Addressing Dr. Christina Parks’s Claims — Deplatform Disease

There is presently a viral video circulating featuring the testimony of Dr. Christina Parks regarding COVID-19 vaccines and mandating them. In this video, she makes a number of blatantly false claims or prevaricates and they are worth going through in detail. Parks recycles a few of her points so this is mostly chronological but if she returned to a particular subject I discuss it in the same section rather than mentioning it a second time.

Gene therapy

The Media

COVID-19 Vaccines and Transmission

Acellular Pertussis Vaccines

Influenza Vaccines and Transmission

Parks also made a comment about how getting multiple consecutive vaccines for influenza increases your risk of severe influenza. Truthfully, I am unsure what she is referencing. The best I can tell, she is misinterpreting how original antigenic sin works in influenza. Original antigenic sin is the concept that the first encounter we have from influenza generates immunological memory that gets recalled with subsequent encounters. However, influenza differs greatly between strains and the immune system may end up focusing on a conserved site between the different strains but one that does not offer good protection. As the discussion by Yewdell and Santos linked previously mentions however, epidemiological evidence for a significant role of original antigenic sin in influenza is at best mixed. When I asked Dr. Jenna Guthmiller about this concept, as I wasn’t sure what was being referred to (and she is a literal expert on the immunology of influenza), she explained to me that there isn’t really a harm per se but after successive boosting you eventually hit a ceiling with your antibodies where you can’t really productively generate new responses effectively, and that you are definitely better off getting your flu vaccine annually than not. I think that if I didn’t know, and Dr. Guthmiller didn’t know, this probably doesn’t have sound basis.

Pre-Licensure Trial Endpoints

Primary Efficacy Endpoints Study C4591001 has two primary endpoints:

First primary endpoint: COVID-19 incidence per 1000 person-years of follow-up in participants without serological or virological evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed ≥7 days after Dose 2

Second primary endpoint: COVID-19 incidence per 1000 person-years of follow-up in participants with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed ≥7 days after Dose 2

Secondary Efficacy Endpoints Study C4591001 has secondary endpoints based on different approaches to COVID-19 case evaluation criteria as follows:

COVID-19 confirmed at least 14 days after Dose 2: COVID-19 incidence per 1000 person-years of follow up in participants either (1) without or (2) with and without serological or virological evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed ≥14 days after Dose 2

Severe COVID-19: incidence per 1000 person-years of follow-up in participants either (1) without or (2) with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed either (1) ≥7 days after Dose 2 or (2) ≥14 days after Dose 2 CDC-defined COVID-19: incidence per 1000 person-years of follow-up in participants either (1) without or (2) with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed either (1) ≥7 days after Dose 2 or (2) ≥14 days after Dose 2.

For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period:

* Fever;

* New or increased cough;

* New or increased shortness of breath;

* Chills;

* New or increased muscle pain;

* New loss of taste or smell;

* Sore throat;

* Diarrhea;

* Vomiting.

For a secondary efficacy endpoint, a second definition, which may be updated as more is learned about COVID-19, included the following additional symptoms defined by CDC (listed at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html):

* Fatigue;

* Headache;

* Nasal congestion or runny nose;

* Nausea.

For another secondary endpoint, the case definition for a severe COVID-19 case was a confirmed COVID-19 case with at least one of the following:

* Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 ❤00 mm Hg);

* Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO);

* Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors)

* Significant acute renal, hepatic, or neurologic dysfunction;

* Admission to an ICU;

* Death.

That’s a lot of words but the short version is that the trial did not evaluate the ability to prevent symptoms- it evaluated the ability to prevent clinically and virologically confirmed SARS-CoV-2 infection. This point is perhaps less disingenuous to some than to others because some might not be aware of the distinction between signs and symptoms. Symptoms are the subjective perceptions that we may feel when we are ill- things like pain, fatigue, nausea, etc. Signs are objective and can be detected by the other person or through diagnostic testing, like a positive PCR for SARS-CoV-2 infection. Suggesting that the vaccines prevent symptoms only is dishonest. They demonstrated spectacular efficacies of ~95% against symptomatic COVID-19, which includes the disease processes it contributes to. The Johnson & Johnson/Janssen (JJJ) vaccine had slightly different primary endpoints:

The co-primary endpoints were efficacy of a single dose of vaccine to prevent centrally confirmed, moderate to severe/critical COVID-19 occurring (1) at least 14 days after vaccination and (2) at least 28 days after vaccination in study participants without evidence of prior SARS-CoV-2 infection at baseline. Evaluation of the co-primary endpoints was triggered by prespecified criteria:

1. The first 50% of participants have at least 2 months of follow-up after vaccination

2. At least 42 moderate to severe/critical cases of COVID-19 with onset at least 28 days after vaccination

3. At least 6 cases of COVID-19 among participants ≥60 years of age (onset ≥28 days after vaccination)

4. At least 5 severe/critical cases of COVID-19 in the placebo group (onset ≥28 days after vaccination) with a favorable vaccine-to-placebo split for both co-primary endpoints.

