June 17, 2022: khansar.net authorizes Moderna & Pfizer-BioNTech COVID-19 Vaccines for children down lớn 6 months of age.

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Comirnaty Information Pfizer-BioNTech Fact Sheets Pfizer-BioNTech Fact Sheet Translations Información sobre las vacunas para el COVID-19

On August 23, 2021, khansar.net announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, và will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age & older.

Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use as a:

Three-dose primary series for individuals 6 months through 4 years of age.Two-dose primary series for individuals 5 years of age & older.Third primary series dose for individuals 5 years of age & older who have been determined khổng lồ have certain kinds of immunocompromise.Single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.First booster dose for individuals 12 years of age and older at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty vaccine.First booster dose for individuals 18 years of age & older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for this first booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.Second booster dose for individuals 50 years of age và older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.Second booster dose for individuals 12 years of age và older with certain kinds of immunocompromise at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

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On February 11, 2022, in consultation with khansar.net, CDC updated the emergency use instructions to provide information about the primary, additional, and booster doses of the Pfizer COVID-19 vaccines in certain individuals.

Comirnaty Information


InformationLast Updated
Package Insert (purple cap)December 2021
Package Insert (gray cap)December 2021
Approval LetterAugust 23, 2021
Supplement Approval LetterDecember 16, 2021
Summary Basis for Regulatory ActionNovember 8, 2021
FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español)February 2, 2022
CDC-issued Emergency Use Instructions (updated)February 11, 2022

MaterialAudienceVaccine Recipient GroupLast Updated
Fact SheetHealthcare Providers6 months through 4 years, maroon cap (must dilute)June 17, 2022
Dear Healthcare Provider LetterHealthcare Providers6 months through 4 years, maroon cap (must dilute)June 17, 2022
Fact SheetRecipients & Caregivers6 months through 4 years of ageJune 17, 2022
Fact SheetHealthcare Providers5 years through 11 years of age, orange cap (must dilute)June 17, 2022
Fact SheetRecipients & Caregivers5 years through 11 years of ageJune 17, 2022
Fact SheetHealthcare Providers12 years of age và older, purple cap (must dilute)June 17, 2022
Fact SheetHealthcare Providers12 years of age và older, gray cap (no dilution)June 17, 2022
Fact SheetRecipients & Caregivers12 years of age và olderJune 17, 2022
Wall ChartHealthcare ProvidersAllJune 17, 2022
Frequently Asked Questions on the Pfizer-BioNTech COVID-19 VaccineAllAllFebruary 16, 2022

InformationDate
Letter of Authorization (Reissued)June 17, 2022
Letter Granting EUA AmendmentJune 1, 2022
Decision MemorandumMay 17, 2022
Letter Granting EUA AmendmentApril 26, 2022
Letter Granting EUA AmendmentApril 13, 2022
Decision MemorandumMarch 28, 2022
Letter Granting EUA AmendmentJanuary 31, 2022
Decision Memorandum AddendumJanuary 6, 2022
Decision MemorandumDecember 30, 2021
Decision MemorandumDecember 8, 2021
Decision Memorandum AddendumNovember 19, 2021
Decision MemorandumNovember 19, 2021
Decision MemorandumOctober 29, 2021
Advisory Committee Meeting InformationOctober 26, 2021
Decision MemorandumOctober 20, 2021
Decision MemorandumSeptember 24, 2021
Advisory Committee Meeting InformationSeptember 17, 2021
Letter Granting EUA AmendmentSeptember 1, 2021
Concurrence LetterAugust 22, 2021
Decision MemorandumAugust 12, 2021
Letter Granting EUA AmendmentMay 19, 2021
khansar.net Decision MemorandumMay 10, 2021
Letter Granting EUA AmendmentApril 6, 2021
Letter Granting EUA AmendmentJanuary 22, 2021
Letter Granting EUA AmendmentJanuary 6, 2021
khansar.net Decision Memorandum December 11, 2020
Advisory Committee Meeting InformationDecember 10, 2020

