Pfizer-BioNTech COVID-19 vaccine immune response in the elderly

In the absence of therapeutic intervention, vaccines are the only available avenue to contain the COVID-19 (coronavirus disease 2019) pandemic. Currently, vaccines against the causal agent, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), are being administered globally.

It is essential to understand the vaccine response to know its efficacy under diverse plans and cohorts. The duration of protection imparted by the current vaccine is unknown in a real-world setting. This is important, particularly in underrepresented groups in clinical trials. One such group is the elderly population, aged above 80 years, who are at the most significant risk of death from COVID-19 disease.

To date, clinical trials have not provided much information on the vaccine efficacy or the neutralizing responses in individuals above the age of 80. To throw light on these aspects, researchers undertook a post-vaccination immunogenicity study in the elderly population.

In a recent medRxiv* preprint publication, the team led by Professor Ravindra K. Gupta has assessed the real-world immune responses following the vaccination against the SARS-CoV-2. The team measured 1) IFN-gamma (interferon-gamma) T cell responses, 2) both total IgG Spike/ IgG Spike RBD (receptor binding domain) and 3) neutralizing antibody responses to Spike in sera.

The spike (S) protein is present on the virus's surface; via this protein, the virus enters the host human cell. The vaccines developed to target this region of the protein, and the antibodies are developed against it.

The mRNA-based vaccine BNT162b2 was administered to populations in the UK on a two-dose approach, separated by a three-week gap. In this study, the cohort included 26 participants. The median age was 82 years.

After each dose of the vaccines, the team analyzed the T cell responses and the antibody activity. They observed that the T cell responses did not correlate with serum neutralization after the first dose.

As expected, the neutralization activity increased between the first and second doses. Notably, they observed poor neutralization activity only in the elderly population - over 80 (compared to those under 80) after the first dose.

When tested three weeks after the second dose, they found increased neutralizing titers between the first and second doses. They observed no significant difference between participants above and below the age of 80 after the second dose.

The researchers also used an approved rapid finger prick antibody test detecting S antibodies to test the participants at both time points. They observed a positive neutralization with 42% sensitivity and 100% specificity three weeks after the first dose. Three weeks after the second dose, it was with 95% sensitivity and 100% specificity.

These rapid antibody testing help to identify suboptimal responders following the second dose and, with evaluation, determine the requirement of boosting.

Here, the researchers describe the immunogenicity data from the real world roll out after the first dose of Pfizer BNT162b2 vaccine, focusing on responses in individuals around age 80. This study shows that among the individuals above the age of 80, certain individuals exhibit suboptimal neutralizing antibody response three weeks after vaccination, whereas the second dose is associated with robust neutralizing responses.

“It will be important to follow all participants over the following months to measure the kinetics of neutralization activity as well as data on reinfection”

Importantly, individuals over 80 years old are likely to be at prolonged increased risk for infection until the second dose. Thus, the SARS-CoV-2 infection during an enlarged window period between doses in the presence of only partially protective antibody titers could generate conditions for selecting escape mutations, the researchers write.

*Important Notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Journal reference:
  • Age-related heterogeneity in Neutralising antibody responses to SARS-CoV-2 following BNT162b2 vaccination, Dami Collier, Isabella Ferreira, Rawlings Datir, Bo Meng, Laura Bergamaschi, The CITIID-NIHR Bioresource COVID-19 Collaboration, Anne Elmer, Nathalie Kingston, Barbara Graves, Barbara Graves, Kenneth GC Smith, John Bradley, Paul Lyons, Lourdes Ceron-Gutierrez, Gabriela Barcenas-Morales, Rainer Doffinger, Mark Wills, Ravindra K Gupta, medRxiv. 2021.02.03.21251054; doi: https://doi.org/10.1101/2021.02.03.21251054, https://www.medrxiv.org/content/10.1101/2021.02.03.21251054v1
Dr. Ramya Dwivedi

Written by

Dr. Ramya Dwivedi

Ramya has a Ph.D. in Biotechnology from the National Chemical Laboratories (CSIR-NCL), in Pune. Her work consisted of functionalizing nanoparticles with different molecules of biological interest, studying the reaction system and establishing useful applications.

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Comments

  1. Robert Clark Robert Clark United States says:

    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

    ___________________________


    Reply

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










    To: [email protected]
      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.


    See 4 more messages
    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.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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