Crucial Quote
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors. This approval also reflects the ongoing potential of our mRNA platform,” Moderna CEO Stéphane Bancel said.
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What Do We Know About The FDA’s Earlier Stance?
In February, Moderna announced that the FDA had rejected its request to review its mRNA flu vaccine. The drugmaker noted that the FDA’s top vaccine regulator, Dr. Vinay Prasad, dismissed the company’s application over its choice of the control flu vaccine the mRNA shot was compared against, which it didn’t consider the best available vaccine. Prasad is a prominent supporter of Kennedy and has been a critic of the Covid-19 vaccine. After the decision drew backlash, FDA Commissioner Marty Makary walked back the decision and said the initial refusal was “part of a conversation that occurs with all drug makers.”
key background
Last year, Kennedy announced he is canceling contracts and grants worth nearly $500 million earmarked to develop mRNA vaccines. The Health and Human Services department described the decision as a “coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA).” Kennedy, a noted vaccine skeptic who has attacked mRNA COVID-19 vaccines despite pushback from medical professionals and scientists, claimed that data showed the 22 mRNA vaccines being backed by BARDA “fail to protect effectively against upper respiratory infections like COVID and flu.” Kennedy also claimed that the HHS will shift this funding towards “safer, broader vaccine platforms that remain effective even as viruses mutate,” without any specifics. Immunologist and former BARDA Director Rick Bright criticized the decision at the time, saying: “BARDA invested in mRNA technology precisely because it could deliver safe, scalable vaccines in record time, a capability proven during COVID. By dismantling that platform, we’re crippling our front-line defense, just ahead of unknown biological threats.”
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further reading
RFK Jr. Cancels $500 Million In Federal Funding For mRNA Vaccine Research (Forbes)
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