J & J Applies for Emergency Use Authorization for COVID-19 Booster

Pharmaceutical giant Johnson & Johnson (JNJ) has submitted its latest data to the U.S. Food and Drug Administration (FDA) to gain approval for the use of its COVID-19 booster shot in individuals over 18 years of age. Shares rose on the news and closed at $159.58 on October 5.

A Phase 3 ENSEMBLE 2 study showed that a JNJ booster shot taken 56 days after the primary dose provided 94 percent protection against symptomatic COVID-19 in the U.S. and 100 percent protection against severe COVID-19, 14 days after taking the booster. (See Johnson & Johnson stock charts on TipRanks)

JNJ also submitted data from its Phase 1/2a study, which showed that when a JNJ COVID-19 vaccine was taken six months after the initial shot, it increased antibody levels nine-fold one week after the booster and twelve-fold four weeks after the booster. In all, the vaccine was well tolerated when given either as a primary dose or booster.

Commenting on the news, Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, said, “We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters… At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”

Last month the company submitted data proving that its single-dose COVID-19 vaccine was 79% effective for COVID-19-related infections and 81% effective for COVID-19 related hospitalizations. Furthermore, the study also proved that vaccine efficacy did not decrease over the period of study from March to July 31, 2021. Comparable vaccine efficacy was witnessed when the study was extended to August 31, 2021, when the Delta variant became dominant in the U.S.

The company also plans to submit its latest data to other health regulators, including the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) worldwide, to enable decision-making on local vaccine administration strategies.

Last month, Morgan Stanley analyst Matthew Harrison downgraded the stock to a Hold from a Buy while maintaining a price target of $187, implying 17.2% upside potential to current levels.

Overall, the stock has a Moderate Buy consensus rating based on 4 Buys and 2 Holds. The average Johnson & Johnson price target of $188.60 implies 18.2% upside potential to current levels. Shares have gained 9.1% over the past year.