How BioNTech went from a little-known to creating Covid vaccine

It was January 24th, 2020 when BioNTech CEO Uğur Şahin knew that Covid-19 was likely to turn into a global pandemic.

Although it took over a month and a half for the World Health Organization to officially declare a pandemic, Sahin met with his wife, BioNTech’s co-founder and chief medical officer, Özlem Türeci. Together they agreed to redirect most of the company’s resources to developing a vaccine.

“He came up to me and explained his thoughts and fears to me,” said Türeci. “And it was immediately clear to both of us that the technology that we have and that we have already developed clinically can contribute to a quick response.”

Until then, BioNTech mainly focused on developing novel cancer therapies. The company was little known internationally. However, the founders were convinced of the potential of their mRNA technology, which they knew could trigger a powerful immune response. BioNTech knew it would need a larger partner to successfully manufacture, test and manufacture a Covid vaccine on a global scale. The company already had a relationship with it Pfizerwho has worked with them since 2018 to develop an mRNA-based flu vaccine that is in clinical trials. So BioNTech reached out to them.

The companies succeeded in doing this. In August, the Pfizer BioNTech vaccine First to receive full FDA approval.

Watch the video to learn more about the rise of BioNTech.

BioNTech co-founder Ozlem Tureci says Covid will probably be with us for years

LONDON – The Co-Founder and Chief Medical Officer of BioNTech, the German company that worked together to develop a Covid-19 vaccine Pfizer, told CNBC that the world should “not live in fear” of the virus.

“Covid will get manageable. It has already started to get manageable,” said Dr. Ozlem Tureci on the latest episode of “The CNBC Conversation”.

However, she added that we “need to return to a new normal because this virus will be with us for a few more years”.

When asked about concerns about new coronavirus variants, she said BioNTech “is continuously evaluating these upcoming variants and there will be more”.

“For all of these variants that are currently in circulation, it seems that boosters alone, which bring the dwindling immune responses back to high levels, are suitable and protect,” she said.

“However, we have to continue screening, because there could be variants for which this is not the case. And for this we have a second pillar, namely that we prepare ourselves to be quick and quick if we have to adapt. ”To a variant … And we do these test runs, not alone, together with the supervisory authorities so that they can also be prepared for the potential need to switch, “Tureci told CNBC.

In 2008, Tureci founded the Germany-based company BioNTech together with her husband, CEO Ugur Sahin. She said more data would be needed to point the way out of the pandemic, but she envisioned future boosters being given “every 12 or every 18 months”.

Covid vaccination in less than a year

The main focus of the company was on “pioneering individualized immunotherapies” for cancer medicine and the use of its mRNA (messenger ribonucleic acid) technology, which stimulates the body’s own immune response. It is also working on developing a vaccine against malaria.

“So we already had the science and knowledge of immune mechanisms and how they can be used against viruses and we could use that,” said Tureci.

“And the other pillar of our answer was our technology, the mRNA technology that enables [it] to be used as a vaccine format, which means it [it] to communicate with the immune system and teach it to react with high precision against this new enemy. ”

“And this technology was already mature because we had used it in clinical studies on cancer patients. We knew how to do clinical trials with it, how to treat people with it, and how to set up a manufacturing process, ”she adds.

Lessons learned

Thanks to his experience, the company was able to develop a vaccine in less than a year.

When asked if this could be the case for all other vaccines in the future, Tureci told CNBC that there were “high priorities needed to address this global threat” but that there were lessons that could be learned and moved forward .

“I think there are a few things that, if we carry them over to future drug developments, can help us be faster. Also, for example, with non-pandemic infections, but also with cancer and autoimmune diseases, ”she said.

Natural gender ratio

With the Oxford AstraZeneca Covid vaccine, which is also led by women scientists, Tureci considers such high-profile examples of gender balance in science to be “very important” and was one of the reasons for the success of BioNTech.

“I really believe that one of the secrets of why we are successful as a team and as a company is that we are a balanced team. Almost half of our workforce is female and half of our employee teams in top management are female, “she said.

“What I also realize is that we don’t recruit women in our teams because we want to meet every gender quota, that goes without saying … And it just turns out that half of them are women,” she continued .

Pfizer and BioNtech start the method of searching for full FDA approval for his or her Covid vaccine

Walgreens Doctor Luis S. Solano prepares a dose of Pfizer BioNTec’s Coronavirus Disease (COVID-19) vaccine on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and German drug manufacturers BioNTech started the process to apply for full approval of the Covid-19 vaccine in the United States. This makes the companies the first to apply for full approval in the nation.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed millions of doses in the US, with the goal of dispensing 300 million doses by the end of July. If approved, Pfizer could market its shots directly to consumers and potentially change the pricing of its cans.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

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BioNTech CEO assured shot works in opposition to India pressure

BioNTech CEO Ugur Sahin told CNBC on Thursday he was “confident” that the company is using the Covid-19 vaccine US partner Pfizer is effective against a variant of coronavirus that was first identified in India.

The trunk, known as B.1.617, contains two key mutations which were found separately in other coronavirus variants. The variant, also known as “double mutant”, was first discovered in Indiawhere it is viewed by some as the cause of a recent surge in new Covid-19 cases.

The variant has since been identified in other countries, including the United States.

Sahin said the German drug maker had tested its two-dose vaccine, currently not available in India, against similar “double mutants”. Based on that data, Sahin said he feels confident the shot will still be protective.

“We evaluate [the strain] … and the data will be available in the coming weeks, “he told CNBC.

“However, we had similar double mutants in our previous tests and are confident from the data we had in the past that we could see a similar way of neutralizing this virus. But we will only know when we have the data. ” in our hands, “he added.

In recent months, US health officials have said they fear that new, highly contagious variants of the virus may one day be able to evade the protection of currently approved vaccines. They urge Americans to get vaccinated as soon as possible before new and potentially more dangerous variants emerge.

Studies have shown that the Pfizer BioNTech vaccine still protects against other strains. including B.1.526, the variant first identified in New Yorkand B.1.1.7, the variant found in Great Britain

An Israeli study found that B.1.351, the variant discovered in South Africa, was able to bypass part of the protection of the Pfizer BioNTech vaccine, although the shot remained highly effective.

Although the shot continues to be effective, Sahin said people will likely need a third shot of his two-dose Covid-19 vaccine as immunity to the virus wears off. Consent to previous comments prepared by Pfizer CEO Albert Bourla and BioNTech Chief Medical Officer Dr. Ozlem Tureci.

In February, Pfizer and BioNTech said They tested a third Dose of their Covid-19 vaccine to better understand the immune response to new variants of the virus.

Sahin said Thursday that researchers are seeing a decrease in antibody responses to the virus after eight months.

“If we give a boost, we could actually increase the antibody response beyond what we had at the beginning, and that could give us a real comfort of protection for at least 12 months, maybe 18 months,” he said.