Johnson & Johnson Advances Coronavirus Vaccine Candidate; EUA Likely In Early 2021

Johnson & Johnson JNJ has joined the big league of frontrunners in the coronavirus vaccine race following its announcement concerning the initiation of the Phase 3 study, which is the preceding step to applying for an emergency use authorization or full approval.

What To Know: The New Brunswick, New Jersey-based company said first participant in the Phase 3 trial, dubbed ENSEMBLE, that is evaluating its coronavirus vaccine candidate – JNJ-78436735 – has been dosed.

The Phase 3 study is designed as a large-scale, pivotal, multi-country trial that will enroll up to 60,000 volunteers across three continents. The trial would study the safety and efficacy of a single vaccine dose versus placebo.

The advancement of the vaccine candidate into the late-stage trial follows the company reporting positive interim results from the Phase 1/2a study, which vouched for the investigational vaccine's safety profile and immunogenicity.

JNJ-78436735 is manufactured using J&J's AdVac technology platform, which was used to develop and manufacture its Janssen unit's European Commission approved Ebola vaccine.

"With Janssen's AdVac® technology, the vaccine, if successful, is estimated at launch to remain stable for two years at -20 °C and at least three months at 2-8° C," J&J said.

This, the company said, will make the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.

Following the footsteps of the other frontrunners, J&J also released the study protocol to provide transparency at a time safety concerns are on the rise.

The assumed vaccine efficacy is 60%, with the target total number of events at 154, the protocol revealed.

Why It's Important: Moderna Inc MRNA, Pfizer Inc. PFE/BioNTech SE – ADR BNTX and AstraZeneca plc AZN/Oxford University are among the companies that have ongoing Phase 3 trials, and are shooting at a year-end timeline for emergency use authorization. These companies are vying with each other in gaining the "first-to-market" advantage.

J&J revealed it has continued scaling up its manufacturing capacity and is on track to meet the goal of providing 1 billion doses of a vaccine each year. The first batches of a COVID-19 vaccine will likely be available for emergency use authorization in early 2021, if proven to be safe and effective, the company said.

In pre-market trading, J&J shares were higher by 2.07% to $147.20.