IThe race for an effective Corona vaccine The American biotech group Moderna has now published the first data on the effectiveness and stability of its own vaccine from its large clinical study with tens of thousands of test subjects. After that, vaccinating Americans has achieved an effectiveness rate of 94.5 percent. In the next few weeks, Moderna wants to apply for an emergency approval from the American Medicines Agency. The European Medicines Agency also launched an accelerated approval process for the vaccine on Monday.
This is a crucial moment in the development of the vaccine. “We have been tracking this virus since the beginning of January with the aim of protecting as many people as possible from it around the world,” said Modern-Chairman Stéphane Bancel. This positive interim analysis is now the first clinical validation that “our vaccination can prevent Covid-19, including severe courses,” he said.
The news was very well received on the stock exchange. The share price of the company, which is listed on the American Nasdaq, rose by more than 17 percent at midday. The Dax also picked up. The American immunologist and government advisor Anthony Fauci said, according to the television channel CNN: “It doesn’t get any better – 94.5 percent are really excellent”. He estimates that the first vaccinations in the United States could begin in December for high-risk groups, with the rest of the population more likely to be around by the end of April. “And that will go into May, June and July. That will take a few months. “
The data, which has been verified by an independent committee, are therefore based on those of 95 with the Coronavirus infected subjects. There were no serious side effects. 90 of the test persons had received a placebo, five had received the vaccine based on the messenger substance mRNA with the name mRNA-1273. The ongoing large clinical study with more than 30,000 subjects aged 18 and over has been carried out in America since the end of July and will finally be evaluated with 151 infected subjects. In addition, eleven serious corona cases were checked in the first interim analysis. These subjects had all received the placebo.
Up to 20 million cans in 2020
Such interim analyzes are common in large-scale studies. Specifically, after a certain number of subjects infected with the virus, the so-called blinding of the data is lifted, i.e. the secrecy of the group assignment, and it is checked how many of the infected subjects had previously received a placebo and how many had received the vaccine candidate.
Of the 95 cases analyzed, 15 people were 65 years or older. Twenty subjects belonged to different ethnic groups, including twelve people with a Hispanic or Latin American background and four with an African American background.
The Mainz biotech company Biontech with partner Pfizer presented data from the large approval-relevant study with around 44,000 test subjects last week. Based on the interim analysis, the vaccination has an effectiveness rate of more than 90 percent. The Tübingen biotech company Curevac, like the other companies, also works with the same technology based on the messenger substance mRNA, but its development is not that far advanced.
In addition, Moderna presented data on the stability of the vaccine, i.e. under which 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 vaccine from Biontech and Pfizer, on the other hand, has to be shipped and stored at minus 70 degrees Celsius, and can be stored for five days at normal refrigerator temperatures.
Moderna plans to produce up to 20 million cans this year and between 500 million and a 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. In advance, governments had secured hundreds of millions of cans from the manufacturers.