Initial Wuhan Strain and Omicron BA.1 Response
SAMBA Production Moderna Bivalent Vaccine Also Approved
[Asia Economy Reporter Kim Young-won] Pfizer's updated vaccine targeting Omicron BA.1 has received import approval.
The Ministry of Food and Drug Safety announced on the 7th that it has approved the import of the COVID-19 bivalent vaccine 'Comirnaty 2-dose 0.1mg/mL (Tozinameran·Litozinameran)' applied for approval by Pfizer Korea.
The Ministry explained that after comprehensively reviewing the safety, efficacy, and quality evaluation results of Comirnaty 2-dose, as well as expert consultations, it decided to grant product approval on the condition that long-term storage test data be submitted post-approval.
Comirnaty 2-dose is a messenger RNA (mRNA) bivalent vaccine expressing antigens for the original Wuhan strain and the Omicron BA.1 variant of COVID-19. It is used for additional vaccination of 0.3mL at least three months after the primary or booster vaccination for individuals aged 12 and older.
According to the Ministry, after administering Comirnaty 2-dose as a booster to 305 people and monitoring adverse events for seven days, the incidence was similar to that of previous vaccine recipients. The most common adverse event was injection site pain (58.1%). The Ministry reported that most adverse events were temporary and mild to moderate, and no serious adverse drug reactions were observed.
Regarding efficacy, four weeks after the booster vaccination, a comparison between 178 recipients of the bivalent vaccine and 163 recipients of the original vaccine showed that the immunogenicity of the bivalent vaccine against the Omicron variant was 1.56 times higher than that of the original vaccine. For the Wuhan strain, the immunogenicity was comparable to that of the original vaccine.
Comirnaty 2-dose has been conditionally approved and authorized for booster use in the European Union (EU) and the United Kingdom since the 2nd of last month, and in Japan since the 13th of the same month.
A Ministry official stated, "After approval, we will strengthen the surveillance system for adverse events following vaccination in cooperation with related ministries and agencies," adding, "In particular, before vaccination, we will conduct national lot release approval to closely review the manufacturer's manufacturing and testing results for each manufacturing unit and perform direct testing to verify product quality."
Meanwhile, the Ministry also approved Moderna's COVID-19 bivalent vaccine 'Spikevax 2-dose,' manufactured domestically by Samsung Biologics, on the same day.
'Spikevax 2-dose' is produced domestically by filling and labeling processes using the same active pharmaceutical ingredient supplied from overseas as 'Moderna Spikevax 2-dose,' which received import approval on the 8th of last month.
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