WHO granted emergency validation to the Pfizer-BioNTech vaccine paving the way for countries worldwide to quickly approve its import and distribution

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The World Health Organization on Thursday granted emergency validation to the Pfizer-BioNTech vaccine, paving the way for countries worldwide to quickly approve its import and distribution.

Britain launched its inoculation drive with the US-German vaccine on December 8, with the United States, Canada and EU countries following suit.

WHO said the Pfizer/BioNTech vaccine was the first to receive its “emergency validation” since the novel coronavirus first broke out in China a year ago.

“This is a very positive step towards ensuring global access to COVID-19 vaccines,” said Mariangela Simao, a top WHO official tasked with ensuring access to medicines.

“But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” she said in a statement.

WHO said its emergency use listing opens the way for regulators in different countries to approve the import and distribution of the vaccine.

It said it also enables UNICEF, which plays a key logistical role in distributing anti-COVID vaccines, and the Pan-American Health Organization to procure the vaccine for countries that need it.

WHO convened its own experts and those from around the world to review the data on the Pfizer/BioNTech vaccine’s “safety, efficacy and quality,” weighing the benefits against the risks.

“The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks,” it said.


On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

Emergency Use Authorization Status:AuthorizedName:Pfizer-BioNTech COVID-19 VaccineManufacturer:Pfizer Inc.

Authorized Use

For the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older

Common Side Effects

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Learn more.

Additional Information

InformationLanguage
Letter of AuthorizationEnglish
Fact Sheet for Healthcare Providers Administering VaccineEnglish
Fact Sheet for Recipients and CaregiversEnglish
FDA Decision MemorandumEnglish
Frequently Asked Questions on the Pfizer-BioNTech COVID-19 VaccineEnglish
Press ReleaseEnglish
12/10/2020 Advisory Committee Meeting InformationEnglish

Translations of the Fact Sheet for Recipients and Caregivers

Fact SheetLanguage
بيان حقائق للمتلقي القاح ومقدمي الرعايةعربي (Arabic)
ကာကွယ်ဆေး လက်ခံရရှိသူများနှင့် စောင့်ရှောက်မှု ပေးသူများအတွက် သတင်းအချက်အလက် စာရွက်မြန်မာ (Burmese)
ᎤᏙᎯᏳ ᎪᏪᎳᏅ ᎾᏍᎩᎾ ᏗᏂᏁᏍᎩ ᎠᎴ ᎤᎾᏓᎦᏎᏍᏗ ᏗᎾᏓᏍᏕᎵᏍᎩᎩᎵᏏ (Cherokee)
TAROPWEN AFFAT (IKA FACT SHEET) REN CHON ANGEI ME CHON TUMUNFoosun Chuuk (Chuukese)
接受者和护理者须知中文 (Chinese, Simplified)
接受者和護理者須知中文 (Chinese Traditional)
MERKBLATT FÜR EMPFÄNGER UND BETREUERDeutsch (German)
પ્રાપ્તકર્તાઓ અને કાળજી રાખનારા માટે ફેક્ટ શીટગુજરાતી (Gujarati)
FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWENKreyòl Ayisyen (Haitian Creole)
प्राप्तकर्ताओं और देखभाल कर्ताओं के लिए तथ्य पत्र/फैक्ट शीटहिन्दी (Hindi)
DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU KEV PAB THIAB COV NEEG ZOV TUHmoob (Hmong)
ZIEN JAUV-LOUC SOU-ZEIV BUN ZIPV TENGX CAUX ZIUX GOUX NYEI MIENHIu Mien (Iu Mien)
បញ្ជីហេតុការណ៍សម្រាប់អ្នកទទួលនិងអ្នកថែរទាំភាសាអង់គ្លេស (Khmer)
환자와 의료진을 위한 정보지한국어 (Korean)
TQANIL YOL TE KYE Q’ANIL IX QE XJAL TUN TOK KYB’AQTuj qyol (Mam)
PEPA IN MEḶEḶE KO REMOOL ÑAN RO REJ LOLOORJAKE Ājmuur IM AENŌṂṂANPālle (Marshallese)
Bich’į’ azláágo Aa’áhál yání Yaa’ áháyánígíí Yaa’áko nízin doo gi Bił Ííshjáán AlnééhDiné Bizaad (Navajo)
ARKUSZ INFORMACYJNY DLA OSÓB SZCZEPIONYCH I ICH OPIEKUNÓWPolski (Polish)
FICHA TÉCNICA PARA RECEPTORES E CUIDADORESPortuguês (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУРусский (Russian)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEDORES DE CUIDADOEspañol (Spanish)
XAASHIDA MACLUUMAADKA EE LOOGU TALAGALAY TALLAAL QAATAYAASHA IYO DARYEELAYAASHASoomaali (Somali)
FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGATagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓCTiếng Việt (Vietnamese)
אינפאָרמאַציע בלאט פאר די וועלכע באקומען און פאר הילפער (גבאים)אידיש (Yiddish)

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