What the new data from Moderna «kleinezeitung.at



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The vaccine from the American company Moderna shows an efficacy of 94.5 percent in protecting against the crown and does not present serious side effects. The data is very similar to that of Pfizer presented last week.

4:26 PM November 16, 2020

© (c) AFP (CHANDAN KHANNA)

In the worldwide effort for one Corona vaccine Another research project reported decisive success. Vaccination of Modern US-Biotechkonzerns showed in an interim analysis the efficacy of 94.5 percent for protection against Covid-19. Moderna hopes to have one in the US in the coming weeks Emergency approval in order to run, the group announced Monday.

What is known about the vaccine?

The data now reported is based on the so-called COVE study, for which more than 30,000 participants in the US received two doses of the vaccine or a placebo. The midterm evaluation is based on 95 people who have Covid-19: According to the statement, there were 90 cases of the disease in the placebo group and only five in the group that had received the vaccine. This results in an effectiveness of 94.5 percent.

In addition, the appearance of severe courses of Covid-19 was examined: consequently, everyone kicked eleven severe courses in the placebo group, not a single one in the vaccine group, which gives hope that this vaccine will protect against severe courses.

America’s Renowned Immunologist and Corona Expert Anthony Fauci I was excited with the dates of Modern American pharmaceutical company to whose crown the vaccine reacts. “These are obviously very exciting results,” Fauci said, according to CNN television. “There is nothing better, 94.5 percent are really excellent,” Fauci said. According to him, First vaccines in the US in December for high-risk groups To begin, the rest of the population could be more likely from the end of April. “And that will last until May, June and July. It will take a few months.”

Like the BioNTech / Pfizer vaccine, the mRNA-1273 vaccine is based on modern messenger RNA technology. Vaccine researchers explain how this principle works Florian Krammer, Icahn School of Medicine at Mount Sinai, New York so:

“Messenger RNA is nothing exotic, it carries information between the cell nucleus and cell factories. RNA vaccines introduce a small portion of RNA into the cell and the cell provides it characteristic of the virus and our immune system can generate an immune response. The messenger RNA then disappears from the body again, after a few weeks it is completely broken down. And since it’s RNA, the vaccine doesn’t interfere with the genome, that’s not possible. “According to Krammer, they are Long-term “very unlikely” side effects.

According to the communication of Moderna the vaccine was well tolerated by the participants. In some cases, study participants reported pain and Redness at the injection site, fatigue, and headaches, joints, or muscles. However, these reactions to the vaccine quickly disappeared.

How do experts rate the vaccine?

“Moderna and Biontech / Pfizer vaccines are very, very similar and therefore comparable. I expected Moderna to be as efficient as Pfizer and it has happened. You could say: the experiment was repeated and the same result was achieved ”, he says. Florian krammer.

Regarding side effects, Krammer says, “I appreciate that Risk profile too. There are temporary side effects such as high fever, tiredness, headache, and pain at the injection site. So far, there have been no serious side effects in either the Pfizer study or the Moderna study. “

“This is once again extremely positive news in a short period of time, which gives hope that we will have the pandemic under control next year.”

Gerd Fätkenheuer, Cologne University Hospital

Leif-Erik Sander, Head of the Research Group for Immunology of Infections and Vaccines, in Charité Berlin, comments:

“The current study included subjects with different backgrounds and age profiles. Among the roughly 30,000 study participants, 7,000 were over the age of 65. So these results are fine certain conclusions about effectiveness in risk groups to.”

“It also seems to confirm that mRNA vaccines are relatively safe. Came to no safety relevant side effects, only mild side effects were reported in a relatively large number of vaccinated people. “

Sander sees the current data on mRNA vaccines as possibly a “turning point for the entire vaccine development”: “If one very high effectiveness with a good safety profile confirmed, then it will certainly have a significant impact and will promote the development of more mRNA-based vaccines and therapies. “

Expedited admission

the The European Medicines Agency EMA, however, has the testing procedure for a Moderna Biotech corona vaccine. Following the first promising results of the studies, the EMA scientific committee gave the green light to the so-called Continuous review process given, announced the authority.

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.

It is unclear how long the review will take. As soon as there is sufficient evidence of the efficacy, safety and quality of the vaccine, approval for the European market can be applied for.

Because data is evaluated as soon as it is available and not just after a formal application for marketing authorization has been submitted, the Process until approval with a continuous review process can be shortened considerably.

At the moment, together with Moderna, also BioNTech / Pfizer and the Anglo-Swedish company AstraZeneca in this way. I only had last week BioNTech and its US partner Pfizer reported that the vaccine offers more than 90 percent protection against Covid-19. The duo plan to apply for an emergency permit in the United States in November.

For EU countries, the European Commission had a framework agreement with BioNTech / Pfizer for the Purchase up to 300 million cans approved.



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