FDA Authorizes Johnson & Johnson COVID-19 Vaccine

On February 27, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the third COVID-19 vaccine, greenlighting a vaccine made by Johnson and Johnson.

“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,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

This marks the third authorization of a COVID-19 vaccine in the U.S. and the first authorization of a single-dose vaccine. The distribution of millions of doses of the vaccine could begin as early as this week. 

A Food and Drug Administration (FDA) advisory panel voted Friday to recommend that the agency authorize the use of Johnson & Johnson’s COVID-19 vaccine in adults eighteen and older to prevent SARS-COV-2, the virus that causes COVID-19. 

The panel called the Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously (22 to 0) in favor of the recommendation. Addressing the panel just after the vote, Archana Chatterjee, MD, dean of the Chicago Medical School and a member of the advisory panel, said “authorization of this vaccine will help meet the needs of the moment.” 

Johnson & Johnson, like Pfizer and Moderna, the two companies behind the two currently authorized COVID-19 vaccines, applied for an emergency use authorization (EUA), rather than full FDA approval. EUAs are permitted in the U.S. for drugs, devices, and vaccines if the benefits outweigh the risks, which is the question the committee voted on.

Data presented to the advisory committee and released by the FDA earlier this week found that overall, the Johnson & Johnson vaccine is 66% effective at preventing COVID-19 infection at least 28 days after vaccination. The vaccine is 85% effective against preventing serious illness from COVID-19.

In comparison, the Pfizer vaccine is 95% effective at preventing infection and the Moderna vaccine is 94% effective. Despite lower numbers, the panel said Johnson & Johnson’s single-dose regimen can help the U.S. reach herd immunity more quickly.

The FDA also said that the Johnson & Johnson vaccine has a “favorable safety profile” and “no specific safety concerns identified that would preclude issuance of an EUA.” The major side effects of the Johnson & Johnson vaccine, according to the FDA, are headache, fatigue, and muscle pain. Data shared with the FDA also suggests the vaccine may be able to curb the transmission of asymptomatic COVID-19 infections, but more review is needed. 

Doses of the vaccine may begin shipping to community vaccination sites within a week. At a White House press briefing on Wednesday,  White House Coordinator for COVID-19 Response Jeffrey Zients said if an EUA is issued, the government anticipates allocating 3 to 4 million doses of Johnson & Johnson vaccine next week.

“Johnson & Johnson has announced it aims to deliver a total of 20 million doses by the end of March [and] we’re working with the company to accelerate the pace in timeframe by which they deliver the full hundred million doses, which is required by contract, by the end of June,” he said.

Differences Between Pfizer and Moderna

The Johnson & Johnson vaccine is notably different from Moderna and Pfizer in two ways: it’s given as a single dose and can be stored for long periods of time in a refrigerator.

Johnson and Johnson, in a press release, state that the vaccine is estimated to remain stable for two years at negative 4 °F, three months of which can be at temperatures of 35 to 46 °F.

Both the Moderna and Pfizer vaccines are given as two-shot vaccines with a wait-period between doses. Vials must also be stored in ultra-low temperature freezers, thawed for use, and used within several hours of being thawed. These stringent storage measures have led some vaccines to expire and be tossed without use.

Johnson & Johnson’s vaccine technology is also different from that of Moderna and Pfizer, both of which use a platform called messenger RNA.

In order to prompt an immune response, the Johnson & Johnson vaccine uses an adenovirus—a type of virus that causes the common cold—that is unable to replicate in the body. This adenovirus carries a gene from coronavirus into human cells, which then produces the coronavirus spike protein, but not the virus itself. This spike protein is what helps the body fight off infection from the virus, producing antibodies and T cells.

Johnson & Johnson has used this technology before in their Ebola vaccine and in investigational vaccines for HIV. And because of this technique, the vaccine temperature is stable, leading to easier storage.

Efficacy and Variants

The EUA request for the Johnson & Johnson vaccine was based on clinical trials in close to 44,000 people in the U.S., Latin America, and South Africa.

Efficacy of the vaccine was:

• 72% in the U.S.
• 66% in Latin America
• 57% in South Africa

There are currently studies underway to determine if a second dose would work to increase the vaccine’s efficacy. But the results of Johnson & Johnson’s two-dose clinical trial are not expected until July at the earliest.

For now, not much is known about how well the Johnson and Johnson vaccine performs against some of the COVID-19 variants emerging around the world. But studies are ongoing.

C. Buddy Creech, MD, director of the Vanderbilt University Vaccine Research Program in Nashville, who is also an investigator for the Johnson & Johnson vaccine, tells Verywell that the vaccine “has [been] shown to be completely effective—100%—in preventing COVID-related hospitalization and death…This gives us a great deal of confidence in the efficacy of this vaccine.”

Creech says in terms of protection against variants “it’s important that the study was done in a number of places (e.g., the U.K. and South Africa) where currently circulating variants may provide a greater challenge for vaccines. Even in those areas, we saw complete protection against COVID-hospitalization and COVID-related death.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.