Just one day after Pfizer announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) had voted on its RSV vaccine candidate, GSK announced the results of the Committee’s vote on its candidate. This follows “exceptional” results of a trial in October.
GSK’s joins Pfizer
With this approval, GSK’s direct competition with Pfizer increases, with the odds leaning in GSK’s favour in terms of the vote. The Committee voted 12-0 on effectiveness and 10-2 on safety. Dr Phil Dormitzer, Global Head of Vaccines R&D at GSK, described the vote as an “important step closer to delivering one of the world’s first vaccines for RSV”.
“We’re delighted that the Advisory Committee recognised the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine.”
Dr Dormitzer stated that RSV imposes a “major health burden on healthcare systems”.
Just as with Pfizer’s results, the final decision on approval will be made by the FDA following these recommendations by the VRBPAC. This decision is expected in May 2023. However, decisions are also expected from regulatory agencies across the world, including the European Medicines Agency, and Japan’s Ministry of Health, Labour, and Welfare. Further submissions will continue throughout the year.
We look forward to hearing more on the progress that we are making towards a successful candidate at the World Vaccine Congress in Washington this April.