Approval comes on 1-year anniversary of first COVID-19 case in New York
164,800 doses of Johnson & Johnson vaccine expected in New York this week
Single-dose vaccine has less restrictive storage requirements
Gov. Andrew Cuomo on Monday announced the New York State Clinical Advisory Task Force unanimously recommended use of Janssen Pharmaceuticals/Johnson & Johnson's COVID-19 vaccine in New York, following the U.S. Food and Drug Administration advisory committee's recommendation for emergency use authorization.
New York expects to receive approximately 164,800 doses of the Johnson & Johnson vaccine this week, pending final FDA authorization. The added doses will supplement the state's expected week 12 supply of 422,780 first doses and 290,500 second doses from Pfizer and Moderna, for a total of approximately 878,080 doses. This will be New York state's highest-ever weekly vaccine allocation.
"One year ago today, the unimaginable tragedy of COVID-19 began for New Yorkers. We've faced great pain and loss over the last 365 days, but there's reason to be hopeful for the future, and the state's Clinical Advisory Task Force's recommendation of the next vaccine for COVID is part of that ongoing convalescence," Cuomo said. "Johnson & Johnson's single-shot vaccine with less-restrictive storage requirements will make it easier for the state to reach more New Yorkers, faster. There's a lot of work ahead, but this vaccine's approval gives us cause for optimism as we move forward to a post-COVID future."
The Johnson & Johnson vaccine is single dose and there are fewer restrictions on its storage. New York state is finalizing plans for the vaccine's prioritization and distribution with partners.
On Sept. 24, Cuomo announced New York state would form an independent clinical advisory task force comprised of leading scientists, doctors, and health experts who will review every COVID-19 vaccine authorized by the federal government, and will advise New York state on the vaccine's safety and effectiveness in fighting the virus. The task force later recommended the Pfizer and Moderna vaccines.
On Saturday, Johnson & Johnson announced the FDA issued emergency use authorization for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the phase 3 ENSEMBLE study that demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
The terms of the EUA allow use of the vaccine while more data are gathered. The company said it plans to file for a biologics license application (BLA) with the FDA later in 2021.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, chairman and CEO at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”