Spritze mit Impfdosen von Biontech.

Biontech Covid-19 Impfstoff


We feel a duty to explo­it our full tech­no­lo­gy and immu­no­the­ra­py exper­ti­se to help address the COVID-19 pan­de­mic emer­gen­cy. Our aim is clear: Making a poten­ti­al vac­ci­ne avail­ab­le to the public as quick­ly as pos­si­ble – worldwide.

Prof. Ugur Sahin, M.D., Chief Exe­cu­ti­ve Officer

Aiming to address the global coronavirus pandemic: Project Lightspeed

We are deve­lo­ping a poten­ti­al vac­ci­ne based on our pro­prie­ta­ry mRNA tech­no­lo­gy to indu­ce immu­ni­ty and pre­vent COVID-19 infec­tions in respon­se to the gro­wing glo­bal health thre­at. In order to acce­le­ra­te the rapid deve­lo­p­ment of our pro­duct can­di­da­te BNT162 we initia­ted the glo­bal deve­lo­p­ment pro­gram Lightspeed. The pro­gram leverages 

  • BioNTech’s pro­prie­ta­ry mRNA plat­forms for infec­tious diseases, 
  • its ful­ly-owned GMP manu­fac­tu­ring infra­st­ruc­tu­re for mRNA vac­ci­ne production, 
  • its glo­bal cli­ni­cal deve­lo­p­ment capa­bi­li­ties, and 
  • col­la­bo­ra­ti­ons with Pfi­zer and Fosun Pharma

Bio­N­Tech was able to bring its first vac­ci­ne can­di­da­tes from con­cept into cli­ni­cal deve­lo­p­ment in less than three mon­ths. Safe­ty, speed and fle­xi­bi­li­ty are of the utmost impor­t­ance in reac­ting to the cur­rent pan­de­mic. Efforts to manu­fac­tu­re the lea­ding can­di­da­tes, at our risk, are gea­ring up. In case the safe­ty and effi­cacy stu­dy is suc­cess­ful, Bio­N­Tech and Pfi­zer plan to seek regu­la­to­ry review as ear­ly as Octo­ber 2020 and, if regu­la­to­ry aut­ho­riz­a­ti­on or appro­val is obtai­ned, expect to manu­fac­tu­re up to 100 mil­li­on doses by the end of 2020 and poten­ti­al­ly more than 1.3 bil­li­on doses by the end of 2021.

Our COVID-19 vaccine development process

Our mRNA-based approach for a COVID-19 vaccine

SARS-CoV‑2 is a mem­ber of a lar­ge fami­ly of coro­na­vi­ru­ses con­sis­ting of sphe­ri­cal­ly-shaped viral par­ti­cles cove­r­ed with spike pro­te­ins pro­tru­ding from their sur­face, which give the virus its crown-like appearan­ce. The­se spikes bind onto human cells, allowing the virus to infect them. Our vac­ci­ne con­sists of a short seg­ment of gene­tic mate­ri­al, cal­led mes­sen­ger RNA, that pro­vi­des inst­ruc­tions for a human cell to make a harm­less ver­si­on of a tar­get pro­te­in, or immu­no­gen, which acti­va­tes the body’s immu­ne respon­se against the SARS-CoV‑2 virus. We expect that our vac­ci­na­ti­on approach will sti­mu­la­te the immu­ne sys­tem to gene­ra­te pro­tec­ti­ve anti­bo­dies. This means the immu­ne sys­tems learns how to reco­gni­ze the SARS-CoV‑2 virus upon expo­sure and pre­vent sub­se­quent infec­tion. Unli­ke other vac­ci­nes, mRNA vac­ci­nes do not con­tain the virus its­elf and the­re­fo­re pose no risk of infection. 

mRNA vac­ci­nes con­sist of gene­tic mate­ri­al, cal­led mes­sen­ger RNA, that pro­vi­des inst­ruc­tions for a human cell to make a tar­get pro­te­in, or immu­no­gen, which acti­va­tes the body’s immu­ne respon­se against the respec­ti­ve virus. The goal of a vac­ci­ne is to sti­mu­la­te the immu­ne sys­tem to gene­ra­te pro­tec­ti­ve, long-las­ting anti­bo­dy and T cell respon­ses against SARS-CoV‑2 and pre­vent sub­se­quent infec­tion upon expo­sure to the virus. mRNA vac­ci­nes are a potent new deve­lo­p­men­tal class of vac­ci­nes with poten­ti­al for high ver­sa­ti­li­ty and favoura­ble safe­ty properties. 

