Hello. I saw where you discussed the efficacy of the Pfizer vaccine for elderly patients. But there are some safety issues that Pfizer has not been fully open about.

I copied below a letter I sent to the European Medicines Agency after they approved the Pfizer vaccine.
A key point needs to be focused on. Pfizer in their vaccine report shows by bar graphs in Figure 2 the number of fevers developed by vaccine recipients:
www.nejm.org/.../nejmoa2034577_f2.jpeg
In discussing that, Pfizer give this confusingly written passage in their report:
Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the vaccine and placebo groups reported temperatures above 40.0°C. Younger vaccine recipients were more likely to use antipyretic or pain medication (28% after dose 1; 45% after dose 2) than older vaccine recipients (20% after dose 1; 38% after dose 2), and placebo recipients were less likely (10 to 14%) than vaccine recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.
The first sentence and the second sentence give different percentages for the number of patients who got what is called in both sentences just “fever”. It must be that what they call in the first sentence “fever” are just those with temperature ≥ 38°C. But in the second sentence they should have referred to the cases they are considering then as high fevers, because these are with temperatures ≥ 38.9°C, which is ≥ 102°F.
Temperatures this high can be life-threatening for elderly patients as we know from the number of elderly patients who contract pneumonia while in hospital and die from it.
The passage I quoted says those with the high fevers was 0.8% for the vaccine group and 0.1% for the placebo group after the 2nd dose.
Even 0.8% of elderly patients getting a high fever after the 2nd dose is concerning. That would be 160 elderly patients in the 20,000 in nursing homes in Norway who got the Pfizer vaccine getting high fevers.
Let me state these facts bluntly:
1st, Pfizer knows the safety profile of their vaccine for elderly patients but hasn't released it to the public.
And
2nd, the public health agencies approving the Pfizer vaccine either don't know the safety profile for elderly patients and approved it anyway, or do know it and haven't released it to the public.

   Robert Clark
===================================================
Hello. I was quite concerned to read of the deaths in Norway after patients were given the Pfizer vaccine. It should be noted in this regard that Pfizer has not provided a complete safety profile for the 2nd dose of their vaccine during testing, only for the 1st dose. See the supplementary file to their published report here:
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P. Polack, M.D., et al.
December 31, 2020
N Engl J Med 2020; 383:2603-2615
DOI: 10.1056/NEJMoa2034577
www.nejm.org/.../NEJMoa2034577
The table showing the safety profile after the 1st dose is Table S3 on page 9.
However, there does not appear in this supplementary file a similar safety profile after the 2nd dose.
The number of deaths of 23 after only 20,000 vaccinations in elderly patients in Norway is quite high. Given these deaths, Pfizer should be required to also reveal the safety profile after the 2nd dose.
Note though that Pfizer did provide a listing of adverse events for the 2nd dose in the paper itself in Figure 2:
www.nejm.org/.../nejmoa2034577_f2.jpeg
The omission I’m referring to is that in the supplementary file in Table S3 on page 9 the listing of adverse events is classified by serious, severe, life-threatening, or fatal, but this was only for the 1st dose. There was no corresponding table for the 2nd dose provided in the supplementary file.
In the bar graphs in Figure 2 linked above they show the number of fevers was much higher than for placebos after the 2nd dose. These fevers could have serious consequences for the elderly patients.
Then Pfizer should be required to provide the safety profile for the 2nd dose where the adverse events are classified by serious, severe, life-threatening or fatal, as was done for 1st dose in Table S3, page 9 of the supplementary file.
Going beyond that, they should also be required to provide the adverse events and safety profile specifically for elderly patients for both the 1st and 2nd doses.
Quite frankly, I’m surprised a vaccine manufacturer can get approval to the general public for a new vaccine without presenting the full safety information on both the 1st and the 2nd doses of their vaccine.
Am I correct in assuming if someone in the public asked the European Medicines Agency what’s the safety profile on the Pfizer vaccine after the 2nd dose their response would be, “We don’t know”?
Robert Clark
======================================================



___________________________

Robert Clark

Dept. of Mathematics

Widener University

One University Place

Chester, PA 19013 USA

___________________________


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Robert G Clark
Tue 2/16/2021 9:17 AM

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  Hello. I saw where you discussed the efficacy of the Pfizer vaccine. But there are some safety issues that Pfizer has not been fully open about.

