Pfizer’s vaccine was officially licensed as the second Corona 19 vaccine in Korea after AstraZeneca. As it was concluded that the licensed vaccination age was 16 years or older, in principle, even high school students, who are minors, can get the vaccination.
The Ministry of Food and Drug Safety held a final inspection committee on the 5th and announced that Pfizer Korea’s COVID-19 vaccine,’Cominatiju’, was approved. The Ministry of Food and Drug Safety said, “As a result of comprehensively reviewing the contents of the previous two consultations, the product is approved under the condition of submitting the final result report after approval.”
The final inspection committee can be considered as the final step of the triple expert advisory meeting for the Corona 19 vaccine approval review.
According to the final review committee, related to the safety of the Pfizer vaccine, the abnormal cases reported after vaccination were common injection site pain, fever, fatigue, chills, headache, and muscle pain, and most of the symptoms recovered from mild to moderate within a few days. . There was one drug-related hypersensitivity reaction (hives) after vaccine administration, and drug-related anaphylaxis (severe systemic allergic reaction) was not reported during the clinical trial.
Pfizer vaccine. AFP=Yonhap News
In clinical trials, serious adverse drug reactions that could not be excluded from vaccine administration were reported, including 4 cases including shoulder wounds. Among them, lymphadenopathy (a symptom resulting from enlarged lymph nodes) and ventricular arrhythmia have recovered, and shoulder wounds, back pain, and bilateral lower limb pain are said to be recovering.
Based on this, the final review committee judged that “the vaccine safety is generally good” and that “for those with a history of hypersensitivity including anaphylaxis, close monitoring after permission is necessary.” After approval, it was recommended to continuously monitor the safety of anaphylaxis and lymphadenopathy through a risk management plan. Regarding effectiveness, it was revealed that about 95% of the preventive effects were shown in multinational clinical trials conducted in the United States and other countries.
Previously, the Verification Advisory Group and the Central Pharmacy Review Committee recommended approval of the item to those aged 16 or older, but the final inspection committee also accepted it. In clinical trials, the preventive effect was confirmed in subjects over 16 years of age, and it is judged that the immune response of adolescents over 16 years of age will not be different from that of adults. I took into account the fact that I did it.
On the 3rd, medical staff such as Soonchunhyang University Cheonan Hospital, which is in charge of vaccination at the vaccination centers in Daejeon, Chungnam, Sejong, and Central Chungbuk, provided in an indoor badminton court in Cheonan, Chungcheongnam-do, use a dedicated syringe to inoculate the Pfizer vaccine to the medical staff directly in charge of the treatment of Corona 19. Are checking. Freelancer Kim Seong-tae
Yoo-hwan, chairman of the Central Pharmacist Review Committee, who attended the meeting said, “It may vary depending on the vaccine supply and demand, but for the first time, it was seen that even 16-17 years old were not affected.” In the case of elderly people, the immunity is relatively weak, so I carefully judged that the efficacy would decrease, but since 16-17 years old can be considered as adults, there is no reason for a decline in immunity.”
Adolescents aged 16-17 have been granted permission to administer the vaccine, but the adolescents are not immediately eligible for vaccination. It seems that the Korea Centers for Disease Control and Prevention should go through the deliberation of the Vaccination Specialist Committee. The authorities currently exclude children and adolescents under the age of 18 from the targets. This is because the clinical trial results are still insufficient.
Pfizer Vaccine is a nucleic acid vaccine that utilizes messenger ribonucleic acid (mRNA, messenger RNA) containing viral genetic information. It induces an immune response by injecting the coronavirus antigen gene into the body in the form of an mRNA to produce an antigenic protein.
The preventive effect is high, but storage and distribution are difficult. It should be stored at a cryogenic temperature around -70 degrees Celsius. In Korea, more than 50,000 people who have been imported through special import through the international vaccine supply organization’CoVax Facility’ are inoculated to medical staff. Separately, 500,000 people out of the 13 million people signed by the government directly with Pfizer will be introduced by the end of this month, and 3 million people will be introduced from the second quarter. Accordingly, the general public will be able to get the Pfizer vaccine as early as next month. However, vaccination is performed in the order set by the quarantine authorities, and the right type of vaccine cannot be determined.
Reporter Hwang Soo-yeon [email protected]
