Johnson & Johnson’s new COVID-19 vaccine under review for Emergency Use Authorization


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COVID-19 Vaccine

Kartik Nath, Staff Writer

The United States (US) is facing one of the worst periods in the COVID-19 pandemic, dealing with the spread of variants of the Sars-CoV-2 virus and problems in the COVID-19 vaccine distribution. So far, Pfizer-BioNTech and Moderna have been granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for their COVID-19 mRNA vaccines. On January 29th, 2021, Johnson & Johnson released data from the Phase 3 trial for their single dose COVID-19 vaccine that was developed by Janssen Pharmaceuticals, a Belgium-based pharmaceutical company owned by Johnson & Johnson. This data was met with skepticism because the efficacy rate was not as high as the Pfizer-BioNTech and Moderna vaccines, so many are wondering if the Janssen COVID-19 vaccine is effective and worthwhile to offer to people. In an interview with the New York Press Club on January 29th, 2021, Dr Anthony Fauci, Chief Medical Advisor to the President and Director of the National Institute of Allergy and Infectious Disease, explained the data, pointing out that the vaccine was 85 percent effective at preventing severe COVID-19 disease and called the vaccine “value added” for the United States. Given the encouraging data, on February 4th, Janssen Biotech, Inc. formally applied for EUA to the US FDA. 

The Janssen Biotech vaccine is different from the Pfizer-BioNTech and Moderna mRNA vaccine as it uses a viral vector mode of delivery. The current vaccines target the spike proteins on the outside of the SARS-CoV-2 virus. These mRNA vaccines use single-stranded RNA to deliver the genetic instructions to the human cells to build the spike protein so that the immune system can build antibodies against the virus. The Janssen COVID-19 vaccine uses a double-stranded DNA virus, a weak and harmless virus, called Adenovirus 26, which delivers the genetic instructions to the human cells. A unique aspect of the Adenovirus 26 virus is that the virus cannot invade and takeover human cells, so they function as a vehicle of delivery. 

Johnson & Johnson released The Phase 3 clinical trial data, showing their study of the single dose COVID-19 vaccine with a sample of 43,783 people with 468 symptomatic cases of COVID-19. The goal of the trial, which took place in the United States, Latin America, and South Africa, areas with known circulating variants of the SARS-CoV-2 virus, was to study whether the vaccine could prevent moderate to severe COVID-19 disease. The efficacy or “level of protection” was 72 percent in the US, 66 percent in Latin America, and 57% in South Africa, 28 days after the vaccination. Dr Fauci clarified in an interview that the vaccine is 85 percent effective in preventing severe disease in all regions 28 days after vaccine in ages 18 years old and older. Furthermore, the vaccine showed protection again COVID-19 related hospitalizations as there were no reported cases of hospitalization among participants of the trial who received the Janssen vaccine 28 days after vaccination.

So, there are three reasons why the Janssen COVID-19 vaccine is good for the US: it prevents moderate to severe COVID-19 disease, prevents hospitalizations and does not have to be stored in extreme cold conditions as it can simply be stored in the refrigerator. Now, it is up to the FDA Center for Biologics Evaluations and Research’s, Vaccine And Related Biological Products Advisory Committee to review the data and make a recommendation for the authorization of the vaccine.