GlaxoSmithKline PLC (LSE:GSK) and Sanofi SA said they plan to submit data from their booster and Phase III trials as a basis for their regulatory applications for a COVID-19 vaccine.
The companies are in talks with regulatory authorities, including the US Food & Drug Administration and the European Medicines Agency.
“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” said Thomas Triomphe, executive vice president of Sanofi Vaccines.
Results from the Phase III trials were expected to be released last year but were delayed as the companies said they needed more data.
“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” said Roger Connor, president of GSK Vaccines.
“Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu. We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period.”