However note here that the vaccine was not evaluated on the basis of its ability to prevent symptoms as Parks states in her testimony.

Mucosal Immunity by the mRNA vaccines

Viral Loads and Delta Variant

Parks repeated the persistently misunderstood claim that viral loads are equal between vaccinated and unvaccinated individuals. This has not been demonstrated, and in fact there is considerable evidence to the contrary. Parks is conflating qPCR Ct values with viral load, which is inappropriate. Ct values are a metric with PCR that reflect how much DNA there is in the sample you run the reaction on (which is itself a proxy for how much viral RNA there is in people’s noses). The issue is that viral RNA does not equate to replication competent virus. In particular, coronaviruses make large quantities of subgenomic RNA, and depending on what the primers used for the PCR are set to (often it is the N gene, which comprises the bulk of subgenomic RNA), the reaction may detect RNA not associated with intact virus that lowers the Ct value, suggesting a higher viral load. Different variants produce different quantities of subgenomic RNA, and thus Ct value alone cannot be used to make comparisons of viral load. Formally, this requires a viral titration, but this is subject to certain challenges. Specifically, working with SARS-CoV-2 requires a Biosafety Level 3 facility, which is not widely available- hence the need for pseudovirus assays as these can be performed at lower biosafety levels. Regardless, this is easy enough to rebut with two studies. Firstly, vaccinated cases who experience breakthrough infections with the delta variant demonstrate a lower likelihood of having positive virus cultures. Notably, this is still not a viral titration, which would be valuable information regarding the relative infectiousness of those cases which do have positive virus and which do not. Additionally, it is noted that patients who experience breakthrough infections with the delta variant have much more rapid clearance of the virus (meaning less opportunity to transmit); though this is noted through longitudinal PCR testing and not directly viral load, there is no clear process to me by which one could selectively diminish the RNAs without affecting viral load and further these cases are matched with naive controls who also had the same variant (delta). While it is possible for post-vaccine infections to transmit, it is a priori less likely for those infections to occur and even when they do they will not be infectious for as long and they may not even have enough virus in their nose to produce new productive infections. However, given the substantial spread of the delta variant, the heterogeneity in vaccine uptake throughout the US (i.e. large pockets of unvaccinated), and the still nontrivial number of positive viral cultures among vaccinated individuals, nonpharmaceutical interventions are needed to control COVID-19 in addition to vaccination.

Barnstable County Outbreak

Stock then brings up the Barnstable County outbreak and he gets applauded for some stupid reason, again ignoring context and misrepresenting data. We have no idea what the denominator for the outbreak described here was (i.e. how many people were exposed to the virus). There is no way to make a conclusion about vaccine effectiveness from that study, despite him trying to imply it shows the vaccine doesn’t work. Here’s a thought experiment for you to understand why this isn’t useful. Suppose I take 100 fully vaccinated people and put them in a room where I introduce aerosolized measles virus. We might expect a few of them to get sick because vaccines aren’t 100% effective (2 doses of MMR-II are 97–99% effective against measles). 100% of the cases will be in people who were fully vaccinated. Does that mean the vaccines don’t work? Secular trends in the incidence of measles would suggest otherwise. See this excellent animation by Dr. Kristen Panthagani in this post from Dr. Jeremy Faust’s Inside Medicine Bulletin showing how breakthrough cases and disease prevalence change with vaccination rates. Provincetown has a 95% vaccination rate. If 74% of the cases were in vaccinated people, that gives vaccines (and this is across all 3 available in the US) 84% effectiveness (assuming everyone in Provincetown had equal likelihood of exposure) against symptomatic COVID-19 under conditions that would really stress test them. In short, this case series does not impugn the effectiveness of vaccines for COVID-19 and anyone claiming that it does either doesn’t understand how vaccine effectiveness works or has an agenda.

ADE/VAERD

Variants and Immunity

Who is hesitant to take vaccines?

Tuskegee Syphilis Study

There is no question that this study and many others like it have resulted in a legacy of justified distrust among BIPOC individuals as they have undeniably been wronged at the hands of the medical system. Dr. Kimberly Manning has written eloquently about her decision to enroll in a vaccine trial despite being a Black woman physician intimately familiar with the legacy of abuse here. She notes quite critically that she had the option of leaving the trial any time she chose. Furthermore, as part of Operation Warp Speed, efforts were taken to recruit a representative sample of trial participants, including BIPOC individuals, such that there would be similar proportions of them in the study as in the general population. The trial composition is given in the briefing documents linked above, which approximates that of the US (note that the trials were conducted across multiple sites in multiple countries and thus cannot be perfectly representative of the US’s composition). It cannot be ignored that the risk to BIPOC individuals from COVID-19 is disproportionate owing to syndemic vulnerabilities they experience. I wrote the following before:

