The head of BioNTech SE that developed the first Covid-19 vaccine, said a new formula is likely to be needed by mid-2022 to protect against future mutations of the virus. (Bloomberg; October 3, 2021)
輝瑞公司/BioNTech SE疫苗在預防冠狀病毒感染方面的有效性從第二次劑量后六個月的88%下降到47%. 因此,可能需要第三剂。
The effectiveness of the Pfizer Inc /BioNTech SE vaccine in preventing infection by the coronavirus dropped to 47% from 88% six months after taking the second dose, thus there may be a need for booster shots. (Reuters; October 5, 2021)
歐盟藥品監管機構表示,免疫系統衰弱的人應該從輝瑞-BioNTech或Moderna接受第三劑COVID-19疫苗,但由成員國來決定。
The European Union's drugs regulator said on Monday people with weakened immune systems should get a third dose of a COVID-19 vaccine from Pfizer-BioNTech or Moderna, but left it to member states to decide if the wider population should have a booster. (Reuters; October 4, 2021)
Merck/Ridgeback Biotherapeutics 宣佈了關於其口服抗病毒藥物molnupiravir的第三階段研究的中期數據。該藥物可使輕度或中度COVID-19的非住院成人患者住院或死亡的風險降低約50%。之后,BioNTech的股价大跌,我不明白,因为,molnupiravir是治疗用,而BioNTech是预防,两者是不同的东西。如果,利用monupiravir来预防,那么,用者可能每天都要服用,相当麻烦。如果,阁下有高见,请分享一下。谢谢
Merck/Ridgeback Biotherapeutics announced positive interim data from a phase III study on their oral antiviral medicine, molnupiravir. The medicine reduced the risk of hospitalization or death by approximately 50% in non-hospitalized adult patients with mild or moderate COVID-19. (ZACKS; October 4, 2021) (Merck is supposed for treatment, while vaccine is for prevention. If someone uses Merck's for prevention (as an oral vaccine) then someone may need to take it daily. Do you think if this is quite troublesome? I don't understand how Merck's medicine can affect BioNTech's stock value. If you have the answer, please let me know.)
FDAfull批准16歲及以上人群用輝瑞/BioNTech疫苗。但他們尚未完全批准將其用作第3次注射。相反,FDA在緊急使用授權下批准了輝瑞的第3次注射,並批准了尚未申請的全部生物製劑許可證(BLA)。FDA希望以色列提供軍事人員的數據可以澄清接受輝瑞/BioNTechCOVID-19第3次注射对年輕人患心肌炎症的風險(安全性度)。
FDA granted full approval for the Pfizer/BioNTech vaccine for people age 16 and older but they have not yet given full approval for its use as a booster shot. Instead, the FDA approved Pfizer's booster under an emergency use authorization with approval on the full biologics license application (BLA) still pending. FDA are hoping data on Israeli military personnel can help clarify the risk of heart muscle inflammation in younger people who have received Pfizer/BioNTech COVID-19 booster shots. (Reuters; October 1, 2021)
本来,中國应该在7月前批准BioNtech的疫苗。但中國研发的疫苗在預防住院治療方面是有效的,而对Delta變種BioNtech的療效降低到64%。另一方面,中國製藥商正在開發自己的mRNA疫苗。The Wall Street Jounral认为:這些因素可能導致BioNtech疫苗審批的延遲。以下是BioNTechCOVID19疫苗的供应分配:
Here tells where BioNTech's vaccine goes:
China was expected to approve the BioNTech vaccine, by July. Chinese vaccines have proven effective at preventing hospitalizations, while the Delta variant cuts BioNTech’s efficacy down to 64%. On the other hand, Chinese drug makers are developing their own mRNA vaccines. These factors may cause the delay for the BioNTech vaccine approval. (The Wall Street Journal; August 27, 2021)
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