Pfizer COVID-19 vaccine for children has been approved

for children and adolescents aged 5 to 11

Item approval from the MFDS

Administration of children and adolescents with permission and EUA from 62 countries, including the United States and the EU

Pfizer's COVID-19 vaccine "Cominatiju 0.1mg/mL," which is subject to vaccination for children and adolescents aged 5 to 11, has obtained an item license.

 

The MFDS (Minister Kim Kang-rip) announced on the 23rd that Pfizer Pharmaceutical Korea has approved "Comirati 0.1mg/mL" applied for permission as an imported item.

 

Depending on the design of the clinical trial, different doses were allocated at the age of 11 and 12, and in the case of 5 to 11 years old, the dose was selected in consideration of the results of the immune response obtained from the clinical trial (phase 1).

 

The vaccine is an mRNA vaccine jointly developed by Pfizera of the U.S.

 

and Bioentech of Germany and imported by Pfizer Pharmaceutical of Korea, which will be diluted with 0.9% sodium chloride injection.

 

According to clinical data submitted by pharmaceutical companies, the overall safety information was similar to those aged 16 to 25 (1064 people) when comparing safety and evaluating 3,109 people aged 5 to 11.

 

The most frequent abnormal cases after vaccination were pain at the injection site, fatigue, headache, redness and swelling at the injection site, muscle pain, and chills, and most of the symptoms were mild to moderate.

 

The probability of redness and swelling at the injection site was 26.4% and 20.%, respectively, higher than 10.3% and 11.4% seen at the age of 16-25 years old.

 

The abnormal cases appeared more in the second inoculation than in the first inoculation, but were reported to have disappeared within three days of the outbreak.

 

There were no deaths, myocarditis, pericarditis, or anaphylaxis, and it was confirmed that no serious adverse drug reactions such as drug-related hospitalization or death occurred.

 

COVID-19 immune responses were compared and evaluated at the ages of 5 to 11 (264) and 16 to 25 (253), and the preventive effect was evaluated as the proportion of patients infected with COVID-19 after administering vaccines (1305 patients) and contrast drugs (663 patients) at the ages of 5 to 11.

 

As a result of comparing the immune responses of ages 5 to 11 and 16 to 25 at one month after the completion of the second inoculation, it was found that both the ratio of neutralizing antibodies and the serum response rate were proven effective.

 

As a result of analyzing the preventive effect seven days after the completion of the second inoculation of 1968 people (1305 in the test group and 663 in the control group) who were not infected with COVID-19, the preventive effect of vaccination was 90.7%.

 

Based on this data, experts agreed that the safety and effectiveness confirmed in clinical trial data can be recognized as a result of consultation by the Central Pharmaceutical Review Committee on the 14th.

 

However, although it did not occur in clinical trials as a risk management plan after approval, it was decided to observe the safety of myocarditis and pericarditis as a preventive measure, and to collect and evaluate abnormal cases arising from clinical trials and post-authorization use.

 

Comernaty 0.1mg/mL (for ages 5 to 11) is a vaccine developed and produced separately by Pfizer of the United States for the purpose of preventing COVID-19 aged 5 to 11, and has the same type of additive, usage, and capacity (tojinameran) as previously approved by the Ministry of Food and Drug Safety.

 

The specific vaccination plan will be announced separately by the Korea Centers for Disease Control and Prevention, taking into account the burden of children's diseases (severe rate, etc.), the epidemic of Omicron mutations, and the schedule of introduction of vaccines for children in Korea.

 

In the future, the Ministry of Food and Drug Safety plans to analyze the manufacturing and test results of manufacturers for each manufacturing unit of Comirati 0.1 mg/mL (5-11 years old) and check the quality once again with national shipping approval.