Administration of AZ vaccine to the elderly is appropriate

Additional confirmation is required with minority opinions, standard dose and appropriate evaluation every 4 to 12 weeks

The MFDS’ verification advisory group composed of domestic experts presented an opinion that there was no reason to exclude the administration of AstraZeneca's COVID-19 vaccine to the elderly.

 

In addition, it was evaluated that the inoculation was performed twice at the standard dose, and the inoculation interval was appropriate for 4 to 12 weeks.

 

The verification advisory group held a meeting on the 31st of last month and made such a decision on AstraZeneca's COVID-19 vaccine.

 

Many experts who participated in the verification advisory group said that ▲the clinical trial plan was designed to confirm the efficacy and safety in subjects over 18 years old, ▲the prevention effect was confirmed in all subjects including 65 years or older, ▲immune response after vaccine administration considering the similarities with these adults and ▲having a good safety profile, it was revealed that administration to the elderly could not be excluded just because the number of elderly people among the participants was small.

 

However, the preventive effect was not proven due to insufficient data on the high-risk elderly, and that the seroconversion rate in immunogenicity was not different from that of adults, but the antibody titer was lower than that of adults under the age of 65.

 

In addition, they suggested that the correlation between immunogenic response and preventive effect is not established, so it is desirable to reflect additional results such as clinical trials.

 

It was judged appropriate to administer the standard dose, two times, in the planned clinical trial.

 

The advisory group said that ▲the planned dose in the clinical trial was the standard dose, ▲the first administration in the low-dose group and the standard-dose group had a higher preventive effect in the standard-dose group, and ▲the dose interval between the low-dose group and the standard-dose group was not appropriate to simply compare the preventive effects due to the different backs, and ▲the reason was that the comparison between groups was limited due to the small number of subjects in the low-dose group.

 

As for the vaccine administration interval, the opinion was that 4-12 weeks were appropriate as requested by the company.

 

The evidence was that the effect lasted up to 12 weeks after the first vaccination, and the effect was confirmed when administered for 4 to 12 weeks in a major clinical trial conducted in Brazil.

 

However, it was recommended that it is necessary to present specific guidelines for administration intervals after approval in the clinical field after consulting with experts.

 

The MFDS synthesizes expert opinions, efficacy, effects, and recommendations obtained through this verification advisory meeting, as well as the review results, to determine the safety, effectiveness, and safety of the applied items, including the use of the elderly in situations where clinical data for the elderly are limited.

 

It announced that it plans to receive advice from the Central Pharmaceutical Affairs Review Committee on the 4th on matters that need to be considered during approval.

 

Results of the Central Pharmaceutical Affairs Review Committee will be released on the same day.

 

On the 5th, a final review committee for Celltrion's COVID-19 treatment CT-P59 will be held, and it is planned to make a final decision at this meeting.