I copied below a letter I sent to the European Medicines Agency after they approved the Pfizer vaccine.
A key point needs to be focused on. Pfizer in their vaccine report shows by bar graphs in Figure 2 the number of fevers developed by vaccine recipients:
www.nejm.org/.../nejmoa2034577_f2.jpeg
In discussing that, Pfizer give this confusingly written passage in their report:
Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the vaccine and placebo groups reported temperatures above 40.0°C. Younger vaccine recipients were more likely to use antipyretic or pain medication (28% after dose 1; 45% after dose 2) than older vaccine recipients (20% after dose 1; 38% after dose 2), and placebo recipients were less likely (10 to 14%) than vaccine recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.
The first sentence and the second sentence give different percentages for the number of patients who got what is called in both sentences just “fever”. It must be that what they call in the first sentence “fever” are just those with temperature ≥ 38°C. But in the second sentence they should have referred to the cases they are considering then as high fevers, because these are with temperatures ≥ 38.9°C, which is ≥ 102°F.
Temperatures this high can be life-threatening for elderly patients as we know from the number of elderly patients who contract pneumonia while in hospital and die from it.
The passage I quoted says those with the high fevers was 0.8% for the vaccine group and 0.1% for the placebo group after the 2nd dose.
Even 0.8% of elderly patients getting a high fever after the 2nd dose is concerning. That would be 160 elderly patients in the 20,000 in nursing homes in Norway who got the Pfizer vaccine getting high fevers.
Let me state these facts bluntly:
1st, Pfizer knows the safety profile of their vaccine for elderly patients but hasn't released it to the public.
And
2nd, the public health agencies approving the Pfizer vaccine either don't know the safety profile for elderly patients and approved it anyway, or do know it and haven't released it to the public.

   Robert Clark
===================================================
Hello. I was quite concerned to read of the deaths in Norway after patients were given the Pfizer vaccine. It should be noted in this regard that Pfizer has not provided a complete safety profile for the 2nd dose of their vaccine during testing, only for the 1st dose. See the supplementary file to their published report here:
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P. Polack, M.D., et al.
December 31, 2020
N Engl J Med 2020; 383:2603-2615
DOI: 10.1056/NEJMoa2034577
www.nejm.org/.../NEJMoa2034577
The table showing the safety profile after the 1st dose is Table S3 on page 9.
However, there does not appear in this supplementary file a similar safety profile after the 2nd dose.
The number of deaths of 23 after only 20,000 vaccinations in elderly patients in Norway is quite high. Given these deaths, Pfizer should be required to also reveal the safety profile after the 2nd dose.
Note though that Pfizer did provide a listing of adverse events for the 2nd dose in the paper itself in Figure 2:
www.nejm.org/.../nejmoa2034577_f2.jpeg
The omission I’m referring to is that in the supplementary file in Table S3 on page 9 the listing of adverse events is classified by serious, severe, life-threatening, or fatal, but this was only for the 1st dose. There was no corresponding table for the 2nd dose provided in the supplementary file.
In the bar graphs in Figure 2 linked above they show the number of fevers was much higher than for placebos after the 2nd dose. These fevers could have serious consequences for the elderly patients.
Then Pfizer should be required to provide the safety profile for the 2nd dose where the adverse events are classified by serious, severe, life-threatening or fatal, as was done for 1st dose in Table S3, page 9 of the supplementary file.
Going beyond that, they should also be required to provide the adverse events and safety profile specifically for elderly patients for both the 1st and 2nd doses.
Quite frankly, I’m surprised a vaccine manufacturer can get approval to the general public for a new vaccine without presenting the full safety information on both the 1st and the 2nd doses of their vaccine.
Am I correct in assuming if someone in the public asked the European Medicines Agency what’s the safety profile on the Pfizer vaccine after the 2nd dose their response would be, “We don’t know”?
Robert Clark
======================================================



___________________________

Robert Clark

Dept. of Mathematics

Widener University

One University Place

Chester, PA 19013 USA

___________________________

RC
Robert G Clark
Tue 2/16/2021 4:20 AM
Hello. I saw that you have privacy issues with the Pfizer vaccine. There are some safety issues as well that Pfizer has not been fully open about either. I copied below a letter I sent to the European Medicines Agency after they approved the Pfizer vaccine.

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RC
Robert G Clark
Mon 2/15/2021 9:54 AM
Hello. I saw your article reporting on the results of the Israel vaccination program. Since the Israeli program focused on the elderly I thought it might also contain safety info on elderly recipients. I was dismayed though to see it contained no safety data.