FDA Fast Track Designation Given to mRNA RSV Vaccine

ER Editor: This short article below from the European Pharmaceutical Review caught our eye for being another attempt to go after very young children and the elderly with yet another mRNA vaccine, and for ANOTHER disease (in addition to coronaviruses) which should NOT be vaccinated against.

Some diseases cannot be fought with vaccines because of what’s known as antibody dependent enhancement (ADE), also called pathogenic priming, etc. As many of us know, animals died in historical coronavirus vaccine trials, leading many researchers to suppose that once the natural Covid virus (or whatever it is) returns in the fall/winter of this year, many vaccinated people will die. Why? Because the vaccine has raised not a protective antibody in the vaccinated person, but instead one that will INVITE IN the disease leading to rapidly severe illness and even death within a matter of days.

Respiratory syncytial virus (RSV) is also one of these diseases that they’ve tried vaccines for and failed (since the 1960s in fact). Here is an extract from the site of the Children’s Hospital of Philadelphia:

Is ADE caused by vaccines?

On a few occasions ADE has resulted from vaccination:

  • Respiratory syncytial virus (RSV) — RSV is a virus that commonly causes pneumonia in children. A vaccine was made by growing RSV, purifying it, and inactivating it with the chemical formaldehyde. In clinical trials, children who were given the vaccine were more likely to develop or die from pneumonia after infection with RSV. As a result of this finding, the vaccine trials stopped, and the vaccine was never submitted for approval or released to the public.

But that doesn’t seem to be stopping them, on the contrary. GlaxoSmithKline recently tried and failed in its attempt to develop an RSV vaccine (see here). Novavax failed back in 2016 (see here).

The cohort Moderna seems to be targeting with fast track designation of its mRNA-1345 vaccine is the over-60 group. It’s currently in Phase 1 trials.

Another one to avoid; another one to warn your friends about.

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FDA Fast Track designation given to mRNA RSV vaccine

Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.

EUROPEAN PHARMACEUTICAL REVIEW

Letters spelling RSV surrounded by various medical equipment and medications - idea of treatment/vaccine development for RSV

The US Food and Drug Administration (FDA) has granted fast track designation to mRNA-1345, Moderna’s investigational single-dose messenger RNA (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,” stated 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. The Fast Track designation for older adults underscores the urgent need for a vaccine against RSV. With our investments in science and manufacturing, we have taken eleven infectious disease vaccines into human clinical trials. 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.”

RSV is a common respiratory virus that generally causes cold-like symptoms which most people recover from in a week or two. However, RSV can be serious, especially for infants and older adults and there is no approved vaccine currently available. RSV is the most common cause of bronchiolitis and pneumonia in children younger than one year of age in the US and can cause pneumonia and respiratory distress in older adults. According to the US Centers for Disease Control and Prevention (CDC), RSV causes, on average, approximately 58,000 hospitalisations in children under five and 177,000 hospitalisations among adults 65 years and older in the US each year. Moreover, the CDC reports RSV causes 14,000 deaths among adults 65 years plus each year.

Fast Track designation is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions that fill an unmet medical need. Programmes with this title may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

mRNA-1345 is currently under evaluation in an ongoing Phase I study. The trial is assessing the vaccine’s tolerability and reactogenicity in younger adults, older adults and children. All four cohorts of younger adults (ages 18-49 years) are fully enrolled, while dosing in the older adult cohort (ages 65-79 years) is ongoing. The company shared the first interim analysis of the study, through one month post-vaccination, of the younger adult cohorts at its annual Vaccines Day on 14 April 2021. Results showed the vaccine candidate generated at least an 11-fold geometric mean rise in neutralising antibodies relative to baseline.

Moderna also intends to evaluate combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults.

About mRNA-1345

mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein. It uses the same lipid nanoparticle (LNP) as the authorised COVID-19 Vaccine Moderna (now Spikevax) and contains optimised protein and codon sequences.

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Source

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