Pfizer and BioNTech Secure $1.95 Billion U.S. Government Order for 100 Million Doses of mRNA-Based COVID-19 Vaccine Candidate BNT162

Compiled by Fan Dongdong

On July 20, Pfizer and BioNTech reached an agreement with the UK government to supply 30 million doses of their COVID-19 vaccine candidate. Recently, Pfizer/BioNTech signed a larger vaccine deal with the U.S. government.

Under the agreement, upon authorization or approval by the U.S. Food and Drug Administration (FDA) of the mRNA COVID-19 vaccine candidate BNT162, co-developed by Pfizer and BioNTech, the U.S. government will receive the initial batch of 100 million doses and pay $1.95 billion. Subsequently, the U.S. government may purchase up to an additional 500 million doses. This means that the U.S. government will secure the first 100 million doses produced.

It is reported that this transaction is also part of the U.S. government’s “Operation Warp Speed” initiative, which aims to deliver 300 million doses by early 2021 while ensuring the safety and efficacy of the vaccines.

Among the four candidate vaccines under Pfizer/BioNTech, two have received Fast Track designation from the U.S. FDA, namely BNT162b1 and BNT162b2, both of which are currently undergoing Phase I/II clinical trials in the United States and Germany. Both BNT162b1 and BNT162b2 are nucleoside-modified mRNA molecules delivered via lipid nanoparticles (LNPs). BNT162b1 encodes the receptor-binding domain (RBD) antigen of the SARS-CoV-2 spike protein, while BNT162b2 encodes the full-length spike protein antigen of SARS-CoV-2.

A few days ago, the two companies just released positive data from the German Phase I/II trial of BNT162b1, which is currently under peer review. In this trial, 48 volunteers received two doses of BNT162b1 at different dose levels, administered 21 days apart, while an additional 12 volunteers received a single vaccination. The results showed that after the second dose, the vaccine induced high levels of SARS-CoV-2 neutralizing antibodies in a dose-dependent manner. Moreover, these neutralizing antibodies demonstrated neutralizing activity against multiple SARS-CoV-2 variants, including the D614G strain that has recently become widely prevalent worldwide.

Furthermore, this trial also demonstrated that BNT162b1 can simultaneously induce high levels of CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD. Moreover, the T cell response showed no clear dose-level dependency, suggesting that T cell stimulation and robust expansion may be achieved at low mRNA dose levels.

Overall, these data indicate that BNT162b1 has a favorable safety and tolerability profile.

Pfizer/BioNTech stated that it expects to initiate Phase 2b/3 safety and efficacy trials later this month. If the trials prove successful, the two companies will seek emergency use authorization or other forms of regulatory approval as early as October this year. They anticipate producing 100 million doses by the end of 2020 and supplying more than 1.3 billion doses by the end of 2021.

Reference Source: PFIZER AND BIONTECH ANNOUNCE AN AGREEMENT WITH U.S. GOVERNMENT FOR UP TO 600 MILLION DOSES OF MRNA-BASED VACCINE CANDIDATE AGAINST SARS-COV-2