AstraZeneca vaccine gets first official approval
The Ministry of Food and Drug Safety authorized Wednesday the use of AstraZeneca’s Covid-19 vaccine for all adults, including people 65 and older, despite concerns over the drug’s efficacy in the elderly.
The ministry granted marketing authorization for the vaccine developed by the British-Swedish pharmaceutical giant and Oxford University on the condition that AstraZeneca submits further data on the ongoing phase three clinical trials on adults aged 18 and over.
Minister of Food and Drug Safety Kim Gang-lip in a briefing Wednesday afternoon announced the conclusions of a final evaluation committee that reviewed the safety and efficacy of AstraZeneca's drug, the first coronavirus vaccine approved in Korea.
The committee, comprised of five officials including Kim and three experts, found the vaccine to be safe overall for adults 18 and older, but said the drug description should state: “Be attentive when administering to individuals aged 65 and older,” because of limited clinical data available for that age group.
AstraZeneca is on track to begin delivery of its first batch of vaccines to Korea, enough to inoculate 750,000 people, starting Feb. 24.
Korea plans to kick off its first Covid-19 vaccinations on Feb. 26.
AstraZeneca’s viral vector vaccine requires two doses recommended to be administered four to 12 weeks apart.
Frontline medical workers and elderly people at nursing homes are included in the initial group of people to get inoculated within the first quarter of this year under a four-stage government vaccination scheme to achieve herd immunity by November.
There have been concerns about the AstraZeneca vaccine being less effective in people 65 and over and its poor initial results in fighting off the South African variant of Covid-19.
Countries including Germany, Italy, France and Sweden recommended the AstraZeneca vaccine be used only on people under 65 and cautioned against its use on the elderly, citing insufficient data on safety and efficacy.
AstraZeneca filed a marketing authorization application with the ministry on Jan. 4. The vaccine underwent a three-tiered review process by an advisory committee, a central pharmaceutical advisory committee and a final evaluation committee based on scientific data.
The final committee concluded that the vaccine is safe and that most of the adverse reactions are predictable after the administering of a vaccine, and are at an “acceptable level.” Such reactions include bruising, fatigue, headache and muscle pain, which disappeared after several days, according to clinical studies.
The central pharmaceutical advisory committee recommended earlier that the safety and immune response in older people were in "normal range” but noted that additional test results are needed because only 660 people aged 65 and older, or 6.7 percent, participated in the clinical trial. It added that physicians should weigh the benefits of vaccination considering the patients’ condition if they fall in this age group.
The Ministry of Food and Drug Safety requested an interim and final report on clinical trials for AstraZeneca vaccines in the United States conducted on 30,000 people, including around 7,500 seniors.
The ministry did not recommend vaccination for pregnant women.
An early study last week made headlines after it indicated that the vaccine did not protect clinical trial volunteers from mild or moderate illness caused by the more contagious virus variant that was first identified in South Africa. The AstraZeneca vaccine was found to be much more effective in fighting severe cases and reducing deaths. South Africa suspended use of AstraZeneca shots in its vaccination program on Sunday.
However, the overseas variant was not a key factor in the Korean government’s approval process for the vaccine. There are 54 cases of Covid-19 variants from overseas reported in Korea so far, of which nine are of the South African variant.
Minister Kim said in the briefing, “Currently, we have not yet secured clear evidence on the effect of the virus variant,” adding national health institutes are conducting research on these strains.
Unlike the Pfizer and Moderna mRNA vaccines, AstraZeneca’s use a chimpanzee common cold viral vector that delivers the gene that allows human cells to make the SARS-CoV-2 spike protein and enables the production of neutralizing antibodies in the body. AstraZeneca’s efficacy rate was over 62 percent, while that of Pfizer and Moderna are around 95 percent effective.
The AstraZeneca vaccine is cheaper and easier to transport and store than the mRNA vaccines, which require tricky ultra cold chain storage.
The AstraZeneca batch to be received in Korea is locally manufactured by SK Bioscience at a factory in Andong, North Gyeongsang.
The first batch of vaccines is expected be delivered nationwide to some 2,000 vaccination centers, hospitals and nursing homes.
“The Ministry of Food and Drug Safety focused all our efforts to thoroughly verify the safety and efficacy of this vaccine to approve Korea’s first coronavirus vaccine,” said Kim. “The ministry will make sure that the results for the ongoing clinical trials are submitted as soon as possible, and we will work with other relevant agencies to strengthen monitoring of any adverse effects after vaccination and establish a monitoring system to ensure that the public can feel safe in getting vaccinated.”
BY SARAH KIM [email@example.com]