Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson

Johnson & Johnson (J&J) has applied to the FDA seeking Emergency Use Authorization (EUA) for the single-dose COVID-19 vaccine candidate developed by the company’s Janssen Pharmaceutical Cos.

The FDA last night scheduled for February 26 a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider the Janssen COVID-19 vaccine candidate, which the company previously referred to as JNJ-78436735.

“[Thursday’s] 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,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a statement.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” Stoffels declared. “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.”

J&J is among leading COVID-19 vaccine developers that are on pace to ship a combined more than 500 million doses over the next two to three quarters, according to a research note Monday by Michael J. Yee, Equity Analyst with Jefferies, and four colleagues. That figure does not include the additional 200 million doses that may come in the third quarter from the other developers cited by Jefferies in reaching its original estimate, Moderna, Pfizer and BioNTech.

“This is plenty to vaccinate everyone who will want one generally in 2021 and, frankly, the time course people are willing to get vaccinated anyway,” Yee and colleagues wrote.

“Daily vaccinations reached 1.3M+ recently and likely to continue to increase as vaccination centers and retail pharmacies come online,” Yee added, crediting Jefferies colleague Brian Tanquilut.

66% overall efficacy

J&J said its EUA will be based on topline efficacy and safety data from the nearly 44,000-patient Phase III ENSEMBLE trial (NCT04505722), which the company announced last week. According to that data, the vaccine was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

While the vaccine candidate met all primary and key secondary endpoints from the ENSEMBLE trial, according to J&J, the company also acknowledged that the efficacy percentages varied depending where the vaccine was administered, with a low of 57% in South Africa, where a variant strain of SARS-CoV-2 from the from the B.1.351 lineage accounted nearly all cases 28 days post-vaccination. Percentages stood at 66% in Latin America and 72% in the U.S.

The onset of protection was seen as early as day 14, J&J said.

ENSEMBLE trial is a randomized, double-blind, placebo-controlled clinical study being conducted in eight countries and three regions, and designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older. ENSEMBLE was also designed to evaluate the safety and efficacy of the Janssen vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

Researchers studying J&J’s vaccine last month published positive clinical data from a Phase I/IIa trial (NCT04436276) showing that the vaccine provided an immune response that lasted for at least 71 days in participants aged 18-55 years. That data appeared in a study published January 13 in The New England Journal of Medicine.

According to the study, neutralizing-antibody titers against wild-type virus were seen in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354), and reached 100% by day 57 with a further increase in titers (GMT, 288 to 488), regardless of vaccine dose or age group. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1,266).

Rolling submissions

J&J said it had begun rolling submissions with several health agencies outside the U.S.—including Europe, where the company said it will submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency “in the coming weeks.”

Investors responded to J&J’s announcement, made after the close of the financial markets, by sending the price of J&J shares rising nearly 2% in after-hours trading, to $164.95 from yesterday’s close of $161.99

J&J’s COVID-19 vaccine candidate is an adenovirus vector vaccine based on constructs created and tested by J&J with Beth Israel Deaconess Medical Center (BIDMC), part of Harvard Medical School, using Janssen’s AdVac® and PER.C6® vaccine technology platforms. AdVac can be used with Janssen’s PER.C6® technology to develop recombinant vaccines against infectious diseases.

AdVac was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

The J&J vaccine candidate is among 21 “Front Runner” leading candidates among the more than 300 COVID-19 therapeutics under study in GEN’s updated and just-launched “COVID-19 Drug & Vaccine Candidate Tracker.”

Federal agencies have committed up to nearly $1.5 billion toward supporting J&J’s vaccine candidate from development through licensure—an award of more than $456.2 million in February from the Biomedical Advanced Research and Development Authority (BARDA), followed August 5 by approximately $1 billion from HHS and the U.S. Department of Defense (DoD) to support a manufacturing demonstration project including the ability to deliver vaccine doses to government-designated locations nationwide.

In its announcement, J&J emphasized that its vaccine can remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C).

That contrasts with two other leading COVID-19 vaccines. The COVID-19 vaccine COMIRNATY®, developed by Pfizer and BioNTech, requires shipping and storage at -70º C. AstraZeneca’s vaccine co-developed with the University of Oxford and a spinout, which also allows for storage and shipping at -20º C.

Moderna instructs that its mRNA-based vaccine “must be stored at 2º to 8º C in a secure area with limited access (unblinded personnel only) and protected from moisture and light until it is prepared for administration.”

However, Moderna announced last fall that its vaccine remained stable at 2º to 8º C for 30 days (up from an earlier estimate of just seven days), and remains stable at -20º C for up to six months, “and at room temperature for up to 12 hours.”

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