[약업신문]Modena Corona Vaccine EU Advisory Committee Conditional Approval Recommendation

Moderna Therapeutics, a biotechnology company specializing in the development of next-generation messenger RNA (mRNA) treatments and vaccines based in Cambridge, Massachusetts, USA, has been ‘It announced on the 6th that it recommended conditional approval for the mRNA vaccine’COVID-19 Vaccine Modena’ (a new name for’mRNA-1273′).

It is said that they supported the use as a vaccine for preventing’Corona 19′ infection in adults over 18 years of age.

CHMP recommended approval of the’Corona 19′ vaccine on the 21st of last month, following conditional approval of’BNT162b2′, an mRNA-based vaccine from Pfizer and BioNTech SE, a German biotechnology company. Second.

After a careful evaluation of the data on the quality, safety and efficacy of the COVID-19 Vaccine Modena, the CHMP came to a conclusion recommending that the EU Commission officially approve it conditionally without any objection.

EMA chief executive Emma Cook said, “This vaccine can be supplied to us as another tool to overcome the current crisis. The decision to recommend conditional approval was made by the World Health Organization (WHO). In less than a year since the announcement of the’Corona 19′ pandemic, it can be said that it is evidence that all the officials who helped to reach the recommendation for the vaccine for the second time made unremitting efforts and dedication. I said.

Chief Executive Officer Emma Cook then pledged, “Like all other medicines, we will conduct close monitoring of efficacy and safety data that will be derived from the process of using this vaccine to protect EU countries.”

In a large-scale clinical trial, the COVID-19 Vaccine Modena has been proven to be effective in preventing adults over the age of 18 from becoming infected with Corona 19.

In the clinical trial, which had a total of 30,000 people, half of the subjects received the vaccine, while the other half received the placebo.

The test was conducted in a double-blind method, so the subjects did not know whether the vaccine or placebo they were administered.

The efficacy of’COVID-19 Vaccine Modena’ was calculated by evaluating about 28,000 adults aged 18 to 94 years old who did not show signs of infection with’Corona 19′.

As a result, 11 out of 14,134 adults vaccinated with this vaccine had’Corona 19′ symptoms, and 185 out of 14,073 adults who received placebo showed signs of’Corona 19′. Stood out.

In other words, the preventive efficiency of this vaccine was found to reach 94.1%.

In addition, even when narrowing the scope to subjects at high risk of developing severe’Corona 19′ due to chronic lung disease, heart disease, obesity, liver disease, diabetes or AIDS infection, the prevention efficiency of’COVID_19 Vaccine Modena’ is 90.9%. Was found to have reached.

In addition, the effectiveness of the vaccine remained the same, with no gender, racial or ethnic differences.

‘COVID-19 Vaccine Modena’ is a vaccine that is given twice at intervals of 28 days.

The most frequent side effects in clinical trials were generally mild or moderate, and improved within a few days after vaccination.

In terms of the types of side effects involved, pain and swelling at the injection site, tenderness, chills, high fever, swelling or pain in the lower arm, headache, muscle pain, joint pain, nausea and vomiting were noticeable.

EMA will continue to monitor the efficacy and safety of this vaccine.