J&J’s single-shot COVID-19 vaccine approved by FDA

The FDA has approved J&J’s single dose COVID-19 vaccine (Ad26.COV2.S) paving the way for distribution in the US.

Last week, the US Food and Drug Administration (FDA) issued Johnson & Johnson’s (J&J) adenovirus type 26 COVID-19 vaccine with Emergency Use Authorization (EUA) making it the third vaccine available to US citizens.

Image/iStock: Aquir

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The US has ordered 100 million doses of the vaccine with the opportunity to increase this amount and Europe has secured 230 million doses. The firm said its “pragmatic approach” will enable it to produce over one billion doses.

Single shot advantage

The J&J vaccine developed primarily by J&J’s Janssen Pharmaceutical division has been found to have a lower efficacy rating than the Moderna or Pfizer/BioNTech vaccine.

Moderna and Pfizer vaccines have reported efficacies of around 95%. J&J’s vaccine recently reported approximately 67% of efficacy in preventing moderate to severe/critical COVID-19 in a trial using 39,321 people from South America, Mexico, and the US.

However, multiple reports state that direct comparison is difficult as the trials had different aims and J&J conducted its trial when new variants of COVID-19 were present.

Despite the difference in efficacy, J&J’s advantage lies in the vaccine’s single shot requirement.

Unlike the mRNA based Moderna and Pfizer vaccines which require two doses, J&J’s vaccine is administered as a single dose giving it an advantage over all the other approved vaccines which require a follow up jab.

With fewer doses needed, fewer medical appointments and medical staff will be required.

In January, Jeylan Mammadova, global sector lead for healthcare at Third Bridge said “Even if Johnson & Johnson ends up requiring secondary dosing, they may still retain an advantage over Pfizer and Moderna,” she added “This is because Pfizer and Moderna may have to convert to a three-dose regimen, in order to tackle the new strain and enhance durability.”

However, Dr Fauci told NBC: “All three of them are really quite good, and people should take the one that’s most available to them. If you go to a place and you have J&J, and that’s the one that’s available now, I would take it.”