COVID-19 has massively exploited structural racism in our society to spread. COVID-19 disproportionately affects people of color, and many explanations have been proposed to explain this, most of which are sociological in nature rather than biological. People of color are more likely to be essential workers and thus more likely to be exposed (an inoculum size effect may contribute to their heightened disease severity). They are also more likely to be un- or under-insured. People of color also bear a disproportionate burden of many of the risk factors for severe COVID-19, including diabetes, heart disease, obesity, renal disease, and liver disease. Curiously, mortality from influenza and pneumonia for the elderly are lower among African American and Latino individuals compared with people of white background.

Thus weaponizing lies about the COVID-19 vaccines to discourage vaccination is especially unconscionable as it could save the life of the vaccinated person, especially if they are high risk.

MMR Vaccine and Autism

There is presently a viral video circulating featuring the testimony of Dr. Christina Parks regarding COVID-19 vaccines and mandating them. In this video, she makes a number of blatantly false claims or prevaricates and they are worth going through in detail. Parks recycles a few of her points so this is mostly chronological but if she returned to a particular subject I discuss it in the same section rather than mentioning it a second time.

Gene therapy

The Media

COVID-19 Vaccines and Transmission

Acellular Pertussis Vaccines

Influenza Vaccines and Transmission

Parks also made a comment about how getting multiple consecutive vaccines for influenza increases your risk of severe influenza. Truthfully, I am unsure what she is referencing. The best I can tell, she is misinterpreting how original antigenic sin works in influenza. Original antigenic sin is the concept that the first encounter we have from influenza generates immunological memory that gets recalled with subsequent encounters. However, influenza differs greatly between strains and the immune system may end up focusing on a conserved site between the different strains but one that does not offer good protection. As the discussion by Yewdell and Santos linked previously mentions however, epidemiological evidence for a significant role of original antigenic sin in influenza is at best mixed. When I asked Dr. Jenna Guthmiller about this concept, as I wasn’t sure what was being referred to (and she is a literal expert on the immunology of influenza), she explained to me that there isn’t really a harm per se but after successive boosting you eventually hit a ceiling with your antibodies where you can’t really productively generate new responses effectively, and that you are definitely better off getting your flu vaccine annually than not. I think that if I didn’t know, and Dr. Guthmiller didn’t know, this probably doesn’t have sound basis.

Pre-Licensure Trial Endpoints

Primary Efficacy Endpoints Study C4591001 has two primary endpoints:

First primary endpoint: COVID-19 incidence per 1000 person-years of follow-up in participants without serological or virological evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed ≥7 days after Dose 2

Second primary endpoint: COVID-19 incidence per 1000 person-years of follow-up in participants with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed ≥7 days after Dose 2

Secondary Efficacy Endpoints Study C4591001 has secondary endpoints based on different approaches to COVID-19 case evaluation criteria as follows:

COVID-19 confirmed at least 14 days after Dose 2: COVID-19 incidence per 1000 person-years of follow up in participants either (1) without or (2) with and without serological or virological evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed ≥14 days after Dose 2

Severe COVID-19: incidence per 1000 person-years of follow-up in participants either (1) without or (2) with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed either (1) ≥7 days after Dose 2 or (2) ≥14 days after Dose 2 CDC-defined COVID-19: incidence per 1000 person-years of follow-up in participants either (1) without or (2) with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen — cases confirmed either (1) ≥7 days after Dose 2 or (2) ≥14 days after Dose 2.

For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period:

* Fever;

* New or increased cough;

* New or increased shortness of breath;

* Chills;

* New or increased muscle pain;

* New loss of taste or smell;

* Sore throat;

* Diarrhea;

* Vomiting.

For a secondary efficacy endpoint, a second definition, which may be updated as more is learned about COVID-19, included the following additional symptoms defined by CDC (listed at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html):

* Fatigue;

* Headache;

* Nasal congestion or runny nose;

* Nausea.

For another secondary endpoint, the case definition for a severe COVID-19 case was a confirmed COVID-19 case with at least one of the following:

* Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 ❤00 mm Hg);

* Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO);

* Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors)

* Significant acute renal, hepatic, or neurologic dysfunction;

* Admission to an ICU;

* Death.

