The government granted conditional approval to Celltrion’s antibody treatment.
A panel of South Korean advisers urged caution over the use of AstraZeneca’s Covid-19 vaccine, for those aged sixty-five or above.
Our Lee Kyung-eun has the details.
South Korea remains cautious about granting approval for AstraZeneca’s COVID-19 vaccine due to a lack of clinical data on its effectiveness on older adults.
The Food and Drug Safety Ministry on Thursday held its second round of meetings
With outside experts, who advised its use on those aged 18 or over.
Specifically, two full-doses with a 4 to 12 week interval with the exception of pregnant women.
However, the panel said further discussions are needed for its use on those aged 65 or above.
“We advised the ministry to cautiously decide on administering the vaccine to those aged 65 or above as there is not enough relevant data,.. and to request that AstraZeneca submit further clinical data in the U.S. and elsewhere.”
That is a different stance from the first meeting with a separate panel of experts, who supported the vaccine’s use on that age group, saying it is safe and effective for all adults.
Some European countries, namely France, Germany, Austria, and Sweden have advised against using the vaccine on those aged 65 or over.
South Korea’s drug agency will now proceed with the final round of expert review before granting approval.
In the meantime, a milestone announcement was made on Friday, as the drug agency has given the green light to the first locally-developed COVID-19 treatment.
“We decided to approve the antibody treatment ‘Regkirona’ on the condition that the drugmaker Celltrion submits results from a phase-three clinical trial.”
The Phase three trial will be carried out in 10 countries.
The drug’s Phase-two trial shows that the treatment can reduce recovery time and the likelihood of developing severe symptoms.
Lee Kyung-eun, Arirang News.
A panel of South Korean advisers urged caution over the use of AstraZeneca’s Covid-19 vaccine, for those aged sixty-five or above.
Our Lee Kyung-eun has the details.
South Korea remains cautious about granting approval for AstraZeneca’s COVID-19 vaccine due to a lack of clinical data on its effectiveness on older adults.
The Food and Drug Safety Ministry on Thursday held its second round of meetings
With outside experts, who advised its use on those aged 18 or over.
Specifically, two full-doses with a 4 to 12 week interval with the exception of pregnant women.
However, the panel said further discussions are needed for its use on those aged 65 or above.
“We advised the ministry to cautiously decide on administering the vaccine to those aged 65 or above as there is not enough relevant data,.. and to request that AstraZeneca submit further clinical data in the U.S. and elsewhere.”
That is a different stance from the first meeting with a separate panel of experts, who supported the vaccine’s use on that age group, saying it is safe and effective for all adults.
Some European countries, namely France, Germany, Austria, and Sweden have advised against using the vaccine on those aged 65 or over.
South Korea’s drug agency will now proceed with the final round of expert review before granting approval.
In the meantime, a milestone announcement was made on Friday, as the drug agency has given the green light to the first locally-developed COVID-19 treatment.
“We decided to approve the antibody treatment ‘Regkirona’ on the condition that the drugmaker Celltrion submits results from a phase-three clinical trial.”
The Phase three trial will be carried out in 10 countries.
The drug’s Phase-two trial shows that the treatment can reduce recovery time and the likelihood of developing severe symptoms.
Lee Kyung-eun, Arirang News.
Reporter : kelee@arirang.com
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