FDA Fast-Tracks RSV mRNA ‘Vaccine’
Respiratory syncytial virus (RSV) — a respiratory virus that causes typically mild cold-like symptoms — has apparently been selected as the next invisible boogey man. Most children have been exposed to RSV by their second birthday.
The fact that most children survive past the age of 2 tells you something about the risks involved. That said, in very rare cases, RSV can progress to pneumonia or bronchiolitis (inflammation of the small airways of the lungs).
RSV Emerges Out of Season Around the World
According to reports, RSV is now raging around the world, from New Zealand1 to Japan2 and the U.S.,3 where it hit so hard in June 2021 that the Centers for Disease Control and Prevention issued an emergency alert4 for parts of the southern United States.
The CDC encouraged testing for RSV among patients who tested negative for COVID-19 but had “acute respiratory illness” symptoms. They also advised health care personnel, child care providers and staff of long-term care facilities to stay home from work if they had respiratory symptoms, even if they test negative for COVID, as they might have RSV.
In New Zealand, health officials said there were few cases of RSV in 2020 during the pandemic and, while it’s normally a winter disease, it’s now making a comeback off-season in 2021. According to Stuff.co.nz,5 the outbreak “was more than twofold greater than the historical average from 2014 to 2019 for this time of year.”
Similar reports have been published in Japan where, in early July 2021, the National Institute of Infectious Diseases warned of RSV infections outside the normal peak period. According to the Japan Times:6
“… the number of RSV patients per medical institution was 3.87 in the week ending June 27 — the highest number of cases since 2019. In 2018, the year the counting system was changed, the infection count peaked in September at 2.46, and it reached 3.45 patients per medical institution a year later.”
August 3, 2021, U.S. health officials reported that RSV had started to taper off by midsummer, but a resurgence is now seen, with a “record-breaking 563 new RSV cases” reported in the week before August 3.7
FDA Fast-Tracks mRNA Shot Against RSV
That same day, August 3, 2021, the Food and Drug Administration granted fast-track designation to Moderna for an mRNA-based injection against this common cold virus. As reported in a Moderna press release:8
“… the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than 60 years of age.
‘We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations — young children and older adults,’ said Stéphane Bancel, Chief Executive Officer of Moderna.
‘We are studying mRNA-1345 in these populations in an ongoing clinical trial and we look forward to sharing data when available … We have accelerated research and development of our infectious disease therapeutic area and we will continue to advance our mRNA vaccines into new areas of high unmet need.’”
Moderna’s press release correctly points out that there’s no approved vaccine available for RSV. What they don’t mention is why. The reason there’s no RSV vaccine on the market is the same reason why there has never been a coronavirus vaccine, and that is because none of them were able to pass trials.
As with coronavirus, previous efforts to develop an RSV vaccine have met with failure as test subjects have a pesky tendency to die or become seriously ill when exposed to the wild virus, thanks to paradoxical immune enhancement (PIE), also known as antibody dependent enhancement (ADE).9
RSV Shot Builds on COVID Jab
Moderna’s RSV shot uses the same lipid nanoparticle as its COVID-19 injection. The primary difference between the two shots is the coding of the mRNA. In the RSV shot, the mRNA encodes for a prefusion F glycoprotein.
Prefusion F protein is a protein that mediates the RSV virus’ entry into your cells and is known to elicit a neutralizing antibody response.10 Under normal circumstances, it’s hard to imagine an RSV vaccine built on a novel mRNA platform getting fast-tracked, but we’re no longer in normal times.
The rollout of mRNA COVID shots have, as predicted, paved the way for any number of new mRNA-based injections going straight to human trials. So, should you ever feel like your body lacks in synthetic mRNA, fear not. This is just the beginning. Those who embrace v
Article from LewRockwell