Stéphane Bancel, Chief Executive Officer of Moderna, said he anticipates more durable protection against variants of concern with mRNA-1273.214, making it the lead candidate for a Fall 2022 booster.
“We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer,” said Bancel.
The US Food and Drug Administration (FDA) is to hold a meeting on June 28 to discuss whether COVID-19 vaccine compositions should be modified for Fall 2022.
“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,” said Moderna’s president Dr. Stephen Hoge.
If the FDA approves this vaccine, the booster could be ready in August.
“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 believe strongly that this data supports an update of the vaccine from the sequence that we’ve been using from years ago,” said Hoge.
FDA officials said the original Moderna COVID-19 vaccines may be swapped with the booster doses since they are showing more protection and have shown to be stronger against all the new variants.
“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.
Dr. Paul Burton, Moderna’s chief medical officer, said the protection of this upgraded booster could last up to a year, which means people might only need an annual booster shot.
“The data is definitely better than I had even hoped,” said Burton. “Given the magnitude of effect — that seven-fold increase in antibody levels — we could for the first time, be at a vaccine that is truly effective with once yearly dosing because we know those antibody levels will decay.”
Given the fact that this could mean only one booster dose a year, will make people feel a little at ease knowing they have that protection for a year. Also, knowing that this booster does not only protects against COVID-19, but against all the other variants.
“I believe that we will be able to get to this once yearly dosing now because we have high levels now. That will probably even increase and mature over time, potentially giving people protection over a full year. We could finally get to that once yearly protection, so I think it’s really important,” said Burton.