Moderna announces that the new corona vaccine under development has achieved a '94.5% preventive effect' in clinical trials

It was announced that the new coronavirus vaccine ' mRNA-1273 ' under development by American biotechnology company Moderna achieved '94.5% preventive effect' in a phase III study .

Moderna's COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study | Moderna, Inc.

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures | Moderna, Inc.

Moderna Covid-19 vaccine results: What 94.5 percent efficacy means for the pandemic --Vox

According to an official announcement by Moderna, mRNA-1273 achieved a 94.5% protective effect in a phase III study under the supervision of the National Institutes of Health's appointed Safety Oversight Board. In this phase III study, more than 30,000 subjects were divided into two groups, one group receiving mRNA-1273 and the other group receiving a placebo (placebo) for mRNA-1273. The effectiveness was evaluated.

In a test performed two weeks after the second vaccination, 95 subjects had a new coronavirus infection (COVID-19). Since 90 of them were in the placebo-treated group and 5 of them were in the mRNA-1273-treated group, the estimated vaccine efficacy was concluded to be '94.5%.'

Furthermore, mRNA-1273 has been confirmed to have the effect of 'lowering the severity' as well as the effect of preventing infection. Of the subjects infected with COVID-19, 11 were judged to be 'severe' in the placebo group, but 0 in the mRNA-1273 inoculated group.

In addition to these findings, Moderna announced that 'mRNA-1273 can be stored in the refrigerator at standard 2 ° C-8 ° C for 30 days and in the freezer at standard -20 ° C or below for 6 months.' Therefore , mRNA-1273 is considered to be 'promising' and is expected to be a vaccine that breaks through the current status of COVID-19, along with Pfizer's ' BNT162b2 ', which also achieved a preventive effect of over 90% in Phase III studies. ..

Pfizer announces that 'new corona vaccine with more than 90% preventive effect' has been developed --GIGAZINE

On the other hand, some points to note are also pointed out in this announcement. The first point to note is that this clinical trial has not been completed and the peer-reviewed paper has not been published. This announcement is, so to speak, a 'breaking news'.

The second point to note is that the exact race and age group of the subjects has not been announced. In the presentation, the subjects infected with COVID-19 were 15 elderly people (65 years old and over), 12 Hispanic Latino Americans, 4 Black / African Americans, and 3 Asian Americans. Announced that there is one compound race, 7,000 people aged 65 and over, and 5,000 subjects under the age of 65 who have a chronic disease with a high risk of COVID-19, such as diabetes. However, the exact distribution of races and age groups has not been revealed. If the race and age group of the subjects this time are significantly different from the actual ones, the preventive effect of 94.5% may not be achieved.

The third caveat is that there are side effects. Severe side effects include pain at the injection site (2.7%) after the first dose and after the second dose. fatigue ( Kentai ) Feeling (9.7%), muscle pain (8.9%), joint pain (5.2%), headache (4.5%), pain ( Pain ) (4.1%), redness of the injection site (2.0%), etc. have been confirmed. Moderna describes these side effects as 'the majority of the confirmed side effects are mild to moderate, and the severe side effects generally subside quickly.'

Moderna will publish a paper later that clarifies all of these caveats. Regarding the production of mRNA-1273, we expect to ship about 20 million units by the end of 2020 and 500 million to 1 billion units by the end of 2021.

in Science, Posted by darkhorse_log