The claims that animal studies have shown significant pulmonary inflammation,

Comment on Are mRNA Vaccines for COVID-19 helpful or harmful? by Sean Pitman.

The claims that animal studies have shown significant pulmonary inflammation, and other negative outcomes, following mRNA vaccination when these animals were then exposed to the live COVID-19 virus (not mentioned in the above-referenced interview with Wakefield) don’t seem to be true as far as I’ve been able to discover. Both of the mRNA vaccines (from Pfizer and Moderna) were simultaneously tested on animals while they were conducting Phase 1 trials on humans. The vaccines were tested on mice and macaques in particular. And, none of these tests showed any enhanced inflammation or reaction with subsequence COVID-19 exposure. Just the opposite is true. For example:

“Vaccination of nonhuman primates with mRNA-1273 induced robust SARS-CoV-2 neutralizing activity, rapid protection in the upper and lower airways, and no pathologic changes in the lung.” (Link).

“Mice vaccinated with these mRNAs were protected against lung infection when researchers later exposed the rodents to SARS-CoV-2, the coronavirus that causes COVID-19” (Link).

“The researchers injected ARCoV into the muscle tissue of 16 mice and provided a booster shot two weeks later. The vaccine elicited the production of high levels of neutralizing antibodies, which protect host cells by preventing the virus from interacting with them. These antibodies were cross-reactive, offering broad protection against three different strains of SARS-CoV-2. In addition, the vaccine increased the number of T cells in the spleen. Mice that received two doses of ARCoV and were exposed to SARS-CoV-2 35 days later showed no signs of viral RNA in the lungs or trachea and no lung damage or inflammation. Results from 20 cynomolgus monkeys showed that two ARCoV doses induced a virus-specific T cell response and the production of neutralizing antibodies at levels that far exceed those seen in most recovered COVID-19 patients. Moreover, none of the vaccinated animals experienced adverse effects.” (Link)

Also, human double-blinded trials in more than 70,000 people showed no such enhanced inflammation or reaction with COVID-19 exposure with prior mRNA vaccination.

University of Pennsylvania professor of medicine Dr. Drew Weissman, who has been studying mRNA and mRNA vaccines for decades, said they do not cause dangerous inflammation to animals. Along with the vaccines for Pfizer and Moderna both passing animal trials, they also passed clinical trials on humans where they were tested on more than 70,000 people (Link).

Perhaps, though, your wife is referring to a paper published by Timothy Cardozo and Ronald Veazey (October, 2020) cited concerns over what is known as “antibody-dependent enhancement” of vaccines? – with the potential to increase a negative response to the actual viral infection as compared to those who never had the vaccine? This concern is based on the observation of more severe disease occurring in individuals who received vaccines such as the one for dengue fever. In a 2018 study, scientists at La Jolla Institute for Immunology showed that newborn mouse pups harboring anti-Zika antibodies were more vulnerable to death from dengue exposure than mice that lacked anti-Zika antibodies. Certainly, this is an example of antibody-dependent enhancement (ADE). However, ADE has not been shown to occur in individuals that received COVID-19 vaccines during the double-blinded trials over many months or since the mRNA vaccines have started to be given to medical providers (like me).

Now, the reasons why ADE isn’t a significant concern for the mRNA vaccines against the COVID-19 virus is partly due to the fact that the COVID-19 virus does not infect macrophages in a way that is pro-inflammatory:

SARS-CoV infection of macrophages is abortive and does not alter the pro-inflammatory cytokine gene expression profile after antibody-dependent uptake4. Findings to date argue against macrophages as productive hosts of SARS-CoV-2 infection (Link).

For more specific details regarding the underlying science of immunology, see:

Vaccines that elicit neutralizing antibodies against the S protein reliably protect animals from SARS-CoV challenge without evidence of enhancement of infection or disease. These data suggest that human immunization strategies for SARS-CoV-2 that elicit high neutralizing antibody titres have a high chance of success with minimal risk of ADE. For example, subunit vaccines that can elicit S-specific neutralizing antibodies should present lower ADE risks (especially against S stabilized in the prefusion conformation, to reduce the presentation of non-neutralizing epitopes8). These modern immunogen design approaches should reduce potential immunopathology associated with non-neutralizing antibodies… It is encouraging that a recent assessment of an inactivated SARS-CoV-2 vaccine elicited strong neutralizing antibodies in mice, rats and rhesus macaques, and provided dose-dependent protection without evidence of enhanced pathology in rhesus macaques (Lee, et. al., 2020).

