The FDA says Not Necessary for Boosters like Moderna, Johnson & Johnson Plead Case

After a detailed investigation, FDA scientists decided to stop approving Moderna’s vaccine for a booster jab, the latest bad news for the company’s depth. Documents published on Tuesday show that a course of Moderna’s two -dose vaccine can generate enough resistance from the virus and the distinct delta that a third dose is “unnecessary”.

The decision makes it possible for the agency to approve Pfizer for a booster jab but not Moderna.

Moderna submitted its data to the FDA’s Vaccines and Biological Products Identification Committee requesting approval of a booster jab for most adults. The biotech upstart, which has become famous thanks to the mRNA technology that supports the most famous COVID jabs, argues that the resistance provided by its jabs increases over time, with several studies showing that resistance started early at the nearly six -month mark. Some studies suggest that natural resistance is more effective than immunity from jabs.

In the report, the FDA said “… Data show that currently licensed in the United States or authorized COVID-19 vaccines still provide protection against severe COVID-19 disease and mortality in the United States. There are many potentially related studies, but the FDA has not independently reviewed or confirmed the underlying data or their conclusions. ”

After detailing all the studies done to test and evaluate the safety of the booster jab, which is when it increases the risk of heart inflammation in men, a remarkable effect has been documented in mRNA jabs, the FDA said. believing it to be the booster safe.

“In adults 18 to 64 years of age, other than axillary inflammation or tenderness of the vaccination arm (showing lymphadenopathy), the requested safety data showed no evidence of increased frequency or severity of local or systemic reactions after dose augmentation… “

While documents released by the FDA on Tuesday show the agency is unlikely to recommend a booster jab – for now, at least – the advisory committee will still meet to discuss the proposal Thursday.

In September, the FDA granted emergency clearance for the third-dose booster vaccine Pfizer-BioNTech with a two-shot vaccine for older people, as well as patients who are at greater risk, or who are at risk because of their work. .

But the news isn’t bad for Moderna: Earlier this month, an EU drug regulator listed booster jabs of Moderna’s vaccine, as well as two -dose shots of Pfizer, for vulnerable patients, even if EU-based decision on patients whose resistance is weakened due to organ transformation.

J&J just asked the FDA for approval of a booster jab for adults 18 and older, and both Moderna and J&J insisted they had collected enough data to show that a booster jab was necessary. justification for the majority of the population.

That would be the worst consequence for them, at least.

Readers will see the briefing documents HERE.

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