Indian vaccine - 78% preventive effect, final analysis of phase 3 clinical trial completed

Recently CNN.co.jp reported the following:

インド国産ワクチン、発症予防効果は７８％　第３相治験の最終分析完了

2021.07.03 Sat posted at 17:05 JST

 ニューデリー（ＣＮＮ） インドの製薬会社バーラト・バイオテックは３日、同社が開発した新型コロナウイルスワクチン「コバクシン」について、重症化予防の有効率は９３．４％以上、発症予防の有効率は７７．８％だったと明らかにした。

同社は発表で、第３相臨床試験（治験）の最終分析を終えたと説明。インド国内のコロナワクチン治験としては最大規模になると述べた。

治験には１８～９８歳の２万５８００人が参加した。このうち２４３３人は６０歳超で、４５００人は併存疾患を抱えていた。

インドで最初に見つかった変異株（デルタ株）に対する予防効果は６５．２％だった。デルタ株は現在、インド国内で支配的な変異株となっている。

今回のデータは、査読前の論文を公開できるサイト「ＭｅｄＲｘｉｖ（メドアーカイブ）」で発表された。

バーラト・バイオテックのクリシュナ・エラ会長は治験結果について、「インドと発展途上国の技術革新に注力する能力を確立した」としている。

２回接種型のコバクシンは１月、第３相治験の暫定結果が出る前の段階で、インド国内における限定的な緊急使用が承認されていた。同社によると、国外ではブラジルやフィリピン、イラン、メキシコを含む１６カ国で緊急使用許可が下りている。

Translation

New Delhi (CNN) - Indian pharmaceutical company Bharat Biotech announced on the 3rd that the new coronavirus vaccine "Covaxin" developed by the company had an effective rate in preventing serious illness stood at 93.4% or more, and the effective rate in preventing the illness was 77.8 %.

The company said in a statement that it had completed the final analysis of a phase 3 clinical trial. It was said that it would be the largest corona vaccine clinical trial in India.

25,800 people aged 18-98 participated in the trial. Of these, 2,433 were over 60 years old and 4,500 had multiple medical complications.

The protective effect against the mutant strain (Delta strain) first found in India was 65.2%. The Delta strain was currently the dominant mutant strain in India.

The data was published on the site of "MedRxiv" where paper before peer-review could be published.

Krishna Ella, chairman of Bharat Biotech, said the results of the trial "established the ability of India and developing countries to focus on innovation."

Double-dose Covaxin was approved for limited emergency use in India in January before the provisional results of the Phase 3 clinical trial were available. According to the company, emergency use authorizations had been granted in 16 countries, including Brazil, the Philippines, Iran and Mexico.

              So, India has developed its own Covid-19 vaccine. I am interested in knowing how well it can protect against other mutant strains apart from the Delta strain.

Notes:

1. “medRxiv” is an Internet site that distributes unpublished papers about health sciences. It posts unpublished manuscripts in the areas of medicine, clinical research, and related health sciences. Such manuscripts have yet to undergo peer review and should not be considered for clinical application, nor should be regarded as established information. (https://en.wikipedia.org/wiki/MedRxiv)

2. Dr. Krishna Ella is the Chairman & Managing Director of Bharat Biotech International Limited which was incorporated in 1996. Under Dr. Ella’s leadership, Bharat Biotech has grown to become a global leader in innovative vaccine. Dr. Ella has also ventured into veterinary vaccines, food processing, and developing biotechnology infrastructure in India. (https://www.bharatbiotech.com/founder_profile.html)