J&J applies for FDA emergency use authorization for Covid-19 vaccine

J&J applies for FDA emergency use authorization for Covid-19 vaccine
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Pharmaceutical giant Johnson & Johnson (J&J) has applied for an emergency use authorization from the US Food and Drug Administration (FDA) for its Covid-19 vaccine.

The application for an emergency use authorization was submitted by J&J to the FDA after publishing results of its Phase 3 trial last week. Data showed that its one-dose Covid-19 vaccine has a 66% average effectiveness.


FDA application

If approved, the J&J vaccine will be the third Covid-19 vaccine to be authorized for emergency use in the US, behind the Pfizer-BioNTech and Moderna vaccines, which were granted authorization in December.

J&J’s chief scientific officer, Dr. Paul Stoffels, said: “Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” Dr. Stoffels explained.


Following J&J’s submission, the FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on February 26 to discuss the emergency use authorization.

Acting FDA Commissioner Janet Woodcock said: “A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine.”

“The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines,” Woodcock added.


Phase 3 results

Results of the phase 3 trial showed that the J&J Covid-19 vaccine was 72% effective in protecting against the virus in the US, while it is 66% in Latin America and 57% in South Africa after four weeks.

They were based on 468 confirmed Covid-19 infections among the more than 43,000 participants. It included infections from the highly contagious South Africa variant, dubbed B.1.351.

According to J&J, the vaccine was 85% effective in preventing severe disease four weeks after vaccination in all adults while offering complete protection against Covid-related hospitalization during the same period.

The company also noted that the vaccine was well tolerated, with no significant safety concerns related to the vaccine reported, as well as no reports of anaphylaxis.

In a statement, J&J chief executive officer (CEO) Alex Gorsky said: “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, pointed out that the J&J vaccine could help reduce stress on the US health care system.

Dr. Fauci said: “If we can alleviate that, that is really important — not only with this candidate, but the others that have already gotten the EUA. If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress and human suffering and death.”

“A vaccine that’s inexpensive, that’s a single dose, and that has no cold chain requirements — that’s pretty good,” he added.