Clinical trials using Omicron-specific vaccinations are now underway, but no data on human participants has been released. Meanwhile, the FDA wants to move COVID vaccines to a flu like model.
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Officials from the Food and Drug Administration (FDA) have suggested a future paradigm for producing new COVID-19 vaccinations based on the method used to produce influenza vaccines.
The existing COVID-19 vaccinations, which are based on a virus strain that is now many generations old, “may need to be updated at some point to ensure the high level of efficacy demonstrated in the early vaccine clinical trials,” according to the FDA.
One source of concern is the constant emergence of new SARS-CoV-2 strains, some of which circumvent vaccine protection better than others. COVID-19 is caused by SARS-CoV-2, commonly known as coronavirus.
The vaccines provides almost zero protection against infection by Omicron, the variant that is currently prevalent in the United States, yet they have proven to be effective against severe disease.
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According to US authorities, an organized and open approach for modifying the formulation of COVID-19 vaccinations ought be established, with the method preferably being followed by nations throughout the globe in addition to the WHO (WHO).
Officials think the procedure can be aided by the framework in place for updating influenza vaccines on an annual basis.
“The strain selection process for determining the composition of seasonal influenza vaccines may provide a general outline for the approach needed for updating the composition of COVID-19 vaccines to address current and emerging SARS-CoV-2 variants,” the FDA said.
The influenza vaccination model works by forecasting which variations will be prevalent in the future. WHO is in charge of the initiative, voting on the vaccine formulation to be used in the northern hemisphere in five to six months and the southern hemisphere in three to four months.
The WHO’s recommended composition is frequently used by US authorities, while the FDA, in collaboration with its expert advisory council on vaccinations, occasionally deviates from the recommendation.
Whereas the flu model can be used as a basis for future COVID-19 vaccines, FDA officials say there are some distinctive concerns with COVID-19 that will have to be acknowledged, including how the seasonal trend for SARS-CoV-2 outbreaks has yet to be established; how COVID-19 vaccines are constructed all over various systems, such as messenger RNA; and how prior experience with those vaccines would not be enough to get authorization or approval without clinical trial data.
Furthermore, even the best-matched flu vaccines are only about 60% effective, a figure that some vaccine producers have criticized.
According to John Moore, a professor of immunology at Weill Cornell Medicine, the suggested change to a flu-like paradigm incorporates “a lot of assumptions.”
Clinical trials using Omicron-specific vaccinations are now underway, but no data on human participants has been released. Animal studies, which are “usually pretty predictive,” Moore added, “do not support the use of that specific vaccine as a boost.” “So if that’s going to be the case in the humans, why go through the complexity of introducing a new vaccine if it’s not needed?”
A briefing document released before of an April 6 conference advocated the new approach. FDA authorities will address several aspects connected to COVID-19 vaccines with the agency’s expert advisers during the meeting. This includes the best use of further COVID-19 doses in the future.
The FDA recently approved fourth doses for millions of Americans without consulting advisers, continuing a trend of diminishing their influence.
Dr. Kanta Subbarao, a WHO official, will speak about the COVID-19 vaccine formulation, and Robert Johnson, a government official, will speak about the creation of variant-specific vaccinations.