UK first to approve Omicron COVID shot with Moderna nod



* UK's JCVI backs using bivalent shot in autumn booster campaign

* Moderna sees Australia, Canada, EU approvals soon

By Natalie Grover

LONDON, Aug 15 (Reuters) - Britain, the first country to approve a coronavirus vaccine in late 2020, has now also given the first green light to a variant-adapted shot that targets both the original and Omicron version of the virus.

The UK medicines regulator (MHRA) gave the so-called bivalent vaccine made by U.S. drug company Moderna MRNA.O conditional approval as a booster for adults on Monday.

Later on Monday, the UK's Joint Committee on Vaccination and Immunisation (JCVI) backed the use of the variant-adapted shot in the country's booster campaign starting September.

The MHRA's Moderna decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original virus, it said.

Moderna in June said trial data showed that when given as a fourth dose, the variant-adapted shot raised virus-neutralizing antibodies by eight-fold against Omicron.

The MHRA also cited an exploratory analysis in which the shot was found to generate a "good immune response" against the currently dominant Omicron offshoots BA.4 and BA.5.

According to Moderna, trial data showed its variant-adapted booster generated virus-neutralizing antibody levels against the subvariants that were 1.69 times higher than those given the original booster.

However, the correlation between neutralizing antibody levels and vaccine effectiveness against disease - in particular severe disease - remains unclear.

No serious safety concerns were identified with the new Moderna formulation, the MHRA added on Monday.

While existing COVID-19 vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved.

"What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve," MHRA Chief Executive June Raine said in a statement.

However, the virus is unlikely to stand still and Omicron-targeted immunity might push the virus down other evolutionary paths, added Jonathan Ball, professor of molecular virology at the University of Nottingham.

"In which case we will be like the Red Queen in Alice and the Looking Glass - having to keep running just to stay in the same place."

FURTHER APPROVALS

European Medicines Agency (EMA) officials expect COVID variant-adapted vaccines to be approved in the European Union by September, and have signalled the regulator is open to using shots targeting the older BA.1 variant this autumn, given those specifically targeting newer subvariants are further behind in clinical development.

In contrast, the U.S. Food and Drug Administration (FDA) has said it will seek the specific inclusion of the newer BA.4 and BA.5 offshoots of Omicron in any new shots used domestically.

On Monday, the chief of Serum Institute of India - which produces AstraZeneca's COVID-19 vaccine under the brand name Covishield - said he expected an Omicron-specific vaccine in the country in six months, NDTV reported.

Moderna, which signed a 1 billion pound ($1.2 billion) deal with the British government to build the country's first mRNA vaccine facility earlier this year, on Monday said it expected further approvals for the adapted vaccine in Australia, Canada, and the EU in the coming weeks.

Pfizer Inc PFE.N and BioNTech 22UAy.DE have also been testing versions of their mRNA vaccine modified to combat Omicron variants.

($1 = 0.8270 pounds)
Reporting by Natalie Grover in London Editing by David Goodman, Mark Potter and Marguerita Choy

免責聲明: XM Group提供線上交易平台的登入和執行服務,允許個人查看和/或使用網站所提供的內容,但不進行任何更改或擴展其服務和訪問權限,並受以下條款與條例約束:(i)條款與條例;(ii)風險提示;(iii)完全免責聲明。網站內部所提供的所有資訊,僅限於一般資訊用途。請注意,我們所有的線上交易平台內容並不構成,也不被視為進入金融市場交易的邀約或邀請 。金融市場交易會對您的投資帶來重大風險。

所有缐上交易平台所發佈的資料,僅適用於教育/資訊類用途,不包含也不應被視爲適用於金融、投資稅或交易相關諮詢和建議,或是交易價格紀錄,或是任何金融商品或非應邀途徑的金融相關優惠的交易邀約或邀請。

本網站的所有XM和第三方所提供的内容,包括意見、新聞、研究、分析、價格其他資訊和第三方網站鏈接,皆爲‘按原狀’,並作爲一般市場評論所提供,而非投資建議。請理解和接受,所有被歸類為投資研究範圍的相關内容,並非爲了促進投資研究獨立性,而根據法律要求所編寫,而是被視爲符合營銷傳播相關法律與法規所編寫的内容。請確保您已詳讀並完全理解我們的非獨立投資研究提示和風險提示資訊,相關詳情請點擊 這裡查看。

我們運用 cookies 提供您最佳之網頁使用經驗。更改您的cookie 設定跟詳情。

風險提示:您的資金存在風險。槓桿商品並不適合所有客戶。請詳細閱讀我們的風險聲明