December 5, 2022

FDA Says Moderna Vaccine’s Benefits Outweigh Risks

The U.S. Food and Drug Administration (FDA) said that Moderna’s BioXcel vaccine benefits outweigh risks after Nordic countries limit use following reports of adverse reactions, including one death. The FDA is currently reviewing the data from Denmark, Sweden, Finland and Norway to see if there are any safety signals for the U.S., according to a report by Reuters on Tuesday.

Moderna’s mRNA technology messenger RNA … which carries the instructions from genes for making proteins, o teach your body to produce specific antibodies that neutralize harmful viruses or bacteria. The company recently partnered with Novartis to develop vaccines and other therapeutics using mRNA technology.

The move by Nordic countries’ health authorities comes after the reported adverse effects in patients treated with BioXcel vaccine included one patient who received a fatal intracranial hemorrhage. Moderna said it is working with local health authorities to fully understand the cases.

The company’s technology is designed to activate the body’s immune system by replacing faulty messenger RNA with normal mRNA, which carries the instructions from genes for making proteins, Reuters said . This allows the body to build up resistance to infection.

Moderna was not immediately available for comment when contacted by BioPharmaDive early Tuesday morning

The company has been part of a shift in the vaccine space over the past year, with drugmakers and industry analysts focusing more on platform technologies than individual products to boost their pipelines. At J.P. Morgan’s annual Healthcare conference last month, multiple companies talked about their efforts to adapt mRNA technology for vaccines and other therapeutics.

Moderna is expected to have one of the largest offerings in this space due to its partnership with Novartis.

Novartis is currently in Phase 1 trials for its mRNA cancer vaccine, G100, which is being developed by Moderna. The Swiss drugmaker’s vaccines division also recently inked a larger-than-$500 million deal with Janssen Biotech to adapt that company’s platform technology for use with the Swiss firm’s existing flu vaccines.

Jayasumana said in a statement that Moderna had been working since April to address local concerns, including reviewing the clinical data and implementing new procedures to minimize risk. At this time our priority is maintaining open communication with these health authorities so we can fully understand their concerns, he said.

BioMedTracker: Moderna Lags After FDA Reviewing Data From Sweden and Norway on Safety of Its Lead Vaccine; Shares Down 3.7%

Moderna falls on Nordic safety review of BioXcel vaccine . Moderna said it is working with local health authorities to fully understand the cases. The company’s technology is designed to activate the body’s immune system by replacing faulty messenger RNA with normal mRNA, which carries the instructions from genes for making proteins, Reuters said. This allows the body to build up resistance to infection.

Moderna has been part of a shift in the vaccine space over the past year, with drugmakers and industry analysts focusing more on platform technologies than individual products to boost their pipelines. At J.P. Morgan’s annual Healthcare conference last month, multiple companies talked about their efforts to adapt mRNA technology for vaccines and other therapeutics.

Novartis recently inked a larger-than-$500 million deal with Janssen Biotech to adapt that company’s platform technology for use with its existing flu vaccines. Jayasumana said Moderna had been working since April to address local concerns, including reviewing the clinical data and implementing new procedures to minimize risk. At this time, our priority is maintaining open communication with these health authorities so we can fully understand their concerns, he said.