On June 14, 2022 CIDRAP confirmed the Moderna alternative to Pfizer for children should shortly be available. This is good timing, as more transmissible BA.4 and BA.5 Omicron sub variants expand their reach into the American community. However CIDRAP advises the FDA committee approves Moderna for kids 6 to 17 despite nagging concerns. These are among others over rare myocarditis complications.
FDA Committee Approves Moderna Vaccine Despite Omicron
The FDA Vaccines and Related Biological Products Advisory Committee VRBPAC approved the medication unanimously. But this was only after they concluded the two-shot vaccine’s benefits outweighed the risks.
However, they did raise concerns over very rare myocarditis complications before conceding these were more likely in adults. Moreover they agreed a second mRNA vaccine gave parents another choice and greater access.
But that said, Paul Offit professor of pediatrics at Children’s Hospital of Philadelphia did consider the pandemic phase we are now in. This was a somewhat different situation he said, to that prevailing at the time FDA approved the Pfizer product.
Therefore, he went on to push for a third Moderna booster dose as part of the treatment. The unanimous VRBPAC recommendation is now with FDA Food and Drug Administration for approval which it will typically grant in due course.
However Centers for Disease Control Must Also Approve
Centers for Disease Control and Prevention CDC must also agree the VRBPAC committee report, to further buttress the system’s independence. Their advisory committee meets on Jun 17 and Jun 18, 2022.
Meanwhile CIDRAP confirms high Omicron spread as the sub variants make headway. On June 14, 2022 the CDC Director said 67% of the US population currently lives in areas with medium or high community transmission. This is up from 55% the previous week.
CIDRAP closes its report with the observation “early findings suggest the two sub variants have mutations linked to immune escape. And this would reduce some of the protection from earlier illness, vaccines, and even treatments.”
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