Big Pharma Eyes Next Childhood Vaccine Cash Cow — mRNA Vaccines for RSV

Share:

Over the decades since childhood vaccines began rolling out on a widespread scale, pediatric vaccine injuries have left many parents regretful for forgetting or ignoring a basic history lesson.

That lesson, in the words of Harvard medical historian David Jones, is that “when it comes to vaccines and immunization … there always has been a risk and there always will be a risk.”

Sixty-five years ago, families learned about the risks of medical experimentation the hard way when they allowed researchers to use their infants as test subjects for a vaccine against a newly discovered illness dubbed “respiratory syncytial virus” (RSV), a common-cold-like illness now considered to affect “virtually all children,” mostly uneventfully, by age two.

The disastrous RSV vaccine led to the death of two infants and to hospitalization for the majority of other young clinical trial participants.

Since that time, vexed researchers have continued to deploy “trial-and-error approaches.” But they admit the “road to an effective RSV vaccine is paved with challenges,” in large part because of the tricky problem of “vaccine-associated disease exacerbation” — a problem that has also plagued coronavirus vaccines.

The gist of the “exacerbation” issue, also called antibody-dependent enhancement or pathogenic priming, is that the vaccine “primes” recipients to later develop more severe disease instead of protecting them.

Lured by the prospect of a large untapped global RSV vaccine market, manufacturers are nonetheless setting their sights on RSV vaccine development — and not just for infants but also for pregnant women and the elderly.

By 2019, capitalizing on the proliferation of new vaccine technologies, clinical trials were evaluating an estimated 30 candidate RSV vaccines, and scientists were gleefully announcing that the world “might be on the brink of clinical implementation soon.”

The crowded field of RSV vaccine candidates includes messenger RNA (mRNA) vaccines. In fact, with COVID injections having opened the floodgates to establish mRNA technology as the “new frontier for vaccine development,” pharma giants appear more confident than ever that they are close to finally producing an RSV winner.

In a nod to these hopes, the U.S. Food and Drug Administration (FDA) has just granted fast-track designation to Moderna for the company’s experimental mRNA-1345 vaccine against RSV. Although the fast-track FDA review applies only to older adults for now, Moderna’s phase 1 trials of its RSV injection also include children as young as 1 year old.