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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.
All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.
Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.
Rate collection and criteria: Click here for more information on rate collection and criteria.