, diverticulitis, urinary tract infections, skin infections): 25 and 14

Six deaths were reported between the two arms:
Vaccine arms:
A >55yo had a stroke and died 3 days after Dose 1
Another had a cardiac arrest 60 days after Dose 2

Placebo arms:
Two <55yo died of unknown causes
One >55yo had hemorrhagic stroke 15 days after Dose 2
One >55yo had a heart attack 16 days after Dose 1

Final analysis of efficacy submitted to the FDA:
After Dose 1:
50 in vaccine arm
275 in placebo arm
Efficacy 82.0%

After Dose 2 (planned primary endpoint):
8 COVID-19 cases in the vaccine arm
162 COVID-19 cases in the placebo arm
Efficacy 94.8% (95% CI: 89.9-97.5%)

Severe COVID-19 (leading to ARDS):
After Dose 1:
1 in vaccine arm
9 in placebo arm

After Dose 2:
1 in vaccine arm
3 in placebo arm

There was no difference in efficacy between age groups, ethnicities or genders.

The FDA approval is contingent on monthly updates of adverse events reported from the vaccine, and distribution as directed by the CDC (they cannot sell doses outside the CDC's distribution plan).

Hey. @Abe , this is awesome. Could you link to the source, please?

[Abe]

https://www.fda.gov/media/144246/download

[Segare]

As tempting as it can be (and you can couch it in softer terms like 'managing people's cognitive bias'), I don't believe that lying about the truth because you're afraid that people are too stupid to handle it is a valid response to this situation.  Either facts and the truth matter, or they don't.

Call it what you want, but is telling people the truth really telling people the truth when you know that the truth isn't what they're going to take away from the truth that's actually told?

The line of reasoning that argues that people can't handle the truth and make their own decisions based on facts and evidence is repugnant to me.

Are there willfully stupid people who will (intentionally or otherwise) misunderstand reality?  Yes.  Absolutely.  Wholesale misinformation campaigns are not a reasonable response to this problem though.  Such an action would destroy any shred of trust in the perpetrating groups and lead to a situation where it's impossible to believe anything anyone says.

As hard as it is, we need to release the truth and then have faith that people will act in their own self interest based upon it.

Yes

[Abe]

https://www.businessinsider.com/the-colbert-report-truthiness-clip-2014-12

[Sid Hoffman]

And I've read elsewhere that mRNA vaccines are specifically designed to be safer in part because they don't last very long in the body, so there should be even less of a chance with them to have long-term problems.

Yup. mRNA vaccines are one of the most amazing new medical advances out there. This is like miracle work, basically. This is a disease where the WHO didn't even admit that it was transmissible via person-to-person contact at the start of the year and now we have a fully tested and approved vaccine by the end of the year.

One of the big things with vaccines is that they manage risk. Because the risk of negative impact from mRNA vaccines is so tiny, it's easy for even the potential of problems to make vaccination's value totally outweigh the known risks of sickness and death if you don't get vaccinated and contract the disease instead. The long term impact of COVID-19 is very real for a lot of people, with the potential for bran damage, lung damage, heart damage, and other problems even if you survive and "recover" in a month. Weighed against that, we already have enough data to know the vaccines have lower impact than the very real negative long term effects of getting COVID-19.