Council of Europe Assembly agreed citizens must be informed that Covid “vaccination is not mandatory and that no one is under political, social or other pressure to be vaccinated if they do not wish to do so”-Jan. 27, 2021

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1/27/21, “Covid-19 vaccines: ethical, legal and practical considerations," Council of Europe, Parliamentary Assembly…National Parliaments…International Partners

“Parliamentary Assembly, Origin, Assembly debate on 27 January 2021 (5th Sitting) (see Doc. 15212, report of the Committee on Social Affairs, Health and Sustainable Development, rapporteur: Ms Jennifer De Temmerman). Text adopted by the Assembly on 27 January 2021 (5th Sitting).”…

“7.3 with respect to ensuring a high vaccine uptake:

7.3.1 ensure that citizens are informed that the vaccination is not mandatory and that no one is under political, social or other pressure to be vaccinated if they do not wish to do so;

7.3.2 ensure that no one is discriminated against for not having been vaccinated, due to possible health risks or not wanting to be vaccinated;

7.3.3 take early effective measures to counter misinformation, disinformation and hesitancy regarding Covid-19 vaccines;

7.3.4 distribute transparent information on the safety and possible side effects of vaccines, working with and regulating social media platforms to prevent the spread of misinformation;

7.3.5 communicate transparently the contents of contracts with vaccine producers and make them publicly available for parliamentary and public scrutiny;”

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Added: In US, FDA has given EUA, Emergency Use Authorization to 3 vaccines, Johnson and Johnson (Janssen), Pfizer-BioNTech, and Moderna, noting that “EUA authorization” doesn’t mean FDA approval or licensure. In a 7/7/21 letter to Moderna, FDA Chief Scientist describes Moderna vaccine as “investigational.” Of all 3 vaccines, FDA states there’s no evidence that they prevent transmission of virus from one person to another, nor any data confirming how long they’re effective. In June and July 2021, FDA published Pfizer’s and Moderna’s heart risks:

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One. Johnson and Johnson/Janssen:

2/27/21, FDA publishes Emergency Use Authorization of Johnson and Johnson/Janssen vaccine, that it’s an “unapproved medical product,” and that “data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission:”

2/27/21, “FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine," FDA.gov

“The EUA [Emergency Use Authorization] allows the Janssen [Johnson and Johnson] COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older….

FDA Evaluation of Available Effectiveness Data…

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA [Emergency Use Authorization] Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency…and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved….

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients….

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.“…

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Two. Pfizer:

June 25, 2021, FDA publishes Pfizer heart risks:

7/23/21, “Pfizer-BioNTech COVID-19 Vaccine,” FDA.gov

“On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.”

5/10/21, “Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions,” FDA.gov

“At this time, there are limited data to address whether the vaccine can prevent transmission of the virus from person to person. In addition, at this time data are not available to determine how long the vaccine will provide protection.”

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Three. Moderna:

7/7/21, FDA publishes Moderna heart risks:

7/7/21, “Moderna COVID-19 Vaccine,” FDA.gov

“On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.”

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7/7/21 Letter to Moderna from Chief Scientist, Food and Drug Administration,  Denise M. Hinton, describes Moderna vaccine as “investigational:”

“It is an investigational vaccine not licensed for any indication.”…

“ModernaTX, Inc. Attention: Ms. Carlota Vinals 200 Technology Square Cambridge, MA 02139

(p. 1) “On July 7, 2021, having concluded that revising this EUA [Emergency Use Authorization] is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA again is reissuing the letter in its entirety with revisions incorporated to clarify terms and conditions that relate to export of Moderna COVID‑19 Vaccine from the United States. Moderna COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older....It is an investigational vaccine not licensed for any indication.”…

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Further from FDA: There’s no evidence that Moderna vaccine prevents transmission of virus from one person to another. Nor does data exist that determines how long Moderna protection will last:

12/18/2020, “FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine," FDA.gov

“The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older….

FDA Evaluation of Available Effectiveness Data…

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.”

Added: FDA: Moderna “may be effective:”

4/13/2021, “Moderna COVID-19 Vaccine Frequently Asked Questions,” FDA.gov

“The FDA has determined…that Moderna COVID-19 Vaccine may be effective in preventing COVID-19.”

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