Moderna announced new data on Wednesday suggesting a new version of its COVID-19 vaccine will offer superior protection to its original formulation of shots, based on studying antibodies generated by their new boosters in blood samples of trial participants.
The company said in to release that it plans to submit its data to the Food and Drug Administration in the coming weeks. If the FDA signs off, doses of the updated vaccine and boosters could be ready to ship “as early as August.”
Moderna’s announcement comes ahead of a meeting of the regulator’s outside vaccine advisers, scheduled for later this monththat will weigh key decisions around potential changes to COVID-19 boosters that may be administered this fall.
“As we look to the fall infection season with respiratory viruses, with SARS-CoV-2, and the ongoing circulation of Omicron and its subvariants, we strongly believe that this data supports an update of the vaccine from the sequence that we’ve been using since years ago,” Moderna’s president Dr. Stephen Hoge told investors on Wednesday.
Moderna’s data comes from testing a 50 microgram “bivalent” version of its vaccine. Unlike the current “monovalent” version of the vaccine, which was designed to target the original “ancestral” strain of the virus, Moderna’s new booster doses will add in a version of its vaccine targeted to the Omicron variant.
The company also said the booster “was generally well-tolerated, with side effects comparable to a booster” of its original vaccine at the same size.
Moderna did not announce data showing how the higher antibodies generated by its bivalent vaccine might translate into actual effectiveness against the virus. However, the company said it was optimistic its findings will be sufficient to meet guidelines laid out by the FDA for allowing updated shots.
“We have obviously been engaged with regulators globally, including the FDA in the United States, about the criteria for this study since the early part of this year. And have reviewed those protocols and designed the study to meet that guidance,” Hoge said.
Pfizer and its partner BioNTech also say they are testing new versions of their COVID-19 vaccine. The FDA has asked to see those results ahead of the meeting of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) later this month.
Regulators have so far been wary of prematurely authorizing a change to the shots, citing the possibility that the onslaught of new variants could render the strategy futile — outrunning decisions to dump the current vaccine supply with only marginal improvements.
But, federal health officials have said they hope a bivalent approach might offer broader protection. The mix of vaccines might guard against not just Omicron but also future variants of concern that are expected to drive a fall and winter wave of infections.
Moderna’s executives said Wednesday that the company has already been working to scale up manufacturing of components that will be needed for the new booster.
“We are confident that through the next several months of hard work, we will be able to supply substantial, large amounts of the updated bivalent booster. Hopefully sufficient to meet all demand that’s out there for this updated vaccine through the fall season,” he said Hoge.
FDA officials have previously said that they expect greenlighting a “booster strain change” to the COVID-19 vaccines will likely mean swapping out the shots not just for booster doses but also the primary series that is offered to any adults who are still unvaccinated.
Moderna’s executives told investors that they are also preparing to study the updated shots in children as well, but noted that it was possible the FDA might not need those studies in order to greenlight an update for the supply of doses in all ages.
They cited the current process for deciding on updates to the US stock of flu shots, which do not rely on specific studies to greenlight changes in different age groups.
Currently, only the shots from Pfizer-BioNTech are authorized for any Americans on June 14 and 15.. Moderna’s request to allow vaccination with a smaller dose of its original vaccine is expected to go before the FDA’s advisory committee, VRBPAC,
“It’s important that, before we go too far down the path of deciding that data is necessary, we do need to hear from regulators, including the FDA in VRBPAC next week,” said Hoge.