Manufacturing “at risk” allows the world’s third largest pharmaceutical company to produce a product before its ultimate design is finalized and released to the public. The company plans to produce its COVID-19 vaccine in the Netherlands, and a facility it is updating in the United States.
“We're manufacturing at risk to ensure that should the clinical development and the trials be successful, we are in a position to kind of flip the switch and ready to go, to create great access across the globe,” J&J CFO Joe Wolk told Yahoo Finance in an interview.
J&J began developing its vaccine for COVID-19 in early January with its European subsidiary Janssen Vaccines & Prevention B.V. It’s using the same biological platform Janssen uses in developmental vaccines for Ebola, Zika and Influenza.
During J&J’s first quarter earnings call, Chief Scientific Officer Paul Stoffels said the company is also negotiating with partners in Europe and Asia to produce the vaccine, and partnerships will be announced in the coming weeks.
“Our goal is to enable the supply of more than 1 billion doses of the vaccine globally,” Stoffels said.
Vaccine eyes early 2021 rollout
J&J entered into a $1 billion partnership with the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture the vaccine.
Wolk says the timeline is pretty certain. “We plan to be first in human testing sometime in early September. Should things progress, we would have data read out in December and that would hopefully lead to an approval the early part of 2021,” he added.
Meanwhile, Stoffels said emergency use authorization for the vaccine could come at the start of next year.
‘It’s for all of us’
Despite the risks, J&J expressed confidence in the vaccine’s effectiveness, based largely on what Stoffels said was “good data in animal models.”
Stoffels said the COVID-19 vaccine candidate is using Janssen Vaccine platforms, which already meet World Health Organization (WHO) key attributes for a successful vaccine. Those include proof of long lasting cellular immunity, low to no risk of enhanced respiratory disease and a well tolerated safety profile.
“More than 50,000 people have been vaccinated” with the base Janssen Vaccine platform according to Stoffels, “and we have demonstrated that it is well tolerated.”
Once approved for use, the vaccine will be produced as a not for profit inoculation, according to J&J.
“It's for all of us,” Wolk said. “It's anything but business as usual. That is about advancing research and development.”
Reference: Yahoo News
