As early as the middle of this month, vaccination against the novel coronavirus infection (Corona 19) will be in full swing.
About 60,000 people (117,000 doses) of Pfizer vaccines secured through the COVAX facility, an international project for joint purchase and distribution of vaccines, will arrive after mid-month, and AstraZeneca (AZ). The vaccine is also expected to supply up to 2.2 million people (4.4 million doses) in the first half of the year.
Among the AstraZeneca vaccines secured by the government through individual contracts, some of the products produced by SK Bioscience in Korea are being promoted to be supplied at the end of this month.
The first vaccine in Korea is a Pfizer product, and medical staff who treat patients with Corona 19 receive the vaccine first.
Interest was the target of AstraZeneca vaccination, and controversy continued day after day over the effect of vaccination on the elderly, but many domestic experts suggested that the elderly may be included in the vaccination target.
Even if the quarantine authority is relatively ineffective, it is a position that it is effective enough to form immunity for the majority of the people, and if safety is confirmed, it can be sufficiently inoculated even for the elderly.
However, in Europe, which has already been approved for conditional marketing, it is noteworthy how the quarantine authorities will determine the scope of AstraZeneca vaccination, given different measures for each country.
◇ Many of the Ministry of Food and Drug Safety verification advisory groups “It is impossible to exclude the elderly from the target of the AstraZeneca vaccine”
According to the quarantine authorities and the Ministry of Food and Drug Safety on the 2nd, the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as the Advisory Group) recommended’conditional approval’ for the Corona 19 vaccine developed by AstraZeneca the day before.
This means that the approval may be subject to the future submission of the final results report of the clinical trial currently in progress and the interim analysis data for the clinical trial in the United States.
The advisory group put a weight on the vaccination side of the’effects of vaccination for the elderly’, which was of particular interest.
A number of experts who participated in the verification team expressed the opinion that “the administration of (vaccination) to the elderly cannot be ruled out just because the number of elderly people among the subjects participating in the clinical trial is small.”
It is explained that vaccination is possible even in the elderly, considering that the vaccination effect was confirmed in all subjects, including those over 65 years of age, and the immune response after vaccination was similar to that of ordinary adults and the elderly.
For example, as a result of evaluating effectiveness based on data from clinical trials conducted in the UK and Brazil, AstraZeneca vaccine showed a prophylactic effect of about 62% in a trial involving 8,895 adults over the age of 18.
This is the result of meeting the criteria (prevention effect of 50% or more) suggested by the World Health Organization (WHO) as a vaccine effect evaluation.
Among the subjects who participated in the test, 660 (7.4%) were also 65 years of age or older, but neutralizing antibodies were generated even in the elderly who received the vaccine, and the advisory group judged that there was no significant difference in the’serum conversion rate’.
Serum conversion rate refers to the proportion of test subjects whose titer of an antibody corresponding to a specific antigen, that is,’antibody value’, increases four times or more compared to before vaccination. In terms of safety, there was no part that could be said to be unique.
However, some of the advisory groups pointed out that there is a lack of data on the elderly.
They commented that the preventive effect was not clearly proven in the process of discussion, and that it is desirable to check additional clinical results and reflect them in the approval matters.
◇ “Relevant data will be available at the end of February” vs. “The efficacy of the elderly cannot be proven”
As AstraZeneca vaccination has already started in several countries, including the UK, both inside and outside the medical field, there is a prospect that sufficient clinical data will be accumulated by the end of February when the AstraZeneca vaccine is introduced in Korea.
“The reality is that the only vaccine available in the first half of the year is AstraZeneca,” said Jeong Jae-hoon, a professor at Gachon University Medical School. “The UK started vaccination in January, but by the end of February, the relevant data will be available, so there is no big problem. said.
Professor Jeong emphasized, “Under limited conditions, the best judgment should be made.” “In terms of the damage to the elderly and the need to protect them first, (AstraZeneca vaccine vaccination for the elderly) is almost the only option available now.”
On the other hand, it is pointed out that, as in some opinions of the advisory group, vaccination for the elderly should be decided carefully.
“It is difficult to say’it is effective’ if the number of (elderly subjects) is only 660,” said Jeong Ki-seok, a professor at Hallym University, who served as the head of the Centers for Disease Control and Prevention. “There is not enough evidence for whether or not to get vaccinated. “No.”
Chairman of the Korean Medical Association (Medical Association) also expressed the opposition to the vaccination of the elderly, saying, “The Medical Association has reviewed the efficacy and safety of the AstraZeneca vaccine and judged that the efficacy for the elderly over the age of 65 has not been proven.”
He said, “There is a high possibility that people aged 65 years or older will become severely affected by Corona 19 infection,” he said. “The Pfizer Modena vaccine, which has been proven to be the most effective and highly effective, should be inoculated.” Insisted.
The quarantine authorities are in the position that once the effectiveness or safety of a certain degree is verified, the vaccination can be given to the elderly.
In a briefing the previous day, the Korea Centers for Disease Control and Prevention (CDC) chief said, “The effectiveness of the AstraZeneca vaccine may be relatively inferior, but if it is effective enough to form a population immunity, and safety is confirmed, it is sufficient to take into account accessibility and frequency of adverse reactions. I think it’s possible.”
However, he explained, “After confirming the contents of the approval from the Ministry of Food and Drug Safety, the detailed plan will be finalized after determining the target of AstraZeneca vaccine and whether the elderly will be vaccinated through deliberation by the Vaccination Review Committee.”