Input 2021.02.23 15:10 | Revision 2021.02.23 15:29
Approval from the Ministry of Food and Drug Safety early next month, plans to introduce 500,000 people at the end of next month
The Ministry of Food and Drug Safety announced the results of the meeting held the previous day by the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ on the afternoon of the 23rd. Starting with the verification advisory group, it is expected to decide whether to approve it early next month after consulting three experts.
About 95% of the preventive effects were found in clinical trials of 36523 patients conducted in the United States and Germany. The elderly and those with underlying diseases also showed an effect of more than 94%. Unlike the AstraZeneca vaccine, the elderly over the age of 65 account for 21.9% (8018 people) of the total, which is evaluated as having high data reliability.
The proportion of confirmed test subjects within a week of administration was significantly different from 8 out of 18,198 in the vaccine group and 162 out of 11,325 in the placebo group receiving saline solution.
The seroconversion rate was 100%. The seroconversion rate is the proportion of subjects whose amount of neutralizing antibodies that neutralize the corona 19 virus increases more than four times after administration of the vaccine. This means that all the subjects who received the vaccine twice had this effect. The AstraZeneca vaccine had this value of 79%.
Vaccines are expected to suffer from mild symptoms even if they are infected, but in clinical practice, statistically significant results were not confirmed as the number of severe cases in both the vaccine group and the placebo group was small.
The advisory group said, “We judge the safety profile (trend) to be acceptable.” Anaphylaxis, which is a severe adverse reaction that causes a sudden systemic reaction, has not occurred in clinical practice, but the advisory group recommended that “people with a history of anaphylaxis need careful monitoring after vaccination.”
Systemic adverse reactions were higher in frequency and severity at the second dose than at the first dose, the younger the age. There was one case of hives, a drug hypersensitivity reaction. There were 4 cases of’significant adverse reactions’ that may have been related to the vaccine, including shoulder wounds, lymphadenopathy, ventricular arrhythmia, low back pain and pain in both legs. The Ministry of Food and Drug Safety explained that “it is not a severe symptom and all of the patients have recovered.”
Adolescents aged 16-17 also showed similar effects and safety to other age groups.
The second advisory group’Central Pharmacy Review Committee’ will hold an advisory meeting on the 25th, and the results will be revealed on the next day, the 26th. The Ministry of Food and Drug Safety is planning to complete the approval process by the beginning of next month in order to inoculate 500,000 Pfizer vaccines to be introduced at the end of next month in a timely manner.
Pfizer’s vaccine is also a Pfizer vaccine, which the government will bring into Korea on the 26th and will inoculate about 50,000 medical professionals from the 27th, but it can be used before approval from the Ministry of Food and Drug Safety thanks to the special import.