Moderna inks COVID-19 booster supply deals, asks FDA to approve fourth shot for all adults
The deal includes an additional option of 7m doses for delivery in 2023 and 2024.
Those volumes are on top of the 7m doses of the US biotech’s booster vaccine scheduled for supply to Switzerland in the second half of 2022, which the Swiss authorities exercised their option to purchase in December 2021.
On Thursday last week, Moderna revealed that it had also secured an agreement with Japanese officials to supply the Asian country with an additional 70m doses of its booster or an updated booster vaccine candidate, if authorized, with delivery anticipated in the second half of 2022.
Stéphane Bancel, Moderna's CEO, said COVID-19 booster doses will “continue to be instrumental” in keeping infection rates down in communities.
The mRNA therapeutics focused firm also reported that clinical trials are ongoing for its omicron-specific booster (mRNA-1273.529) and a bivalent omicron-specific booster (mRNA-1273.214).
Submission to FDA for fourth shot
Meanwhile, last Friday, Moderna announced it had sought federal approval for a fourth dose of its COVID-19 shot (mRNA-1273) for US adults.
It submitted a request to the US Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine in people, 18 years of age and older, who have received an initial booster of any of the authorized or approved COVID-19 vaccines.
The request to include all adults was made to provide flexibility for the US Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or comorbidities, explained the company.
The submission is based in part on recently published data generated in the US and Israel following the emergence of omicron, according to the filing.
Pfizer and BioNTech said, last week, that they have asked US regulators to authorize a fourth dose of its Covid-19 vaccine booster as well, but, in their case, only for people 65 and older, who are at higher risk of serious illness and death from the virus.
Efficacy of fourth dose
The results of a study, published last week in The New England Journal of Medicine, showed a fourth shot did not provide a substantial difference in levels of protective antibodies against the omicron variant, when compared to a third dose. The study, undertaken by Israeli researchers, involved 800 healthy young care workers.
Commenting on the findings of that paper, Dr Simon Clarke, associate professor in cellular microbiology, University of Reading, said that, unfortunately, these data were only from a cohort of relatively young, healthy people and did not show particularly strong efficacy against infection or someone’s ability to spread the virus. “So, it’s questionable how effective the fourth dose was in this group. The picture may be different however in elderly and clinically vulnerable people.”
Prof Paul Hunter, professor in medicine, University of East Anglia in the UK, also reacted:
“To my mind the implications of this study are that we shouldn’t rush to broaden the roll out of the current plans for a fourth dose in the UK, though I would still progress with what is currently planned for our most vulnerable groups. Hopefully, by the autumn, we will have a better understanding about the potential value of further boosters a year after the third dose. Future roll outs of vaccine boosters on an annual or less frequent basis do need to be proven to have value before being implemented.”
Dr Julian Tang, honorary associate professor/clinical virologist, respiratory sciences, University of Leicester, commented on the study as well, saying if “omicron continues circulating and we are still using the current first generation COVID-19 vaccines against it, then I agree with the authors that the benefits to otherwise healthy, younger people will be marginal – and any fourth dose boosters will be more beneficial to the older and more vulnerable groups (e.g. those with comorbidities).”
New COVID-19 vaccines, designed specifically against omicron, are needed to improve protection for the most vulnerable, in the same way that the seasonal flu vaccine is updated each year to ensure the best possible match against the currently circulating virus strain, he added.