Will Sanofi's vaccine be available by 2021?
Sanofi is currently working on two vaccine candidates, with one based on existing recombinant DNA technology, while the other uses novel messenger RNA technology.
The race to develop, approve and administer a vaccine in record time following the emergence of the coronavirus pandemic in March has advanced at breakneck speed, with Sanofi and GSK's recombinant vaccine identified among the most promising candidates over the past few months, along with other candidates from Pfizer and Moderna.
Following the historic rollout of Pfizer and BioNTech’s Covid-19 vaccine in the UK on Tuesday, the US FDA finally approved that vaccine on Saturday. Some 2.9 million doses of the Pfizer shot will be delivered to hospitals and clinics in all 50 states over the weekend with the first shots expected to be given to high-risk health care workers on Monday.
The Trump administration will also purchase 100 million doses of the Moderna vaccine, which, like Pfizer’s vaccine, has shown an efficacy rate of more than 90 percent and could receive FDA approval within weeks.
Sanofi to delay rollout of vaccine
It was hoped that Sanofi and GSK’s vaccine would also be made available in early 2021 as late-stage clinical trials were previously expected to begin in the US in December after the US government agreed to buy 100 million doses back in late July.
However, on Friday, the announcement that Sanofi and GSK’s experimental recombinant vaccine did not appear to work well in older adults has served as a significant setback for the pharmaceutical companies. As a result, the vaccine's potential availability has been pushed back "from mid-2021 to Q4 2021," Sanofi said in a statement.
“Sanofi is planning to launch a phase 2b study with an optimized candidate vaccine in February 2021, with support from the Biomedical Advanced Research and Development Authority (BARDA) in the US,” it said.
“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. If the vaccine meets clinical requirements on safety and efficacy, and once approved by regulatory authorities, a vaccine can expected in the fourth quarter of 2021.”
Sanofi is pursuing two vaccine candidates
Sanofi is currently working on two vaccine candidates. The first one being developed in partnership with GSK is based on recombinant DNA technology.
“We are using an existing technology that was designed for influenza, and we’re applying it to the new virus that causes COVID-19 disease,” said John Shiver, Head of Sanofi Vaccine R&D. “Having the existing platform and partnerships are key to finding the optimal vaccine that we hope can both have impact against disease while contributing to vast and urgent global demand.”
Sanofi’s second vaccine candidate, meanwhile, utilizes novel messenger RNA (mRNA) technology, and is being developed in partnership with Translate Bio. Pfizer and Moderna’s vaccines are also made from mRNA, the molecule that cells naturally use to carry DNA’s instructions to cells’ protein-building machinery. Pfizer’s vaccine is the first-ever mRNA vaccine to be approved by the FDA.
Sanofi and Translate Bio’s mRNA-based candidate could start phase 1/2 clinical trials in early 2021, with earliest potential approval in the second half of the year, according to the Sanofi statement.
With approval of both candidates expected in the second half of 2021, Sanofi has confirmed that it plans to expand its manufacturing capabilities, which will allow for the manufacture of up to a billion doses per year of the recombinant vaccine, and between 90 to 360 million doses of the mRNA vaccine.
“The company is working across six countries and in coordination with multiple partner manufacturing sites to be able to make vaccines at the extremely large scales required by the pandemic. The manufacturing process is a complex, never-ending job, but our aim is to supply the vaccine to as many as need it,” said Vincent Hingot, Head of Vaccine Industrial Affairs at Sanofi.