InformationDate
Press ConferenceJune 17, 2022
Press ReleaseJune 17, 2022
Advisory Committee WebcastJune 15, 2022
Press ReleaseMay 17, 2022
Media CallMarch 29, 2022
Press ReleaseMarch 29, 2022
Press ReleaseJanuary 3, 2022
Press ReleaseNovember 19, 2021
Press ReleaseOctober 29, 2021
Press ConferenceOctober 29, 2021
Advisory Committee WebcastOctober 26, 2021
Press ReleaseOctober 20, 2021
Media CallOctober 20, 2021
Press ReleaseSeptember 22, 2021
Advisory Committee WebcastSeptember 17, 2021
Press ReleaseAugust 23, 2021
Press ReleaseAugust 12, 2021
khansar.net In BriefMay 19, 2021
Press ReleaseMay 10, 2021
Press ConferenceMay 10, 2021
Press ReleaseFebruary 25, 2021
Press ReleaseDecember 11, 2020
Press ConferenceDecember 11, 2020
Advisory Committee WebcastDecember 10, 2020

Translations of the Pfizer-BioNTech Fact Sheet for Recipients và Caregivers for 5 through 11 years of age 


Fact SheetVaccine Recipient GroupLanguage

HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 5 A 11 AÑOS(May 17, 2022) 

5 - 11 years of ageEspañol (Spanish)

为接种者和护理者提供的关于用于预防2019新冠肺炎(COVID-19)的辉瑞生物技术公司2019新冠肺炎疫苗以个人使用的信息概况说明书 5岁至11岁 (May 17, 2022) 

5 - 11 years of age中文 (Chinese, Simplified)

5 세에서 11 세에 해당하는사람들에게 코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한화이저 (PFIZER)-바이오엔텍 (BIONTECH) 코비드-19 백신에 대한 환자와 의료진을 위한 백신 정보지(May 17, 2022) 

5 - 11 years of age한국어 (Korean)

BAKUNA IMPORMASYON FACT SHEET PARA SA MGA TUMANGGAP AT MGA TAGAPAG-ALAGA TUNGKOL SA PFIZER-BIONTECH COVID-19 BAKUNA UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) PARA SA PAGGAMIT SA MGA INDIBIDWAL 5 HANGGANG 11 TAONG GULANG(May 17, 2022) 

5 - 11 years of ageTagalog (Tagalog)

BẢNG THÔNG TIN VỀ VẮC XIN DÀNH mang lại NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ VẮC XIN PFIZER-BIONTECH COVID-19 NHẰM PHÒNG NGỪA BỆNH CORONAVIRUS 2019 (COVID-19) ĐỂ SỬ DỤNG mang lại CÁ NHÂN TỪ 5 TỚI 11 TUỔI (May 17, 2022) 

5 -11 years of ageTiếng Việt (Vietnamese)

Translations of the Pfizer-BioNTech Fact Sheet for Recipients và Caregivers for 12 years of age and older


Fact SheetVaccine Recipient GroupLanguage
HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE COMIRNATY (VACUNA DE ARNm CONTRA EL COVID-19) Y LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 12 AÑOS O MÁS(May 17, 2022) 12 years of age và olderEspañol (Spanish)
关于复必泰 (2019核糖核酸新冠肺炎疫苗)以及辉瑞-BioNTech2019新冠肺炎疫苗预防2019新冠肺炎的接受者和护理者须知(May 17, 2022) 12 years of age và older中文 (Chinese, Simplified)
 코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한 코멀나티 (코비드-19 백신, 메신저 RNA)와 화이저 (PFIZER)-바이오엔텍 (BIONTECH) 코비드-19 백신에 대한 환자와 의료진을 위한 백신 정보지(May 17, 2022) 12 years of age & older한국어 (Korean)
FACT SHEET NG IMPORMASYON SA BAKUNA PARA SA MGA TANGGAP AT CAREGIVERS TUNGKOL SA COMIRNATY (COVID-19 VACCINE, mRNA)AT BAKUNA na PFIZER-BIONTECH COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19)(May 17, 2022) 12 years of age & olderTagalog (Tagalog)
TỜ DỮ KIỆN THÔNG TIN VỀ VẮC XIN DÀNH đến NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ COMIRNATY (VẮC XIN COVID-19, mRNA)VÀ VẮC XIN PFIZER-BIONTECH COVID-19 ĐỂ PHÒNG NGỪA BỆNH CORONAVIRUS 2019 (COVID-19)(May 17, 2022) 12 years of age & olderTiếng Việt (Vietnamese)