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J&J's (JNJ) HIV Vaccine Study in Young African Women Fails

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J&J JNJ announced data from a phase IIb HIV vaccine study, which showed that its vaccine candidate did not provide a sufficient level of protection against HIV infection in young women in sub-Saharan Africa.

The primary analysis of the Imbokodo study was conducted 24 months after participants received their first vaccinations. Data from the study showed that 63 of the 1,109 participants who received placebo acquired HIV compared to 51 of the 1,079 participants who received the HIV vaccine, which is based on the adenovirus design. The study showed a 25.2% vaccine efficacy, based on which the company decided that it will be discontinued. However, the vaccine was found to be safe and no vaccine-related safety signals were identified.

Meanwhile, the global phase III Mosaico HIV study evaluating a different composition of the vaccine regimen will continue. The study is evaluating the vaccine regimen in different populations like men who have sex with men (MSM) and transgender individuals and is being conducted in the Americas and Europe.

The decision to continue the Mosaico HIV study has been taken after consultation with the Mosaico study independent Data and Safety Monitoring Board (DSMB).

This year so far, J&J’s shares have risen 10% compared with an increase of 16.2% for the industry.

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Zacks Investment Research


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J&J has a thriving HIV business. In January this year, the FDA approved J&J and Glaxo’s GSK HIV subsidiary, ViiV Healthcare’s long-acting injectable regimen, Cabenuva. Cabenuva comprises Glaxo’s cabotegravir and J&J’s Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults. Cabenuva is also approved in Canada and the EU. The long-acting regimen will reduce the frequency of treatment days from 365 to 12 per year, thereby removing the need to take daily oral pills.

Pfizer PFE and Japan-based company Shionogi also have stakes in ViiV Healthcare.

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked stock from the biotech sector is Regeneron REGN, which sports a Zacks Rank #1.

Regeneron’s earnings per share estimates have moved north from $49.96 to $54.15 for 2021 and from $40.91 to $44.11 for 2022 in the past 30 days. The stock has risen 39.4% so far this year.


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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

GlaxoSmithKline plc (GSK) : Free Stock Analysis Report

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