Johnson & Johnson's COVID-19 Vaccine Data: What You Need to Know

Johnson & Johnson JNJ released much-awaited top-line results Friday from a large scale, late-stage study of its coronavirus vaccine candidate.

The data hasn't gone down well with investors, with the shares of the health care company ticking lower in the session. 

What Happened: A late-stage study dubbed ENSEMBLE showed that the single-shot investigational vaccine developed by J&J's Janssen unit was 66% effective in preventing moderate to severe disease across all regions studied 28 days after vaccination, the New Brunswick, New Jersey-based company said in a statement.

The level of protection was at 72% in the U.S., 66% in Latin America and 57% in South Africa 28 days post-vaccination, with the onset of protection from day 14.

Here are the other key findings:

-85% effective in preventing severe disease across all regions studied 28 days after vaccination

-Efficacy against severe disease increased over time, with no cases reported in study participants after day 49

-complete protection against COVID-19-related hospitalization and death 28 days after vaccination

-Clear effect on COVID-19 cases requiring medical intervention

-Effective against newly emerging strains of coronavirus, including some highly infectious variants present in the U.S., Latin America and South Africa

-Safety profile consistent with other vaccine candidates using Janssen's AdVac technology, with 9% overall fever rates and no allergic reactions

J&J's vaccine candidate, codenamed JNJ-78436735, uses an adenovirus — a type of virus that causes common cold — that is inactivated.

This viral vector carries a gene from the coronavirus into the human cell, producing the coronavirus spike protein, triggering an immune response to ward off future infection by the coronavirus.

The ENSEMBLE study was meant to evaluate the efficacy and safety of the vaccine candidate in adults 18 years and older, 14 days and 28 days following vaccination, in protecting against both moderate and severe COVID-19 disease.

Related Link: The Daily Biotech Pulse: Novavax Vaccine Readout, Clinical Hold On Bellicum Study Lifted, Lilly Earnings, NLS Pharma IPO

Why It's Important: J&J's single-shot vaccine candidate is compatible with standard vaccine distribution channels and provides important tool in pandemic setting, J&J said.

"These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response," Paul Stoffels, the company's chief scientific officer, said in a statement. 

The vaccine candidate can remain stable for two years at negative 20 degrees Celsius, at least three months of which can be at temperatures of 2-8 degrees Celsius. 

The company added that it will ship the vaccine using the same cold chain technologies it uses to transport other innovative medicines.

What's Next: J&J said trial participants of the phase 3 ENSEMBLE study will continue to be followed for up to two years for assessments of safety and efficacy.

The comprehensive available data set will be submitted to a peer-reviewed journal in the coming weeks, the company said. 

J&J intends to file for emergency use authorization in the U.S. in early February and expects to have the product available to ship immediately following authorization.

The anticipated manufacturing timeline will help to meet its 2021 supply commitments, including those signed with governments and global organizations, J&J said. 

The company said it is committed to bringing an affordable COVID-19 vaccine on a not-for-profit basis for emergency pandemic use pending regulatory authorizations.

JNJ Price Action: At last check, J&J shares were down 2.84% to $164.35. 

Related Link: The Week Ahead In Biotech (Jan 24-30): J&J, Lilly to Kickstart Big Pharma Earnings, Amgen FDA Decision and More

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