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

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.

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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.

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(Featured image by geralt via Pixabay)

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