Pfizer vaccine can be administered over the age of 16 years

The effectiveness and safety of adolescents aged 16-17 can be extrapolated to adult data

The results will be released next week

The Central Pharmaceutical Affairs Review Committee, an expert advisory body for the MFDS, recommended the approval of Pfizer's COVID-19 vaccine.

 

They gathered opinions that it is possible to administer them even over the age of 16.

 

The MFDS explained the results by announcing the results of the Central Pharmaceutical Affairs Review Committee meeting held on the 25th.

 

This Central Pharmaceutical Affairs Review Committee meeting is held with 19 external experts including 13 standing members of the Biopharmaceutical Subcommittee, which is a specialized subcommittee for deliberation on the safety and effectiveness of vaccines, 5 verification advisory members, and 1 expert recommended by the Korea Medical Association and the MFDS.

 

Eight members, including the general review team, clinical review team, and quality review team of COVID-19 Crisis Response Support Division, attended the vaccine review team.

 

They gathered opinions that item approval is possible when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group.

 

In particular, based on the preventive effect confirmed in the results of clinical trials involving 16 years of age or older, it was concluded that it is reasonable to approve it for subjects 16 years of age or older like the efficacy and effect.

 

Considering that the immune response of adolescents over 16 years of age is not different from that of adults, and considering the availability of adult clinical trial data, it was found that 'effectiveness and safety in adolescents aged 16 to 17 were extrapolated from the data of adults' in Korea as in the United States.

 

The safety advisory result was an acceptable level for the safety profile, such as adverse events that occurred in clinical trials, but it was an opinion that close monitoring after administration was necessary for people with a history of hypersensitivity, including anaphylaxis.

 

It was recommended that the reported abnormal cases be clearly reflected in the package insert.

 

Based on this opinion, the MFDS announced that it plans to hold a final inspection committee by combining the efficacy and effect, indications and dose, and recommendations to determine whether or not to finalize the approval.

 

The approval is expected to be decided next week.