Ridgewood NJ, In a potential game changer for vaccine distribution, Pfizer and BioNTech asked the U.S. Food and Drug Administration to allow their Covid-19 shot to be stored at temperatures found in normal pharmaceutical freezers. Up until now, the doses had to be stored in super-cold specialty freezers, complicating distribution.
Ridgewood NJ, the COVID19 vaccine developed by Pfizer appears to be effective against the more transmissible variants of the coronavirus, including the one first discovered in South Africa, according to a new report in the New England Journal of Medicine.
Ridgewood NJ, according to Johns Hopkins Center for Health Security , the US FDA announced that its Vaccines and Related Biological Products Advisory Committee will convene on December 10 to review the Emergency Use Authorization (EUA) requests submitted by Pfizer and BioNTech for their candidate SARS-CoV-2 vaccine. FDA Commissioner Dr. Stephen Hahn emphasized that while the advisory board “will review the request as expeditiously as possible,” it is unclear how long the review process will take. That being said, this represents another major step toward authorization for a SARS-CoV-2 vaccine. The FDA intends to livestream the meeting via its YouTube, Facebook, and Twitter accounts as well as from the FDA website.
The US government has finalized an agreement with Pfizer and BioNTech to acquire 100 million doses of their candidate SARS-CoV-2 vaccines, worth US$1.95 billion. Additionally, the US government could purchase an additional 500 million doses under the agreement. Pfizer and BioNTech currently have several candidate vaccines in the development pipeline, including various stages of clinical trials. According to a press release issued by Pfizer, the companies aim to begin Phase 2b/3 clinical trials later this month with the goal of securing US FDA authorization for at least one vaccine by October and delivering the vaccine doses by the end of 2020. The companies also hope to expand production to a total of 1.3 billion doses by the end of 2021. The agreement was signed as part of Operation Warp Speed, which has resulted in similar agreements—to support research and development, scale up manufacturing capacity, and purchase vaccine doses—with other pharmaceutical companies pursuing their own candidate vaccines.
MAINZ, Germany & BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), and Pfizer Inc. (NYSE: PFE) today disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020.
The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.
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