In hopes of a late-stage COVID-19 vaccine candidate hitting the 50% efficacy threshold set by the U.S. Food and Drug Administration, U.S. drugmakers who have partnered with the U.S. government could begin to manufacture doses of a preventative treatment by the end of summer, Reuters reported.
An unnamed U.S. official told the news agency that vaccine manufacturing under development in conjunction with the federal government’s Operation Warp Speed program is likely to begin within the next four to six weeks – although no vaccine for the novel coronavirus has yet to be approved by the FDA. The government has been procuring the raw materials and equipment needed to manufacture hundreds of millions of vaccine doses, the official told Reuters. Operation Warp Speed was initiated to ensure massive numbers of doses would be available against COVID-19 by the end of the year to begin inoculating U.S. citizens. By the end of 2021, Operation Warp Speed has the goal of providing more than 300 million doses of a vaccine.
Although no vaccine candidate that is part of Operation Warp Speed has made it through Phase III clinical testing, the U.S. official told Reuters that results from trials that are set to begin this month could be known in a matter of weeks, which is why it’s imperative to be able to begin manufacturing at a large scale. In the interview with Reuters, the U.S. official did not indicate which vaccine candidate was seen as a front-runner for additional manufacturing support. It’s likely that things are being set in place to support whichever program is the first to read out with positive data that will meet the FDA’s 50% threshold for vaccine approval.
Operation Warp Speed has provided billions of dollars to companies to support the development of several vaccine programs, including Moderna’s mRNA vaccine candidate, as well as Johnson & Johnson’s candidate and the preventative medication under development by AstraZeneca and the Jenner Institute at Oxford University. Last week, Operation Warp Speed provided Maryland-based Novavax with $.16 billion in funding to advance its vaccine candidate, NVX‑CoV2373.
Moderna announced earlier this month that its Phase III trial would be delayed until the end of July. The company had initially planned to already be in Phase III, but that was delayed due to squabbles with U.S. scientist over trial protocols and directives on how to run the study, Reuters reported this week. Part of that appears to be due to the fact that government scientists expressed concern that Moderna has not run a trial of this size before and lacks the staff and expertise to do so, according to the report. Still, the trial is expected to begin before the end of the month with data expected after Thanksgiving.
AstraZeneca announced last month that it planned to manufacture two billion doses of its vaccine, with 400 million slated for the U.S. and UK, and one billion allotted for low- and middle-income countries.