Moderna announced new data on Wednesday suggesting that a new version of its COVID-19 vaccine will offer superior protection over its original vaccination formulation, based on the study of antibodies generated by its new enhancers in blood samples. of the trial participants.
The company said in a statement that it plans to send its data to the Food and Drug Administration in the coming weeks. If approved by the FDA, the updated vaccine doses and boosters could be ready to be shipped “as soon as August.”
Moderna’s announcement comes ahead of a meeting of the regulator’s external vaccine advisers, scheduled for later this month, which will weigh key decisions on possible changes to COVID-19 reinforcements that could be administered this fall.
“As we look at the season of respiratory virus infection, with SARS-CoV-2 and the ongoing circulation of Omicron and its sub-variants, we firmly believe that these data support a vaccine update from of the sequence we’ve been using for years, “Moderna president Dr. Stephen Hoge told investors Wednesday.
Moderna’s data comes from testing a 50-microgram “bivalent” version of her 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 aimed 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 of the same size.
Moderna did not announce data showing how the higher antibodies generated by its bivalent vaccine could translate into real effectiveness against the virus. However, the company said it was optimistic that its findings would be sufficient to comply with FDA guidelines to allow for updated features.
“Obviously, we’ve been engaged with regulators worldwide, including the U.S. FDA, on the criteria for this study since the beginning of this year. And we’ve reviewed these protocols and designed the study to meet that guidance.” , said Hoge.
Pfizer and its partner BioNTech also say they are testing new versions of their COVID-19 vaccine. The FDA has requested to see these results before the meeting of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) later this month.
So far, regulators have been wary of allowing a premature change to injections, citing the possibility that the attack of new variants could render the strategy useless, overcoming decisions to dump the current supply of vaccines with only improvements. marginal.
But federal health officials have said they expect a bivalent approach to offer broader protection. The combination of vaccines could protect not only Omicron, but also future variants of concern that are expected to drive a wave of infections in the fall and winter.
Moderna executives said Wednesday that the company has already been working to increase the manufacture of components that will be needed for the new reinforcement.
“We are confident that over the next few months of hard work, we will be able to supply substantial and large amounts of the updated bivalent booster. We hope it will be enough to meet all the demand for this updated vaccine during the fall season,” he said. Hoge.
FDA officials have previously said they hope giving the green light to a “change of strain strain” on COVID-19 vaccines will likely mean changing vaccines not only for booster doses, but also for the primary series that is offered to any unvaccinated adult.
Moderna executives told investors that they are also preparing to study updated injections in children as well, but noted that the FDA may not need these studies in order to give the green light to an update for dose delivery. at all ages.
They cited the current process for deciding on US flu vaccine stock updates, which are not based on specific studies to give the green light to changes in different age groups.
Currently, only Pfizer-BioNTech injections are authorized for Americans under the age of 18. Moderna’s request to allow vaccination of children up to 6 months with a smaller dose of their original vaccine is expected to be before the FDA’s advisory committee, VRBPAC, on June 14 and 15.
“It’s important that before we go too far down the path of deciding that data is needed, we need to listen to regulators, including the FDA at VRBPAC next week,” Hoge said.
More Alexander Tin
CBS News reporter covering public health and pandemic.