The MFDS released the minutes of the Advisory Meeting

The elderly over the age of 65 have difficulty with a single plan for vaccination

The Central Pharmaceutical Affairs Review Committee, a legal advisory body of the MFDS, also found that there was a controversy over the AstraZeneca (AZ) COVID-19 vaccine, which has been delayed for vaccination for 65-year-olds.

 

It is administered to adults over the age of 18, including those over 65, but there was an opinion that the elderly should specify that "the vaccination should be carefully decided" in the precautions for use.

 

However, no conclusions were drawn, including the recommendation of the MFDS’ Vaccination Committee to discuss whether to be vaccinated at the age of 65.

 

The MFDS released the minutes of the Advisory Meeting of the Central Pharmaceutical Affairs Review Committee on the approval of the AZ COVDI-19 vaccine on the 4th.

 

The AZ COVDI-19 vaccine was approved for vaccinations over the age of 18, subject to future US clinical data submission as advised by the Central Pharmaceutical Affairs Review Committee on the 10th.

 

However, it stated in the precautions for use that the use for the elderly over the age of 65 should be carefully decided.

 

It was the reason for the lack of clinical data if limited to 65 years of age or older.

 

In addition to the efficacy and effect, which are the most important paragraphs in the permit, the indication was set to be 18 years or older, so that the elderly 65 years or older can also be included.

 

The Central Pharmaceutical Affairs Review Committee also debated whether or not to allow vaccinations for seniors over 65 years of age.

 

The majority opinion was that the vaccine should be made available to people over 65.

 

One member said, "The supply of other vaccines may not be available because the supply timeline of other vaccines is tight.

 

It should be allowed to reduce concerns about severe morbidity in the elderly." Another member also said, "Pregnant women are limited, but for people over 65 years of age, limiting as a matter of effectiveness should be considered differently." He said, "In consideration of the vaccine supply, it would be better to allow it to be 18 years of age or older, and that the effect may be inferior to 65 years of age or older.

 

But there were also objections.

 

One member argued that "the vaccine is not approved because it has a good immune response, and the effect in the elderly is unknown." He added that it is necessary to include restrictions on the use of 65 years of age or older.

 

Another member argued, "It is reasonable to wait for the results of the US clinical trial, not to deny that there is a benefit to the patient, but to consider the impact of the US clinical trial results." At this meeting, it was not easy to gather opinions on whether or not to be vaccinated over the age of 65.

 

When the first agenda was discussed, when a single proposal was not prepared, other agendas were discussed and discussed again.

 

Eventually, the chairman made a single proposal, stating that "there was a considerable compromise of opinions" and "let's give the elderly an opportunity to use it." However, One member also said, "It's different from saying that people over 65 are not recommended until there is additional evidence." In addition, there was an opinion that amendment was proposed as "there is insufficient data on the effect, so it must be carefully determined until the effectiveness is verified." In response, the MFDS argued that "until the effectiveness is verified" may require additional explanation as to whether the effectiveness has not been verified." An official from AZ said, "It was conducted according to the clinical trial plan, and it is judged that it showed safety and efficacy in research subjects including 65 years or older." "The results of the analysis of US data are expected to be released at the end of April, and the efficacy data for the elderly in the UK is 55%, and the P-value is similar to that of young adults with a P-value of 0.005, and is being monitored by UK regulators." Regarding the additive and chimpanzee adenovirus controversy, "Polysorbate 80 is an additive used in other vaccines and has a good safety profile," he said.

 

"The PEG used in mRNA vaccines was associated with anaphylaxis reactions." He said, "The chimpanzee adenovirus was strategically selected for a virus that has not been immune to existing immunity, and it was evaluated on a large scale in other clinical trials such as tuberculosis, Ebola, HIV, and malaria vaccines, and there was no safety concern."