Yahoo Finance Pfizer/BioNTech to Begin Coronavirus Vaccine Study in Germany
Pfizer PFE and Germany-based biotech, BioNTech BNTX announced that they have received approval from the local regulatory authority, the Paul-Ehrlich-Institute, to initiate a phase I/II study to evaluate BioNTech’s BNT162 vaccine program to prevent COVID-19 infection. The companies plan to initiate the study shortly.
Last month, the companies had signed a deal to jointly develop mRNA-based vaccines for COVID-19. The companies have been developing mRNA-based vaccines for influenza under previously signed agreement since 2018.
Meanwhile, they are planning to start a clinical study in the United States, following regulatory approval, which is expected soon.
Following the announcement of the coronavirus vaccine study approval, shares of Pfizer and BioNTech were up 1.8% and 26.6%, respectively, on Apr 22. However, shares of Pfizer have declined 7.5% so far this year compared with the industry’s decrease of 3.1%.
The phase I/II study will evaluate four vaccine candidates from BioNTech’s COVID-19-focused project — Lightspeed. The four vaccine candidates include — two candidates that utilize nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA) and one vaccine candidate utilizes self-amplifying mRNA (saRNA). Two of the vaccine candidates include a larger spike sequence of the SARS-CoV-2 while the other two candidates include a smaller optimized receptor binding domain from the spike protein.
The dose escalation portion of the study will evaluate dose range of 1µg to 100µg in approximately 200 healthy subjects aged 18 to 55 to determine an optimal dose of the vaccines. The study will also evaluate the safety and immunogenicity of the vaccine as well as effects of repeated immunization for the two modRNA candidates and uRNA candidate.
The second part of the study will evaluate the candidates in patients who are at higher risk of a severe COVID-19 infection.
BioNTech is responsible for providing supply of the candidates to Pfizer during clinical development stage. Pfizer had previously stated that the two have potential to supply millions of vaccine doses by the end of 2020 if they receive the necessary regulatory approvals. Thereafter, they can rapidly scale up capacity to produce hundreds of millions of doses in 2021.
Moderna MRNA is also developing an mRNA-based vaccine for COVID-19 in collaboration with the Biomedical Advanced Research and Development Authority ("BARDA") in a phase I study. TranslateBio is jointly developing an mRNA-based coronavirus vaccine with Sanofi SNY, currently in pre-clinical stage.
Several other big drugmakers like J&J and Glaxo as well as smaller biotechs like Vaxart and Kamada, Inovio among others are also engaged in developing vaccines using different existing technology/platform.
Please note that apart from developing a coronavirus vaccine, Pfizer is also screening antiviral compounds and has confirmed a lead compound based on the results of initial screening assays. The company plans to start a potential clinical study of the lead molecule in the third quarter of 2020. It is also evaluating azithromycin for its antiviral properties. Moreover, an independent, investigator-initiated phase II study to evaluate Pfizer’s JAK inhibitor, tofacitinib, in patients with SARS-CoV-2 interstitial pneumonia in Italy has also been planned.
Zacks Rank
Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Click to get this free report Sanofi (SNY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research