The American biotech firm previously announced plans to apply in the second quarter, but a delay in getting manufacturing data involving quality, consistency, and stability tests for manufacturing and storage of vaccine has pushed back the timeline, Erck said.
“The hard part of the regulatory filings for us right now is getting all the manufacturing data put together, getting all the very complex biologic assays that we have to do developed — they have to be qualified and then validated, which are two sequential processes, and it’s just taking us longer than we wanted,” Erck told CNN.
“I don’t believe we’re going to be able to make it by the end of June. Therefore we have to push off the guidance until third quarter,” Erck said. “Obviously, it will be in everybody’s benefit for us to get it done as early in the third quarter as possible, but we’re not putting a date on it right now.”
Erck said that the company is currently “stockpiling inventory” and has made “tens of millions of doses” of its vaccine, which is administered as two injections, 21 days apart.
US Phase 3 trial results expected ‘in a few weeks’
Currently, three vaccines have emergency use authorization in the US — those made by Moderna, Pfizer/BioNtech and Johnson & Johnson’s Janssen vaccine arm.
“We’re still unblinding in the second quarter — that hasn’t changed. It’s just not in April, obviously, and so it’ll be in a few weeks,” Erck said in Monday’s phone interview.
The new timeline “gives us the ability to count more cases,” Erck said. “It gives us a bit more robust data, hopefully, and allows us to catch more severe events, and also take a closer look at what variants were infecting our population.”
Erck added that the trial data will reveal the efficacy level of the vaccine in the United States and Mexico as well as which variants were circulating at the time of the trial and what the efficacy of the vaccine will be against those variants.
‘The booster for everyone’
In the United States, Novavax’s coronavirus vaccine could be used as a booster shot later this year for people who have already been vaccinated against Covid-19, Erck said.
“In the US, I think it will be the booster for everyone, particularly if we get it out late in the third quarter,” Erck said in the phone interview. “It’s going to be time to start boosting — whether it’s six months or at a year point.”
Currently, the US Centers for Disease Control and Prevention says vaccine types and brands are not interchangeable for the initial immunization, and there has been no decision either in the US or globally on the need for booster doses yet, let alone which vaccine might be appropriate for any booster.