Pfizer's latest Covid vaccine wins nod, 2 Covid treatments get insurance coverage

Korea’s Ministry of Food and Drug Safety (MFDS) said Friday that it has granted approval for Pfizer Korea and BioNTech’s Comirnaty injection (tozinameran), a vaccine specifically tailored to combat the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage.

As the Covid-19 virus continues to mutate, targeted vaccines are becoming crucial. The newly approved Comirnaty injection, utilizing mRNA technology, is designed to stimulate the immune system to produce antibodies and blood cells specifically against the JN.1 variant. 

This vaccine, slated for use during the 2024-2025 flu season, has already received regulatory approval in Europe, the U.K. in July, and Japan in August. 

It is intended for individuals aged 12 and older, administered as a single 0.3 mL intramuscular dose. For those who have previously been vaccinated against Covid-19, the recommended interval before receiving this new shot is at least three months.

This approval comes just a day after the Korea Health Insurance Review and Assessment Service (HIRA) said that two Covid-19 treatments have been approved for health insurance coverage. 

The newly reimbursed treatments include Gilead Sciences’ antiviral drug Veklury (remdesivir), an intravenous injection for hospitalized Covid-19 patients, and Pfizer’s Paxlovid tablets (nirmatrelvir and ritonavir), an oral medication for adults with mild to moderate Covid-19 who are at high risk of severe disease progression.

HIRA’s Pharmaceutical Benefit Assessment Committee has recommended both medications for insurance reimbursement. The final decision on coverage will follow pricing negotiations with the National Health Insurance Service and further review by the Health Insurance Policy Review Committee within the Ministry of Health and Welfare.

HIRA said this decision marks a significant step in making these Covid-19 treatments more accessible to the public through insurance coverage, pending the completion of the final approval process. 

In addition to these Covid-19 treatments, the committee also approved three potassium-competitive acid blocker medications—Jaqbo, Qzetas, and OnCap tablets, all containing the active ingredient zastaprazan—developed by Onconic Therapeutics, a subsidiary of Jeil Pharma Holdings. These medications were deemed eligible for coverage, provided their pricing falls within assessed limits.

However, Gilead Sciences' breast cancer drug Troldelvy (sacituzumab govitecan) was sent back for reconsideration. The committee determined that the drug requires further review, particularly concerning pricing, before reimbursement can be approved. 

Troldelvy is a third-line treatment for metastatic triple-negative breast cancer and was launched in Korea in October following approval in May of last year. Despite its current reimbursement status, patient advocacy groups have called for its inclusion in insurance coverage due to its high cost—approximately 5-6 million won (about $4,000)  per injection, with three injections needed per month.