Biontech requests approval in Europe: “You can administer the vaccine in a few hours”

northAfter the race to develop a corona vaccine, major manufacturers are now in a head-to-head race to get approval in Europe and the US.

Mainz-based biotech company Biontech and its partner Pfizer have submitted a conditional marketing authorization application for the candidate vaccine BNT162b2. The company announced on Tuesday.

The American company Moderna is likely to apply for approval in Europe around the same time. Moderna ran a corresponding announcement over the weekend.

“Everything there is can be distributed in hours”

According to its own statements, Biontech could deliver the vaccine “in a few hours” after approval from the authorities, CFO Sierk Poetting said at a joint press conference with Research Minister Anja Karliczek (CDU). “We have been producing in stock, and everything that is there can really be distributed in a few hours.”

Be well prepared for this distribution. The vaccine is delivered in boxes and can be cooled in boxes with dry ice for up to 30 days at the respective vaccination center or for up to five days in a standard refrigerator. Freezers only become important when it comes to long-term storage.

Manufacturers await the green light this year

The approval process for both candidate vaccines is already underway in the US Biontech and Pfizer had already requested an emergency approval for their vaccine on November 20, Moderna followed at the beginning of the week.

All three manufacturers are confident that regulators on both sides of the Atlantic could give the green light later this year. “If the EMA concludes that the benefits of the candidate vaccine for protection against Covid-19 outweigh the possible risks, the agency will recommend the granting of a conditional marketing authorization. This could allow the use of BNT162b2 in Europe sooner. by the end of 2020 ”, announced Biontech.

According to the two companies, the Biontech and Pfizer vaccine should offer 95 percent vaccination protection. The modern vaccine is 94.1 percent effective.

So far, the three companies have unanimously announced that there have been no serious side effects for their two products.

“As a company based in the heart of Europe, today’s milestone is immensely important to us as we continue to strive to enable global distribution following the possible approval of BNT162b2,” said Biontech boss and co-founder Ugur Sahin.

The company will continue to work with regulatory authorities around the world to enable rapid global distribution of the vaccine if approved. “We would like to contribute to global efforts in the fight against the virus to get back to normal.”

According to Pfizer and Biontech, the vaccination protection against Covid-19 was achieved in the subjects seven days after the administration of the second dose. Efficacy was consistent across age and gender groups and across the diverse study population.

Vaccination protection for adults over 65, and therefore in the particularly endangered age group, was 94 percent.

Germany has been preparing intensively for a long time for the fastest possible distribution of vaccines as soon as they are approved. Biontech wants to have 50 million doses of vaccines ready worldwide by the end of the year, the American manufacturer Moderna 20 million.

The EU Commission, like several other industrialized nations, had obtained a one million euro quota for Europe from both manufacturers.

However, it is not yet clear how much vaccine from the first phase of production will end up in individual countries. In an interview with WELT AM SONNTAG, Moderna boss Stéphane Bancel recently admitted that most of the first production will likely be distributed in the US, but that a small part is also expected for Europe. The United States government had supported Moderna with about a billion dollars in vaccine development.

The American company produces its vaccine for Europe in Switzerland. At Biontech, part of the production takes place in Mainz and Idar-Oberstein, and Marburg will be added later. The Biontech vaccine for Europe is packaged in Puurs, Belgium, where partner Pfizer has a great location.

The third vaccine that is relatively ahead in the race is the Astra Zeneca vaccine. However, the British company recently admitted a range of doses in the clinical study and received much criticism for it. So far, the Astra Zeneca vaccine is the cheapest of the race.

The company only wants to call between three and four dollars. The American manufacturer Moderna, on the other hand, charges $ 25 to $ 37 per dose. For the vaccine from Biontech and Pfizer, the US pays $ 19.50 per dose for the first 100 million units, the EU Commission pays 15.50 euros.