COVID-19 VACCINE LETHAL INJECTIONS

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Pfizer
COVID-19 Vaccine

(Pfizer, USA)

The Official Story

PFIZER–BIONTECH COVID-19 VACCINE
(Pfizer, USA)

The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in people aged five years and older in some jurisdictions, twelve years and older in some jurisdictions, and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada.

Clinical trials began in April 2020; by November 2020, the vaccine entered phase III clinical trials, with over 40,000 people participating. An interim analysis of study data showed a potential efficacy of 91.3% in preventing symptomatic infection within seven days of a second dose and no serious safety concerns. Most side effects are mild to moderate in severity and are gone within a few days. The most common include mild to moderate pain at the injection site, fatigue, and headaches. Reports of serious side effects, such as allergic reactions, are very rare and no long-term complications have been reported.

The vaccine is the first COVID 19 vaccine to be authorized by a stringent regulatory authority for emergency use and the first cleared for regular use. In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis. It is authorized for use at some level in the majority of countries. On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the United States by the Food and Drug Administration (FDA) for those aged sixteen years and older.

As of September 2021, more than 1.5 billion COVID-19 vaccine doses have been shipped by the company worldwide. As of 30 March 2021, Pfizer and BioNTech aimed to manufacture about 2.5 billion doses in 2021. Distribution and storage is a logistical challenge because the vaccine needs to be stored at extremely low temperatures.

In August 2022, a bivalent version of the vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) was authorized for use as a booster dose in individuals twelve years of age and older in the United States. In September 2022, the BA.1 version of the bivalent vaccine (Comirnaty Original/Omicron BA.1) was authorized as a booster for use in the United Kingdom for people aged twelve years of age and older. In September 2022, the European Union authorized both the BA.1 and the BA.4/BA.5 booster versions of the bivalent vaccine for people aged twelve years of age and older.

Pharmacology

The BioNTech technology for the BNT162b2 vaccine is based on use of nucleoside-modified mRNA (modRNA) which encodes a mutated form of the full-length spike protein found on the surface of the SARS-CoV-2 virus, triggering an immune response against infection by the virus protein.

Authorizations

Although jointly developed with Pfizer, Comirnaty is based on BioNTech’s proprietary mRNA technology, and BioNTech holds the Marketing Authorization in the United States, the European Union, the UK, and Canada; expedited licenses such as the US emergency use authorization (EUA) are held jointly with Pfizer in many countries.

Expedited

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the vaccine “rapid temporary regulatory approval to address significant public health issues such as a pandemic” on 2 December 2020, which it is permitted to do under the Medicines Act 1968. It is the first COVID 19 vaccine to be approved for national use after undergoing large scale trials, and the first mRNA vaccine to be authorized for use in humans. The United Kingdom thus became the first Western country to approve a COVID 19 vaccine for national use, although the decision to fast-track the vaccine was criticized by some experts.

After the United Kingdom, the following countries and regions expedited processes to approve the Pfizer–BioNTech COVID 19 vaccine for use: Argentina, Australia, Bahrain, Canada, Chile, Costa Rica, Ecuador, Hong Kong, Iraq, Israel, Jordan, Kuwait, Malaysia, Mexico, Oman, Panama, the Philippines, Qatar, Saudi Arabia, Singapore, South Korea, the United Arab Emirates, the United States, and Vietnam.

The World Health Organization (WHO) authorized it for emergency use.

In the United States, an emergency use authorization (EUA) is “a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID 19 pandemic”, according to the Food and Drug Administration (FDA). Pfizer applied for an EUA on 20 November 2020, and the FDA approved the application three weeks later on 11 December 2020. The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) approved recommendations for vaccination of those aged sixteen years or older. Following the EUA issuance, BioNTech and Pfizer continued the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States. On 10 May 2021, the US FDA also authorized the vaccine for people aged 12 to 15 under an expanded EUA. The FDA recommendation was endorsed by the ACIP and adopted by the CDC on 12 May 2021. In October 2021, the EUA was expanded to include children aged 5 through 11 years of age. In June 2022, the EUA was expanded to include children aged six months through four years of age.

