Johnson & Johnson's Single-Dose Coronavirus Shot Gets Favorable FDA Review Ahead Of Adcom Meeting

Johnson & Johnson JNJ shares were advancing Wednesday following the release of the FDA briefing document meant for the Friday Adcom meeting to discuss the company's coronavirus vaccine candidate.

What Happened: Johnson & Johnson's single-shot vaccine — Ad26.COV2.S — was effective in preventing PCR-confirmed COVID-19 occurring at least 14 days after receipt of the vaccine, with efficacy findings generally consistent across evaluable subgroups, according to FDA staffers who reviewed the company's filing for emergency use authorization.

Ad26.COV2.S is an inactive adenovirus type 26 vectored vaccine encoding a stabilized variant of the SARS-CoV-2 protein. The proposed dosing regimen is a single intramuscular injection at the dose level of 5×1010 viral particles.

J&J is seeking emergency use authorization for the vaccine candidate as an active immunization option to prevent COVID-19 in individuals 18 years and older.

"Although a lower efficacy overall was observed in South Africa, where there was a predominance of B.1.3.5 lineage during the time period of this study, vaccine efficacy against severe/critical COVID-19 was similarly high across the United States, South Africa, and Brazil," the briefing document said.

FDA staffers also viewed the single dose option as vesting operational benefits to mass vaccination campaigns.

On safety, FDA officials deemed the data submitted was adequate for review and to make conclusions about the safety of Ad26.COV2.S vaccine.

"Local site reactions and systemic solicited events among vaccine recipients were frequent and mostly mild to moderate," FDA staffers noted.

Experts, however, listed the duration of protection and effectiveness with respect to high-risk, pediatric and re-infected populations as being among the unknown risks.

Local and systemic adverse reactions as compared to the placebo arm, usually lasting one to two days, and safety in certain subpopulations such as pregnant and lactating women, and immune-suppressed individuals were listed among the known risks from vaccination.

Why It's Important: J&J reported interim data from the Phase 3 ENSEMBLE study in late January, showing the vaccine was 66% effective in preventing COVID-19.

Subsequently, on Feb. 4, J&J's Janssen unit submitted the emergency use authorization request. FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet between 9 a.m. and 5:30 p.m. Friday to discuss about authorizing the vaccine for emergency use.

If approved, J&J would become the third vaccine developer to receive emergenc approval in the U.S. and it would mark the first approval for a single-dose vaccine.

JNJ Price Action: At last check, J&J shares were adding 0.83% to $161.78.