UK for the First Time in the World to Approve Bivalent Vaccine for Omicron Strain

Recently CNN.co.jp reported the following:

オミクロン株対応の２価ワクチン、英国が世界初の承認

2022.08.16 Tue posted at 11:40 JST

  （ＣＮＮ） 新型コロナウイルスの従来株とオミクロン株に対応する「２価ワクチン」が、世界で初めて英国で承認された。英政府が１５日に発表した。

承認されたのは米モデルナ製の追加接種用ワクチン。英医薬品医療製品規制庁（ＭＨＲＡ）がデータを精査し、安全性、品質、有効性の面で基準に適合すると判断した。

モデルナは臨床試験の結果として、オミクロン対応の追加接種で免疫反応が強化され、変異系統の「ＢＡ．４」「ＢＡ．５」にも有効であることが分かったと報告している。

ＭＨＲＡによれば、副反応は従来のモデルナ製ワクチンと同様で一般的に軽く、自然に消失するという。政府は「重大な安全上の懸念は見つからなかった」と述べた。

ＭＨＲＡのレイン長官は、ウイルスが変異を続けるなかで、この２価ワクチンは国民を守るための「鋭利さを増した武器」になると述べた。

接種の時期や対象者は明らかでない。接種体制については政府の諮問機関である予防接種合同委員会（ＪＣＶＩ）が助言する予定だ。

米ファイザーと独ビオンテックも６月にオミクロン株対応の追加接種用ワクチンの臨床試験を実施し、初期結果として現行のワクチンより免疫反応が高まったと報告している。

Translation

  (CNN) The world's first 'bivalent vaccine' against the conventional and Omicron strains of the new coronavirus had been approved in the UK. The UK government announced this on the 15th.

The approved booster vaccine was made by Moderna. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) had reviewed the data and determined that it had met the criteria for safety, quality and efficacy.

As a result of clinical trials, Moderna reported that booster vaccination against Omicron had strengthened the immune response and was also effective against mutant strains "BA.4" and "BA.5."

According to the MHRA it was said that side effects were similar to those seen with Moderna vaccines that were generally mild and would disappear on their own. The government said it "did not find any serious safety concerns".

MHRA Chief Executive Raine said the bivalent vaccine would be a "sharpened tool" to protect the public as the virus continued to mutate.

The timing of vaccination and the target population were not clear. The government's advisory body, the Joint Committee on Vaccination and Immunization (JCVI), would give advice on the vaccination order.

The US Pfizer Inc. and Germany BioNtech Inc. also conducted clinical trials of booster vaccines against the Omicron strain in June, and an immune response that was stronger than current vaccines was reported in early results.

So, the world's first 'bivalent vaccine' by Moderna  has been approved in the UK. As the US Pfizer Inc. and Germany BioNtech Inc. are also conducting clinical trials of booster vaccines, it seems that more options on Covid-19 vaccination will be available soon. Meanwhile Japanese will received 'bivalent vaccine' around October this year.