‘Time for the FDA to do its job’: Biden welcomes Johnson & Johnson coronavirus vaccine

President Biden said he is “encouraged” by COVID-19 vaccine data from Johnson & Johnson, the single-shot dose of which puts a third inoculation on the horizon in the United States and one that could help simplify distribution and expand access.

The results of a large global trial showed the vaccine was 66% effective at preventing moderate and severe illness, according to a company statement issued on Friday. Against severe disease, the vaccine prevented 85% of severe infections and 100% of hospitalizations and death. Johnson & Johnson will apply for emergency authorization of the vaccine from the Food and Drug Administration.

Biden “also knows that this is just new data, and now is the time for the FDA to do its job of evaluating the safety and efficacy of the vaccine,” White House press secretary Jen Psaki said during a White House press briefing on Friday. “We don’t have a timeline of when that will happen. We leave that to the FDA.”

About 100 million doses could be ready by this summer if the FDA gives the green light.

“We’ll rely on our health and medical experts to advise, if there are additional vaccines, if and when I’ll be optimistic, that are approved by the FDA and how that will impact our vaccination vaccine distribution plan,” Psaki added.

The White House is pushing Congress to pass a $1.9 trillion aid package, part of which would support getting vaccines distributed, a process fraught with challenges, including the need to deliver two spaced doses of the currently available vaccines made by Pfizer and Moderna.

By requiring only one dose, Johnson & Johnson’s drug would free up appointments to receive the vaccine that are heavily in demand.

The administration announced this week that while it was on track to vaccinate all of the public this summer, finding enough vaccinators was a challenge.

While the Johnson & Johnson candidate would simplify this process, it is less effective against new, highly transmissible variants of COVID-19, performing slightly worse than its two competitors.

Protection varied by region, ranging from 72% overall effectiveness in the United States to 66% in Latin America and 57% in South Africa, where a highly contagious variant is driving many new cases.

The FDA has signaled that it would approve a vaccine that is safe and more than 50% effective.

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