Thursday, the FDA granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
The approval comes for the updated vaccines from Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE) / BioNTech SE (NASDAQ:BNTX).
The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.
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In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines.
Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.
The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals six months through 11 years of age.
- Unvaccinated individuals six months through 4 years of age are eligible to receive three doses of the Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated Moderna COVID-19 Vaccine.
- Individuals six months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of Moderna or Pfizer-BioNTech COVID-19 vaccines.
- Individuals 5 through 11 years of age, regardless of previous vaccination, are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
- Individuals 12 and older can receive a single dose of Comirnaty or Spikevax.
- Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in vaccine fact sheets.
The FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines.
Moderna said the Spikevax 2024-2025 formula is expected to be available across the U.S. in the days immediately following approval.
Pfizer also said shipping will begin immediately.
Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine was left out in today's approval. Earlier, the company mentioned that it anticipates commercial delivery of the protein-based vaccine in the U.S. in September, pending authorization.
Price Action: PFE stock is down 1.18% at $28.69, BNTX stock is down 0.85% at $88.23, MRNA stock is down 5.08% at $82.25, and NVAX stock is down 5.72% at $12.20 at last check Thursday.
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週四，FDA授權更新的mRNA COVID-19疫苗（2024-2025配方），增加了與Omicron變異株KP.2的單價（單個）成分相對應的配方。
現代納（納斯達克：MRNA）和輝瑞（紐交所：PFE）/ biontech SE（納斯達克：BNTX）的更新疫苗獲得了批准。
根據這一配方，更新的mRNA COVID-19疫苗更接近目前流行的變種，能夠更好地防護COVID-19的嚴重後果，包括住院和死亡。
此前曾有研究顯示，阿斯利康、輝瑞BioNTech和moderna的新冠疫苗出現了致心臟病發作、中風的問題，但一項英國研究顯示這些疫苗仍然削減了引起心臟病發作和中風的主要血栓表現。
6月初，FDA建議持有許可和授權COVID-19疫苗的製造商使用COVID-19疫苗（2024-2025配方）作爲單價JN.1疫苗。
基於SARS-CoV-2的進一步演變以及COVID-19病例的增加，機構隨後確定並建議製造商，如果可能的話，COVID-19疫苗（2024-2025配方）的首選JN.1系列是KP.2變種。
更新的mRNA COVID-19疫苗包括Comirnaty和Spikevax，兩者均獲得12歲及以上人群的批准，並且Moderna COVID-19疫苗和Pfizer-BioNTech COVID-19疫苗都獲得了6個月至11歲人群緊急使用授權。
- 6個月至4歲未接種疫苗的人員有資格接種兩劑更新的Moderna COVID-19疫苗或三劑輝瑞-BioNTech COVID-19疫苗。
- 6個月至4歲的個體，如果已接種過COVID-19疫苗，則有資格接受1或2劑現代或輝瑞-拜恩泰克COVID-19疫苗。
- 5至11歲的個體，無論是否接種過疫苗，都有資格接受更新的、授權的現代或輝瑞-拜恩泰克COVID-19疫苗的單劑；如果之前接種過疫苗，則接種至少在最後一劑COVID-19疫苗之後的2個月內進行。
- 12歲及以上的個體可以接受一劑Comirnaty或Spikevax。
- 根據疫苗說明書，對於年齡在6個月至11歲之間的某些免疫功能受損的個體，授權使用額外劑量。
FDA評估了製造和非臨床數據，以支持將2024-2025年配方納入mRNA COVID-19疫苗的改變。
Moderna表示，Spikevax 2024-2025年的配方預計在獲得批准後的幾天內在全美上市。
輝瑞也表示將立即開始發貨。
納斯達克(NASDAQ:NVAX)的COVID-19疫苗在今天的批准中被遺漏。此前，該公司提到預計在9月在美國獲得授權後商業化交付基於蛋白質的疫苗。
PFE股票下跌1.18%，報28.69美元，BNTX股票下跌0.85%，報88.23美元，MRNA股票下跌5.08%，報82.25美元，NVAX股票下跌5.72%，報12.20美元，截至週四最新數據。
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