Central Pharmacopoeia, AZ vaccine vaccination for the elderly’reserved judgment’… Schedule setback’unavoidable’

As the government decided to vaccination against the novel coronavirus infection (Corona 19) from this month, the issue of whether to allow the AstraZeneca (AZ) vaccination to the elderly aged 65 or older has emerged as a key issue.

If the decision to allow AZ vaccination for the elderly is made, the large-frame plan can be carried out without major disruption, but if the decision to disapprove is made, the plan itself is inevitable.

According to quarantine authorities and countries announced on the 6th, the European Union (EU) officially approved the conditional sale of the AstraZeneca vaccine on the 29th of last month, but Germany and France were under the age of 65 because there were insufficient data to prove the efficacy of the vaccine to the elderly. Recommended for vaccination only.

Belgium has lowered the age of vaccinated people to under 55 years of age, and Italy recommended preferential use for those under 55 for the first time, but recently revised the opinion that even over 55 years old can get the vaccine if they are healthy.

Although not a member of the EU, the Swiss government has suspended approval for the AstraZeneca vaccine and demanded that additional data be submitted, and Norway has officially announced that it will not vaccinate people over the age of 65.

The situation in Europe is having a direct impact on Korea.

As a result of the Central Pharmacist Review Committee (Central Pharmacy) meeting, the second expert advisory stage on AstraZeneca vaccine the previous day, the Ministry of Food and Drug Safety approves AstraZeneca vaccination to those aged 18 and over, but the disease control agency later It said that it was recommended to be discussed by the Vaccination Expert Committee (Vaccination and Vaccination Committee).

It did not make a judgment on whether or not to be vaccinated, and turned over the responsibility for the final judgment to the KMA.

At the first stage verification advisory group meeting held on the 1st, the majority opinion was’Vaccination for all age groups, including the elderly’, but the second stage central pharmacy trial came to a different conclusion that it was’reservation of judgment’.

The Ministry of Food and Drug Safety is undergoing a’triple’ expert advisory procedure leading to the COVID-19 vaccine safety and effectiveness verification advisory group (verification advisory group), the Central Pharmacopoeia, and the final inspection committee.

The KFDA issued a statement immediately after the decision of the Ministry of Food and Drug Safety and the Central Pharmaceutical Affairs Deliberation the day before, “reflecting the results after the final approval and examination by the Ministry of Food and Drug Safety, and reviewing the’Corona 19 Vaccine Expert Advisory Group’ and reviewing the’Vaccination Specialized Committee’. After that, the AstraZeneca vaccination plan for the elderly 65 years or older will be confirmed.”

However, amid controversy in Europe, even the Chinese medicine center raises the need for a careful decision, so it is expected that the Agency for Disease Control and Prevention will not be able to draw conclusions easily.

If the schedule of the final inspection committee, which is the final stage of deliberation by the Ministry of Food and Drug Safety, has not been specified, and the decision on the vaccination committee by the Korean Disease Service is required, the time remaining until the start of vaccination at the end of this month is very short.

Vaccination can be disrupted from the start.

From the end of this month, the government has made plans to vaccinate medical staff such as doctors, nurses, hospital workers, etc. who care for Corona 19 patients, and residents of nursing hospitals and facilities with a large number of elderly people over 65 years old.

Currently, the timing of introduction of vaccines directly supplied by pharmaceutical companies in Korea is from Q1 for AstraZeneca (for 10 million people), from Q2 for Janssen (for 6 million people) and 20 million for Modena (for 20 million people), and Pfizer (for 10 million people). Are held from 3Q.