After much deliberation and testing, the FDA has finally approved the emergency use of the J&J SARS CoV-2 vaccine, on Saturday. The key decision came one day after The Vaccines and Related Biological Products Advisory Committee voted 22-0 in favor of granting EUA to the J&J vaccine. The vaccine is said to have preventive qualities to stop asymptomatic individuals from spreading the virus. The committee had recommended emergency use authorization in light of the data from its clinical trials.
J&J Vaccine Granted Emergency Use Authorization By The FDA
The vaccine has completed extensive third phase trials and was developed by the Johnson and Johnson vaccine division, Janssen Pharmaceuticals. This single-dose vaccine is fridge stable and can be stored or transported at standard refrigerator temperatures, according to sources. Dr. Jarod Fox, from Orlando Health, said that this is going to allow for easier delivery to different parts of the country. It would “ enable a greater proportion of the country to be vaccinated,” he added.
This in contrast to the Pfizer-BioNTech and Moderna-NIAID vaccines is much easier to be stored and shipped. The two available vaccines need to be stored in ultracold temperatures and need to be thawed before use.
The FDA panel found that the vaccine offers strong protection from moderate to severe Covid-19. And despite its overall effectiveness being low, it has “no specific safety concerns” said the panel. The recommendation of the committee is often followed up by the FDA and the EUA did not surprise many.
The third stage trials of the J&J vaccine involved people from United States, Brazil, and South Africa. The analysis of the data revealed that the vaccine varied in overall efficacy from country to country, but its efficacy against severe infections was common in all regions. The vaccine showed an overall efficacy of 64-72 percent. The lowest was in South Africa where a new strain of the bacteria is prevalent. South Africa also had lower efficacy rates for the Astrazeneca and Novavax vaccines.
The J&J vaccine is on par with other vaccines in the prevention of severe Covid-19 infection at 82-88 percent in the three countries. This means that a virus infection even after the immunization cannot lead to hospitalization or death. The study showed that the vaccine immunized a person within 14 days from vaccination.
Dr. Fox, who is not part of the FDA panel, said that the vaccine had lower efficacy in the 60+ demographic. It was even lower for those with chronic heart disease or diabetes. He said that this could be cause for concern as it put this group “at higher risk of having a severe or critical illness with the coronavirus,” He added that it was good to see it had moderate efficacy in this age-group, only compared to that of the 18-50 group.
Efficacy is a measure of how well vaccines work in trials, say experts. But the real-world efficacy might be even lower due to several factors. The experts warn that it is difficult to compare these vaccines with each other as they were tested under different conditions and times.