Re: Covid-19 vaccines: In the rush for regulatory approval, do we need more data?
Re:
Covid-19 vaccines: In the rush for regulatory approval, do we need more data? Peter Doshi. 373:doi
10.1136/bmj.n1244
Dear Peter Doshi,
Thank you for your coverage of COVID-19 and for sharing your critical thinking on serious issues [1].
It is my contention that two new aspects of the rollout of the Pfizer EUA product have risen to the level of reckless endangerment, and I am hopeful you will explore this and provide your thoughts.
On May 12, 2021, the United States Advisory Committee on Immunization Practices (ACIP) voted to recommend the investigational Emergency Use Authorization (EUA) Pfizer shot to children ages 12 to 15.[2] They also voted to end restrictions around co-administration with other vaccines even though there has not been a single clinical trial administering any of the shots with any other vaccine. [3]
Why are young teens being targeted with EUA shots? And why allow co-administration?
This is an age group that does not tend to be susceptible to severe infection, and CDC says from March of 2020 through April 2021, those aged 12-17 made up just 9% of the reported cases and a total of 127 deaths [3]. As with adults, children with underlying health issues are more at risk. Most children experience low to no symptoms and several studies now show that natural immunity is robust and likely long-lasting [4].
There are concerns that some children infected with SARS-CoV-2 are experiencing multisystem inflammatory syndrome (MIS-C). As of May 3, 2021, there have been 3742 cases, the majority of which recovered, but 35 were fatal.[5]
A case study says:
“MIS-C is considered to be caused by a late response to SARS-CoV-2 infection, as some patients have a negative RT-PCR but a positive IgM/IgG serology, highlighting the involvement of aberrant innate immunity as the main mechanism. There is also evidence that antibodies to SARS-CoV-2 accentuate the disease through a facilitating mechanism that enhances viral entry or antibody replication as has been observed in dengue.” [6]
Why is that important in regards to the Pfizer shot in children? Because the Pfizer shot, along with Moderna and the Janssen/J&J shots, all work by getting the recipient’s own cells to make a synthetic, genetically altered, stabilized version of the part of the virus now known to cause the most severe outcomes—the spike protein—and this means extreme caution should be taken with vaccine administration [7]. The recipient’s immune system creates antibodies to that spike protein. Will antibodies to the vaccine-induced spike protein cause MIS-C in some children? We have no idea. The study was far too small to catch rare outcomes.
While we of course want to protect children from severe disease and from MIS-C, there is zero evidence any of the shots are capable of doing this, or if they will instead cause these outcomes. What should be done is to look for underlying factors for why some children are experiencing severe disease or MIS-C after exposure to the virus so we can better protect and recover them. Obesity has been associated with both, and obesity is associated with low Vitamin D levels.
COVID-19 treatments are available and early treatment saves lives. Doctors around the country and around the world are calling for early treatment. [8] [9] Why are the CDC and NIH still silent on early ambulatory treatments?
The ACIP’s change of guidance to now allow co-administration adds another potential danger. Again, not a single study was done, not even in animals, to see if it is safe to give the Pfizer mRNA shot with any other vaccine. [3]
After the vote, some ACIP members gave their reason.
They only had one. They don't want to miss an opportunity to vaccinate.
That's it. Science be hanged, safety unknown, by gosh, they didn't want doctors to miss an opportunity to give other vaccines.
What happens when a 12-year-old is injected with Gardasil with its highly reactogenic aluminum AAHS adjuvant in one arm and the Pfizer mRNA shot in the other? What happens when the child’s cells begin pumping out spike protein in the presence of an adjuvant that is revving up their immune system to go on the attack?
We have no idea.
What on earth were the members of the ACIP thinking? Why would they make a recommendation allowing for co-administration based on zero safety science?
FiercePharma, the drug industry's insider online magazine, provided a likely answer within hours of the ACIP's vote:
“As revenues for several Big Pharma players slumped to start the year, execs blamed part of the problem on the accelerating COVID-19 vaccine rollout. The CDC had recommended people don't get another shot within two weeks of their COVID-19 vaccine, hitting sales for key products.
Now, the CDC is doing away with that suggestion entirely in an effort to boost routine immunizations among teens. The move could spell financial rewards for leading vaccine companies such as Merck, GlaxoSmithKline and Pfizer.” [10]
This is not science.
With all major and social media companies censoring anything critical of the COVID-19 vaccines, how can parents be warned about this lack of safety science? How many children will be harmed before it is stopped?
[1] Peter Doshi, ‘ Covid-19 vaccines: In the rush for regulatory approval, do we need more data?’, BMJ 2021; 373 doi:
Covid-19 vaccines: In the rush for regulatory approval, do we need more data? - https://doi.org/10.1136/bmj.n1244 (Published 18 May 2021)
[2]
ACIP May 12, 2021 Presentation Slides | Immunization Practices | CDC - https://www.cdc.gov/vaccines/acip/meetings/slides-2021-05-12.html
[3]
https://www.fda.gov/media/144414/download
[4] Sekine, T., Perez-Potti, A., Rivera-Ballesteros, O., Strålin, K., Gorin, J.-B., Olsson, A., Llewellyn-Lacey, S., Kamal, H., Bogdanovic, G., Muschiol, S., Wullimann, D. J., Kammann, T., Emgård, J., Parrot, T., Folkesson, E., Rooyackers, O., Eriksson, L. I., Henter, J.-I., Sönnerborg, A., … Unge, C. (2020). Robust T Cell Immunity in Convalescent Individuals with Asymptomatic or Mild COVID-19. Cell, 183(1).
Redirecting - https://doi.org/10.1016/j.cell.2020.08.017
[5]
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-05-12/0...
[6] Garcia-Dominguez, M., Angeles-Meneses, Y., Lares-Payan, A., Velazquez-Rios, C. A., Tostado Morales, E., & Perez-Gaxiola, G. (2020). Multisystemic Inflammatory Syndrome in Children Associated With SARS-CoV-2 Infection: A Case Series Report in a Pediatric Center in Mexico. Journal of medical cases, 11(12), 375–378.
Multisystemic Inflammatory Syndrome in Children Associated With SARS-CoV-2 Infection: A Case Series Report in a Pediatric Center in Mexico | Garcia-Dominguez | Journal of Medical Cases - https://doi.org/10.14740/jmc3584
[7] Suzuki, Y. J., & Gychka, S. G. (2021). SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines. Vaccines, 9(1), 36.
SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines - https://doi.org/10.3390/vaccines9010036
[8] Kory, P., Meduri, G. U., Varon, J., Iglesias, J., & Marik, P. E. (2021). Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. American Journal of Therapeutics, 28(3), e299–e318.
Review of the Emerging Evidence Demonstrating the Efficacy... : American Journal of Therapeutics - https://doi.org/10.1097/MJT.0000000000001377
9] McCullough, P. A., Kelly, R. J., Ruocco, G., Lerma, E., Tumlin, J., Wheelan, K. R., Katz, N., Lepor, N. E., Vijay, K., Carter, H., Singh, B., McCullough, S. P., Bhambi, B. K., Palazzuoli, A., De Ferrari, G. M., Milligan, G. P., Safder, T., Tecson, K. M., Wang, D. D., … Risch, H. A. (2020). Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection. The American Journal of Medicine, 134(1), 16–22.
Redirecting - https://doi.org/10.1016/j.amjmed.2020.07.003
[10]
https://www.fiercepharma.com/pharma/cdc-throws-out-covid-19-vaccine-coad...