Moderna has released new Wednesday data showing that the revised COVID-19 shot offers better safety than the original formulation. This was based on the study of antibodies made by new boosters using blood samples from trial representatives.
According to a company release, it stated in a statement that it will submit its data in the coming days to the FDA. The FDA may approve that the doses of boosters and vaccines can be shipped from August.
Moderna’s announcement was made before a meeting with the regulator’s outside vaccine consultants. The meeting will take place later in the month. This meeting will discuss important decisions about possible modifications to COVID-19 boosters which could be administered in the Fall.
Moderna’s president Dr. Stephen Hoge stated to investors that “as a fall infection season, with respiratory viruses such as SARS-CoV-2 and the continued circulation of Omicron,” he believed strongly that these data support a new vaccine from the same sequence that Moderna has been using since years ago.
Moderna’s data was derived from the testing of a 50-microgram, “bivalent,” vaccine. Moderna will now offer booster doses to target Omicron versions of the vaccine, instead of the monovalent current version.
The booster was said to be “generally well tolerated” and that side effects were comparable to those of the original vaccine booster.
Moderna didn’t release data that would show how higher levels of antibodies from its bivalent vaccine could translate into virus resistance. The company expressed optimism that its results would be sufficient to comply with FDA guidelines for allowing new shots.
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“We have been in constant contact with regulators all over the world, including FDA in America, about the criteria for this study since the start of the year. Hoge stated they reviewed the protocols, and that the study was created to conform to those guidelines.
BioNTech and Pfizer, its partner, also indicated that they are now testing new versions for their COVID-19 vaccine. The food and Drug Administration requested these results in advance of meeting the FDA’s Vaccines and Related Biological Products Advisory Committee meeting this month.
The regulators have been cautious about authorizing changes to the shots too soon. They cite the possibility of new variants making the strategy ineffective. This could be a reason for avoiding decisions to eliminate the existing vaccine supply.
Federal officials believe that a multivalent approach might offer more protection. The combination of vaccines may not only protect Omicron but also future variants which could lead to a fall-and-winter wave of infectious diseases.
Moderna administrators spoke Wednesday to say that they are already working to increase the manufacturing of components required for the new booster.
“We believe we can provide large quantities for the updated bivalent boost in the coming months. This is due to our hard work. Hoge claimed that the updated vaccine will meet all requirements through the fall season.
Food and Drug Administration officials previously stated that they anticipate greenlighting a “booster-strain change” to COVID-19 vaccines. This will likely mean that the shots are not only being offered for booster doses, but also the primary series to adults still unvaccinated.
Moderna administrators informed investors that they also plan to study the updated shots to be given to children. However, it is possible that the FDA might not require such studies to approve the update of the supply of doses to all ages.
They also referred to the current procedure of updating the U.S. flu shot stock, which does not rely on specific studies that would approve changes in different age groups.
Pfizer BioNTech shots are now approved for Americans below 18 years old. VRBPAC will review Moderna’s request that children aged under 18 can receive lower doses of the original vaccine. It is expected to arrive at them on June 14th and 15.
Hoge stated, “It is important that we hear from regulators before we move too far down that path of deciding that data are necessary,”