Connect with us


BioNTech has great news: Its corona vaccine is in the approval process

Biotech companies around the world have entered the race to find a coronavirus vaccine. In view of the increasingly critical situation of the coronavirus pandemic, the pace is being stepped up further. Currently, BioNTech and Pfizer are conducting a Phase 2/3 clinical trial with the vaccine at 120 study centers worldwide. The news was well received on the stock market.



For a few days, it was suspiciously quiet at BioNTech, the last announcement of the Mainz biotech company was dated September 17th – after that it was quiet. However, on October 6th, this calm has come to an end, BioNTech reported news about the currently most important vaccine project BNT162 – the vaccine against the pathogen of the rampant corona pandemic, the SARS-CoV-2 virus.

Don’t waste your time scrolling the internet for the best financial news in the world, download for free the Born2Invest mobile app, and let our team of journalists bring you the latest breakthroughs in the biotech sector and the most important news so you can stay on top of the market.

BioNTech and Pfizer are conducting Phase 2/3 clinical trials

Together with its development partner Pfizer, BioNTech has “initiated the so-called “rolling review” submission process for the ongoing review of BNT162b2 at the European Medicines Agency (EMA),” according to BioNTech. This is based on the data from previous clinical studies with the vaccine. “These indicate that vaccination with BNT162b2 triggers the production of neutralizing antibodies and leads to CD4+ and CD8+ T-cell responses, particularly of type TH-1, against SARS-CoV-2,” BioNTech said. According to the company, these antibodies “play an important role in protecting against viral infection and disease.”

In view of the increasingly critical situation of the coronavirus pandemic, the pace is being stepped up further. Currently, BioNTech and Pfizer are conducting a Phase 2/3 clinical trial with the vaccine at 120 study centers worldwide. Based on the data from this study, applications for approval are to be submitted. So far, 37,000 people have participated in the study, 28,000 have been treated with two doses of vaccine. Data are to be presented in the coming weeks and – if they turn out well – an application for approval in the USA will be filed.

The way vaccines are developed has been completely changed by the current pandemic

“A global crisis on the scale of COVID-19 has completely changed the process of vaccine development and review,” said Peter Honig, Senior Vice President and Head Worldwide Safety and Regulatory at Pfizer.

 “We are making every effort to develop a safe and effective vaccine in compliance with regulatory requirements and are proud to take this historic step together with the European Medicines Agency for our COVID-19 vaccine candidate BNT162b2,” said the Pfizer manager.

As part of the ongoing review, the committee has begun reviewing the data from the preclinical studies. The formal application for marketing authorization can be finalized following the ongoing review. This is contingent on the demonstration of vaccine efficacy and safety as well as confirmation from the EMA that the data submitted is sufficient. The vaccine candidate will continue to be subject to the strict quality, safety and effectiveness standards of the EMA.

The stock market responded positively to the news

The news has been well received on the stock market, as they are also important indications for the upcoming US approval process. On the Frankfurt stock market, BioNTech’s share price has climbed to $92.2 (€78.49) today and is currently at $90 (€76.4), up more than 13 percent. 

In the days before, the biotech share had already climbed significantly, after a slide from the $110 (€94) mark to $54.3 (€46.13). On a US basis, this was a drop from the all-time high of $105 to $54.1. Most recently, the BioNTech stock was able to generate strong buy signals on the NASDAQ.


(Featured image by geralt via Pixabay)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in 4 investors, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

Suzanne Mitchell juggles the busy life of a full-time mom and entrepreneur while also being a writer-at-large for several business publications. Her work mostly covers the financial sector, including traditional and alternative investing. She shares reports and analyses on the real estate, fintech and cryptocurrency markets. She also likes to write about the health and biotech industry, in particular its intersection with clean water and cannabis. It is one of her goals to always share things of interest to women who want to make their mark in the world.