That’s a lot of words but the short version is that the trial did not evaluate the ability to prevent symptoms- it evaluated the ability to prevent clinically and virologically confirmed SARS-CoV-2 infection. This point is perhaps less disingenuous to some than to others because some might not be aware of the distinction between signs and symptoms. Symptoms are the subjective perceptions that we may feel when we are ill- things like pain, fatigue, nausea, etc. Signs are objective and can be detected by the other person or through diagnostic testing, like a positive PCR for SARS-CoV-2 infection. Suggesting that the vaccines prevent symptoms only is dishonest. They demonstrated spectacular efficacies of ~95% against symptomatic COVID-19, which includes the disease processes it contributes to. The Johnson & Johnson/Janssen (JJJ) vaccine had slightly different primary endpoints:

The co-primary endpoints were efficacy of a single dose of vaccine to prevent centrally confirmed, moderate to severe/critical COVID-19 occurring (1) at least 14 days after vaccination and (2) at least 28 days after vaccination in study participants without evidence of prior SARS-CoV-2 infection at baseline. Evaluation of the co-primary endpoints was triggered by prespecified criteria:

1. The first 50% of participants have at least 2 months of follow-up after vaccination

2. At least 42 moderate to severe/critical cases of COVID-19 with onset at least 28 days after vaccination

3. At least 6 cases of COVID-19 among participants ≥60 years of age (onset ≥28 days after vaccination)

4. At least 5 severe/critical cases of COVID-19 in the placebo group (onset ≥28 days after vaccination) with a favorable vaccine-to-placebo split for both co-primary endpoints.

However note here that the vaccine was not evaluated on the basis of its ability to prevent symptoms as Parks states in her testimony.

Mucosal Immunity by the mRNA vaccines

Viral Loads and Delta Variant

Barnstable County Outbreak

Stock then brings up the Barnstable County outbreak and he gets applauded for some stupid reason, again ignoring context and misrepresenting data. We have no idea what the denominator for the outbreak described here was (i.e. how many people were exposed to the virus). There is no way to make a conclusion about vaccine effectiveness from that study, despite him trying to imply it shows the vaccine doesn’t work. Here’s a thought experiment for you to understand why this isn’t useful. Suppose I take 100 fully vaccinated people and put them in a room where I introduce aerosolized measles virus. We might expect a few of them to get sick because vaccines aren’t 100% effective (2 doses of MMR-II are 97–99% effective against measles). 100% of the cases will be in people who were fully vaccinated. Does that mean the vaccines don’t work? Secular trends in the incidence of measles would suggest otherwise. See this excellent animation by Dr. Kristen Panthagani in this post from Dr. Jeremy Faust’s Inside Medicine Bulletin showing how breakthrough cases and disease prevalence change with vaccination rates. Provincetown has a 95% vaccination rate. If 74% of the cases were in vaccinated people, that gives vaccines (and this is across all 3 available in the US) 84% effectiveness (assuming everyone in Provincetown had equal likelihood of exposure) against symptomatic COVID-19 under conditions that would really stress test them. In short, this case series does not impugn the effectiveness of vaccines for COVID-19 and anyone claiming that it does either doesn’t understand how vaccine effectiveness works or has an agenda.

ADE/VAERD

Variants and Immunity

Who is hesitant to take vaccines?

Tuskegee Syphilis Study

There is no question that this study and many others like it have resulted in a legacy of justified distrust among BIPOC individuals as they have undeniably been wronged at the hands of the medical system. Dr. Kimberly Manning has written eloquently about her decision to enroll in a vaccine trial despite being a Black woman physician intimately familiar with the legacy of abuse here. She notes quite critically that she had the option of leaving the trial any time she chose. Furthermore, as part of Operation Warp Speed, efforts were taken to recruit a representative sample of trial participants, including BIPOC individuals, such that there would be similar proportions of them in the study as in the general population. The trial composition is given in the briefing documents linked above, which approximates that of the US (note that the trials were conducted across multiple sites in multiple countries and thus cannot be perfectly representative of the US’s composition). It cannot be ignored that the risk to BIPOC individuals from COVID-19 is disproportionate owing to syndemic vulnerabilities they experience. I wrote the following before:

COVID-19 has massively exploited structural racism in our society to spread. COVID-19 disproportionately affects people of color, and many explanations have been proposed to explain this, most of which are sociological in nature rather than biological. People of color are more likely to be essential workers and thus more likely to be exposed (an inoculum size effect may contribute to their heightened disease severity). They are also more likely to be un- or under-insured. People of color also bear a disproportionate burden of many of the risk factors for severe COVID-19, including diabetes, heart disease, obesity, renal disease, and liver disease. Curiously, mortality from influenza and pneumonia for the elderly are lower among African American and Latino individuals compared with people of white background.

Thus weaponizing lies about the COVID-19 vaccines to discourage vaccination is especially unconscionable as it could save the life of the vaccinated person, especially if they are high risk.

MMR Vaccine and Autism

Originally published at https://www.deplatformdisease.com on September 2, 2021.

I write about vaccines here. You can find me on Twitter @enirenberg and at deplatformdisease.com (where I publish the same content without a paywall)

I write about vaccines here. You can find me on Twitter @enirenberg and at deplatformdisease.com (where I publish the same content without a paywall)