[H/T Pollard]
ransomnote: This has to stop. There're already injecting children as young as 12 years old with 'shots' that had an insufficient Phase II trial (They didn't even pretend to have a Phase III trial - the FDA awarded them an EUA. AN EUA requires an emergency. WHERE Is the emergency?Normal Phases of Drug Trials:Phase I - tests if people survive the treatment (whose children did they test on?) usually very small number of volunteers.Phase II - larger group - usually 900 or more. Often 1-2 years. Tests 'tolerability' of usually 2 or more doses. This should be lab rats testing the high dose and seeing if they can stand it, not being tested on children!Pfizer's Phase II for shots intended for 5 year olds was 600 people for few months. These are children and babies who are not at risk of Covid, andwhom would benefit from natural exposure, which builds their powerful immune responses. In the real world, PFizer doesn't have a significant Phase II trial to refer to and there are accounts of children just dying in their sleep already.Phase III normally takes years, but it hasn't occurred yet for the children's shots. THey just skipped testing and are putting shots in children.The adult Pfizer vax had a phase III trial of about 35K people, and some experts point out it was not valid based on the conduct of the trial. And then they injected the world full of adults with it. I just beleived instincts would prevent adults from offering up their children to the Wuhan machinery.
NOW according to the update of Dec 22, they want to inject babies down to six months of age.Will America just let the CCP/Pfizer Co. kill her children over a vaccine they don't need? One that is already devastating adults? There's a reason they added a compound to the children's version to reduce risk of heart attack. They want to inject as many with this toxin, and have enough still alive to KEEP INJECTING MORE.Much more information at the link. I included Elegibility inclusion/exclusion criteria below. I can't help but note that relatives of Pfizer and onsite staff are specificially excluded from the trials.Ethics, you know. /sEligibility Criteria
Information from the National Library of MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 6 Months to 18 Years (Child, Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes CriteriaInclusion Criteria
- Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation and for participants ≥5 to <30 years of age, at the time of randomization, at Visit 1 for the lower-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age.
- Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
- Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
- Negative urine pregnancy test for female participants who are biologically capable of having children.
- Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
- The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).
Exclusion Criteria
- Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
- Phase 1 only: Known infection with HIV, HCV, or HBV.
- Receipt of medications intended to prevent COVID-19.
- Previous or current diagnosis of MIS-C.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Female who is pregnant or breastfeeding.
- Previous vaccination with any coronavirus vaccine.
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- Previous participation in other studies involving study intervention containing LNPs.
- Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816643
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 94 study locationsSponsors and Collaborators
BioNTech SE
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | BioNTech SE |
| ClinicalTrials.gov Identifier: | NCT04816643 History of Changes |
| Other Study ID Numbers: | C4591007 2020-005442-42 ( EudraCT Number ) |
| First Posted: | March 25, 2021 Key Record Dates |
| Last Update Posted: | December 22, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
