Seoul, Feb 10 (efe-epa).- South Korea approved Wednesday the use of a coronavirus vaccine developed by AstraZeneca and Oxford University in adults, including those over 65.
It, however, said there was a lack of data on the efficacy of the vaccine in the elderly.
South Korea set up a committee to carry out a fast track evaluation when AstraZeneca, whose vaccines will begin to be administered in the Asian country on Feb. 26, sent the corresponding documentation on Jan. 4.
This body granted approval for the vaccine “on condition of submitting results of Phase III clinical trial that is ongoing in countries including the US (United States),” South Korean Food and Drug Safety Minister Kim Ganglip said in a press conference.
The committee has deemed the vaccine safe considering “most of the reported adverse reactions are predicted adverse reactions following administration of a vaccine and that they are in a range of acceptable level,” Kim added.
With regard to the vaccination of the elderly, the committee has decided to include the following warning in the specifications of the drug: “Be attentive when administering to individuals aged 65 and older.”
Kim said that the studies carried out to date have shown that the safety and immune response of the AstraZeneca vaccine in the elderly is normal but added that since there have not been enough participants from that age group so far, there is insufficient data to demonstrate its effectiveness in older people.
For this reason, even though the European Medicines Agency (EMA) authorized the use of the vaccine in anyone over 18 years, many European countries have restricted its use to those under the age of 65 and some countries including Spain, Belgium and Italy, even to those under 55 years, as the bulk of the participants in the trials were below that age.
AstraZeneca’s vaccines will be the first to be used in the Asian country, where they are being manufactured by the South Korean pharmaceutical company SK Bioscience, which has announced that it will deliver the first batches of the vaccine on Feb. 24. EFE-EPA