J&J Kicks Off Phase 3 Covid-19 Vaccine Trial With Single Dose

Johnson & Johnson shares are up 2.3% in Wednesday’s pre-market trading after the healthcare company announced that it is kicking off with a large-scale, pivotal, multi-country Phase 3 trial of its COVID-19 vaccine candidate, JNJ-78436735.

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J&J (JNJ) said that the initiation of the trial follows positive interim results from its Phase 1/2a clinical study, which showed that the safety profile and immunogenicity after a single vaccination were supportive of further development. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), the Phase 3 trial will enroll up to 60,000 volunteers across three continents, the company added. The trial will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said J&J CEO Alex Gorsky. “This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”

J&J reaffirmed that it remains on track to meet its goal of providing 1 billion doses of a vaccine each year, should it prove to be safe and effective. The healthcare company also confirmed that it is committed to develop an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and that it anticipated the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021.

In parallel, J&J has also agreed in principle to collaborate with the UK and Northern Ireland on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of its vaccine candidate.

JNJ shares have now almost fully recovered since plunging to a multi-year low in March and are now trading 1.2% lower than at the start of year. (See JNJ stock analysis on TipRanks).

Credit Suisse analyst Matt Miksic recently reiterated a Buy rating on the stock with a $163 price target, saying that intra-quarter analysis of JNJ’s US pharma business for July appears to be tracking roughly in-line with his estimates for Q3.

“JNJ’s Pharma franchises are less affected by COVID-19 than device businesses, which are more directly tied to elective procedures, making the stock attractive for investors concerned about the potential resurgence of COVID-19 infections and the potential corresponding impact on elective surgery trends,” Miksic wrote in a note to investors.

Overall, the rest of the Street shares Miksic’s bullish outlook on the stock. The Strong Buy analyst consensus boasts 7 unanimous Buy ratings. That’s with a $166.86 average price target indicating upside potential of 16% in the coming 12 months.