Johnson & Johnson has submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of its investigational single-dose COVID-19 vaccine candidate.
J&J’s (JNJ) said that the EUA application is supported by efficacy and safety data from its Phase 3 clinical trial, which showed that the investigational single-dose vaccine met all primary and key secondary endpoints. In addition, the drug maker plans to submit a Conditional Marketing Authorisation Application (cMAA) of the vaccine with the European Medicines Agency in the coming weeks and has initiated rolling submissions with health agencies outside the US.
Following the FDA approval, J&J will start vaccine distribution to the US government. It expects to supply 100 million doses to the US in the first half of 2021.
“Submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said J&J’s Chief Scientific Officer Paul Stoffels. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
The FDA will discuss J&J’s EUA request for its COVID-19 vaccine at a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26.
Shares of JNJ are up 16% over the past three months, and the stock scores a bullish Strong Buy Street consensus rating. That’s with 10 Buy ratings versus only 1 Hold rating. Meanwhile, the average analyst price target of $189.90 indicates almost 16% upside potential lies ahead.
On Jan. 26, Raymond James analyst Jayson Bedford ramped up the stock’s price target to $183 from $158 as he expects “modest multiple expansion” driven by improving growth.
“We believe J&J’s growth algorithm is intact, and we continue to believe the multiple can expand with consistent execution,” Bedford wrote in a note to investors. “2021 will be a bit more back-end loaded than expected, but J&J has managed expectations well, and we view 2021 as financially de-risked.” (See Johnson & Johnson stock analysis on TipRanks)
What’s more, J&J scores a “Perfect 10” Smart Score, which implies that the stock is expected to outperform the market going forward.
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