[Press Release Feb. 26, 2021 / Unofficial Translation]


The Central Pharmaceutical Advisory Committee Meeting Outcome Regarding Pfizer Korea’s COVID-19 Vaccine



1. Current Marketing Authorization Review Status

(Please refer to the pictogram in the attached file)


□ On February 25, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) held the Central Pharmaceutical Advisory Committee (CPAC) meeting at the headquarter in Osong, Chungbuk province, regarding safety and efficacy of COMIRNATY Inj., Pfizer Korea’s COVID-19 vaccine.

○ The CPAC advisory panels were comprised of 19 external experts ？including 13 standing committee members of the Biopharmaceutical Subcommittee, five panel members of the Advisory Committee and one expert recommended by the Korea Medical Association ？ as well as eight officers from the Overall Evaluation Team, Clinical Evaluation Team and Quality Evaluation Team of the “COVID-19 Emergency Response Support” in the MFDS.

○ The MFDS collects a broad range of opinions from specialists from multiple disciplines in order to maintain expertise and objectivity throughout the COVID-19 vaccine marketing authorization process.
- Regarding safety and efficacy of new drugs, the ministry seeks advice from the CPAC, a legal advisory body of the MFDS, in accordance with the Pharmaceutical Affairs Act 18.
-Considering the urgent situation of the COVID-19 pandemic, the MFDS has also created a three-tier advisory review process additionally establishing the Advisory Committee for the Safety and Efficacy Assessment of COVID-19 Vaccine (hereinafter Advisory Committee) and the Final Evaluation Committee.


2. Overview
□ The CPAC has shared its view on the safety and efficacy of COMIRNATY Inj., Pfizer Korea’s COVID-19 vaccine, and marketing authorization for the vaccine based on the submitted data including clinical trial data.

○ Based on their expertise, the advisory panels had a comprehensive discussion on the proposed indication in individuals aged 16 years of age and older, overall safety and effectiveness of the vaccine and safety management measures.


3. Meeting Outcomes
□ The CPAC panel members had discussions regarding the safety and efficacy based on the submitted data for the marketing authorization of Pfizer Korea’s COVID-19 vaccine COMIRNATY Inj. and the meeting outcomes are as follows:

○ The CPAC recommended granting marketing authorization for COMIRNATY Inj., in recognition of the necessity of vaccines in this urgent pandemic situation and after a comprehensive consideration of the Advisory Committee meeting outcomes regarding safety and efficacy of the COVID-19 vaccine.

○ (Appropriateness for Use in Persons Aged 16 and Older) The advisory panels of the CPAC recommended granting marketing authorization for use of the vaccine in persons 16 years of age and older since the protective effect in the age groups was demonstrated in the clinical trial.
- The CPAC has considered that results from the clinical trials in adults can be used as reference for adolescents aged 16 and 17 years of age since the age group’s immune responses are similar to that of adults. The advisory panels therefore recommended that as in the U.S., the label should describe that marketing authorization of COMIRNATY Inj. for use “in adolescents 16 and 17 years of age is based on extrapolation of safety and effectiveness from adults 18 years of age and older.”

○ (Advice on Safety) The CPAC viewed that, as the Advisory Committee advised, the safety profile of the vaccine demonstrated in the clinical trial result is in an acceptable range. Meanwhile, the committee recommended more meticulous follow-up monitoring on individuals with medical history of hypersensitivity such as anaphylaxis after vaccine administration. The advisory panels have also recommended including reported adverse events in the label.

○ (Views on Efficacy) The CPAC viewed that, as the Advisory Committee advised, the vaccine is effective in preventing COVID-19 as the submitted data show.
* Preventive effect: about 95% (8 COVID-19 cases in the vaccinated group versus 162 in the placebo group)

○ (Safety Management after Marketing Authorization) The advisory panels of the CPAC viewed that the proposed safety management plan is acceptable. The panels also recommended that after granting marketing authorization, there should be continued follow up and monitoring of safety through risk management plan and that adverse events occurred in clinical trials should continuously be collected and assessed.

○ As a result of the meeting, the CPAC panels recommended granting marketing authorization for Pfizer Korea’s COVID-19 vaccine, COMIRNATY Inj.


4. Future Plans
□ The MFDS will comprehensively take into consideration of expert advice gathered from the meetings of the Advisory Committee and the CPAC regarding the proposed indication, dosage, administration among others.

○ At the same time, after reviewing additionally submitted document on quality* of COMIRNATY Inj., the MFDS will hold the Final Evaluation Committee meeting and make the final decision on granting marketing authorization.
* Reports on process validation for finished products, quality data on additives (lipid nanoparticles), etc.