#Pfizer operation warp speed trial#

governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that is designed to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using various technology platforms, produced by multiple manufacturers worldwide. with 30 million doses of their BNT162, to be delivered this year and next. Through Operation Warp Speed, HHS and participating agencies have committed sums ranging from hundreds of millions of dollars to more than $1 billion developers of several other COVID-19 vaccine candidates that are in advanced clinical studies -including $1.2 billion to AstraZeneca toward AZD1222, being developed with University of Oxford and a spinout company $483 million to Moderna toward mRNA-1273 and $1.6 billion to Novavax toward NVX-CoV2373.īioNTech and Pfizer also announced Monday that they committed to supplying the U.K.

#Pfizer operation warp speed trial#

That study may begin as soon as later this month.īNT162 is also under study in China, where the companies’ partner company Fosun Pharma said July 14 that a subsidiary received acceptance of its clinical trial application for BNT162b1 by China’s National Medical Products Administration. Pfizer and BioNTech said further data from the Phase I/II trials of the four vaccine constructs will enable the selection of a lead candidate and dose level for an anticipated global Phase IIb/III safety and efficacy study in as many as 30,000 patients. Phase I/II trial ( NCT04368728), a randomized, placebo-controlled, observer-blinded study designed to assess the safety, tolerability, and immunogenicity of escalating dose levels of the vaccine candidate. On July 1, Pfizer and BioNTech said BNT162b1 showed encouraging immunogenicity and a favorable safety profile in preliminary Phase I/II data from an ongoing U.S. The data emerged from an ongoing German Phase I/II, open-label, non-randomized, non-placebo-controlled, dose-escalation trial (EU Clinical Trials Registry EudraCT number 2020-001038-36). The most advanced construct of BNT162-BNT162b1-was the subject of a preprint study published in medRxiv on Monday that showed BNT162b1 to have elicited high, dose level-dependent SARS-CoV-2-neutralizing titers and receptor binding domain (RBD)-binding immunoglobulin G (IgG) concentrations after the second dose. Both constructs were granted the FDA’s Fast Track designation earlier this month. The two most advanced of the four constructs are BNT162b1, which encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, and BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike protein antigen.

Pfizer and BioNTech are studying four constructs of BNT162: Two nucleoside modified mRNA (modRNA) candidates (BNT162b1 and BNT162b2) a uridine containing mRNA (uRNA) candidate and a candidate using self-amplifying mRNA (saRNA).

“We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”īNT162 is one of 18 “ Front Runner” programs among more than 270 COVID-19 therapeutics included in GEN’s updated “ COVID-19 DRUG & VACCINE CANDIDATE TRACKER.” “We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” Bourla added. government funding: “We believe we can move faster if we don’t have to involve a third party,” Bourla said May 28 at during a virtual briefing organized by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The Operation Warp Speed award reverses what had been the companies’ reluctance until now to tap into U.S. The companies have agreed to carry out clinical development and manufacturing of BNT162 at their own risk “to ensure that product would be available immediately if our clinical trials prove successful and an emergency use authorization is granted,” Pfizer chairman and CEO Albert Bourla, DVM, PhD, stated.