Johnson & Johnson announced on Friday that it is preparing to resume the Phase 3 US trial of its Covid-19 vaccine candidate, saying that it has found “no evidence” that the vaccine caused a serious illness in a study participant.
J&J (JNJ), which had halted its late-stage Covid-19 vaccine trial on Oct. 12 after a study participant fell ill for an unexplained reason, said that is getting ready to resume recruitment in the pivotal Phase 3 trial.
“There are many possible factors that could have caused the event,” J&J said in a statement. “Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event.”
The move to resume the Covid-19 trial follows the recommendation by the independent Data Safety and Monitoring Board (DSMB), which is overseeing the Phase 3 study, the company said. In addition, J&J is also consulting with the US Food and Drug Administration (FDA), as it prepares to resume the US trial, and submissions for approval by the Institutional Review Boards, are now underway.
Discussions with other regulators around the world to resume the clinical trial program are progressing, the company added.
The Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of a single dose of a vaccine versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those who are over the age 60.
JNJ shares have almost fully recovered since plunging to a multi-year low in March and are now trading less than 1% lower than at the start of year. (See JNJ stock analysis on TipRanks).
Cantor Fitzgerald analyst Louise Chen on Oct. 14 raised the stock’s price target to $180 (24% upside potential) from $168 and maintained a Buy rating, saying that J&J’s Q3 EPS and sales beat, reflect solid performance and positive trends across its diversified business model.
Commenting on the Covid-19 trial pause , Chen said that although it was creating some noise, it did not change her investment thesis on the company.
Overall, the stock scores a very bullish Strong Buy Street consensus. That’s with 4 back-to-back buy ratings over the last three months. What’s more, the $169 average price target indicates upside potential of 16% in the coming 12 months.