On 16 February 2021, the South African Health Products Regulatory Authority (SAHPRA) in South Africa issued Section 21, Emergency Use Approval for the vaccine.

On 5 May 2021, Health Canada authorized the vaccine for people aged 12 to 15. On 18 May 2021, Singapore’s Health Sciences Authority authorized the vaccine for people aged 12 to 15. The European Medicines Agency (EMA) followed suit on 28 May 2021.

On 4 June 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) came to a similar decision and approved the use of the vaccine for people twelve years of age and older.

Standard

On 19 December 2020, the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary authorization for the Pfizer–BioNTech COVID 19 vaccine for regular use, two months after receiving the application, saying the vaccine fully complied with the requirements of safety, efficacy and quality. This is the first authorization under a standard procedure.

On 21 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting conditional marketing authorization for the Pfizer–BioNTech COVID 19 vaccine under the brand name Comirnaty. The recommendation was accepted by the European Commission the same day.

On 23 February 2021, the Brazilian Health Regulatory Agency approved the Pfizer–BioNTech COVID 19 vaccine under its standard marketing authorization procedure. In June 2021, the approval was extended to those aged twelve or over. Pfizer’s negotiation process with Brazil (and other Latin American countries) was described as “bullying”. The contract prohibits the state of Brazil from publicly discussing the existence or the terms of their agreement with Pfizer–BioNTech without the former’s written consent. Brazil was also restricted from donating or receiving donations of vaccines.

In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older.

The Pfizer-BioNTech Comirnaty COVID-19 vaccine was authorized in Canada on 16 September 2021, for people aged twelve and older.

In July 2022, the FDA approved the vaccine for use for those aged twelve years and older.

In September 2022, the CHMP of the EMA recommended converting the conditional marketing authorizations of the vaccine into standard marketing authorizations. The recommendation covers all existing and upcoming adapted Comirnaty vaccines, including the recently-approved adapted Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4/5.

Source: Wikipedia

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Pfizer–BioNTech COVID-19 Vaccine

The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA vaccine produced by the German company BioNTech and the American company Pfizer. In Hong Kong, Macau, and Taiwan, Comirnaty is distributed by Fosun Pharma.

Pfizer–BioNTech Worldwide Authorizations

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Full (10)

Emergency (145)

Afghanistan
Albania
Algeria
Andorra
Argentina
Armenia
Azerbaijan
Bahrain
Bangladesh
Benin
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brunei
Cambodia
Cameroon
Cape Verde
Chile
Colombia
Congo-Kinshasa
Costa Rica
Djibouti
Dominican Republic
East Timor
Ecuador
Egypt
El Salvador
Eswatini
Fiji
Gabon
Georgia
Ghana
Guatemala
Guinea
Honduras
Indonesia
Iraq
Israel
Ivory Coast
Japan
Jordan
Kazakhstan
Kenya
Kosovo
Kuwait
Kyrgyzstan
Laos
Lebanon
Libya
Malawi
Malaysia
Maldives
Mexico
Moldova
Monaco
Mongolia
Montenegro
Morocco
Namibia
Nepal
Nicaragua
Nigeria
North Macedonia
Oman
Pakistan
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Qatar
Rwanda
Samoa
San Marino
Serbia
Singapore
Somalia
South Africa
South Korea
Sri Lanka
Sudan
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Tonga
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Vatican City
Vietnam
Yemen
Zambia

Emergency (EMA countries)

Emergency (CARPHA countries)

Non-country entities

American Samoa
Anguilla
Aruba
Bermuda
British Virgin Islands
Caribbean Netherlands
Cayman Islands
Cook Islands
Curaçao
Faroe Islands
French Polynesia
Gibraltar
Greenland
Guadeloupe
Guam
Guernsey
Hong Kong
Isle of Man
Jersey
Macau
Martinique
Montserrat
New Caledonia
Niue
Northern Cyprus
Northern Mariana Islands
Puerto Rico
Sint Maarten
Tokelau
Turks and Caicos Islands
World Health Organization

Bivalent original–BA.1

Japan

EMA countries

Bivalent original–BA.4/5

United States

EMA countries

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