FDA eyes decision on J&J jab’s EUA application by next week

FILE PHOTO: A nurse draws from a vial of Johnson & Johnson coronavirus disease (COVID-19) vaccine, in Los Angeles, California, U.S., March 25, 2021. REUTERS/Lucy Nicholson/File Photo

MANILA, Philippines — Food and Drug Administration (FDA) Director-General Eric Domingo hopes that a decision on the emergency use authorization (EUA) application of Johnson & Johnson’s COVID-19 vaccine can be made next week amid reports of blood clotting among those who have received it in the United States.

In an interview with INQUIRER.net’s INQside Look, Domingo said the national government’s vaccine expert panel was already scheduled to submit their recommendation on the vaccine on Wednesday. This was, however, delayed following reports on the effects of the J&J vaccines—including blood clots—in the United States.

“What they did was instead of giving the reports immediately, since nabalitan nila, they got more data na rin on this phenomenon that is being observed in the US and is now going to be included in their deliberations,” Domingo said.

Asked for a timeline on the decision on the EUA application, Domingo said: “I want it to be done by next week.”

“For these applications from companies that already have an EUA from a stringent regulatory authority like US, EU [European Union], at WHO [World Health Organization], alam kasi naman natin, kumpleto naman na ‘yung requirements diyan [as we all know, requirements for that are already complete],” Domingo said.

“I think they applied March 31, so they are on their 14th or 15th day, I want it to be done by next week,” he added.

No huge effect

The US and South Africa temporarily suspended the administration of the Janssen COVID-19 jab amid reported blood clots among recipients. J&J has also delayed the rollout of its vaccine in Europe.

J&J earlier said it is aware of an “extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received [its] COVID-19 vaccine.”

It added that the US Centers for Disease Control and FDA are reviewing data involving six reported US cases out of more than 6.8 million vaccine doses that were administered.

Despite this, Domingo believes the reported blood clots would not have a “huge effect” on J&J’s EUA application.

“It will affect [the EUA application] in a way na siguro, magkakaroon—possibly that you might have to put some condition to the EUA. Hindi malaki ‘yung effect kasi the events are very, very rare,” Domingo said.

(It will affect the EUA application in a way probably there will be —possibly that you might have to put some condition to the EUA. The effect is not that huge because the events are very, very rare.)

“One in a million. Imagine mo naman na yung one in a million [Imagine how many is one in a million], always the benefit will outweigh the risks if you are vaccinating one million people against COVID which is really devastating and is making a lot of people sick and killing people,” he added.

However, Domingo said since the manufacturer has already recognized that there could be effects following vaccination, some safeguards and condition may be put in place.

JPV