J&J is confident of the success and supply of its COVID-19 vaccine candidate after securing manufacturing capacity and receiving approval of Ebola vaccines based on the same adenovector technology.
Johnson & Johnson’s candidate – SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant – is set to enter Phase I/IIa studies later this month (see textbox).
It is one of a number of coronavirus vaccines in development but according to the firm, the candidate’s potential for success has been bolstered by the verification of the technology platform it is built on.
The candidate is based on Janssen’s AdVac viral vector and PER.C6 cell line technology, the same as the firm’s Ebola vaccines Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) that this month received Marketing Authorization in Europe.
“The EMA approval is the culmination of work that begun in response to the West Africa Ebola epidemic in 2014… The approval marks the first major regulatory approval of a vaccine developed by Janssen, confirming the potential of our adenovector technology,” J&J CSO Paulus Stoffels said on a Q2 results call yesterday.
Stoffels on clinical development
“We are also planning for a Phase II study in the Netherlands, Spain and Germany and plan to conduct a Phase I study in Japan. We anticipate the initiation of the trial on July 22 in Belgium and the following week in the U.S. We are also in discussions with the National Institute of Health with the objective to start a Phase III clinical trial ahead of its original schedule, potentially in late September, to evaluate the effectiveness of our vaccine. We are using epidemiology data to predict and plan where our study should take place.”
“Our COVID-19 vaccine program is leveraging Janssen’s adenovector technology that provides the ability to rapidly develop new vaccine candidates,” he continued, adding it is also the same platform used to construct J&J/Janssen’s HIV, RSV and Zika vaccine candidates.
Stoffels also said J&J’s pragmatic approach to securing manufacturing capacity will enable the firm to produce over a billion doses if the candidate progresses.
“In parallel with the clinical development, we are working to expand our global manufacturing capacity to be able to deliver more than one billion doses of our COVID-19 vaccine by the end of 2021. We have made excellent progress on this front as well,” he told stakeholders.
As well as J&J/Janssen’s internal manufacturing network, the firm has inked deals with contract development and manufacturing organizations (CDMOs) to secure both drug substance and drug product capacity, including: Emergent BioSolutions, Catalent, and Vibalogics.
“availability of a vaccine will be starting early next year. We’ll have some dosages before the year-end which will be used for clinical trials and maybe for other reasons, but the larger quantity will start first quarter of next year,” said Stoffels.
“We have the manufacturing sites. We have the filling sites. We have everything what’s needed to deliver that one billion vaccines and more next year.”