SANOFI Phase 2 Trial for RNA Covid Vaccine Generated Strong Levels of Antibodies
Sanofi and GSK announced positive results from a Phase 2 clinical trial of their joint Covid-19 vaccine, saying it generated strong levels of neutralizing antibodies in recipients across all ages studied. The partners said a large international Phase 3 trial will begin in coming weeks.
The duo, two of the world’s largest vaccine manufacturers, is far behind in the effort to produce a Covid vaccine and lock down markets for their product, having suffered a setback in an earlier Phase 1/2 trial last year. But with vaccine supplies expected to trail global need into the foreseeable future, the companies believe there is still a place for their vaccine.
“Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and, which can be stored at normal temperatures increases,” Thomas Triomphe, executive vice president and head of the vaccines division at Sanofi Pasteur, said in a statement.
The companies said they will begin producing the vaccine “at risk” — meaning before they are certain it will work. While there is financial uncertainty in that approach, if the vaccine does prove to be efficacious, they will have product ready to distribute as soon as the vaccine is authorized for use. The companies are projecting a possible regulatory approval in the fourth quarter of 2021.
The companies released limited information about the results of the trial, saying they will publish the data shortly in a peer-reviewed journal. But they reported the vaccine induced strong rates of neutralizing antibodies, in line with what is seen in people who have recovered from Covid-19. The favorable response was seen across all adult age groups, though there were higher levels observed in people 18 to 59 years old. There were no safety or tolerability concerns arising from the trial.
High neutralizing antibody levels were generated after a single dose in participants with evidence of prior SARS-CoV-2 infection, which the companies said suggests the vaccine could be given as a booster used after an initial vaccination series.
“We believe that this vaccine candidate can make a significant contribution to the ongoing fight against Covid-19 and will move to Phase 3 as soon as possible to meet our goal of making it available before the end of the year,” said Roger Connor, president of GSK Vaccines, said in a statement.