Moderna announced new data on Wednesday suggesting that a new version of its COVID-19 vaccine will offer superior protection to its original vaccine formulation, based on studying the antibodies generated by their new boosters in blood samples from participants in the test.
The company said in a statement that it plans to submit its data to the Food and Drug Administration in the coming weeks. If the FDA approves, 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 external vaccine advisers, scheduled for later this month, that will weigh in on key decisions about potential changes to COVID-19 boosters that could be administered this fall.
“As we look to the fall infection season with respiratory viruses, with SARS-CoV-2, and the continued circulation of Omicron and its subvariants, we strongly believe that these data support a vaccine update from the sequence we were used years ago,” Moderna Chairman 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 a version of its vaccine targeted at 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 has not announced 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 that its findings would be sufficient to meet guidelines set by the FDA to allow updated shots.
“We have obviously been engaged with regulators around the world, including the FDA in the United States, on the criteria for this study since the beginning of this year. And we have reviewed those protocols and designed the study to meet those guidelines,” Hoge said.
Pfizer and its partner BioNTech also say they are testing new versions of their COVID-19 vaccine. The FDA asked to see those results before the FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC) meeting later this month.
So far, regulators have been wary of allowing vaccines to be changed prematurely, citing the possibility that the onslaught of new variants could render the strategy futile – overriding decisions to empty the current vaccine supply with only improvements. marginal.
But federal health officials said they hoped a bivalent approach could offer broader protection. The vaccine mix could protect not only Omicron, but also future variants of concern that are expected to drive a surge of infections in the fall and winter.
Moderna executives said Wednesday that the company is already working to ramp up manufacturing of the components that will be needed for the new booster.
“We are confident that over the next few months of hard work, we will be able to supply substantial and large quantities of the updated bivalent booster. Hopefully these will be sufficient to meet all the demand that exists for this vaccine. updated throughout the fall season,” Hogé said.
FDA officials have previously said they expect the green light of a “booster strain change” for COVID-19 vaccines will likely mean swapping shots not just for booster doses. , but also the first series offered to all adults who are still not vaccinated.
Moderna executives told investors they were also preparing to study the updated injections in children, but noted that the FDA may not need those studies to give the go-ahead. an update for the provision of doses to all ages.
They cited the current process for deciding on updates to the US stockpile of flu vaccines, which does not rely on specific studies to give the green light to changes in different age groups.
Currently, only Pfizer-BioNTech vaccines are licensed for all Americans. Moderna’s request to authorize vaccination with a smaller dose of its original vaccine is scheduled to be presented to the FDA’s advisory committee, VRBPAC, on June 14-15.
“It’s important that before we go too far down the road of deciding that data is needed, we need to hear from regulators, including the FDA at VRBPAC next week,” Hoge said.