Johnson & Johnson (JNJ) revealed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has given its green light to a booster dose of the company’s COVID-19 vaccine for individuals above 18 years of age.
The company said that the request for emergency use authorization was approved with a unanimous vote of 19-0. The dose is supposed to be administered at least two months after the initial vaccination. (See Johnson & Johnson stock charts on TipRanks)
The committee’s decision was based on the company’s two clinical trials, including the Phase 3 ENSEMBLE 2 study, which evaluated the efficacy of booster dose, and a large and robust real-world evidence study. The studies showed that JNJ’s single-shot dose was strong and long-lasting.
“Johnson & Johnson is steadfast in its commitment to protect as many people globally as possible against the continued spread of COVID-19,” said, Mathai Mammen (M.D., Ph.D.), the Global Head of Janssen Research & Development at Johnson & Johnson.
He added, “We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of COVID-19.” (See Insiders’ Hot Stocks on TipRanks)
To enable decision-making on local vaccine administration strategies, the company plans to submit its latest data to other health regulators worldwide, including the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs).
Last month, Morgan Stanley analyst Matthew Harrison downgraded the stock’s rating to Hold from Buy while maintaining a price target of $187 (15.9% upside potential).
The rest of the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 4 Buys and 2 Holds. The average Johnson & Johnson price target of $188.60 implies 16.9% upside potential to current levels.
Furthermore, Johnson & Johnson scores a “Perfect 10” from TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations.