MFDS Pre-Review of Pfizer Vaccine for Omicron BA.1 Response

[Image source=AP Yonhap News]

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) has begun a preliminary review of Pfizer's COVID-19 vaccine developed to respond to Omicron BA.1.

On the 5th, the MFDS announced that it has started reviewing the clinical trial data for Pfizer Korea's COVID-19 vaccine 'Comirnaty 2-dose 0.1 mg/mL' following the submission of a preliminary review application.

Earlier, since the 29th of last month, the MFDS has been conducting a product approval review for Moderna's Omicron-targeted vaccine 'Moderna Spikevax 2-dose.'

'Comirnaty 2-dose 0.1 mg/mL' is a multivalent vaccine expressing antigens for both the original coronavirus and the Omicron BA.1 variant. It uses the same messenger RNA (mRNA) technology as the existing Pfizer vaccine and was developed as a booster dose for individuals who have completed their primary vaccination series.

An MFDS official explained, "If additional non-clinical and quality data are submitted for product approval, we will conduct a prompt and thorough review and consult vaccine experts, including infectious disease specialists, regarding the safety and efficacy of the vaccine."

Meanwhile, Pfizer's Omicron-targeted vaccine is also undergoing preliminary review procedures in Europe and other regions. The United States signed an additional supply contract for 105 million doses of this vaccine in June.

This content was produced with the assistance of AI translation services.