TEHRAN (Iran News) – Sanofi administered the first patients with its experimental COVID-19 vaccine on Thursday, bringing it a step closer to the late-stage clinical trials it aims to kick start before year-end.
The Paris-based drugmaker launched human studies at 11 sites across the United States. The phase 1/2 trial – which compresses the early and middle stages of clinical tests – will assess 440 healthy patients in two age groups: 18 to 49, and over 50.
Sanofi, which is developing the vaccine in partnership with GlaxoSmithKline, aims to have results by December, at which point it hopes to accelerate into late-stage studies.
Though Sanofi and Glaxo are just now starting their latest trial, the vaccine front-runners may deliver interim data from their late-stage studies as early as this month.
There are more than 175 COVID-19 vaccines currently in development, according to the World Health Organization, and 33 in human trials. A handful have ambitions to secure emergency use authorizations in the fall.
“I’m not concerned that we’re a few months behind some of the other vaccine candidates,” Dr. John Shiver, Sanofi’s senior vice-president of global vaccine research and development, said in an interview. The firm’s expertise in conducting trials and “experience with very similar viruses” will allow it to gain back time on its peers, he said, and ultimately, multiple shots will be needed, Bloomberg reported.
The vaccine candidate relies on technology Sanofi uses to make influenza shots and Glaxo’s adjuvants, which enhance the body’s immune response. Sanofi also has a messenger RNA vaccine in development. Dr. Shiver said both candidates reported compelling data in pre-clinical studies.
“They showed very, very high levels of neutralizing antibodies in monkeys that are comparable to levels in humans who recovered from the COVID-19 infection,” Dr. Shiver said of the pre-clinical studies, which are to be published in medical journals later this year. That data gave Sanofi confidence as it moves to the next stage, he said.
As Sanofi turns its attention to phase 1/2 trial enrolment, it is focused on recruiting a diverse cohort that reflects different geographies, races, ethnicities, genders and ages.
“Older people, unfortunately, people like me over the age of 50, tend not to respond as well to vaccines,” Dr. Shiver said. Sanofi is targeting the enrolment of 140 people aged above 50 to identify a vaccine formulation that is best suited for them, he said. The Sanofi-Glaxo vaccine will likely require a two-dose regimen.
COVID-19 vaccine clinical trials have thus far relied on test pools with largely White participants, though Dr. Shiver said Sanofi will be focused on recruiting “tremendous diversity” in the 30,000-person phase 3 trial it aims to start in December. It will take place in multiple countries, and particularly where COVID cases continue to rise. Sanofi is currently consulting with epidemiologists on how to best design the trial.
The Trump administration’s “Operation Warp Speed” effort is providing as much as US$2.1 billion (S$2.9 billion) to Sanofi and Glaxo to fast-track its shot and secure 100 million doses should it prove successful.
The United States has an option to receive an additional 500 million doses longer term. The European Commission and the United Kingdom have reached supply deals as well.
If successful with a regulatory approval in the first half of 2021, the companies plan to make one billion doses next year.
“That’s all feasible if the pandemic continues in the way that it’s been proceeding so far this year,” Dr. Shiver said. “I expect cases are going to accumulate later this year when our phase 3 trial starts.”
- source : Tasnim, Iran News