Moderna insists on offering COVID-19 booster supply, asks FDA to approve fourth shot for all adults
The agreement includes an additional option of 7 million doses for delivery in 2023 and 2024.
These amounts are on top of the 7 million doses of the US biotechnology booster vaccine scheduled for delivery to Switzerland in the second half of 2022, which the Swiss authorities exercised their option to purchase in December 2021.
It followed the announcement Thursday last week that Moderna has secured an agreement with Japanese officials to supply this country with another 70 million doses of its booster or an updated booster vaccine candidate, if approved, with delivery expected in the second half of 2022.
Stéphane Bancel, Moderna’s CEO, said COVID-19 booster doses will “continue to be instrumental”to keep the infection rate down in communities, as the company also reported that clinical trials are underway with 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 revealed that it was seeking federal approval for a fourth dose of its COVID-19 shot (mRNA-1273) to U.S. adults; it submitted a request to the US Food and Drug Administration (FDA) for an amendment to the Emergency Use Authorization (EUA) to allow a fourth dose of its COVID-19 vaccine for adults 18 years and older who have received a first dose booster of any of the approved or approved COVID-19 vaccines.
The request to include adults over the age of 18 was made, it said, to provide flexibility to the U.S. Centers for Disease Control and Prevention (CDC) and health care providers to determine the appropriate use of an additional booster dose of mRNA-1273, incl. for those at higher risk for COVID-19 due to age or comorbidities.
The submission is based in part on recently released data generated in the US and Israel following the advent of Omicron, according to the filing.
Unlike Moderna, Pfizer and BioNTech announced last week that they have asked U.S. regulators to also approve a fourth dose of their Covid-19 vaccine booster, but in their case only for people 65 and older who are at higher risk. to get serious illness and death as a result of COVID.
The effectiveness of the fourth dose,
The results of a study published last week in New England Journal of Medicine,,, Showed that a fourth shot did not make a significant difference in levels of protective antibodies to the omicron variant compared to a third dose. The study, conducted by Israeli researchers, involved 800 healthy young nursing staff.
In a comment on the results of this paper, Dr. Simon Clarke, associate professor of cellular microbiology, University of Reading, said that these data were unfortunately only from a cohort of relatively young, healthy people and did not show a particularly strong effect against infection or anyone’s ability to spread the virus. “So it is doubtful how effective the fourth dose was in this group. However, the picture may be different in elderly and clinically vulnerable people. “,
Prof Paul Hunter, Professor of Medicine, University of East Anglia in the UK, also responded:
“In my view, the implications of this study are that we should not rush to expand the rollout of current plans for a fourth dose in the UK, although I would still make progress on what is currently being planned for our most vulnerable. “Hopefully by the autumn we will have a better understanding of the potential value of additional boosters one year after the third dose. Future rollouts of vaccine boosters on an annual or less frequent basis should be proven to be valuable before they are implemented.”,
Dr. Julian Tang, Honorary Lecturer / Clinical Virologist, Respiratory Science, University of Leicester, also commented on the study, saying if “Omicron continues to circulate, and we still use the current first generation of COVID-19 vaccines against it, so I agree with the authors that the benefits for otherwise healthy, younger people will be marginal – and every fourth dose of boosters will be more beneficial for the older and more vulnerable groups (e.g. those with comorbidity).,
New COVID-19 vaccines, designed specifically against Omicron, are needed to improve protection for the most vulnerable, just as the seasonal flu vaccine is updated every year to ensure the best possible match against the currently circulating virus strain, he added.