Sanofi announced positive phase 2 results of the experimental COVID-19 vaccine that it is co-developing with GlaxoSmithKline PLC, paving the way for late-stage trials and a possible approval in the fourth quarter of the year, adding another potential shot to the pharmaceutical industry's arsenal developed in the wake of the pandemic.
Paris-based Sanofi intends to start a phase 3 trial of the vaccine in 35,000 people in the coming weeks, assessing the efficacy of two formulations targeting the variants identified in Wuhan, China, and South Africa. These trials will be "operationally quite challenging" given that COVID-19 vaccines have already rolled out in many parts of the world, so the focus will likely be on Latin America and Asia, Su-Peing Ng, Sanofi's global head of medical for vaccines, said. The variant identified in India — and any of the circulating virus strains in the location the study is going to be carried out — will also be evaluated, Ng added.
 Sanofi and GSK's vaccine triggered a strong immune response in adults of all age groups. Source: pixabay.com |
"We think that it's really important too, because we want to demonstrate the public health relevance," Ng said on a May 17 call with reporters. "And this is a unique opportunity with this study, to be able to have variant formulations [being] assessed in a very large-scale efficacy study. It's one of our probably last chances to actually be able to conduct such a study and to demonstrate efficacy."
Full results of the phase 2 study will be published in a peer-reviewed journal after interim data showed that the vaccine triggered a strong immune response in adults of all age groups and neutralizing antibodies similar to those generated by natural infection. The study of 722 volunteers, carried out in the U.S. and Honduras, also suggested the shot may have strong potential as a booster vaccine; further studies with various variant formulations will gauge if a lower dose could generate a strong booster response regardless of the initial type of vaccine received, Sanofi and GSK said.
The French pharma giant's pandemic efforts have lagged behind some of its peers — including AstraZeneca PLC and Pfizer Inc.-BioNTech SE — despite receiving funding from the U.S. government's Biomedical Advanced Research and Development Authority, illustrating the complexity and unpredictability of scientific research. In the interim, the third-largest vaccine manufacturer in the world has stepped in to make shots developed by Moderna Inc., Johnson & Johnson and BioNtech, which Sanofi's global head of vaccines, Thomas Triomphe, said the company will continue to do for the duration of the contracts.
"It's been a major effort to get here," Triomphe said on the call. "We know the world needs more than one platform, we need the flexibility of different platforms, different manufacturing and distribution to address the global needs all around us. While there are many lessons learned, we know that different vaccines are needed to defeat this pandemic."
UBS analyst Laura Sutcliffe said the latest announcement highlights the vaccine's potential for use as a booster product without onerous storage requirements, "but we do not know how this compares to other vaccines doing the same or what the response looks like in patients who have already had another vaccine."
"On top of this, mRNA vaccines can be quickly redesigned to match new variants closely. Given all this, we do not expect today's news to excite investors too much and think the focus will remain on other areas of the Sanofi pipeline," said Sutcliffe, who has a "buy" rating on Sanofi.
Analyzing variants
Separately, Oxford University and Oracle announced the creation of a Global Pathogen Analysis System, or GPAS, which combines Oxford's pathogen library and Oracle's infrastructure to help governments rapidly identify new COVID-19 variants, the latest of which has caused a surge of cases in India and threatens to derail the easing of lockdown measures in the U.K.
First used for tuberculosis, Oxford's pathogen data platform, known as SP3, has been repurposed to standardize, analyze and compare sequences of the coronavirus. Oxford, which has already processed half the world's SARS-CoV-2 sequences, said it will now be able to identify variants and their potential impact on vaccine and treatment effectiveness via a dashboard showing which strains are spreading fastest and whether genetic features contribute to increased transmissibility.
"The opportunity of applying systematic examination for genetic variants in a range of pathogens will have major benefits for global public health," John Bell, the university's Regius Professor of Medicine, said in a May 17 statement. "This program, with Oracle as a partner, takes us a step closer to this goal."