Our global clinical program 

Bio­N­Tech was one of the first Euro­pean com­pa­ny to enter cli­ni­cal tes­ting, having star­ted a cli­ni­cal tri­al in Ger­ma­ny in April and a fur­ther cli­ni­cal tri­al in the United Sta­tes at the begin­ning of May. BioNTech’s deve­lo­p­ment pro­gram­me for BNT162 is one of the broa­dest deve­lo­p­ment pro­gram­mes glo­bal­ly, with four vac­ci­ne can­di­da­tes being tes­ted in par­al­lel. The BNT162 pro­gram is eva­lua­ting at least four expe­ri­men­tal vac­ci­nes, each of which repre­sent a uni­que com­bi­na­ti­on of mes­sen­ger RNA (mRNA) for­mat and tar­get antigen. 

Pivotal Global Phase 2/3 Study 

In July, Bio­N­Tech and Pfi­zer announ­ced their lead can­di­da­te: BNT162b2. The nucleosi­de-modi­fied mes­sen­ger RNA (modR­NA) can­di­da­te BNT162b2 from their BNT162 mRNA-based vac­ci­ne pro­gram against SARS-CoV‑2 will be tes­ted at a 30 µg dose level in a two dose regi­men into a glo­bal Pha­se 2/3 Stu­dy. By the end of the tri­al, the Pha­se 2/3 stu­dy is expec­ted to be acti­ve at appro­xi­mate­ly 120 cli­ni­cal inves­ti­ga­tio­nal sites around the world, inclu­ding 39 sta­tes across the United Sta­tes and coun­tries inclu­ding Argen­ti­na, Bra­zil, and Germany.

The can­di­da­te and dose level selec­tion was infor­med by an exten­si­ve review of pre­cli­ni­cal and cli­ni­cal data obtai­ned in Pha­se 1/2 stu­dies con­duc­ted in the U.S.  and Ger­ma­ny, and in con­sul­ta­ti­on with the U.S. Food and Drug Administration’s Cen­ter for Bio­lo­gics Eva­lua­ti­on and Rese­arch (CBER). BNT162b2, one of the two BNT162 can­di­da­tes to recent­ly have recei­ved Fast Track desi­gna­ti­on by the U.S. Food and Drug Admi­nis­tra­ti­on (FDA), encodes an opti­mi­zed SARS-CoV‑2 full length spike gly­co­pro­te­in (S), which is the tar­get of neu­tra­li­zing anti­bo­dies that are belie­ved to inac­ti­va­te the virus. 

During pre­cli­ni­cal and cli­ni­cal stu­dies of four BNT162 RNA vac­ci­ne can­di­da­tes, BNT162b1 and BNT162b2 emer­ged as strong can­di­da­tes based on assess­ments of safe­ty and immu­ne respon­se. Pfi­zer and Bio­N­Tech selec­ted BNT162b2 as the can­di­da­te to pro­gress to a Pha­se 2/3 stu­dy based on the tota­li­ty of avail­ab­le data from our pre­cli­ni­cal and cli­ni­cal stu­dies, inclu­ding selec­ted immu­ne respon­se and tole­ra­bi­li­ty parameters. 

In the pre­cli­ni­cal stu­dies, BNT162b1 and BNT162b2 can­di­da­tes indu­ced favor­able viral anti­gen spe­ci­fic CD4+ and CD8+T cell respon­ses, high levels of neu­tra­li­zing anti­bo­dy in various ani­mal spe­ci­es, and bene­fi­cial pro­tec­ti­ve effects in a pri­ma­te SARS-CoV‑2 chal­len­ge model.

Preliminary clinical data for the nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1

Preli­mi­na­ry U.S. data from the most advan­ced of the four inves­ti­ga­tio­nal vac­ci­ne can­di­da­tes from our BNT162 mRNA-based vac­ci­ne pro­gram were announ­ced on 1 July 2020. Over­all, the preli­mi­na­ry data it was demons­tra­ted that BNT162b1 could be admi­nis­te­red in a dose that was well tole­ra­ted and gene­ra­ted dose depen­dent immu­no­ge­ni­ci­ty, as mea­su­red by RBD-bin­ding IgG con­cen­tra­ti­ons and SARS-CoV‑2 neu­tra­li­zing anti­bo­dy titers. 

