On February 4, it was announced that, The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”
Janssen COVID-19 Vaccine
The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. The Janssen AdVac viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets that are currently unpreventable or untreatable.
The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the US, Latin America and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.
“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development.
“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible. The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”
The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed.
The members of the VRBPAC are independent, scientific and public health experts from around the country who provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request. However, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
“In terms of timing for convening the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.
While the FDA cannot predict how long its ongoing evaluation of the data and manufacturing information will take following the VRBPAC meeting to make a decision on the request for an EUA, the agency will review the request as expeditiously as possible, taking into consideration the discussion by the advisory committee, while still doing so in a thorough and science-based manner,” – The FDA said.