1. What is the status of your vaccine development?
On February 23 2022, we announced the results of our booster and Phase 3 efficacy trials on our first-generation adjuvanted recombinant protein COVID-19 vaccine candidate which contains the original parental D614 strain, and we have submitted this data to the EMA to support its marketing authorization.
On June 13 2022, we reported data from two trials, VAT02 Cohort 2 and CoviBoost VAT013, conducted with our next-generation COVID-19 booster candidate modelled on the Beta variant. We intend to submit these additional data to regulatory agencies to support the marketing authorization of this next-generation vaccine, with the aim of making it available later this year.
3. Does Sanofi have an mRNA COVID-19 vaccine candidate?
On September 28, 2021, we reported positive phase 1/2 study interim results for our mRNA COVID-19 vaccine candidate.
Taking into account public health needs and given sufficient mRNA COVID-19 vaccines supply can be expected going forward, we decided not to pursue the development of that COVID-19 mRNA candidate into a Phase 3 clinical study.
The initial data confirmed the potential of Sanofi’s mRNA and Lipid nanoparticle (LNP) platform. We are now focusing our mRNA resources in our newly created mRNA Center of Excellence to address future pandemics and other infectious diseases and therapeutics where there is a strong unmet need.
4. Are you able to manufacture COVID-19 vaccines from other companies?
It is our responsibility towards public health to contribute to solving the COVID-19 pandemic in every way possible. We continue to manufacture doses of currently approved vaccines.
5. How does Sanofi plan to manufacture so many doses of COVID-19 vaccines without disrupting regular business?
We have a large global R&D and industrial footprint that we are extending across sites in the US and in Europe to support our COVID-19 manufacturing. And we continue to receive market authorizations for several new treatments and vaccines as well as meet our product supply commitments around the world, despite the pandemic.
6. 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 still become infected with COVID-19. The efficacy percentage indicates the likelihood the vaccine will protect a person from infection based on the outcome of participants’ infection rates in each group, vaccine and placebo, over a given amount of time (~ 1 month after second dose for COVID-19 vaccines). 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 reduction of hospitalizations and severe cases are averted. Over time, that level of efficacy can wane and the emergence of virus variants that can evade some levels of vaccine protection have driven most public health authorities today to recommend booster vaccines.
7. How will Sanofi’s vaccines be allocated to people around the world?
We will work with our partners, governments, and NGOs to ensure our COVID-19 vaccine, if and when approved, will be available worldwide. Financial systems such as Advance Purchase Agreements and the COVAX Facility have been established to help support broad vaccine supply.
We are unable to speculate on regulatory approval timelines, but we will be ready to start shipments as soon as possible upon approval.
8. How can Sanofi assess safety with accelerated development timelines?
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 is integrated in our development programs. Sanofi is accelerating the process in other areas, for example some clinical trial phases overlap one another to shorten the total development time. Regulatory authorities are also helping by reviewing data on a rolling basis over the course of 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. In the Phase 3 efficacy and booster studies both our first-generation (D614) and our next-generation (Beta) vaccine were well-tolerated with no safety concerns.
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