FDA Grants EUA to Next-gen COVID-19 Vaccines BA.5次世代疫苗過EUA 供12歲以上追加劑

The Food and Drug Administration announced on Oct. 26 that it has granted emergency use authorization to next-generation bivalent COVID-19 vaccines from BNT and Moderna that target the Omicron BA.4 and BA.5 subvariants. They will be offered as boosters to people aged 12 and above.

The Food and Drug Administration announced on Oct. 26 that it has issued an Emergency Use Authorization (EUA) for next-generation bivalent COVID-19 vaccines from BNT and Moderna that target the Omicron BA.4 and BA.5 subvariants. Individuals aged 12 and above will be able to get them as boosters once three months have passed since their last shot. Experts say next-generation vaccines targeting the BA.1, BA.4, and BA.5 subvariants are effective against severe disease and people shouldn't wait until new vaccines are available to get vaccinated because R&D can't keep up with viral mutations.

Lee Ping-ing, Convener, ACIP: “Their protection against severe disease may not be greatly affected. In addition, right now there are already new variants emerging. If you're waiting for next-generation vaccines, you should know that they'll never be able to keep pace with viral mutations.”

CECC Commander Victor Wang said Taiwan has already signed a contract with Moderna to procure next-gen vaccines, so they could arrive quickly. The Advisory Committee on Immunization Practices met on Oct. 27 to discuss the vaccination schedule. At the earliest, 600,000 Moderna boosters targeting the BA.4 and BA.5 subvariants will arrive in the first half of November.

Victor Wang, Commander, Central Epidemic Command Center: “There is a chance that they will arrive in the first half of November. Yes, that's correct. That's the latest information I have from the CDC. Since we granted the EUA, I'll ask them to start making the arrangements.”

Procuring BNT vaccines will require contract negotiations. Wang said the current strategy is to first use Moderna shots. If they are insufficient, then an agreement with BNT will be signed to avert waste.

 

BA.5次世代疫苗要來了。衛福部食藥署26日核准BNT、莫德納的新冠次世代BA.4、BA.5雙價疫苗EUA，將核准專案輸入，適用於12歲以上青少年及成人，作為追加劑接種，間隔至少3個月施打。專家表示，不論是國內已開打的BA.1次世代疫苗，或是即將到貨的BA.4、BA.5次世代疫苗，對於重症保護效果一樣。建議民眾不要等新疫苗出現才打，因為疫苗研發、永遠趕不上病毒變異速度。

衛福部疫苗接種組召集人李秉穎說道：「它們對於重症的保護力可能不會受到很大的影響，而且那個現在其實已經有新的變異病毒又出來了，你如果一直在等新的變異株的次世代疫苗的話，大概永遠會趕不上變異病毒出現的速度。」

而疫情指揮中心指揮官王必勝表示，台灣已與莫德納公司簽訂次世代疫苗合約，因此叫貨速度可望加快，27日週四將召開ACIP專家會議，討論接種方式，預估最快11月上旬，會有60萬劑莫德納BA.5次世代疫苗抵台。

疫情指揮中心指揮官王必勝表示：「11月上旬應該有機會可以到貨，對，沒有錯，剛剛聯絡是這樣，那個是疾管署跟我（說），因為EUA過了，我請他們安排進貨。」

至於BNT疫苗則需要另外洽談合約，王必勝強調，目前策略是先用莫德納，若有不足才會再與BNT簽約，以避免疫苗浪費。