🧵💉A summary / reminder of where we stand on pediatric Novavax / Nuvaxovid access as of April 2026: We still haven’t heard anything regarding results from Novavax’s large pediatric trial (Hummingbird), which is running fairly late at this point. Per FDA docs (fda.gov/media/186545/downloa…), Hummingbird had an expected completion date of Oct. 28, 2025 and a Final Report Submission date of Mar. 4th, 2026. Here is the trial page where any results would first be made available: clinicaltrials.gov/study/NCT… Trump’s FDA has also instituted a new requirement for an additional immunogenicity study to support expansion to <12s. That new study has a completion date of Dec. 31, 2027 and a Final Report date of July 31, 2028. So, if nothing changes, and everything goes according to plan, we’re likely be looking at pediatric approval for the fall 2028 season. You can check the status of FDA postmarketing commitments here: accessdata.fda.gov/scripts/c… Hummingbird is still listed as “Ongoing” and the 2nd immunogenicity study is listed as “Pending: The study has not been initiated but does not meet the criterion for delayed.” I’m not sure how diligent manufacturers or FDA are about updating those statuses. Of course, Nuvaxovid, following last May’s BLA approval, is now able to be used off-label for pediatric use. And the wait is entirely too long, so in the meantime, the better bets are going to be: • As mentioned, working within the off-label framework and educating patients, providers, and pharmacies; creating reliable lists of friendly providers; etc. • Other groups having success in getting mRNA vaccines removed from the market, or at least an ACIP recommendation against them, and successfully steering that conversation in a direction that results in an immediate pediatric expansion. • Getting RFK Jr impeached and removed from office after the midterms, and removing the requirement for the additional immunogenicity study. • A pressure campaign aimed the new CBER director (who has not been announced yet - Prasad is leaving at the end of April) to remove the additional immunogenicity requirement, even in the absence of RFK’s removal. When talking to providers in attempt to get a pediatric prescription, folks can mention: • Japan has lowered the indication to ages 6 : ir.novavax.com/press-release… • A successful, completed pediatric safety and immunogenicity trial from India: pmc.ncbi.nlm.nih.gov/article… • A large safety study regarding the same dose Matrix-M adjuvant from the R21 malaria vaccine: thelancet.com/journals/lance… • Ongoing administration of that vaccine, which has now been administered to millions of kids in Africa down to 5 months of age and has been successful at cutting the Malaria rate by 50%: gavi.org/vaccineswork/kebbi-… • Novavax’s Hummingbird trial, which, while we have no data yet, obviously has no major safety signals, or else it would’ve been promptly reported on. We also have Reddit user /u/MilkThistleGenus in the community, a provider who has been super helpful at facilitating the process for many, through prescriptions & administration. After someone does have a prescription, finding a pharmacy that will administer can still be tough. It’s surprisingly the much harder part. We’ve heard many accounts at this point of pediatricians who are willing to look at the information and write a prescription, but many less pharmacies who are willing to fulfill them. Obviously, the best bet is going to be independent pharmacies, but we’ve also heard of success at Costco and Kroger-owned stores (specifically Smith’s) when it comes to chains, suggesting that there’s not necessarily a blanket policy against administration in many cases. Here is a helpful thread from someone who got administration at Costco, which is a nice summary of most things that I’ve already mentioned here, and they even created a Google doc with the studies that I’ve provided so that someone can easily send them to their provider: x.com/criticalaerosol/status…

📢Some small progress updates on Hummingbird, Novavax’s large phase 2b/3 trial to study the safety and immunogenicity of Nuvaxovid in children aged 6 months to 12 years: 1. On April 29th, the FDA updated its postmarketing commitment database (which it does quarterly), and in that update, they reported that: • Novavax/Sanofi had requested an extension for Hummingbird on December 4th, which was granted by FDA on January 15th • As such, the projected date for the final report submission shifted from March 4th to May 22nd 2. The Hummingbird trial listing on ClinicalTrials.gov was indeed updated on that same projected date (May 22nd), for the first time since 2024, to shift from “Active, not recruiting” to “Completed”. Finally looks like some real progress, to me. Keep in mind that this trial alone was originally deemed good enough by the FDA to support an expansion of the label to pediatric populations, before FDA commissioner Makary and CBER director Prasad put in place a requirement for an additional immunogenicity study. Those guys are long gone now, and the rumor on the street is that RFK Jr. might not be far behind. FDA PMC database: accessdata.fda.gov/scripts/c… Trial listing: clinicaltrials.gov/study/NCT…

Oh yeah this is good- an array of small emitters just like we prefer. Punches in Bunches👍🏻 This should actually work really well. Will do a deep dive later with machine translation.

📢💉🇨🇦Big update on Novavax / Nuvaxovid availability for Canada! Today, @SanofiCanada has announced, via @CNWNews, that they have completed the acquisition of Nuvaxovid market authorization from @Novavax and that Nuvaxovid will be available to Canadians in the fall. • Nuvaxovid will be made available in Canada by Sanofi for the fall 2026-2027 season • Provincial and territorial availability will be confirmed pending ongoing discussions and provincial assessments "With the launch of Nuvaxovid, a non-mRNA protein-based COVID-19 vaccine, Sanofi is now able to offer Canadians greater choice when it comes to COVID-19 protection. The availability of Nuvaxovid means that every Canadian will have the opportunity to access their personal COVID-19 vaccine choice. Canadians have clearly expressed a need for a non-mRNA option when it comes to COVID-19 protection. With this transfer, Sanofi can now respond to that need." - Delphine Lansac, General Manager, Canada, Vaccines at Sanofi. Press release: newswire.ca/news-releases/sa… Sanofi appears to have created a webpage for the Canadian product here, which includes the current product monograph: sanofi.com/en/canada/your-he…

Our latest preprint is out, where we investigated a profound SARS-CoV-2 epidemiological anomaly: BA.3.2.2 is selectively infecting children. Here, we show that the lack of ancestral-strain immune imprinting is promoting BA.3.2.2 pediatric infections. 1/9 biorxiv.org/content/10.64898…

Our latest preprint is out, where we investigated a profound SARS-CoV-2 epidemiological anomaly: BA.3.2.2 is selectively infecting children. Here, we show that the lack of ancestral-strain immune imprinting is promoting BA.3.2.2 pediatric infections. 1/9 biorxiv.org/content/10.64898…

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