J&J Charges the US Government $10 Per Coronavirus Vaccine
The U.S. Department of Health and Human Services (HHS) and Department of Defense announced an agreement with the Janssen Pharmaceutical Companies of Johnson & Johnson, to demonstrate large-scale manufacturing and delivery of the company's COVID-19 vaccine candidate, known as Ad26.COV2-S.
Under the terms of the agreement announced on August 5, 2020, the US government will own the resulting 100 million doses of vaccine and will provide approximately $1 billion to support the manufacturing demonstration project including the ability to deliver vaccine doses to government-designated locations across the country.
If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost.
The US government also can acquire additional doses up to a quantity sufficient to vaccinate 300 million people.
The vaccine doses could be used in clinical trials or, if the U.S. Food and Drug Administration (FDA) authorizes use as outlined in agency guidance, the doses would be distributed as part of a COVID-19 vaccination campaign.
HHS Secretary Alex Azar said in a press statement: "Today's investment represents the next step in supporting Janssen's vaccine candidate all the way through manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people."
This manufacturing demonstration project will take place while clinical trials are underway. Working in parallel this way expedites the traditional vaccine development timeline. This step builds toward the U.S. government's Operation Warp Speed goal to begin delivering millions of doses of safe and effective vaccines to the American people by the end of the year.
The vaccine project announced today includes fill-finish manufacturing in U.S.-based facilities. This fill-finish manufacturing step ensures vaccine doses are packaged and ready to ship immediately, subject to successful clinical trials and FDA authorization.
As is customary with US government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
To date, BARDA has provided approximately $456 million for clinical trials and other vaccine development activities under an existing, long-term partnership with Janssen. The company's investigational vaccine relies on Janssen's recombinant adenovirus technology, AdVac, a technology used to develop and manufacture Janssen's Ebola vaccine with BARDA support.
This Janssen Ebola vaccine received European Commission approval and was used in the Democratic Republic of the Congo and Rwanda during the recent 2018-2020 Ebola outbreak.
The goal of this two-dose vaccination approach, (Zabdeno (Ad26.ZEBOV), Mvabea (MVA-BN-Filo), is to induce long-term immunity against Ebola Virus Disease.
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.
Precision Vaccinations publishes coronavirus vaccine development news.