Johnson & Johnson encouraged by phase 1, phase 2 vaccine trials

Coronavirus
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INDIANAPOLIS — Johnson & Johnson recently released data on its phase 1 and phase 2 trials for a COVID-19 vaccine.

The goal in its first two trials was to show that the vaccine is safe and can produce antibodies.

“This is a phase 1 and phase 2 study. The results are promising, but these results still show that this vaccine is still safe,” said Regenstrief Institute Research Scientist Dr. Babar Khan, MD, MS.

There are differences between Johnson & Johnson’s vaccine and others. Only one dose is needed, and it lasts in the refrigerator for months. Meanwhile, Moderna and Pfizer’s vaccines require a second shot and have a shorter shelf life.

“Again, if we give them the vaccines, how can we make sure that we get them back in? We can set up their appointment, but it’s up to them to understand it’s very important to get that second dose,” said IU Health Special Pathogens Programs Manager Mary Kay Foster.

Johnson & Johnson’s phase 1 and 2 trials show 100% of participants had an antibody response two months after the single dose and 90% showed it within 29 days. The side effects between Johnson & Johnson, Moderna and Pfizer are also similar.

“The side effect profile is very similar to other vaccines. The profile was just injection soreness, fever and some fatigue there. They only had five serious adverse events noted after the follow up, and four of them were unrelated. And the only one that was related was fever, which required the patient to seek medical care but then was discharged very quickly,” explained Dr. Khan.

Now Johnson & Johnson will focus on proving efficacy with a phase 3 trial to uphold the Food and Drug Administration standards.

“Which is essentially a technical term to say that the vaccine was efficacious in preventing disease among patients when it was compared to a placebo,” said Dr. Khan.

The FDA efficacy requirement is above 50%. The vaccine must also avoid causing serious adverse events two months after the dose.

Johnson & Johnson reports that it hopes to apply for Emergency Use Authorization by the end of the month.

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