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BioWorld - Tuesday, April 21, 2026
Home » Biontech SE

Articles Tagged with ''Biontech SE''

Drug vials and syringe

Pandemic vaccine ‘OWS party’ draws guests aplenty, but who will stay over?

Dec. 29, 2020
By Randy Osborne
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
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Sinovac-12-28

China approves NDA for CNBG COVID-19 vaccine

Dec. 28, 2020
By Gina Lee and Elise Mak
HONG KONG and BEIJING – China’s Sinovac Biotech Ltd. delayed releasing trial data from its Coronavac COVID-19 vaccine while the National Medical Products Administration (NMPA) accepted an NDA from China National Biotec Group (CNBG) for its own vaccine, BBIBP-CorV.
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Map of Latin America, South America
Sourcing disparities across the Americas

Latin America awaits COVID-19 vaccine; race in the region is on

Dec. 23, 2020
By Sergio Held
CAJICA, Colombia – The 33 countries across Latin America, Central America and the Caribbean are taking vastly different approaches to secure, acquire and distribute COVID-19 vaccines. A handful of the region’s wealthier countries have signed deals with vaccine suppliers or plan to manufacture them, but it is unclear how others will source or distribute vaccines to protect roughly 657 million people. Many are counting on the COVAX initiative.
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European Union map and coronavirus

EMA authorizes Pfizer/Biontech vaccine as new SARS-CoV-2 variant emerges

Dec. 21, 2020
By Nuala Moran
LONDON – The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use. The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27.
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Moderna receives the FDA’s second EUA for COVID-19 prevention

Dec. 21, 2020
By Lee Landenberger and Mari Serebrov
A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna.
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Biontech vaccine

EMA accelerates assessment of Pfizer-Biontech COVID-19 vaccine

Dec. 15, 2020
By Cormac Sheridan
DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.
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Coronavirus vaccine illustration

Let the vaccinations begin

Dec. 14, 2020
By Mari Serebrov
A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup.
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Vaccine administration

Vaccine EUA not a total slam dunk with adcom

Dec. 10, 2020
By Mari Serebrov
The FDA’s vaccine advisory committee voted 17-4 with one abstention Dec. 10 to recommend an emergency use authorization (EUA) for the Pfizer Inc./Biontech SE mRNA vaccine BNT-162b2 to prevent COVID-19 in individuals 16 and older.
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Canada follows the U.K. in approving COVID-19 vaccine

Dec. 9, 2020
By Mari Serebrov
Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
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Regulatory front

Canada follows the U.K. in approving COVID-19 vaccine

Dec. 9, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Sacklers threatened with House subpoena; DEA proposes de-scheduling Alkermes drug; Marburg MCMs protected under PREP; OPDP: Don’t make risks a P.S.; U.S. Senators sound off on E&M offsets.
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