J&J Submits Emergency Use Application for COVID-19 Vaccine

For a year now, we have been living with fear that we or our loved ones could become very ill, and in some cases so ill that we could be hospitalized or succumb to COVID-19.  

 One year ago, #MyCompany committed the full strength of our resources to create a solution to help combat the historic COVID-19 global pandemic. On behalf of my team, our committed and talented partners, and the participants in our trial, I am thrilled that we have just submitted our Phase 3 ENSEMBLE data to the FDA for application for Emergency Use Authorization.  The FDA will gather independent physicians and scientists to look at our data at an FDA Advisory Committee Meeting on February 26th, 2021. 

 Our team spent time selecting from among various spike protein antigens that optimized the immune response in two ways – T-cells and antibodies. Both are important in combatting viral infections. Antibodies and CD8+ T-cells offer two quite different and strong layers of defense. And importantly, the two mechanisms are differently susceptible to side-stepping by variants of a virus. That is, mutations that might lead to escaping neutralizing antibodies by changes to the receptor-binding domain of spike protein do not necessarily escape T-cell based protection against serious illness.  T

While our work to combat the COVID-19 pandemic began a year ago, the journey actually began nearly a decade ago as Paul Stoffels and team acquired key technology and made a big bet on vaccines. Our investigational vaccine candidate is built on our validated AdVac? technology, which was used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates for use in more than 200,000 people to date. Using this technology, our investigational vaccine candidate is by design able to induce a multi-pronged immune response. It induces antibodies that neutralize and clear the virus, and it induces T-cells that clear cells infected by the virus. We believe that protection against severe disease caused by certain variants around the world, including B1.351 first observed in South Africa, may require a multi-pronged immune response.  

A vaccine’s real-world effectiveness is dependent both on the data taken from a clinical trial and the degree of complexity in the regimen and distribution. The great news is that our investigational vaccine candidate is a single-shot regimen and can be stored in the fridge for a substantial period of time. The ease of delivery and storage provides a potential solution to reaching as many people as possible.

We continue to work hard to help change the trajectory of this pandemic. 

https://www.jnj.com/johnson-johnson-announces-submission-of-application-to-the-u-s-fda-for-emergency-use-authorization-of-its-investigational-single-shot-janssen-covid-19-vaccine-candidate