The company said the VRBPAC meeting, which has been scheduled for 28 July 2017, is close to the HEPLISAV-B Prescription Drug User Fee Act (PDUFA) date of 10 August 2017 solely as a function of meeting logistics.
According to the company, the US FDA will communicate specific questions for the VRBPAC to address closer to the meeting date and will post a draft agenda and draft questions on its website 48 hours prior to the meeting.
In both age groups, at least 99.9% ofTdap-IPV recipients had seroprotective levels of antibodies for diphtheria and tetanus, and responses to pertussis antigens were comparable to those observed following a 3-dose primary pertussis vaccination series as defined by VRBPAC
Antibodies produced following vaccination with the 2001-02 vaccine containing the A/Panama/2007/99 (H3N2) virus reacted equally well with recent influenza A (H3N2) viruses and the vaccine strain (2); therefore, VRBPAC recommended that an influenza A/Moscow/10/99-like (H3N2) virus be retained in the 2002--03 vaccine.
The hemagglutinin of most influenza A (H1N1) and A (H1N2) viruses were related antigenically to A/New Caledonia/20/99; therefore, VRBPAC recommended that an A/New Caledonia/20/99 (H1N1) virus be retained in the 2002-03 vaccine.
preliminary meeting summary for March 6, 2002.
Therefore, VRBPAC recommended changing the A (H3N2) vaccine strain to A/Panama/2007/99-like (H3N2) virus.
Therefore, VRBPAC recommended changing the A (H1N1) vaccine strain to A/New Caledonia/20/99-like (H1N1) virus.
Because A/Beijingl262/95-like viruses produce a cross-reactive antibody response to A/Bayern/7/95-like viruses, VRBPAC recommended retaining A/Beijing/262/95 for the 1999-2000 vaccine.
For the United States, VRBPAC recommended retaining a B/Beijing/184/93-like virus for the vaccine.
recommended changing the influenza A(H1N1) component for the 1997-98 season to an A/Bayern/07/ 95-like virus.
The Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC
) has recommended that the 1996-97 trivalent influenza vaccine for the United States contain A/Wuhan/359/95-like(h3n2), Aftexas/36/91-like (H1N1), and B/Beijing/184/93-like viruses.