Copyright 2021 Robert Clark
UPDATE: 4/11/2021
Normally, I put updates at the bottom of the original blog post but this is so important I'm putting it at the beginning.
Public health agencies have focused on giving the COVID vaccine to elderly recipients, such as nursing home residents. It's surprising then that the safety info has not been released to the public specifically for elderly recipients.
The Pfizer research report included the safety data for those over 55 and the Moderna report for those over 65. On that basis it was claimed the safety data has been provided for the elderly, say, those over 75 such as residents in nursing homes. But the safety issues for vaccines specifically for the elderly can be significantly different compared to those even in the range of 65 to 74:
Coronavirus Vaccine and Seniors: Could There Be a Problem?
The fact that elderly people do not respond well to immunizations has largely been ignored in most discussions of COVID-19 vaccines, despite this being the group in greatest need. Most of the scientific community’s experience with vaccine development for any disease has been focused on vaccinating the relatively young.
by Byram W. Bridle Shayan Sharif
July 24, 2020 Topic: Public Health Region: World Blog Brand: The Reboot Tags: Coronavirus COVID-19 Vaccines Senior Citizens Elderly
https://nationalinterest.org/blog/reboot/coronavirus-vaccine-and-seniors-could-there-be-problem-165360
So the fatalities for those contracting flu among the elderly, ~75 yrs. and above, is 8 times higher than even those in the 65 to 74 yrs age range.
Then a key issue is that the COVID vaccines cause flu-like reactions in a large percentage of people. From the vaccine trials we would estimate the number of all people who would get fevers after the second shot, the more injurious one, to be ~15%. But disturbingly data taking from actual vaccine recipients with the v-safe collection method put the number having fever after the second dose as ~30%:
Advisory Committee on Immunization Practices (ACIP)
March 1, 2021
Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Vaccine Task Force
Vaccine Safety Team
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I copied below some communications I had with the European Medicines Agency (EMA) through their online contact form about the safety of the COVID-19 vaccines specifically for elderly patients.
I have since read other reports that now make it imperative that Pfizer release a detailed safety report on 2nd dose AE's, classified by serious, severe, life-threatening, and fatal, as well as providing an analogously detailed safety report for elderly patients.
Here's one of the reports I'm referring to:
Second COVID Shot Packs the Big Punch.— First dose also worse for those with previous COVID, but "small price to pay" for protection.
by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today February 11, 2021
https://www.medpagetoday.com/
Note that though Pfizer has acknowledged that a large percentage of recipients will experience some side effects, what's key here is these side effects in many will occur concurrently. So the common side effects of headache, fever, chills, fatigue will occur at the same time, effectively incapacitating them for a day or more.
I had been concerned about the high fevers for the elderly but now knowing these adverse events can occur in combination it becomes even more worrisome considering the large percentage at which they occur. Younger, healthier people could weather this combination of symptoms, but elderly, frail patients may not be.
Also, worrisome is that these symptoms, debilitating in combination, can also occur after just the 1st dose for patients who already had COVID-19. So this serious combination of symptoms could be life-threatening even after just the 1st dose for elderly patients if they had COVID-19 already.
I don't know if this is the case in Europe but I know in the U.S. it's being recommended by health agencies that people who have had already COVID-19 should also get the vaccine. Again, for the elderly this could result in a life-threatening combination of symptoms after just the first dose, and for the young and healthy could be debilitating for a day or more.
This also raises the possibility that those who had COVID-19 but were asymptomatic or with mild symptoms, not being aware they had it, could also suffer this serious combination of symptoms after just the first dose.
This possibility of a life-threatening reaction for the elderly with prior COVID-19 after just the first dose may have been realized in the examples described in this report:
Deaths of Elderly Who Recovered From COVID-19, but Died After Vaccine, Raise QuestionsSharyl Attkisson
February 10, 2021 Updated: February 16, 2021
https://www.theepochtimes.com/
{may require registration}
We now know also the occurrence of the deaths in Norway nursing homes after taking the vaccine was not an outlier but rather is now something occurring worldwide:
02/16/21
46 Nursing Home Residents in Spain Die Within 1 Month of Getting Pfizer COVID Vaccine
Health officials have reportedly halted administration of the second shot of Pfizer’s vaccine at the Spanish nursing home.
“The UK Medical Freedom Alliance — a group of doctors, scientists, lawyers and other professionals who advocate for informed consent in the UK — published an urgent open letter to Nadhim Zahawi, Minister for COVID-19 vaccine deployment; Matt Hancock, the Secretary of State for Health and Social Care; and two vaccine oversight agencies calling for an immediate audit of the deaths following vaccination in the UK.
