Janssen COVID-19 Vaccine Prepares for Boosting

New Jersey-based Johnson & Johnson announced on October 15, 2021, the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for a 'booster' dose of the Janssen COVID-19 vaccine for adults aged 18 and older.

In the U.S., there is sufficient supply to support boosting to those who have received the more than 15 million doses of the Jenssen COVID-19 vaccine that have been administered as primary vaccinations.

The booster dose should be administered at least two months following the initial single-shot vaccination.

When given as a booster or primary dose, the vaccine is generally well-tolerated, with no new safety signals observed in the two-dose ENSEMBLE 2 trial compared with single-dose studies.

"Today's recommendation is based on the totality of the evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19," stated Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, in a press release.

The single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received initial EUA in the United States on February 27, 2021, and Conditional Marketing Authorization by the European Commission on March 11. The World Health Organization issued Emergency Use Listing on March 12, 2021, and the Company received an interim recommendation by the Strategic Advisory Group of Experts on Immunization on March 17, 2021.

Many more authorizations have been granted in countries worldwide, and various regulatory submissions are ongoing.

For more information on the Company's multi-pronged approach to helping combat the pandemic, visit www.jnj.com/covid-19.