By Carl O’Donnell and Abhijith G
Aug 10 – Novavax Inc’s manufacturing capacity is sufficient to meet the U.S. demand for COVID-19 vaccines in 2021, which it believes could be as high as 500 million to 600 million doses, company executives said on Monday.
Novavax said last week its experimental vaccine produced high levels of antibodies against the novel coronavirus, according to initial data from a small, early stage clinical trial.
Novavax expects to begin producing vaccine at large scale in the beginning of 2021 and to be able to make “well over” 2 billion doses of its vaccine annually overall if its vaccine is authorized for use by regulators, the executives added during an investor call.
Novavax is still waiting on the U.S. Food and Drug Administration to review data from its early stage study of its vaccine candidate, but has said it expects to start a large Phase III trial as soon as late September.
Novavax research chief Gregory Glenn told Reuters last week the late-stage clinical trial could potentially glean enough data to obtain regulatory approvals as early as December.
Maryland-based Novavax has said its vaccine candidate, NVX-CoV2373, produced higher levels of the antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients and the vaccine was “well tolerated” overall.
“We are seeing a safety profile that in many ways looks like the safety profile of many other vaccines, so it’s not going to prevent the use of the vaccine,” Novavax’s chief financial officer John Trizzino said in an interview.
The Novavax vaccine has received U.S. funding under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.
The U.S. government in July agreed to pay Novavax $1.6 billion to help cover costs related to testing and manufacturing its vaccine, with the aim of procuring 100 million doses by January 2021. (Reporting by Carl O’Donnell in New York and Abhijith G in Bengaluru; Editing by Dan Grebler, Grant McCool and Sonya Hepinstall)