Sanofi to Produce J&J Covid Vaccine in France

23.02.2021 - On the same day that Sanofi and GSK announced the start of a new Phase 2 study of their delayed adjuvanted recombinant protein-based Covid-19 vaccine candidate, Sanofi disclosed it had signed an agreement to manufacture 12 million doses of Johnson & Johnson’s single-dose adenovirus-based Covid vaccine.

Sanofi’s  deal with J&J follows a similar pact with Pfizer-BioNTech to take up the slack in producing 100 million doses of the American-German duo’s mRNA based shot at its plant in Frankfurt, Germany, during 2021.

As soon as the J&J candidate wins the green light from regulatory authorities, Sanofi said it will give the US healthcare giant’s pharma subsidiary Janssen access to its Marcy l’Etoile, France, where its workforce will formulate the vaccine and handle fill &finish. 

CEO Paul Hudson said the French drugmaker’s offer to J&J “demonstrates ongoing commitment to the collective effort to ending this crisis as quickly as possible.” At the time, he said that while Sanofi “remains committed” to its own two Covid-19 vaccine program, it is “stepping forward to show solidarity.”

Neither Sanofi nor J&J disclosed where the vaccines would be distributed in Europe, the US or elsewhere.

Johnson & Johnson has just completed a Phase 3 trial with 35,000? people. Its application to the FDA for an Emergency Use Application (EUA) is to be discussed at the drugs agency’s advisory committee vote on Feb. 26. The US group also has applied to the European Medicines Authority (EMA) for conditional marketing authorization. Its candidate has been under a rolling review by the EMA since the beginning of December 2020.

Sanofi-GSK vaccine alliance to start Phase 2 trials

After repeated setbacks, Sanofi and GSK have been forced to rework their joint vaccine development plans. The new Phase 2 study will assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults, the companies said.

Assuming positive results from Phase 2, the French and British partners plan to initiate a Phase 3 study that would start in this year’s second quarter.  Parallel to the current candidate, they hope to develop a candidate that would address Covid variants.

The upcoming Phase 2 trial with 720 volunteers is a randomized, double-blind, multi-center dose-finding study conducted in adults aged 18 years of age and older to evaluate the safety, reactogenicity and immunogenicity of two injections given 21 days apart.

This study will include equal numbers of adults 18 to 59 years and additionally those 60 years and above. Three different antigen doses with a fixed dose of adjuvant will be tested in the US, Honduras and Panama. The study concluded in December 2020 showed an immune response comparable to patients who had recovered from Covid-19 in adults aged 18 to 49 years, but produced a lower immune response in older adults, which the partners think may have been due to an insufficient concentration of the antigen.

Sanofi and GSK are receiving funding for their vaccine development from the US government’s emergency preparedness agency Biomedical Advanced Research and Development Authority (BARDA).  Their candidate was selected by the US authority in July 2020 to accelerate its development and manufacturing.

Author: Dede Williams, Freelance Journalist