FDA To Review Johnson & Johnson's Coronavirus Vaccine Friday

NEW BRUNSWICK, NJ — The U.S. Food and Drug Administration will meet this Friday to decide whether or not to give emergency-use authorization to Johnson & Johnson's Covid-19 vaccine, according to the U.S. pharmaceutical giant.

Once that expected emergency authorization is given, Johnson & Johnson says it is ready to deliver enough doses to more than 20 million Americans by the end of March.

This was all told to U.S. Congress Tuesday, when Dr. Richard Nettles, vice president of U.S. medical affairs at Janssen Pharmaceutical Companies/Johnson & Johnson, testified before the House Committee on Energy & Commerce subcommittee.

"Our plan is to begin shipping immediately upon emergency use authorization, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans," he said in his testimony, which you can read here. "We are confident in our plans to deliver 100 million single-dose vaccines to the United States during the first half of 2021."

This is different than what President Biden's Covid czar Jeff Zients said just last week, saying Feb. 17 Johnson & Johnson did not have “a big inventory” of its vaccine, and the pharma company only has "a few million doses."

But J&J is aggressively ramping up its manufacturing, Nettles said.

"We are working around the clock to develop and broadly scale our manufacturing capabilities to supply the United States," he testified before Congress Tuesday.

J&J said they expect to deliver one billion doses globally by the end of 2021. In the U.S., Johnson & Johnson's vaccine production sites are in Indiana, Michigan and Pennsylvania. They also plan to manufacture the vaccine in Europe, Asia and Africa.

Janssen Pharmaceutical Companies/Johnson & Johnson is headquartered here in New Brunswick, and they actually used Rutgers undergrad students in their coronavirus vaccine trial. Ultimately, Johnson & Johnson's COVID vaccine trial included nearly 45,000 participants from eight countries across three continents, including the United States, Europe, Japan, Central and South America and South Africa.

Johnson & Johnson's single-shot jab is widely viewed as what will be a game changer in U.S. in ending coronavirus. Health officials say that once the single-shot vaccines are approved, it will greatly increase the speed of vaccine roll-out. J&J's vaccine can also be stored in temperatures similar to a household refrigerator.

"Although we are cautious not to prejudge the outcome of the ongoing FDA review process, we believe that our single-dose COVID-19 vaccine will be a critical tool for fighting this global pandemic," said Dr. Nettles. "The study showed that our single-dose vaccine addresses the most important healthcare need in the pandemic: the prevention of COVID-19 related hospitalization and death."

Johnson & Johnson said its vaccine also shows protection against the new variants currently circulating, including the virulent B.1.351 variant first observed in South Africa, and the P2 variant first observed in Brazil.

According to Dr. Nettles, Johnson & Johnson's coronavirus trial results have shown:

• The vaccine provided complete protection against COVID-19 related hospitalization and death, as compared to those study participants who received a placebo.
• The vaccine demonstrated 85% effectiveness overall in preventing severe disease, including across countries with newly emerging variants.
• The vaccine demonstrated 72% effectiveness in the United States (and 66% effectiveness overall) at preventing moderate to severe disease.

Johnson & Johnson started its initial human clinical trials in July in the United States and Belgium, follow by Japan and then the Netherlands, Spain and Germany. They launched their large-scale clinical trial in September, released their results in January and applied to the FDA for emergency-use authorization on February 4.

Johnson & Johnson's vaccine is very different than Monderna's and Pfizer's: It functions more like a traditional vaccine in that it puts a strain of the adenovirus into the body, according to the CDC. Adenovirus is the virus that causes a common cold.

Pfizer and Moderna are mRNA vaccines, which is new vaccine technology. Instead of injecting a virus, as traditional vaccines do, mRNA vaccines alter or teach cells to make a spike protein and thus trigger an immune response that creates antibodies. Read the CDC's explanation of how mRNA vaccines work.

Past Patch reporting on Johnson & Johnson's coronavirus vaccine: Rutgers Students Wanted For Johnson & Johnson's Vaccine Trial (Nov. 2020)

Johnson & Johnson Seeks Emergency Use Approval For COVID Vaccine (Feb. 5, 2021)

Johnson & Johnson To Give Poor Countries 500M Free COVID Vaccines (Oct. 8, 2020)

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