Some of the earlier attempts at a SARS vaccine showed ADE effects in mouse models, and further work showed that this seemed to be linked not so much to the antibody response as to the T cell response. Specifically, a “Th2” heavy response (as opposed to more Th1 or a balance between the two), was linked to lung pathology. Those are subdivisions of the CD4+ T cells, based on which cytokines they produce, and these results alerted everyone to keep an eye out for that. Mouse immunogenicity studies with the current vaccine candidates did not show these effects… This has been why we’ve seen so many vaccines taking care to put the Spike protein into its “prefusion” conformation. The worry has been that if antibodies are generated to it after it’s had a chance to bind to human cells, that gives you a better chance for nonneutralizing ones (and thus potentially a better chance for ADE). And you’ll have noticed the emphasis on neutralizing antibody titers along the way as well – that would have been there anyway, but a high proportion of outright neutralizing antibodies is also a safeguard against antibody-driven enhancement of disease. (Dr. Derek Lowe, December 18, 2020)

So, I fail to see any solid support for Wakefield’s claim here either. There is just no scientific evidence to support any of Wakefield’s main concerns or arguments against the mRNA vaccines – from either human or animal testing. To the contrary, these mRNA vaccines have proven themselves to be safer and more effective in humans than would have been originally predicted – in the face of extensive testing in tens of thousands of human subjects (soon to be millions – including me since I’ve already received the first Pfizer vaccine injection, with my second injection scheduled for this coming Friday).

Sure, I’m just a pathologist (with some fairly extensive training in genetics and the immune system via my subspecialty in hematopathology – which includes the study of the white blood cells that make up the immune system), but I know some vaccine experts and many on the front lines who are directly dealing with this pandemic face-to-face. The vast majority of those who are most familiar with COVID-19 and the mRNA vaccines, and their relative risks, strongly favor getting the vaccine – and have taken it themselves and would give it to their friends and family if they could at this point.

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Sean Pitman Also Commented

Are mRNA Vaccines for COVID-19 helpful or harmful?
I don’t know about Dr. Botha, in particular, but others have made similar claims. Of course, I see no credible evidence to support such sensational claims…

Are mRNA Vaccines for COVID-19 helpful or harmful?
Just because the effectiveness of vaccines may wane over time doesn’t mean that they aren’t working. They are working, very well. The vast majority of those who are being hospitalized right now with severe COVID-19 infections are the unvaccinated – by a ratio of more than 10:1 over the vaccinated.

Here’s an explanation from Shane Crotty, Ph.D. (Immune system and vaccine scientist. Professor, La Jolla Institute for Immunology (LJI), a non-profit research institute): Link

Are mRNA Vaccines for COVID-19 helpful or harmful?

As of June 11, 2021, approximately 296 million doses of mRNA COVID-19 vaccines had been administered in the United States, with 52 million administered to persons aged 12–29 years; of these, 30 million were first and 22 million were second doses. Within the Vaccine Adverse Event Reporting System (VAERS) (4), the national vaccine safety passive monitoring system, 1,226 reports of myocarditis after mRNA vaccination were received during December 29, 2020–June 11, 2021. Among persons with reported myocarditis after mRNA vaccination, the median age was 26 years (range = 12–94 years), with median symptom onset interval of 3 days after vaccination (range = 0–179). Among 1,194 reports for which patient age was known, 687 were among persons aged <30 years and 507 were among persons aged ≥30 years; of 1,212 with sex reported, 923 were male, and 289 were female.§§ Among 1,094 patients with number of vaccine doses received reported, 76% occurred after receipt of dose 2 of mRNA vaccine; cases were reported after both Pfizer-BioNTech and Moderna vaccines. Informed by early reports, CDC prioritized rapid review of myocarditis in persons aged <30 years reported during May 1–June 11, 2021; the 484 patient records in this subset were evaluated by physicians at CDC, and several reports were also reviewed with Clinical Immunization Safety Assessment Project investigators,¶¶ including cardiologists. At the time of this report, 323 of these 484 cases were determined to meet criteria in CDC’s case definitions for myocarditis, pericarditis, or myopericarditis by provider interview or medical record review (Table 1). The median age of the 323 patients meeting CDC’s case definitions was 19 years (range = 12−29 years); 291 were male, and 32 were female. The median interval from vaccination to symptom onset was 2 days (range = 0−40 days); 92% of patients experienced onset of symptoms within 7 days of vaccination. Of the 323 persons meeting CDC’s case definitions, 309 (96%) were hospitalized. Acute clinical courses were generally mild; among 304 hospitalized patients with known clinical outcomes, 95% had been discharged at time of review, and none had died. Treatment data in VAERS are preliminary and incomplete; however, many patients have experienced resolution of symptoms with conservative treatment, such as receipt of nonsteroidal antiinflammatory drugs. Follow-up is ongoing to identify and understand longer-term outcomes after myocarditis occurring after COVID-19 vaccination. (Link)

In comparison, those who are infected with COVID-19 have a much higher rate of myocarditis as well as a much MUCH higher rate of long-term injuries and death. Up to a third of otherwise young healthy people, including athletes and even children, end up with myocarditis following even mild infections with COVID-19.