Janssen Pharmaceutica of Johnson & Johnson recently applied to the Food and Drug Administration (FDA) for emergency use authorization of the Johnson & Johnson coronavirus disease (COVID-19) vaccine, according to an article from Rutgers Today.
Rutgers has been acting as a clinical trial site for the phase 3 clinical research study of the Johnson & Johnson vaccine candidate since November 2020, The Daily Targum previously reported. The initial results of the trial were released in late January, and a total of 840 participants from the Rutgers community and throughout the state were involved, according to Johnson & Johnson.
Co-lead investigator Jeffrey Carson, a distinguished professor in the Department of Medicine and provost at Rutgers Biomedical and Health Sciences, said that although he cannot say for certain, he does believe it is highly likely the vaccine is going to be approved for emergency use.
“These emergency use applications are hundreds of pages long of detailed information related to all their evaluations of this vaccine, including this trial that we're ... participating in … all that data (is going to be) scrutinized by the FDA,” he said. “The next step is that there is an external advisory committee that also looks at that report and then makes a final decision.”
Carson said that he expects this decision to be made by the end of the month.
As for the vaccine itself, he said it possesses several key distinctions from the Moderna and Pfizer vaccines including differences in type, temperature and duration of storage, number of doses and efficacy rates.
The Johnson & Johnson vaccine uses an adenovirus approach rather than the messenger ribonucleic acid (mRNA) approach being used by both Moderna and Pfizer, Carson said.
Instead of using mRNA to ultimately create an immune response, it uses a virus that causes the common cold to transport a COVID-19 gene into human cells, which then produces a COVID-19 spike protein that gets the immune system ready to fight the infection, according to Rutgers Today.
Carson said the two main advantages of the Johnson & Johnson vaccine are its ability to be stored in much higher temperatures for several months and having one dose rather than two. These advantages will help alleviate logistics issues posed by sub-zero, short-term refrigeration and multiple doses, he said.
“(Johnson & Johnson has) promised 100 million doses by the summer. That means 100 million people could get vaccinated,” Carson said. “If any of the other companies ... depending on the number of doses they can provide, whatever it is, it's (only) half the number of people because it's two doses.”
He said that despite the Moderna and Pfizer vaccines being approximately 95 percent effective in comparison to the 72 percent effectiveness of the Johnson & Johnson vaccine, they are not automatically better.
Since the trials were done in different time periods, Carson said it does not take into account that COVID-19 is mutating and that there are now different variants from the original virus that are potentially more infectious or more resistant to the vaccine.
“We cannot determine whether ... one vaccine is different than the other in terms of efficacy without having tested it at the exact same time and head to head,” he said. “I don't know that ... this vaccine’s any worse than the other two.”
Additional findings from the trial included complete protection against hospitalizations related to COVID-19 after 28 days and 85 percent effectiveness in preventing severe forms of COVID-19, according to Johnson & Johnson. Also, it was found to be 66 percent effective at preventing moderate to severe COVID-19 overall, taking into account areas with a viral variant, 28 days after vaccination.
Carson said the team will continue to follow up with participants as the trial is still ongoing and is supposed to last two years. He also mentioned that they are having to “unblind” many participants, or let them know if they had the placebo or not, to prevent individuals from getting multiple vaccines or to encourage those who had the placebo to get vaccinated.
Overall, Carson said it is important to stay vigilant during this time, especially with new, potentially more infectious variants spreading.
“One thing that I would like to really emphasize is that even with these vaccines … (Everyone) needs to ... continue to be really careful,” he said. “That means they need to social distance, that means they need to wear a mask, they need to wash their hands.”