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The vaccine is here – Biontech won the race
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Biontech and Pfizer request approval of the vaccine
Mainz-based company Biontech and US pharmaceutical giant Pfizer applied for emergency approval of their crown vaccine from the US FDA. Biontech and Pfizer announced this in a joint communication.
The German company and its US partner Pfizer have submitted the candidate Covid-19 vaccine for approval in the United States. Now the supervisors have to decide. If the approval is successful, it will pave the way for a new class of vaccines.
reThe global race for a Covid-19 vaccine has a clear first winner: Mainz-based biotech company Biontech and American pharmaceutical company Pfizer today submitted an emergency approval request for their candidate vaccine to the US drug regulatory authority. US FDA.
The two companies are the first Western corporations to do so, less than ten months after the global search for a vaccine began. There is already a Russian and a Chinese vaccine that are vaccinated in their respective countries. However, until now, neither of them meet the stringent requirements that regulators around the world impose on clinical vaccine research and development, and are therefore not comparable.
According to the World Health Organization, there are now 212 vaccine projects around the world seeking an effective weapon against the new coronavirus and the Covid-19 disease it causes.
“Applying for an emergency license in the US is a crucial step in making our vaccine candidates available to the world’s population as quickly as possible,” says Biontech boss and co-founder Ugur Sahin. “We want to continue working with regulatory agencies around the world to enable rapid global distribution of our vaccine.”
Biontech and Pfizer trust extraordinary technology
If the FDA approves the application quickly, the provision of vaccines for particularly vulnerable population groups in the US could be possible in mid to late December 2020. The United States would be the first country where a vaccine against the new coronavirus.
However, Sahin also stressed that interactions with the European Medicines Agency (EMA) are “of particular importance” to the company: “We continually provide data to the EMA as part of our ongoing review process.”
A few weeks ago, Biontech and Pfizer had already started the so-called continuous submission process at the EMA, in which supervisors can examine the data as soon as it is available. This is an important tool to significantly speed up the approval process, which typically takes many weeks, if not months. According to the companies, more requests to other regulatory authorities are planned in the coming days.
What’s particularly remarkable about the success of Biontech and Pfizer is that the two companies relied on a new kind of technology when developing their BNT162b2 vaccine. Unlike conventional vaccines, the opponent in question does not have to be first laboriously cultured and then inoculated in an inactivated form. In contrast, in the case of mRNA vaccines, the human body itself can make proteins according to the model of the virus, which trigger a targeted immune response.
Logistics is becoming the central challenge
If FDA supervisors approve the vaccine for commercialization, BNT162b should pave the way for an entirely new class of vaccines that can be produced much cheaper and faster than conventional vaccines. The corresponding products have been in the works for a long time at the three leading companies in this field, in addition to Biontech, the American biotech company Moderna and the Tübingen-based manufacturer Curevac.
Germany, which has long since lost its former status as the world’s pharmacy, is also taking on a new luster as a place of excellent research thanks to this surprising success.
The candidate vaccine, which has been shown to be 95 percent effective in the major third clinical study, is not yet approved for use in any country in the world. However, Biontech and Pfizer have long ago started manufacturing and storing vaccine doses so that they can be distributed as quickly as possible if approved. Up to 50 million doses of vaccines are planned for this year, and the two companies aim to produce 1.3 billion units by the end of 2021.
However, logistics could become challenging, because the vaccine must be stored at an arctic temperature of minus 70 degrees Celsius. The two competitors, Moderna and Curevac, have now mentioned significantly higher storage temperatures for their vaccine candidates. However, it is quite possible that Pfizer and Biontech could also demonstrate shelf life even at higher temperatures based on relevant studies. That could also make logistics easier for BNT162b2.
