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FDA issues emergency use authorization for Johnson & Johnson COVID-19 vaccine

Four million doses are expected to go out this week and 20 million doses by the end of March.

Susan Morse, Managing Editor

On Saturday, the U.S. Food and Drug Administration issued an emergency use authorization for the Johnson & Johnson vaccine for the prevention of COVID-19.

The EUA allows the Johnson & Johnson Janssen COVID-19 vaccine to be distributed in the U.S for individuals 18 years of age and older. Four million doses are expected to go out this week and 20 million doses by the end of March.

WHY THIS MATTERS

Approval means there are now three COVID-19 vaccines for use in the United States, which speeds up the vaccination process.

The Janssen COVID-19 vaccine has the benefit of being administered as a single dose. The current Pfizer and Moderna vaccines that are being administered require two doses. 

Its effectiveness is less than that of the Pfizer and Moderna vaccines, which each reported at least a 94.5% effective rate.

Johnson & Johnson is at least 66% effective in preventing moderate to severe COVID-19 and at least 77% effective in combating severe to critical COVID-19.

The FDA said the totality of the available data provides clear evidence that the Janssen COVID-19 vaccine may be effective in preventing COVID-19. 

THE STUDY

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine.

Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. 

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. 

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. 

The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted one to two days.

As part of the authorization, the FDA is mandating that Janssen Biotech and vaccination providers report any serious adverse effects to the Vaccine Adverse Event Reporting System.

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS of which they become aware, and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports that are submitted to the FDA.

THE LARGER TREND

The secretary of the Department of Health and Human Services declared a public health emergency on Feb. 4, 2020 and issued a declaration that circumstances justified the authorization of emergency use of unapproved products.

The issuance of an EUA is different from FDA approval, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials.

This is important as pharma companies pursue vaccines to combat COVID-19 variants.

ON THE RECORD

"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," said Acting FDA Commissioner Dr. Janet Woodcock.

"The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com