Will the Committee allow AZ vaccine in the elderly?

Meeting from 2pm today, results announced around 6pm

The verification advisory group said, "There is no reason to exclude the administration of the elderly"

This is because the Central Pharmaceutical Affairs Review Committee, a specialized advisory body for the MFDS, determines the adequacy of the approval from 2pm.

 

While it is expected that the Central Pharmaceutical Affairs Review Committee has decided on item approval, it is noteworthy how it will decide on the administration of the elderly.

 

Earlier, the 1st expert meeting, Verification Advisory Group, suggested the use of the vaccine, saying, "There is no reason to exclude the administration of AstraZeneca’s vaccine to the elderly." The MFDS will hold an advisory meeting on the Central Pharmaceutical Affairs Review Committee for AZ Vaccine in a conference room at the headquarters in Osong, Chungbuk at 2 pm on the 4th.

 

The MFDS is holding expert meetings three times in the case of COVID-19 vaccines and treatments.

 

Final approval is decided through the first verification advisory group, the second Central Pharmaceutical Affairs Review Committee, and the third final review committee.

 

In general, the agenda has been decided mostly through the Central Pharmaceutical Affairs Review Committee.

 

In consideration of public interest and securing trust in screening for COVID-19 vaccines and treatments, the expert meeting was increased three times.

 

However, since the committee has made a final decision, it seems that the approval of AZ vaccine will be decided through this meeting.

 

The number of participants in AZ's COVID-19 vaccine clinical trial (UK and Brazil) was 8,895 adults over the age of 18 (4,440 vaccine groups, 4,455 control subjects).

 

The average age was 42.2 years old, and 7.4% (660 people) of the elderly over 65 years old verified the effectiveness.

 

Some European countries have recommended vaccination restrictions due to the fact that there are fewer seniors in clinical trials.

 

Authorities in Germany, France, Sweden, Austria, Poland, Italy and Belgium recommended that older people should limit vaccination.

 

However, the European Medicines Agency (EMA), which oversees drug approval in EU countries, did not place any restrictions on the administration of AZ vaccine to the elderly.

 

The verification advisory group, who first consulted on whether or not to obtain permission in Korea, also stated that there was no reason to exclude the administration of the elderly.

 

At the verification advisory meeting held on January 31 of last month (including 8 infectious internal medicine specialists, clinical statistics specialists, etc.), a number of experts said, "It is impossible to rule out administration to the elderly just because the number of elderly persons among the participants is small." However, some opinions suggested that the administration of the elderly aged 65 or older should be decided through additional clinical trials.

 

A number of experts from the advisory group said, "In the clinical trial of the AstraZeneca’s vaccine, the prevention effect was confirmed in all subjects, including over 65 years of age, and the immune response after white administration is similar to that of adults and the safety profile is good." A small number of experts say that the preventive effect has not been proven due to lack of data, and that the antibody titer is lower than that of adults under the age of 65 and that the correlation between the immunogenic response and the preventive effect has not been established.

 

In the end, according to the majority opinion, the verification advisory group recommended that vaccination is possible even for elderly people over 65 years of age.

 

The meeting is expected to involve more experts than the verification advisory group.

 

Earlier, a total of 18 people, including members of the verification advisory group, attended the Central Pharmaceutical Affairs Review Committee of Celltrion's COVID-19 treatment Rekirona.

 

The results of the Central Pharmaceutical Affairs Review Committee meeting in Rekirona were different from that of the Verification Advisory Board.

 

While the verification advisory group determined that it could be used for all mild patients, the Central Pharmaceutical Affairs Review Committee recommended that only high-risk patients be allowed among mild patients.

 

Therefore, even at the Central Pharmaceutical Affairs Review Committee meeting of AZ’s vaccine, the possibility of results contrary to the previous verification advisory's position to allow the administration of the elderly cannot be excluded.

 

It is analyzed that there is a high probability that a similar decision will be made in Korea as the European EMA, the agency most trusted by the MFDS, has not placed restrictions on vaccination for the elderly.

 

If AZ vaccine is limited to the administration of elderly people, the vaccination plan should be changed.

 

This is because most of the vaccines vaccinated in the first quarter are AZ vaccine.

 

In particular, elderly people in nursing hospitals have difficulty in getting the Pfizer vaccine, which is introduced in mid-February because of their mobility.

 

Pfizer vaccines require frozen storage and can only be inoculated at specific centers.