The mRNA will be sent to another Pfizer facility in Kalamazoo, Michigan. That facility makes the lipid nanoparticles that coat the mRNA and protect it from enzymes in the body that degrade it. Kalamazoo also has vaccine vial-filling operations.
South of Boston, Moderna’s Norwood, Massachusetts facility has clean-room suites for making mRNA and the lipid nanoparticles that coat the fragile genetic material. Formerly owned by Polaroid, the factory is the vaccine maker’s first and has been rapidly scaling up since the pandemic began.
In 2020, it took Moderna 42 days to produce batches of its original Covid vaccine and 63 days to start human trials with government researchers. With omicron, “our goal is to hit a timeline like that for sure” Hoge, the Moderna president, said.
One reason that both Pfizer and Moderna can move quickly with omicron is that they have the honed the process with both the original vaccines as well as variant vaccines for beta and delta strains the companies produced earlier this year. While the delta and beta variant vaccines may not be needed, it provided a dry run for omicron.
Even after the vials of vaccine are filled and finished, uncertainties loom, starting with what human trials regulators will require, if any. The FDA’s current guidance, which the agency reiterated in an email, calls for immunogenicity trials to compare the human immune response to virus variants induced by the modified vaccine against the response to the authorized vaccine.
But Pfizer research head Mikael Dolsten says the company is exploring whether, in an emergency, it could obtain clearance without the omicron-specific trials. The agency may allow the drugmakers to submit human data from other variant-specific vaccines that show its approach is likely to be successful.
The FDA declined to comment on ``confidential discussions with vaccine developers.’’ It said it encourages them to reach out early and often to discuss clinical data needed for new vaccines to help fight Covid.
Should fresh trials of immune response to the booster be required, they would likely involve a few hundred people and take a couple months to complete, Moderna’s Hoge said. “Ultimately, the FDA has to tell us what they want,” he said.
Another question is how quickly omicron expands outside of South Africa. The strain appeared at a time when the country’s caseload was quite low -- there wasn’t that much competition from other variants. In a best-case scenario, the new strain might be outspread by delta in most countries and gradually fade away.
In the meantime, though, the drugmakers can’t bank on that possibility. Pfizer plans to have the new doses ready by February or early March, Dolsten said.
This article was provided by Bloomberg News.