An analysis of VAERS reports shows that contrary to the FDA’s briefing document claiming that the majority of adverse events in Pfizers’ clinical trial were non-serious – at least 58 cases of life-threatening side effects in infants under 3 years old who received mRNA vaccines were reported. For some, it is unclear if they survived. It is also unclear why the infants were vaccinated, and whether they were part of the clinical trials. However, in the upcoming FDA meeting on Wednesday, the FDA will not be able to argue it did not know
| Ranit Feinberg & Yaffa Shir-Raz | English
- While the FDA is preparing to approve the mRNA COVID-19 vaccine for infants and toddlers aged 6 months to four years, and claims in its’ VRBPAC Briefing Document released today that the majority of adverse events found in Pfizers’ trial were non-serious – Real-Time magazine analysis reveals at least 58 life-threatening adverse events in infants and toddlers aged under 3 years old reported to VAERS.
- The most common serious adverse events were life-threatening bleeding, anaphylactic shock, anticholinergic syndrome, encephalitis, hypoglycemia and neuroleptic syndrome. In most of the reported cases, these are multi-system injuries.
- In some cases it is not clear what happened to the babies – did they survive? And if so, have they recovered?
- Most reports do not specify under what circumstances the infants were vaccinated, and if they participated in the clinical trials.
- While the FDA claims in its’ briefing document that the vaccine efficacy in infants is 80.4%, the document reveals that the claim is based on a total of 10 symptomatic cases of COVID-19 identified in the trial among 1415 participants – 7 of them in the placebo group vs. 3 in the vaccine group.
Assisted in the preparation of the article Shani Cohen
“Chest pain; cardiac arrest; Skin cold clammy”. This short description of a cardiac arrest, which occurred one hour after receiving a Pfizer-BioNTech COVID-19 vaccine, is taken from the VAERS system – the US Vaccine Adverse Eve Reporting System ( case number 1015467), and it does not refer to an elderly person, nor to a young adult, or even a teenager. It is hard to believe, but this report refers to a two-month-old baby. “A 2-month-old male patient received bnt162b2 (PFIZER-BioNTech COVID-19 VACCINE) lot number: EL 739, via an unspecified route of administration on 02 Feb 2021 at single dose for COVID-19 immunisation”, thus stated in the report. “Patient administered vaccination, observed for 15 minutes left the clinic then returned one hour later on 02 Feb 2021, presenting as skin cold, clammy and with chest pain, cardiac arrest event then developed, patient stabilised and transferred for further medical treatment… The outcome of the events was unknown. This case was reported as serious with seriousness criteria-life threatening from HA. No follow-up attempts possible. No further information expected”.
How did a 2-month-old baby receive the mRNA vaccine? These vaccines have not yet received EUA (Emergency Use Authorization) for approved use in children ages five and under by the FDA, or any other regulatory authority, and even if it will, the EUA will only include babies 6 months and older.
Was this baby a participant in Pfizer-BioNTech’s clinical trials, testing efficacy and safety among babies?
The answer is unclear. According to the person who wrote the report “Unsure if patient was enrolled in clinical trial”. However, the author of the report also states that the report was ”received from a contactable Other Health Care Professional by Pfizer from the Regulatory Agency”. This note implies that the infant might have actually participated in Pfizer’s trial. The regulatory agency report Safety Report Unique Identifier GB-MHRA-ADR 24687611 – indicates that the report came from Great Britain (the first 2 letters in the report ID stand for the country of origin, GB- Great Britain, and MHRA indicate that the source of reporting was its’ drug authority).
Why did they not follow up on the 2-month-old baby’s condition, after going into cardiac arrest an hour after receiving an experimental vaccine? Why is there no further information? Is it because he died? Or was the baby removed form an experiment? Why would the author of the report not mention this?
Shockingly, it turns out that this incident is not isolated, but in fact one of many in the VAERS system, describing babies and children under five exposed to mRNA Covid vaccines, who suffered life-threatening adverse reactions.
Even though children under five were not considered eligible for these vaccines unless they were part of a clinical trial, astonishingly, it appears that there are many reports in the system describing babies and toddlers who were vaccinated. Some of the children suffered from life-threatening adverse events. In some cases, it is not clear what happened to them; did they survive and recover, do they still suffer from health problems, or did they die.
In a couple of days, on June 15, the FDA’s Vaccines and Related Biological Products Advisory Committee will discuss Moderna and Pfizer’s EUA requests for vaccines for infants and toddlers aged 6 months to 4 years – the only group not yet eligible for COVID-19 vaccination today. According to the FDA’s briefing document released today ahead of the VRBPA committees’ meeting, there were “245 US reports” to the VAERS system “in children 6 months through 4 years of age”, who were injected (“product administered to patient of inappropriate age” or “off-label use”) or exposed to the vaccine “via breastmilk”. Nevertheless, both companies announced already in May that their findings indicate that their vaccines are safe and effective. The VRBPAC Briefing Document lists a variety of adverse events reported following the exposure to the vaccine in this age group, including “pyrexia…, body temperature…, cough, headache, rash, diarrhea”. According to the document, “Among US VAERS reports for individuals aged 6 months through 4 years, which may reflect unauthorized use of the vaccine or may reflect a reporting error, the majority (96.3%) were non-serious”. While the document specifies safety concerns identified from post-authorization safety surveillance data in VAERS, including anaphylaxis, myocarditis, and pericarditis, it does not relate to these safety concerns identified in the younger age group. Instead, it states: “No unusual frequency, clusters, or other trends for adverse events were identified that would suggest a new safety concern”.
But is that really the case? It seems that regardless of the results, and despite the disturbing and shocking findings that are being exposed from Pfizer’s documents, it is expected that both companies will receive the desired EUA very soon. In fact, the CDC website, already in April, had advertised a protocol regarding children’s vaccination, which included babies 6 month to 4 years as well.
In light of this expected approval, RT Magazine conducted an analysis of the cases reported in the VAERS system referring to babies up to 3 years old.
During the analysis, cases were removed in which it was stated that the exposure to the vaccine was through breastfeeding (these cases were analyzed separately and will soon be presented in a follow-up article), as well as cases that were identified as errors in the age registration.
The analysis shows there were at least 58 cases of severe and life-threatening adverse reactions among babies and toddlers 3 years old and younger. This finding is especially puzzling considering the fact that they weren’t supposed to be vaccinated at this age to begin with. Sadly, similarly to the case reported above, most VAERS reports do not indicate how and under which circumstances they were exposed to the vaccine – were they participants in the companies’ trials? And if not, why and in which circumstances were they vaccinated?
Both companies have not yet released the safety data from their trials on this age group. However, one thing is clear from the VAERS reports: there were many babies who were injured after receiving the vaccine. Whether they were vaccinated in the trials or illegally in their communities, Pfizer and Moderna will defiantly not be able to claim, when presenting their data to the FDA, that the vaccine is safe for babies, and that there weren’t any severe adverse events in this age group. Moreover, the FDA’s committee experts who will discuss the EUA approval will not be able to ignore those cases and argue that they did not know. The data presented in this article demonstrate beyond any doubt the complete opposite, and this time – these data are presented to the public in advance, before the EUA is granted and ahead of the VRBPAC discussion.
The outcome of the events: Did not recover
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