Table of Contents
Biontech’s COVID-19 vaccine outperforms competition – vaccination deliveries may start in December as a “Christmas present”.
The first people in Europe could be vaccinated in the second half of December according to the Mainz-based company – if all goes well. The share price is rising.
The Mainz-based biotech company Biontech and its US partner Pfizer have cleared the decisive hurdle for a possible approval of their corona vaccine in the USA. After a final analysis of the pivotal study, the vaccine has shown a 95 percent protection against Covid-19, the two companies announced on Wednesday.
This protection was also achieved in people over 60 years of age, who are considered a particularly vulnerable group. The data on the safety profile of the drug are convincing, the companies added. They now plan to submit the emergency marketing authorization to the U.S. Food and Drug Administration (FDA) within a few days.
The vaccine is more efficent than initally assumed
Biontech and Pfizer thus report an even higher efficacy than initially assumed. Last week, they were the first companies in the world to present successful data for a corona vaccine and, after an initial evaluation, reported protection of more than 90 percent.
According to the final analysis, the duo’s vaccine would now be a little more successful than that of their U.S. competitor Moderna. The biotech company had also reported on Monday that its project had broken through and had put the protection of its product at 94.5 percent.
Both vaccines are based on the novel mRNA technology. This involves the injection of a natural messenger substance, modified in the laboratory, which allows body cells to temporarily produce individual parts of the coronavirus. The immune system reacts to this and builds up protection.
The race of the two manufacturers has also had an impact on their stock market prices: On Monday, Biontech shares had lost 15 percent after the announcement of Moderna. On Wednesday, the stock, which is listed on the US technology exchange Nasdaq, gained four percent to 90 dollars at the start of trading.
In addition to efficacy, the safety profile presented by the manufacturers is crucial for rapid approval. The FDA has drawn up clear guidelines for this: After the second dose has been injected, patients must record data on any side effects that occur for two months. This must be done in at least half of the study participants.
Biontech CEO Ugur Sahin hopes to obtain emergency approval for his COVID-19 vaccine in the USA before the end of December, so that the deliveries can start. “I could imagine that approval could be granted in the USA at the end of the first half of December, second half of December,” Sahin said this Wednesday in an interview with Reuters TV. “If you like, a Christmas gift.”
On Friday, Biontech plans to submit the necessary underlays to the FDA in the USA: “We have already started submitting our underlays to the EMA here in Europe, so the next package will now be very quickly. We are in very close coordination with the authorities”. If all goes well, the first people in Europe could be vaccinated in the second half of December.
FDA requirements clearly exceeded
Biontech and Pfizer report good tolerability with only mild to moderate side effects, which quickly subsided. Only two effects are mentioned in the evaluation as serious side effects: Tiredness or exhaustion occurred in 3.8 percent of the test persons, headache in two percent. A total of 43,000 test persons took part in the study.
The safety profile of the Biontech vaccine thus also outperforms that of Moderna’s competitor product. In the interim analysis, the U.S. company discovered side effects of its active ingredient, such as pain and redness at the injection site as well as muscle, joint and headaches. These reactions, which are common with vaccinations, were observed in up to ten percent of the study participants.
Both vaccines significantly exceeded the FDA’s requirement of at least 50 percent efficacy. According to Biontech, protection was shown across all groups, regardless of age, gender and ethnic origin. In older adults over 64 years of age, the observed efficacy was more than 94 percent.
Moderna will present detailed data in the coming weeks. The company has already stated that its vaccine can also significantly reduce the risk of severe disease progression.
The efficacy of the Biontech agent of 95 percent is based on the following calculation: 170 cases of Covid-19 disease occurred among the study participants. Eight of these occurred in the group of those to whom the vaccine was administered.
162 diseases occurred in the group that received only one ineffective agent, a so-called placebo. In total, there were ten severe courses of disease, nine of which occurred in the placebo group.
EU has already secured vaccine doses
“The data show that our vaccine, at a dose of 30 micrograms, can produce high protection against Covid-19 only 28 days after the first dose,” said Biontech CEO Ugur Sahin. The vaccine is administered twice at a dose of 30 micrograms each. This is a lower dose than the 100 micrograms of Moderna vaccine.
The vaccine from the Tübingen biotech company Curevac, which like the agents from Biontech and Moderna is based on messenger RNA, will even be tested with a dose of only 12 micrograms. However, Curevac has not yet started the pivotal study.
A major advantage of the Moderna vaccine so far is that it is stable for 30 days at normal refrigerator temperatures and can be stored at minus 20 degrees Celsius for up to six months. The vaccine from Biontech and Pfizer, on the other hand, must be shipped and stored at minus 70 degrees Celsius and can be stored for five days at normal refrigerator temperatures. Biontech is already working on extending the shelf life of its vaccine.
50 million doses will be produced this year
Biontech and Pfizer confirmed that they intend to produce up to 50 million doses of vaccine this year and up to 1.3 billion next year. The European Union has already secured up to 300 million doses. Delivery could start as early as the end of 2020, because the manufacturers have not waited until the tests have been successfully completed, but have built up production capacities in parallel.
These include four Pfizer factories in the USA and Belgium as well as the German sites of Biontech. The U.S. has signed a contract with the companies for the supply of 100 million cans worth around USD 1.95 billion, with an option to purchase a further 500 million cans.
