Tuesday, March 16, 2021

Vaccine companies keep hidden COVID-19 safety data for elderly patients. UPDATED: 4/11/2021

                                                 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

 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%:

COVID-19 vaccine safety update
Advisory Committee on Immunization Practices (ACIP)
March 1, 2021
Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Vaccine Task Force
Vaccine Safety Team


 Judging by the vaccine trials these fevers only last a day or so. However for about 1-2% of cases the fever can last over a week. That would be quite concerning for an elderly patient.

 And still note this data is still not telling us about the important case of elderly patients. Then I was still looking for some reports discussing the safety question of the vaccines for the elderly.

 Two recent articles looked at the COVID vaccine for elderly recipients:

Age-dependent immune response to the Biontech/Pfizer BNT162b2 COVID-19 vaccination.


Vaccine effectiveness after 1st and 2nd dose of the BNT162b2 mRNA Covid-19 Vaccine in long-term care facility residents and healthcare workers – a Danish cohort study

 They both concluded the effectiveness in the elderly after the 2nd shot is only ~60%. This is surprising since both the Pfizer and Moderna trial reports both implied that the effectiveness in the elderly approached the 90% range seen in younger recipients. But it is in keeping with the prior results that vaccines are not as protective for the elderly. 

 BUT these two recent report still did not consider the safety issues.

 Quite astonishingly there have been no reports that looked at the safety data for the COVID vaccine specifically for elderly recipients.
 A report that might allow us to make a comparison of the COVID vaccine recipients for serious medical conditions has recently come out:

 Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study.

 The title is rather misleading in that it does not give the number of adverse events for COVID vaccine recipients. It estimates instead the prevalence of conditions such as strokes, blood clots, and heart attacks in the general population. This is especially important to know given the recent reports of strokes in vaccine recipients in order to see how they deviate from the rates in the general populations. 

 Now we can compare to the data collected by the v-safe collection method described in the CDC report "COVID-19 vaccine safety update, Advisory Committee on Immunization Practices (ACIP)" cited above.

 The report makes a comparison for the COVID vaccines both to unvaccinated and vaccinated cases:

 The researchers found no significant difference here.

  However, the researchers in making a comparison to other vaccinated cases claimed also "no significant difference" while actually a sizable difference is apparent in the data for some adverse events:

  This illustrates a phenomenon criticized by statisticians that is common in some medical studies, where differences apparent in the data are disregarded as "not real" because the significance level does not reach the rather arbitrarily defined "0.5" level.
Scientists rise up against statistical significance.
Valentin Amrhein, Sander Greenland, Blake McShane and more than 800 signatories call for an end to hyped claims and the dismissal of possibly crucial effects.
Valentin Amrhein , Sander Greenland & Blake McShane

 This is actually a quite serious problem in medical studies: it results in life-saving drugs and life-threatening side effects being dismissed because of it.

 In scenarios like this, rather than dismissing the validity of the results, what it is actually signaling is that larger studies need to be done to strengthen the significance level. 

 In this particular case with the number of cases in the v-safe database of 800,000 it should be doable to get a quite high level of statistical significance to determine the validity of these numbers

   Robert Clark

 (Below the original blog post discussing the fact the vaccine companies and public health agencies have not released the safety data specifically for elderly patients.)


  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.

 After writing these, the question occurred to me, “Why am I having to go through this rigmarole to get the data that should be freely available about elderly recipients of the vaccine?”

 And I finally came to a stunning realization, "I'm being stonewalled."

 A large segment of the public is already skeptical about vaccines. This concern is worse now for new vaccines, and it’s even worse for a different kind of vaccine, and still worse again when the usual roll-out period of 5 to 10 years was shortened down to a single year. Then the vaccine manufacturers should be “purer than Caesar's wife”, in regards to the openness of their vaccine data.

 Yet the vaccine manufactures have not revealed the safety data specifically for elderly patients. And the impression I got from the EMA and also from the CDC is they are no more interested than the vaccine manufacturers in providing this information. 

 The conclusion that the vaccine companies are intentionally hiding the safety data for elderly recipients from the public was confirmed by this recent report:

Early effectiveness of COVID-19 vaccination with BNT162b2 mRNA vaccine and ChAdOx1 adenovirus vector vaccine on symptomatic disease, hospitalisations and mortality in older adults in England.
Jamie Lopez Bernal, et al.

 Every other report on the COVID-19 vaccines when they were discussing younger recipients, reported both the efficacy and safety of the vaccine.

 But in this report discussing elderly recipients, only the efficacy is reported, not the safety.

 Let this sink in for a minute:

 If you were to ask the CDC or the EMA or any other public health agency what is the safety profile for the COVID-19 vaccine specifically for elderly patients, their response would be, "We don't know."

 You don't have to believe me on this. I ask any doctor in any country anywhere in the world that specializes in treating elderly patients or oversees care in nursing homes to ask for this data.

 Here’s the CDC contact page:

 Here’s the EMA contact page:

 The contact person for the NEJM report by Pfizer on their vaccine trial is given here:

 It is possible that if your specialty is gerontology that they'll provide you this information since clearly in your case it would be extremely important to know that, but my guess is you'll be stonewalled too.

    Robert Clark

Re: [EXTERNAL:]AskEMA - Response to ASK-78662 - Safety of the Pfizer vaccine.

 I read the report you suggested [https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdfand found it was less informative than the NEJM article I was referencing in regards to adverse events. For instance it doesn't say that high fevers at > 38.9⁰C (102⁰F) temperatures occur at 0.8% of cases for the vaccine compared to 0.1% for the placebo.

 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

 It details that healthcare workers commonly have to take off work because of side effects of the second dose. These are people of relatively good health, yet a large number are wiped-out after the 2nd dose, to the extent they have to take off a day or so to recover.

 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 Questions
Sharyl Attkisson
February 10, 2021 Updated: February 16, 2021 
{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:

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.

Similar graphs for Israel, Ireland, Bahrain and Jordan show a similar correlation.”

  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


Robert Clark

Dept. of Mathematics

Widener University

One University Place

Chester, PA 19013 USA


From: AskEMA No-Reply <AskEMA....@ema.europa.eu>
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.
Dear Mr Clark

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/documents/product-information/comirnaty-epar-product-information_en.pdf) are based on the safety database in all patients given the licensed regimen in prelicensing studies and our information is increasingly being supplemented with real-world evidence from the millions of persons who have now received the vaccine. EMA will take any necessary regulatory action should a signal of new side effects or a change in frequency of known side effects in particular groups be confirmed.

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/contact]www.ema.europa.eu/contact Telephone: +31 (0)88 781 6000


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


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.europa.eu/en/medicines/human/EPAR/comirnaty]. You raise some concerns about the data provided in a published paper in the New England Journal of Medicine and ask whether EMA has information on the safety of the medicine after a second dose.

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/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf].

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/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-january-2021_en.pdf]. This addresses the issues reported in frail elderly individuals in Norway.

EMA also intends to publish the more detailed information it has from the clinical studies on its clinical data site ([https://clinicaldata.ema.europa.eu/web/cdp/home]) once this has been redacted of personal/confidential information.

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:


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/contact]www.ema.europa.eu/contact Telephone: +31 (0)88 781 6000


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

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:


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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