The Committee recommended AZ vaccine approval

Vaccinations for seniors must be carefully determined

Insufficient data for elderly patients stated

Recommendation for submission of US clinical trial results

Administration of senior citizens over 65 years old is discussed in the Korea Advisory Committee on Immunization Practices (KACIP)

The Central Pharmaceutical Affairs Review Committee of the MFDS, which consulted on AstraZeneca's approval of the COVID-19 vaccine, recommended item approval, subject to the submission of ongoing clinical results.

 

In addition, for vaccinations over 65 years of age, it was gathered that opinions should be made carefully in the matters of approval, and that it is recommended to be discussed later in the Korea Advisory Committee on Immunization Practices.

 

The Central Pharmaceutical Affairs Review Committee held a meeting at the Osong headquarters of the MFDS on the 4th and made this decision.

 

According to the MFDS, The Central Pharmaceutical Affairs Review Committee recognizes the need for the domestic COVID-19 prevention purpose of the applied item, and submits the results of clinical trials currently in progress when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group.

 

It advised that item approval is possible on the condition of that.

 

The dose and interval should be judged based on scientific verification, and it was possible to administer twice the applied dose at intervals of 4 to 12 weeks whose efficacy was confirmed, considering the standard dose and administration interval and two doses planned in the clinical trial.

 

As for vaccination of elderly patients 65 years of age or older, the same as in Europe, they should be 18 years of age or older.

 

It was also recommended to submit analysis data on the results of US clinical trials later.

 

At the same time, and it is recommended to be discussed at the KACIP later.

 

Regarding the safety of the vaccine, the safety profile (trend), such as adverse events that occurred in clinical trials, is acceptable, but the opinion that the occurrence of nervous system-related adverse events, including transverse myelitis, should be monitored after approval.

 

Inoculation for pregnant women is not recommended, and for nursing mothers, it is appropriate to state in the precautions for use that'it is not known whether this drug is secreted into breast milk', he said.

 

At the Central Pharmaceutical Affairs Review Committee meeting, 12 standing members of the Subcommittee on Biological Medicines, 5 verification advisors, 1 expert recommended by the Korea Medical Association, 7 members of the Vaccine Review Team, Clinical Review Team, and Quality Review Team attended the COVID-19 Crisis Response Support Division inside the MFDS.

 

Previously, a verification advisory group composed of experts supported the approval of the AstraZeneca's COVID-19 vaccine, and recommended that elderly patients not be restricted.

 

The Central Pharmaceutical Affairs Review Committee allows the administration of the elderly, but takes a more cautious approach and delays the decision to the Korea Advisory Committee on Immunization Practices in the future.

 

Based on this consultation, the MFDS is planning to convene a final inspection committee to make a final decision on whether to approve AstraZeneca's COVID-19 vaccine.