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IIn the race for an effective corona vaccine, the American biotechnology group Moderna has published the first data on the efficacy and stability of its own vaccine from its large clinical study with tens of thousands of test subjects. After that, vaccinating Americans has reached a 94.5 percent success rate. In the coming weeks, Moderna wants to apply for an emergency approval from the US Drug Agency. The European Medicines Agency also launched an expedited approval process for the vaccine on Monday.
This is a crucial moment in the development of the vaccine. “Since the beginning of January we have been chasing this virus with the intention of protecting as many people as possible around the world,” said Moderna CEO Stéphane Bancel. This positive interim analysis is now the first clinical validation that “our vaccine can prevent Covid-19, including severe courses,” he said.
The news was very well received on the stock market. The company’s share price, which is listed on the US Nasdaq, rose more than 17 percent at noon. The Dax also responded. The American immunologist and government adviser Anthony Fauci said, according to the television channel CNN: “There is nothing better: 94.5 percent are really excellent.” He said the first vaccinations in the United States could begin in December for high-risk groups, with the rest of the population likely more likely by the end of April. “And that will come in May, June and July. That will take a few months. “
The data, which was verified by an independent committee, is therefore based on that of 95 test subjects infected with the coronavirus. There were no serious side effects. 90 of the test persons had received a placebo, five had received the vaccine based on the mRNA messenger substance with the name mRNA-1273. The large ongoing clinical study with more than 30,000 subjects 18 years and older has been conducted in the United States since the end of July and will finally be evaluated with 151 infected subjects. In addition, eleven severe cases of corona were controlled in the first interim analysis. All of these subjects had received the placebo.
Up to 20 million cans in 2020
These interim analyzes are common in large-scale studies. Specifically, after a certain number of test subjects infected with the virus, the so-called data blinding is lifted, that is, the confidentiality of the group assignment, and it is checked how many of the infected test subjects had previously received a placebo and how many had received the candidate vaccine.
Of the 95 cases analyzed, 15 people were 65 years or older. Twenty subjects belonged to different ethnic groups, including twelve people of Hispanic or Latin American origin and four of African American origin.
Mainz biotech company Biontech, with its partner Pfizer, submitted data from the large study relevant to approval with around 44,000 test subjects last week. Based on interim analysis, the vaccine has an effectiveness rate of more than 90 percent. The Tübingen-based biotech company Curevac, like the other companies, also works with the same technology based on the messenger substance mRNA, but its development is not so advanced.
In addition, Moderna presented data on the stability of the vaccine, that is, under what storage and transport conditions it remains effective and stable. After that, the vaccine does not need extremely low temperatures, but remains stable for 30 days at normal refrigerator temperatures of two to eight degrees and can be stored for up to six months at minus 20 degrees Celsius. The Biontech and Pfizer vaccine, on the other hand, should be shipped and stored at minus 70 degrees, and at normal refrigerator temperatures it can be stored for five days.
Moderna plans to produce up to 20 million cans this year and between 500 million and 1 billion cans next year. To this end, the Americans also work with contract manufacturers, in Europe, for example, with Lonza in Switzerland. For comparison: Biontech and Pfizer want to provide 50 million doses this year and up to 1.3 billion doses in 2021. Beforehand, governments had obtained hundreds of millions of cans from manufacturers.
