Pfizer and BionTech Covid-19 Vaccine: Supply to US Gov| Expect to manufacture up to 100 million doses


On July 2, Pfizer and BioNTech have reported positive preliminary results from the ongoing Phase I/II clinical trial of BNT162b1, a potential Covid-19 vaccine.



BNT162b1 is the most advanced of the four Covid-19 vaccine candidates being assessed as part of Pfizer and BioNTech’s BNT162 mRNA-based vaccine programme.



A nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1 encodes an optimised SARS-CoV-2 receptor binding domain (RBD) antigen.



The randomised, placebo-controlled, observer-blinded Phase I/II trial is being performed in the US to assess the safety, tolerability and immunogenicity of escalating dose levels of BNT162b1.
For the initial part of the study, 45 healthy adults aged 18 to 55 years were enroled.



Preliminary data was obtained from 24 participants who were given two 10µg and 30µg injections, 12 subjects who had a single 100µg injection and nine subjects who received two doses of placebo.



The results showed that the vaccine candidate could be given at a dose that was well tolerated and produced dose dependent immunogenicity.
The most common local reaction was injection site pain, which was mild to moderate, without any serious adverse events.



BioNTech CEO and co-founder Ugur Sahin said: “These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 (Covid 19) is able to produce neutralising antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels.”



These preliminary results, along with additional preclinical and clinical data, is expected to help establish a dose level and select among several vaccine candidates to advance to a large, global Phase IIb/III safety and efficacy trial planned for next month.



On July 14, Pfizer Inc. and BioNTech SE have announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program being developed to help protect against SARS-CoV-2 (the coronavirus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).


BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

On July 23rd, Pharmaceutical giant Pfizer and German biotechnology firm BioNTech announced that it will supply the US government with 100 million doses of their coronavirus vaccine (for COVID 19) under a $1.95 billion deal. This is the largest investment yet in a vaccine that has not been proved effective, Trump administration’s Operation Warp Speed program.

The US government also has an option to acquire an additional 500 million doses of BNT162, as the vaccine candidate for COVID 19 is called. It still must secure regulatory approval or authorization that Pfizer projects it may seek as early as October.


The agreement could allow the U.S. to buy a large portion of the coronavirus vaccine Pfizer plans to make through the end of 2021 and comes on top of the government’s vaccine contracts with AstraZeneca for 300 million doses and Novavax for at least 100 million doses.


The Pfizer vaccine for COVID 19 would be free to the American people, according to the government. The U.S moves are part of a larger initiative to secure coronavirus vaccines for the U.S., officially dubbed Operation Warp Speed.

свернуть