What makes Sanofi’s COVID-19 programs different from others?
Sanofi’s vaccine division Sanofi Pasteur has nearly 100 years of experience in the development and delivery of vaccines. We are not only developing effective COVID-19 vaccines, but also to manufacturing them on a massive scale and ensuring they will be accessible and affordable around the world. We are uniquely positioned to do so in several ways:
- We are pursuing two different vaccine candidates in parallel to increase chances of success and maximize production capacities to help meet worldwide demand.
- We are doing so in unique partnerships with industry peers, including GSK (for the recombinant protein vaccine) and Translate Bio (for the mRNA vaccine) as well as governments, including the US and EU.
- One of our vaccine candidates is developed with well-established, recombinant-protein technology already used effectively in influenza vaccines.
- The fact that this vaccine technology is well established also means the distribution channels and methods are already in place to help assure high-volume, timely supply.
- We have a massive vaccine manufacturing and pharmaceutical industrial footprint, which is being scaled up with support from partners and governments worldwide.
How can Sanofi assess safety with accelerated development timelines?
Monitoring and evaluating the safety of any investigational vaccine is of utmost priority. The development of a vaccine candidate will continue only if its risk/benefit profile remains acceptable, as with any new vaccine.
In the development of COVID-19 vaccines, safety controls are no different from what we normally do for any new vaccine candidate. We are working with regulatory authorities to ensure all required safety data are collected and an Independent Data and Monitoring Committee will be integrated in our development programs. Sanofi Pasteur is accelerating the process in other areas, for example some clinical trial phases will overlap one another to shorten the total development time. Regulatory authorities are also helping by reviewing data in real time throughout clinical trials and prioritizing new COVID-19 vaccine reviews. We are carrying out full safety monitoring that occurs in all our clinical trials, which includes rigorous and objective scientific review of safety and efficacy data prior to any regulatory agency’s approval of our COVID-19 vaccines.
What does it mean for a vaccine to be less than 100% effective?
Efficacy rates are estimates scientists make when observing clinical trials. In those trials, they compare the number of people in a group of vaccinated participants who may still become infected with COVID-19, with the number of people in a control group who have received a placebo and who have become infected with COVID-19. The efficacy percentage indicates the likelihood the vaccine will protect a person from infection. The World Health Organization (WHO) has established a target product profile for COVID-19 vaccines, including optimal efficacy levels at less than 100% (and a minimum of 50%). Even with vaccines that achieve less than 100% efficacy in clinical trials, a significant number of hospitalizations and severe cases would be averted.
How will Sanofi’s vaccines be allocated to people around the world?
We will work with our partners, GSK and Translate Bio, governments and NGOs to ensure our COVID-19 vaccine(s), if and when approved, will be available worldwide. Financial systems such as the Advance Purchase Agreements have been established to help support and extend our production capacities for the recombinant protein vaccine candidate. As part of these agreements, governments can secure quantities of vaccines for their populations. This is the case for the US, the EU, the UK and Canada.
In addition, the international public health community has organized a global pooled procurement mechanism called the COVAX Facility (led by the WHO, Gavi and others). COVAX helps participating countries gain access to the vaccine in an efficient and optimally equitable way. We are participating in this Facility and will continue discussions with WHO, Gavi and partners as the pandemic and vaccine project development evolve.
How does Sanofi plan to manufacture so many doses of COVID-19 vaccines without disrupting regular business or diverting from other activities?
Our COVID-19 activities are in addition to all our pre-existing activities and we continue to both receive new market authorizations for new drugs and vaccines as well as meet our product supply commitments around the world. Sanofi benefits from a large global R&D and industrial footprint that we are extending across our manufacturing sites in the US and in Europe to support COVID-19 vaccine projects. We are also partnering with GSK for their adjuvant on the recombinant protein vaccine initiative and with Translate Bio on the mRNA initiative, and these partners’ capacities greatly support scaleup. In addition, new ramp up is supported by new financial systems such as Advance Purchase Agreements, established to quickly support the extension of our production capacities, and as part of the agreements, governments can secure quantities of vaccines for their populations.
What will your clinical trials show for each vaccine?
The phase 1/2 study interim results for the recombinant protein adjuvanted vaccine candidate showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults, likely due to an insufficient concentration of the antigen. We are planning a phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA). The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, with the vaccine’s potential availability in Q4 2021.
Sanofi routinely publishes key protocol details on clinical trial registries such as clinicaltrials.gov and full protocols and statistical plans are also shared at the time of publication of study results.
Due to the exceptional nature of the COVID-19 pandemic, we will make available our phase 2b and phase 3 protocols before each phase begins.
Our mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies. Two doses induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients. Phase 1/2 clinical trial are anticipated to begin in Q1 2021.
Where are Sanofi’s clinical trials being held and where can I learn more?
We are planning to enroll around 30,000 people in our clinical program for the recombinant protein adjuvanted vaccine. The phase 1/2 trials and phase 2b for this project are in the US. Phase 3 will be conducted in multiple countries around the world to help ensure we are present where SARS-CoV-2 is circulating to help us make an optimal assessment of vaccine efficacy.
For the mRNA technology, we are planning to enter phase 1/2 clinical trials in Q1 2021 and are currently studying geographies for that study.
When will Sanofi’s vaccines be available?
We are following the science in the development of our two vaccine projects. If data from our phase 2b trial (planned to start in February 2021) are positive, a global phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, with the vaccine’s potential availability in Q4 2021. With the mRNA technology we will enter phase 1/2 clinical trials by Q1 2021.