FDA approves 1st mRNA flu shot, from Moderna (nbcnews.com)
¶The Food and Drug Administration on Wednesday approved the U.S.’ first flu shot that uses mRNA technology: mFlusiva, from drugmaker Moderna.
¶In a late-stage trial, mFlusiva was found to be about 27% more effective than a standard flu shot.
¶One promise of mRNA vaccine technology has always been the speed with which a vaccine can move from initial design to production, which is of particular importance for pathogens that change on a regular cycle, like flu. Moderna, thankfully, has been pressing on with its work despite the current environment surrounding vaccine policy. And now those efforts are producing results. The company can have its newly approved mRNA vaccine “available for this fall’s flu season.”
¶That’s the good news.
¶Here’s the great news:
¶Moderna said it takes two to three months from picking the strain to rolling out its flu shot, compared with about six months for traditional flu shots.
¶The speed advantage provided by mRNA vaccines is being realized, providing more time each year to observe developing strains before committing to a particular design. This will make these vaccines more effective year after year, and we will all benefit from that.
¶But, there is some not-so-great news:
¶Vaccines, however, are typically formally recommended by the CDC’s vaccine advisory committee — called the Advisory Committee on Immunization Practices (ACIP) — before they are used. But a federal judge has blocked the committee from convening.
¶Levy said mFlusiva could still be legally prescribed in the U.S. without ACIP’s sign-off.
¶However, he said, patients most likely would not be able to get insurance coverage, as private insurers generally cover only ACIP-recommended shots, and the public distribution of the vaccine would be severely limited with no official federal guidance on whom the shots should go to. Federal programs, such as Vaccines for Children and Medicaid, also rely on ACIP’s guidance.
¶So, we’ve got a new, more effective flu vaccine that will provide valuable time when designing the vaccine each year. The benefits of this new vaccine will compound over time. But, we either won’t have access to it or we’ll have to pay for it out of pocket, which, of course, will limit its uptake.
¶This is where we’re at.
¶But, there’s good and great news, and that’s a positive development.