FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization

Emergency use authorization for Johnson & Johnson's single-shot vaccine candidate could help speed deployment of COVID-19 vaccines

BOSTON –⁠ The U.S. Food and Drug Administration granted emergency use authorization for the third COVID-19 vaccine — developed in collaboration with Beth Israel Deaconess Medical Center (BIDMC) immunologist Dan Barouch, MD, PhD — for use in adults 18 years and older. The decision comes one day after the FDA's Vaccine and Related Biological Products Advisory Committee voted unanimously in favor of issuing the EUA for Johnson & Johnson’s investigational COVID-19 vaccines.

In phase 3 clinical trials including more than 43,000 participants in 8 countries, the vaccine has been shown to confer robust protection against multiple variants of SARS-CoV-2, the virus that causes COVID-19.

"This was the largest and most complex COVID-19 vaccine study conducted in the world and we knew the data were very strong going in," Barouch said immediately after Friday's vote. "The committee members were universally positive. It was gratifying to see consensus across all stakeholders, including the general public. It is really an amazing feeling."

In January, the vaccine's maker, the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), released preliminary data from ongoing clinical trials showing that the vaccine candidate is 100 percent effective at preventing COVID-19 related hospitalization and death, 28 days post-vaccination. Updated data released by the FDA in advance of the committee meeting showed that the vaccine had a 72 percent overall efficacy rate in the United States and was 86 percent effective preventing severe disease related to COVID-19. In South Africa — where a highly infectious viral variant dominates new COVID-19 cases — the Johnson & Johnson vaccine demonstrated 64 percent overall efficacy, with 82 percent efficacy preventing severe COVID-19.

"The vaccine clearly reduced the incidence of severe COVID-19 cases requiring medical intervention," said Barouch, who is Director of the Center for Virology and Vaccine Research at BIDMC. "Additionally, these results include efficacy against the worrisome emerging strains of coronavirus, including some highly infectious variants present in the United States, Latin America and South Africa."

"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 Janet Woodcock, MD, in an official statement Saturday night.

"I believe that the vaccine is as safe and effective as other vaccines approved for other illnesses, such as influenza," VRBPAC member Jay M. Portnoy, MD, an immunologist at the University of Missouri-Kansas City School of Medicine, commented at Friday's meeting. "We’re dealing with a pandemic right now and we’re in a race to stop the virus. Fewer infections means less opportunity for a more virulent strain to emerge, so we’re in a hurry to get this vaccine out and I do think the evidence supports that."

"We look forward to the roll out of this vaccine to the general public as soon as possible to start saving lives," said Barouch, who is also Professor of Medicine at Harvard Medical School and a member of the Ragon Institute of MGH, MIT, and Harvard.

The temperature-stable, single shot vaccine's innovative design uses a common-cold virus as a vector. Barouch and colleagues at BIDMC and Janssen engineered that virus, called an adenovirus, to deliver a fragment of COVID-19 genetic material into host cells, where it stimulates the body to raise immune responses against the virus.

Over the last 20 years, Barouch has worked on the adenovirus strategy for use against pathogens such as HIV, also in collaboration with Janssen and other partners. One such candidate HIV vaccine developed by Barouch, Janssen and colleagues is currently in clinical efficacy trials at sites around the world. It is only the fifth HIV vaccine candidate to be evaluated in human volunteers in large-scale clinical trials in the nearly 40-year history of the global HIV epidemic. Trial results are expected later this year.

Barouch, Janssen, and colleagues successfully applied the strategy in 2016 developing an early stage Zika vaccine candidate.

The emergency use authorization represents a major milestone in a months-long marathon for Barouch and his colleagues, who began working on a COVID-19 vaccine on January 10, 2020, the night Chinese scientists released the SARS-CoV-2 virus' genome.

By March 2020, Johnson & Johnson — in collaboration with the United States Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services — pledged to invest $1 billion to develop the vaccine candidate developed with Barouch. Clinical trials in human volunteers began in July. The company filed for EUA in early February and expects to be able to fill the United States’ order for 100 million doses by summer 2021.

"We were able to move so quickly in part because we were able to build on our previous vaccine research against other pathogens, including HIV and Zika," said Barouch. "That prior work allowed us to move forward at an unprecedented pace without sacrificing any of the established safeguards for vaccine development."

"There's a huge sense of urgency"" said Barouch in April. "We have people working long days, no weekends off, just to try to move things forward even just a little bit faster. Everybody wants to contribute to this global crisis as best they can."

Those contributions have not gone unnoticed. In October, Barouch was elected to the National Academy of Medicine in recognition of his work developing preventative vaccines for HIV and other pathogens. Last month, Elon Musk's charitable foundation pledged $5 million to the laboratories of Barouch and Galit Alter, PhD, a Professor of Medicine at the Ragon Institute, to support their vaccine research.

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority under OTA No. HHSO100201700018C.

Editor’s note: This story has updated from a previous version posted February 26, 2021.