Pfizer will apply for FDA approval after announcing vaccine’s 95% percent effectiveness
Fox News medical contributor Dr. Marc Siegel with Pfizer vaccine analysis and his take on when emergency authorization will likely take place.
Pfizer and BioNTech announced on Friday that they were submitting an emergency use authorization request to the FDA for its coronavirus vaccine. If it’s approved, which the companies believe will be by mid-December, when will it be ready to ship for distribution?
According to Friday’s press release, the answer is “within hours after authorization.”
“While Pfizer and BioNTech await potential authorization or approval from regulatory agencies, the companies continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to authorization or approval, to help ensure it can reach those most in need as quickly as possible,” the press release said.
“Pfizer is bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the U.S. and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade. Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity and regulatory approval or authorization),” the press release said.
When Pfizer first announced the promising clinical trial results earlier this month, concerns were raised about the vaccine's low-temperature storage requirement, and how it would be possible to keep the cold chain intact while transporting it for distribution to remote parts of the world, or in areas with warm climates.
However, Pfizer said that they have been able to successfully ship and distribute the experimental vaccine to over 150 clinical trial sites across the U.S., Europe, Latin America and South Africa.
“Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization,” the press release said.
It also, in collaboration with Operation Warp Speed officials, launched a pilot program with four states in the U.S. to help formulate a distribution plan, whenever the Centers for Disease Control and Prevention (CDC) formulates how and when the public will be able to get the vaccine. The U.S. government has already finalized a deal to secure 100 million doses, with the option to acquire an additional 500 million doses.
The pilot program includes Rhode Island, Texas, Tennessee and New Mexico “because of their differences in overall size, diversity of populations, and immunization infrastructure, as well as the states’ need to reach individuals in varied urban and rural settings.”
“This pilot program and our collaboration with U.S. and state officials will help us prepare for broader vaccine deployment in the near future, subject to authorization or approval, as we work to address this urgent public health need,” said Angela Hwang, group president, Pfizer Bio group president, Pfizer Biopharmaceuticals group. “We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID—19 vaccine programs.”
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