Neutralizing antibody, 122 times more of early Corona and 1.75 times more of Omicron than those who received previous vaccines
The Ministry of Food and Drug Safety (MFDS) announced on the 8th that it has approved Moderna’s 2-valent COVID-19 vaccine ‘Moderna Spikebox 2 Weeks’, which was also developed to respond to omicron mutations.
The Food and Drug Safety Administration decided to approve the product after comprehensively reviewing the results of this vaccine’s safety, effectiveness and quality review and expert advice.
However, the condition was that long-term storage test data had to be submitted to set the expiry date after approval.
Moderna Spikebox 2 weeks is a bivalent vaccine developed to respond simultaneously to the initial Corona virus 19 and the Omicron ‘BA.1’ mutant virus.
Moderna Korea applied to the Ministry of Food and Drug Safety for preliminary review and item approval for this vaccine in July.
The Food and Drug Safety Administration reviewed US phase 3 clinical trial results and quality data for approval.
A Phase 3 clinical trial was conducted on adults aged 18 years or older who have completed the primary vaccination and the first booster vaccine with the ‘Spikebox Injection’ made to respond to the initial virus.
As a result, no serious adverse drug reactions have been observed among those receiving this vaccine.
Although mild and moderate adverse events such as pain and fatigue at the injection site appeared temporarily, they were at a similar level to some existing vaccines, so the Food and Drug Safety Administration decided that the safety was acceptable.
effectiveness was also recognized.
As a result of comparing the immune response of this vaccine with the neutralizing antibody of those vaccinated with the previous vaccine, the amount of neutralizing antibody was 1.22 times higher for the initial Corona virus 19 and 1.75 times higher for the mutation Omicron, confirming excellence.
This vaccine is currently used as a booster shot (booster shot) with conditional approval in the European Union (EU), the UK, Switzerland and Australia.
The Ministry of Food and Drug Safety said, “We will strengthen the monitoring system for abnormal cases after vaccination in collaboration with relevant ministries and do our best to ensure that the public can be vaccinated with confidence through thorough monitoring and response prompt.”
In addition, he said he will review the manufacturer’s manufacturing and test results and conduct direct testing to confirm the product’s quality when it is approved for national shipment.
/happy news