On July 20, 2020, Bio­N­Tech and Pfi­zer announ­ced preli­mi­na­ry data from our ongo­ing Ger­man Pha­se 1/2 tri­al of BNT162b1. The initi­al part of this open-label, non-ran­do­mi­zed, non-pla­ce­bo-con­trol­led stu­dy is eva­lua­ting the safe­ty, tole­ra­bi­li­ty and immu­no­ge­ni­ci­ty of esca­la­ting dose levels of BNT162b1, one of four vac­ci­ne can­di­da­te vari­ants in deve­lo­p­ment as part of our BNT162 pro­gram. In 34 of the 36 sub­jects who recei­ved two vac­ci­na­ti­ons at 10µg, 30µg, or 50µg dose levels of BNT162b1, RBD-spe­ci­fic CD4+ T cell respon­ses were obser­ved. All sub­jects but the two excep­ti­ons at the lowest dose level had cyto­ki­ne pro­filing of the RBD-spe­ci­fic CD4+ T cells that demons­tra­ted a TH1-domi­nant pro­fi­le for the­se cells.

FDA fast track designation for two investigational mRNA-based vaccine candidates against SARS-CoV‑2

Fast Track is a pro­cess desi­gned to faci­li­ta­te the deve­lo­p­ment, and expe­di­te the review, of new drugs and vac­ci­nes that are inten­ded to tre­at or pre­vent serious con­di­ti­ons that have the poten­ti­al to address an unmet medi­cal need. This desi­gna­ti­on was gran­ted based on preli­mi­na­ry data from Pha­se 1/2 stu­dies that are cur­r­ent­ly ongo­ing in the United Sta­tes and Ger­ma­ny as well as ani­mal immu­no­ge­ni­ci­ty studies.

At a glance: COVID-19 vaccine program

  • Con­cept: mRNA-based vac­ci­ne tar­ge­ting SARS-CoV‑2 Spike-Pro­te­in and RBD.
  • mRNA For­mat: uri­di­ne-con­tai­ning mRNA (uRNA), nucleosi­de modi­fied mRNA (modR­NA), and self-ampli­fy­ing mRNA (saR­NA) pro­vi­ding high immunogenicity.
  • mRNA Deli­very For­mu­la­ti­on: Lipid nano­par­ti­cles (LNPs).
  • Deve­lo­p­ment Approach: Glo­bal deve­lo­p­ment pro­gram, in col­la­bo­ra­ti­on with Pfi­zer and Fosun Pharma.
  • Lead Can­di­da­te: BNT162b2 (modR­NA).


Our collaborations to accelerate global COVID-19 vaccine development: Pfizer and Fosun

The col­la­bo­ra­ti­on with Pfi­zer builds on the 2018 agree­ment to joint­ly deve­lop an mRNA-based influ­en­za vac­ci­ne. It 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. During the cli­ni­cal deve­lo­p­ment sta­ge, Bio­N­Tech and its part­ners will pro­vi­de cli­ni­cal sup­ply of the vac­ci­ne from its GMP-cer­ti­fied mRNA manu­fac­tu­ring faci­li­ties in Euro­pe. Bio­N­Tech and Pfi­zer will work tog­e­ther to sca­le-up manu­fac­tu­ring capa­ci­ty at risk to pro­vi­de world­wi­de sup­ply in respon­se to the pan­de­mic. Bio­N­Tech and Pfi­zer will also work joint­ly to com­mer­cia­li­ze the vac­ci­ne world­wi­de (exclu­ding Chi­na which is alrea­dy cove­r­ed by BioNTech’s col­la­bo­ra­ti­on with Fosun Phar­ma) upon regu­la­to­ry approval.

As part of their stra­te­gic col­la­bo­ra­ti­on announ­ced in March 2020, Bio­N­Tech and Fosun Phar­ma will joint­ly con­duct cli­ni­cal tri­als of BNT162 in Chi­na, lever­aging BioNTech’s pro­prie­ta­ry mRNA vac­ci­ne tech­no­lo­gy and Fosun Pharma’s cli­ni­cal deve­lo­p­ment and com­mer­cia­liz­a­ti­on capa­bi­li­ties in Chi­na. Fosun Phar­ma will com­mer­cia­li­ze the vac­ci­ne in Chi­na upon regu­la­to­ry approval. 

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