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According to Biontech, the American company Moderna has also reported successes with a possible corona vaccine: Interim results showed an effectiveness of 94.5 percent, he explained. According to its own information, the EU is already negotiating.
In the race for a corona vaccine, another research project has reported high effectiveness. The vaccine from the American company Moderna shows an effectiveness of 94.5 percent in an intermediate analysis, according to a statement from the pharmaceutical company. This would have led to tests in 30,000 people in the so-called phase III of the clinical trial.
This makes Moderna the second major US pharmaceutical company in a week to submit positive data from the relevant study for approval with a potential corona vaccine. Last Monday, Mainz-based pharmaceutical company Biontech and its US partner Pfizer announced that, according to preliminary results, their vaccine offered more than 90 percent protection against Covid-19.
Negotiations with the EU Commission
Moderna plans to apply for emergency approval from the US pharmaceutical agency FDA in the coming weeks. Applications to the approval authorities of other countries are also planned. According to its own information, the EU Commission is currently negotiating with the company the delivery of up to 160 million doses of vaccines. A contract has not yet been concluded.
Renowned American immunologist and corona expert Anthony Fauci reacted enthusiastically to the group’s data. “These are obviously very interesting results,” he said, according to CNN. “There is nothing better: 94.5 percent are really excellent.” According to Fauci’s assessment, the first vaccinations in the United States could begin in December for high-risk groups, and the rest of the population is more likely to increase in late April. “And that will last until May, June and July. It will take a few months.”
Trump: Big Discoveries Under My Watch
US President Donald Trump wrote on Twitter: Historians must remember that these great vaccine discoveries “were made under my supervision.” The United States government has supported several pharmaceutical companies, including Moderna, with billions in payments and a special program to develop vaccines.
President-elect Joe Biden, who will take office in January, welcomed the progress. At the same time, he asked for caution. “Today’s news of a second vaccine is another reason to be hopeful,” he wrote on Twitter. He praised those responsible for the “advance.” However, there are still months before a large part of the population can be vaccinated. Until then, people would have to keep their distance and wear masks.
New RNA vaccines
Both the Biontech and Pfizer preparation and the Moderna preparation are so-called RNA vaccines. Thanks to this new technology, the preparation contains genetic information about the pathogen. It is not necessary to vaccinate, as has happened so far with dead and live vaccines.
In the clinical studies on the Moderna preparation, half of the 30,000 test subjects received the vaccine, the other half acted as a control group and received a placebo. So far, a total of 95 study participants have contracted Covid-19. Of these, only five cases were actually vaccinated subjects, 90 cases were diagnosed in the control group. This results in an effectiveness of 94.5 percent. It is about the extent to which the vaccine can prevent the disease. So far there are no data on the degree to which the vaccine prevents infection.
Optimistic scientists
In opening statements, several scientists emphasized the similarity of the Moderna vaccine to that of Pfizer and Biontech. Gerd Fätkenheuer, Head of Infectious Diseases at the University Hospital Cologne, spoke of “nearly identical results” and a strong indication that the new RNA vaccine technology really works against the corona pathogen. “If, after the Biontech results, one could have high hopes for the effectiveness of vaccines, this hope has now grown much more.”
Florian Krammer, a professor of vaccines at the Icahn School of Medicine at Mount Sinai Hospital in New York, estimates the risk from the vaccine to be low based on early data. “There are transient and temporary side effects, such as high temperature, fatigue, headache and pain at the injection site, which are uncomfortable but not dangerous,” he said. So far, there have been no serious side effects in either the Pfizer or Moderna study.
However, experts emphasize that in Moderna, as in the case of Biontech and Pfizer, only the results of a preliminary analysis by the independent panel of experts are available and there is no scientific publication yet.
Modern: less storage effort
Moderna says it will be ready by the end of the year to deliver about 20 million doses of vaccines to the US if approved. Up to 1 billion cans are expected to be made in the next year. Biontech and Pfizer expect to have 50 million doses of vaccines available by the end of this year.
Vaccine distribution is particularly difficult due to delicate storage. The colder a vaccine must be stored, the greater the logistical requirements. Pfizer and Biontech cans should be stored below 70 degrees. Moderna has now announced that its own preparations can be kept longer in normal refrigerators after defrosting than previously thought – up to 30 days.
EMA launches test procedures
The European Medicines Agency (EMA) has already begun testing Moderna Biotech in Spain, a subsidiary of the American company. The EMA’s CHMP scientific committee had given the green light to the so-called continuous review process after the first promising results from the studies, the authority announced.
With this accelerated approval process, pharmaceutical companies can report their vaccine candidates to the EMA in a kind of preliminary procedure for approval during the clinical studies phase. Data from ongoing studies is submitted continuously and is evaluated by the EMA.
