Moderna announced new data on Wednesday that suggests a new version of its COVID-19 vaccine will offer superior protection over its original injection formulation, based on testing antibodies generated by their new boosters in blood samples from participants. the test.
The company said in a statement that it plans to provide its data to the Food and Drug Administration in the coming weeks. If the FDA signs, doses of the updated vaccine and boosters may be ready for delivery “in August at the earliest.”
Moderna’s announcement comes ahead of a meeting of the vaccine regulator’s external advisers later this month, which will weigh key decisions on potential changes to COVID-19 boosters that could be implemented this fall.
“As we look at the autumn season of respiratory infections, SARS-CoV-2 and the continued circulation of Omicron and its sub-variants, we strongly believe that these data support updating the vaccine from the sequence we have been using for years,” he said. of Moderna Dr. Stephen Hoge in front of investors on Wednesday.
Moderna’s data comes from testing a 50 microgram “bivalent” version of her vaccine. Unlike the current “monovalent” version of the vaccine, which is designed to target the original “native” strain of the virus, Moderna’s new booster doses will add a version of its vaccine that targets the Omicron variant.
The company also said the booster was “generally well tolerated, with side effects comparable to the booster” of the original vaccine of the same size.
Moderna has not released data showing how higher antibodies generated by its bivalent vaccine could be effective against the virus. However, the company said it was optimistic its findings would be enough to meet the FDA’s guidelines for allowing updated photos.
“Obviously we are committed to regulators worldwide, including the FDA in the United States, on the criteria for this study from the beginning of this year. And we reviewed these 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 vaccine against COVID-19. The FDA asked to see these results before a meeting of the FDA’s Advisory Committee on Vaccines and Related Organic Products (VRBPAC) later this month.
So far, regulators have feared allowing early changes to vaccines, citing the possibility of new options rendering the strategy useless – ahead of decisions to discard current vaccine supplies with only minor improvements.
But federal health officials said they hoped a bivalent approach could offer broader protection. The combination of vaccines can protect not only from Omicron, but also from future options of concern, which are expected to cause a wave of autumn and winter infections.
Moderna executives said Wednesday that the company is already working to increase production of 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 deliver significant, large quantities of the updated bivalent booster. We hope that they are enough to meet the whole demand for this updated vaccine during the autumn season, “Hoge said.
FDA officials have previously said they expect the green light to “change the booster strain” of vaccines against COVID-19 is likely to mean replacing vaccines not only with booster doses, but also the primary series available to all adults who have not yet been vaccinated.
Moderna executives told investors that they are also preparing to study the updated photos in children, but noted that the FDA may not need these studies to give the green light for an update on dose delivery for all ages.
They cite the ongoing decision-making process for updates to the US stockpile of influenza vaccines, which do not rely on specific studies for green changes in different age groups.
Currently, only Pfizer-BioNTech vaccines are approved for all Americans under 18 years of age. Moderna’s request to allow the vaccination of children 6 months of age with a lower dose than the original vaccine is expected to be addressed to the FDA’s advisory committee, VRBPAC, on June 14 and 15.
“It’s important that before we go too far on the road to decide that the data is needed, we need to hear from regulators, including the FDA at VRBPAC next week,” Hoge said.
More Alexander Tin
CBS News reporter covering public health and the pandemic.
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