🧵 1/12 To report successful pediatric off label(<12) use. Disclaimer: I make no recommendation on using Novavax off label for your child and only report our experiences. I was one of the first few thousand outside of clinical trials to receive mRNA vaccines. I am thankful.
2/12 But I now only receive Novavax because the literature shows it has less side effects and may provide more durable immunity while immunity from mRNA vaccines may wane more rapidly. Novavax has been approved for 6 and up in Japan and I felt it should be safe for my 6 year old.
3/12 I mentioned all of this to the pharmacist that gave me Novavax this year. I asked if he would give Novavax to my 6 y/o with a doctor's prescription. He said yes he would. I immediately sent over a message to my child's pediatrician asking about off label use of Novavax.
4/12 I stated that I understand Novavax is not approved for his age & had not been fully studied in the US but that it should be safe based on the following: many children got Novavax in the large, ongoing Hummingbird trial and it has not been terminated due to safety concerns.
5/12 In a study in India, 460 children aged 2 to 11 were given Novavax and they found no safety signals and a noninferior immune response compared to adults. The dose was the same 0.5mL(5mcg of antigen and 50mcg of adjuvant) as adults and the approved 12 and up doses.
6/12 The same dose of the Matrix-M adjuvant was used in a pediatric malaria vaccine study with participants aged 5-36 months and found good safety with 5,477 subjects. This vaccine is WHO approved and given as a *4 dose series* in malaria endemic countries.
7/12 A 2021 analysis determined that it would be legal & ethical to use covid vaccines off label prior to approval for children. Again I stated that I understood this would be unapproved and off label but that this evidence supports use. The articles were included in my message.
8/12 After a couple of days the pediatrician replied & agreed it would be okay and sent over a prescription to the pharmacy where a pharmacist had previously agreed. The prescription went to another pharmacist who asked corporate for approval and said it would take weeks.
9/12 Undeterred, I also went to multiple other chain pharmacies to discuss if they would accept an off label prescription for Novavax. All of them would want higher approval and I opened up cases with their corporate offices. There are no independent pharmacies here with Novavax.
10/12 After a week of waiting I got a phone call from the manager of our local Costco pharmacy. They agreed it would be okay to give Novavax off label with a doctor's prescription. Much to my surprise, insurance even covered it. My son got his flu shot at the same time.
11/12 Novavax was well tolerated and didn't seem to affect him any more or less than getting Moderna + Flu shot in previous years. He did experience a headache, muscle aches & fever about 16-20 hours post vaccination. This was short lasting.
12/12 Attribution: I got the idea of off label use and found the studies on the Novavax_vaccine_talk subreddit. I believe one of the users that posted there is also @Biff234523 but he has not responded. Here are the studies: drive.google.com/drive/folders/…
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1/20🧵 Family fit testing Friday is back! 2024 edition! Previously, I did lots of community testing. I am back at it with some major improvements. How? By empowering people to learn how to test themselves and take that skill home their family.
2/20 I have set up fit testing kits including: a Portacount 8020A, all accessories, the N95 Companion, custom probe installers made by me and designed by @masknerd , portacount probes given to me by @NukitToBeSure , and a computer for fit testing or data collection software.
3/20 We must always remember that the objective of fit testing is to ensure that the mask, as worn, fits to the face. The fit test allows us to determine if it fits and if there is a leak. For me this means to stabilize the sampling tube to make sure we aren't creating a leak.
1/11 🧵 On a month+ of extended use of the ZM95S. There has been discussion on which type of masks are best suited for reuse and how the straps/nose seal/mask rigidity place into all of this and if the best masks to reuse are also comfortable.
2/11 The ZM95S features a semi rigid frame, an elastomeric like cloth seal, and adjustable straps, & very high fit factors. I speculated that these properties make it ideal for reuse. The straps can be tightened and the filter media provides a generous margin for safety.
3/11 My son used the same ZM95S for over a month- 2 to 3 times each week, & each use up to 3 hours. I modified the face seal before the first use. I manually tightened the straps to his face each time. Here it is ported after all that use(20 hours?) Some light wear and soiling.
🧵 1/12 Testing of the Zimi ZM95W (earloop only) which is under a newer Chinese kids mask standard. Surprisingly this is not a KN95 like the other kids Zimi I tested. It is actually listed as GB/T 38880-2020, Class W. Follow to see what that means.
2/12 You may have noticed your KN95 says "GB 2626-2019" or 2006. It is required for this to be on the mask to meet the standard. This means the mask maker tested it things such as the particle filtration efficiency (PFE) (%) is ≥95%, the breathing resistance is ≤210 Pa.
3/12 So the kids masks with GB/T 38880-2020 standard means that: breathing resistance is ≤ 45 Pa for Class F(protective) masks, and no strict requirement I found for Class W(hygenic) masks like the ZM95W- but it happens to be 45Pa. This means the kids masks are more breathable.
1/12🧵 The Zimi ZM95S (earloop). My son says "it is 100% comfortable, it is 100% good. I love it". This mask is a KN95 available in headbands and earloops for kids 4-7. Read for more information on the Zimi masks and limited testing results.
2/12 The design of the Zimi is modeled after the Japanese Shigematsu DD11V. This type of mask uses a semi rigid plastic frame with nose foam and an outer filter with a cloth-like soft seal. This is becoming a popular design in East Asia.
3/12 I was first altered to the Zimi by @noms780, however these are no secret within China. See the excellent threads by @paibangzhu explaining some benefits of this design which may lead to increased breathability and better fit.
1/5🧵A newly published study on N95 reuse is being shared. This does not show that "dome" N95 are necessarily better for reuse vs trifolds. It only shows certain respirator models(all but 3M 9205+ are surgical respirators) worked better for reuse, partly due to strap material.
2/5 2 of the 3 "dome" 95 have very sturdy straps (3M 1860, 1860s) and both of the trifolds(3M 1870+, 3M 9205+) have weaker straps. I would always limit reuse on those two models. However to compare different styles for public use you would need to compare w/ similar straps also.
3/5 3M Aura 9210+ and Drager 1950 have straps that are suited for some reuse. They can also be far more comfortable. The "dome" style N95 are outdated and the least comfortable- I had pressure ulcers on my nose from using these in 2020. Don't recommend "dome" as first choice.
1/21 🧵 On fit testing my family on Canadamasq Q100. This is a unique opportunity to try something that we don't often use, earloops! Canada has now allowed them under their new standard for respirators, CSA Z94.4.1:21. CSA(Canadian Standards Association). What does it all mean?
2/21 In 2020 CSA was tasked w/ creating a Canadian respirator standard. Leading up to this 3M Canada was the only long established big respirator company and new Canadian mask makers had to obtain NIOSH approval. NIOSH gave priority to US applicants over new Canadian mask makers.
3/21 A need was identified both for domestic production and approval of respirators and efforts were also made to improve upon NIOSH standards by incorporating quantitative fit testing, and attempting to meet physiological/functional/comfort needs of the wearer.