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Read more: The U.S. government will receive the first 100 million doses of the vaccine and pay it $1.95 billion, after which it could buy up to 500 million more.
, Pfizer and BioNTech reached an agreement with the British government on July 20th to provide 30 million doses of the new crown vaccine.
, Pfizer/BioNTech has signed a larger vaccine agreement with the U.S. government.
the agreement, the new mRNA candidate vaccine BNT162, developed by Pfizer/BioNTech, will be approved or approved by the U.S. FDA and will be awarded the first 100 million doses of the vaccine and pay it $1.95 billion, after which the U.S. government can buy up to 500 million more.
means the U.S. government will have the original 100 million doses of vaccine.
the deal is understood to be part of the US government's Operation Warp Speed programme.
the plan aims to deliver 300 million doses by early 2021, while ensuring that vaccines are safe and effective.
two of the four Pfizer/BioNTech candidates have been FDA fast-track certified, respectively, BNT162b1 and BNT162b2, and are currently underGoing Phase I/II clinical trials in the United States and Germany.
BNT162b1 and BNT162b2 are nucleoside-modified mRNAs delivered by lipid nanoparticles (LNP), whereT162b1 encodes the receptor binding domain (RBD) antigen of the new coronavirus sting protein, while BNT162b2 encodes the new coronavirus full-length sting protein antigen.
a few days ago, the two companies have just released positive data on the BNT1621b1 German I/II trial, which is currently under peer review.
in the trial, 48 volunteers received two different doses of BNT162b1 at intervals of 21 days, and 12 volunteers received one vaccination.
results showed that after the second vaccination, the vaccine produced dose-dependent high levels of new coronavirus neutralizing antibodies.
and these neutralized antibodies can neutralise a variety of neo-coronavirus variants, including the D614G strain, which has recently become widely popular worldwide.
, the trial also demonstrated that BNT162b1 can simultaneously induce high levels of CD4 plus and CD8 plus T-cell responses for the new coronavirus RBD.
and there is no clear dose-level dependence in T-cell response, indicating that stimulation and robust amplification of T-cells may be achieved at low mRNA dose levels.
overall, these data show good safety and tolerance of BNT162b1.
Pfizer/BioNTech said it expects to begin phase 2b/3 safety and efficacy trials later this month.
if the trial is successful, the two companies could seek emergency use authorization or other forms of regulatory approval as early as October.
they expect to produce 100 million doses by the end of 2020 and more than 1.3 billion by the end of 2021.
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