Johnson & Johnson Vaccine Candidate To Begin Phase 3 of Human Trials

Johnson & Johnson (J&J), alongside the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services, has been developing a single-dose vaccine for coronavirus. The pharmaceutical company recently announced preparations for stage three of human trials.

The late-stage trials for the vaccine candidate JNJ-78436735 will include 60,000 enrollees. International recruits will come from over 200 locations, including the United States, countries in South America, and South Africa.

Johnson & Johnson is among the nine companies selected in the government's Operation Warp Speed. Companies such as Moderna, Pfizer, and AstraZeneca have all received funding to expedite the development of vaccine candidates. J&J aims to make 100 million initial doses by 2021 if their single-dose vaccine successfully results after the last phase of trials.

Phase 3 of Vaccine Trials

The vaccine, developed by J&J's Janssen Pharmaceutical Companies, phase 3 trials (ENSEMBLE), will test the safety and efficacy of their vaccine candidate compared to a placebo shot. They shared that the vaccine is similar to how their Ebola vaccine was developed, a combination of coronavirus genetic material and an altered adenovirus (common cold).

J&J has yet to release the official study results from earlier testing. Paul Stoeffels shared that the immune response of people to the vaccine had the same successful results with their animal testing. The fever would typically be gone within two days of getting a shot.

The countries chosen for the ENSEMBLE study are locations with high cases of coronavirus such as Brazil, Mexico, and the United States. In the U.S., they will also include a significant representation of minorities such as "Black, Hispanic/Latinx, American Indian, and Alaskan Native participants."

CEO Alex Gorsky shared that as the pandemic continues, the company's goal is for their scientific innovation and global reach "to help bring an end to this pandemic." He ensures that they are researching according to rigorous safety standards with the help of regulators. They are also "committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol."

Developing Treatments for Covid-19

The company's Ebola vaccine was developed using their AdVac technology platform, enabling them to make several vaccine candidates for illnesses, including HIV and Zika virus. The same technology has already been used to vaccinate over 100,000 people, shared the company. Moreover, the vaccine candidate is stable at -4 degrees Fahrenheit for two years and can be stored at 35.6 to 46.4 degrees Fahrenheit for about three months.

There will also be a separate clinical study for volunteers in the United Kingdom, exploring the efficacy and safety. Aside from the vaccine candidate, the company continues to study molecules such as antivirals to discover possible treatments for Covid-19.

Dr. Anthony Fauci said that the J&J candidate has shown "promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose."

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