The group refers to graphs showing a surge in care home deaths and cites data from the Office for National Statistics that residents’ deaths tripled in the two weeks between January 8- 22 at a time when there was a massive increase in the rate of vaccinations in care homes.
https://
Given these examples, which apparently are common to both approved COVID-19 vaccines, both vaccine manufacturers should put out advisories making doctors aware of the possible dangers when used in these situations.
Robert Clark
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Robert Clark
Dept. of Mathematics
Widener University
One University Place
Chester, PA 19013 USA
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Sent: Friday, February 12, 2021 9:09 AM
To: Robert G Clark <rgc...@widener.edu>
Subject: [EXTERNAL:]AskEMA - Response to ASK-78662 - Safety of the Pfizer vaccine.
Thank you for your follow-up response regarding the safety of Comirnaty.
I am afraid there is not much I can add to our previous response. As noted there, we cannot comment on the information published in medical journals, which is a matter for them. Similarly, we cannot comment on what public information may or may not be available in other jurisdictions.
The side effects included in the licensed product information for the EU (https://www.ema.europa.eu/en/
Kind regards
**** ****, Stakeholders and Communication Division
European Medicines Agency
Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
Send us a question. Go to [http:://www.ema.europa.eu/
______________________________
We received your question(s) on: 10/02/2021
Subject of your enquiry: Safety of the Pfizer vaccine.
Your question(s):
Thank you for your quick response. I will read the safety reviews you made.
By the way, I can't remember if I mentioned this to you but among the fevers mentioned as occurring in the published report were also high fevers.
This is another key point that needs to be focused on. The Figure 2 of the report shows by bar graphs the number of fevers developed by vaccine recipients. In discussing that, they give this confusingly written passage:
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 die in hospital after contracting pneumonia.
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.
The data given doesn’t allow us to say how many of the elderly developed the high fevers, but if it were 0.8% of elderly patients getting a high fever after the 2nd dose that would be concerning. That would be 160 patients of the 20,000 in nursing homes in Norway who got the Pfizer vaccine.
For this reason, Pfizer should still be required to release the data to the public on the safety profile on the 2nd dose including the classification of the adverse events by serious, severe, life-threatening, and fatal.
And in addition a similar safety profile should be provided specifically for the elderly patients.
Robert Clark
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AskEMA No-Reply
Tue 2/9/2021 2:14 AM
To: Robert G Clark
Dear Mr Clark
Thank you for your message to the European Medicines Agency (EMA) regarding the safety of the Pfizer/BioNTech COVID-19 vaccine, marketed in the EU as [Comirnaty|https://www.ema.
I must point out that it is important not to confuse the information presented in papers printed in medical journals, which will have been edited by the journal and adapted for publication, with the much fuller information provided to regulators for assessment. EMA is in receipt of a full data package for the medicine, which has been provided bit by bit over the course of a rolling review. This naturally includes assessment of safety in recipients who have had both indicated doses.
You can find a report of EMA’s scientific evaluation of the vaccine, including its assessment of safety, at: [https://www.ema.europa.eu/en/
Because the medicine was granted a conditional marketing authorisation, one of a number of options available under EU pharmaceutical law, further information is expected to be provided over time. This includes input from the EU’s extensive pharmacovigilance monitoring system, which has been enhanced in the context of the mass vaccination campaigns expected for COVID-19 vaccines.
Regular safety summaries are being published to keep the public updated on new information regarding the safety of these medicines as we receive it, and the first such summary is available at: [https://www.ema.europa.eu/en/
EMA also intends to publish the more detailed information it has from the clinical studies on its clinical data site ([https://clinicaldata.ema.
We cannot comment on the specifics of the published paper in NEJM, but you might consider contacting the corresponding author should you wish to enquire further about the information provided therein.
I hope you find this information helpful. We would be grateful if you could take part in a short survey on our service, which you can access through the following link:
[https://ec.europa.eu/
Kind regards
**** ****, Stakeholders and Communication Division
European Medicines Agency
Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
Send us a question. Go to [http:://www.ema.europa.eu/
______________________________
We received your question(s) on: 03/02/2021
Subject of your enquiry: Safety of the Pfizer vaccine.
Your question(s):
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
https://www.nejm.org/doi/full/
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:
https://www.nejm.org/na101/
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
___________________________
Dept. of Mathematics
Widener University
One University Place
Chester, PA 19013 USA
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