Comirnaty COVID19 Drug approved by FDA

Posted on 1st September, 2021

 

 

"The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines", says Peter Doshi - British Medical Journal

 

With young fit minors continuing to be injured (PDF) and dying, due to the experimental jab, it's still safer to wait before 'encouraging' colleges and schools to advise minors to take the jab, especially if they don't have parental consent (PDF)

 

Letters sent directly to 16/17-year-olds pg1 and pg2, indicating no parental consent required to 'grab-a-jab', including a conflicting 'licenced' jab information leaflet (PDF). See Gillick Competence.- consent to medical procedures for minors (PDF)

 

UK DRUGS NEED TO BE 'LICENCED' FOR MARKETING

NOT JUST 'APPROVED' UNDER EMERGENCY AUTHORISATION

THE CURRENT JABS ARE STILL IN TEST PHASES

Pfizer, AstraZenecaandJohnson & Johnson end 2023, Moderna ends 2022,

 

Cominaty, aka BNT162b2 mRNA COVID-19 Vaccine, is the drug (conditionally) approved by the UK government for use on 12-17 year-olds, as indicated in the JCVI statement on 04 August 2021,

"Vaccine choice At this time, the Pfizer-BioNTech BNT162b2 vaccine is the only vaccine authorised (conditionally approved not licenced/not fully tested) for persons aged 12 to 17 years in the UK. The Conditional Marketing Authorisation for Pfizer-BioNTech BNT162b2 came into effect on 9 July 2021, with approval previously being provided under Regulation 174. JCVI advises that only UK authorised COVID-19 vaccines should be offered to those aged less than 18 years." (Statement and PDF)

Pfizer Cominaty Package Insert states,  COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. It is not known whether COMIRNATY is excreted in human milk.

 

On 23AUG21, the day of FDA approval, the British Medical Journal  published an article entitled, 'Does the FDA think these data justify the first full approval (licence for marketing) of a covid-19 vaccine?' (Article and PDF)

The FDA approved (licenced in the US only) the Cominaty COVID19 drug despite it only appearing to be based on a 'Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine' dated 28JUL21. This clearly states "This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice"  (Article and PDF) and Full report)

On August 23, 2021, the FDA approved (licenced for marketing) the first COVID-19 vaccine, stating:

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. (Article and PDF).

Additional FDA, UK and EU versions of FDA packaging information appear to exclude certain information?

  • FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) (Link and PDF)
  • VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) (Link and PDF)
  • Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions (Link and PDF)
  •  

Due to the waning effectiveness of the drug within 6 months, the USA seems to be recommending boosters, starting in September (Article and PDF), yet WHO states 'No need for booster jabs for now' (Article and PDF).

 

Israel says Pfizer Covid vaccine is just 39% effective as delta spreads, but still prevents severe illness, stating "“We have to be prepared and we have to be nimble that people may need a booster at some point,” he added. “This close surveillance that’s happening in countries like Israel, the U.K. and other parts of the world is going to be very helpful in driving policy if and when we do need boosters” (PDF). Others speculate,

"Israel will then reconfigure its Green Passports, granting them only to the triple-vaccinated, and limiting their validity to six months. In anticipation of this change, the number of unvaccinated Israelis getting their first shots has tripled since the beginning of August." This implies that the double jabbed will be considered unvaccinated, restricting their lives the same as completely unjabbed. (Article and PDF) 

On 13AUG21 ACIP published 'Update on Emerging SARS-CoV-2 Variants and Vaccine Considerations' (Link  and PDF)

  • Page 9, Boosters 12+ graph, indicates that the USA COVID19 cases were 94% Delta variant, plus a number of sub-mutations, i.e nearly full Delta, yet ...
  • Page 22 states, "No Delta-specific booster vaccine studies shared to date"
  • The Highwire indicate, via the summary of the available evidence pages, 'No efficacy or effectiveness studies of COVID-19 prevention following a 3rd dose' and 'There are no safety studies of an additional mRNA dose in immunocompromised adolescents'

U.S. officials’ decision on Covid-19 booster shots baffles — and upsets — some (pro-vaccination) scientists:

"To many experts, including Baylor, the sequencing of the decisions being made is also out of whack. While U.S. health officials said booster shots could start being offered the week of Sept. 20, the Food and Drug Administration has not even ruled yet on Pfizer’s application for approval of a third shot; it was filed only Monday. Moderna hasn’t yet asked the agency to authorize a third shot at all."

 

"“I would have preferred that this had been vetted a little bit more,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia, who is on an expert committee that advises the FDA on vaccines. “This just seems to be a declaration without the kind of vetting you would like to have seen.”

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