Image 1 — Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test
Image 2 — Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test
Image 3 — Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test

Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test

US-based diagnostics company Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test.

This will become the second molecular test available on the U.S. market — the sole option now being Aptitude Medical’s Metrix platform following the exit of Cue, Lucira, and 3EO in recent years.

This test will be single-use (disposable), and fully integrated, so following the Lucira model instead of the Metrix/Pluslife model with a reusable reader. However, it will be powered via USB-C cable instead of batteries like Lucira. It will be nasal swab only, requires a mobile app, and results will be available in 30 minutes.

The Visby test boasts a much lower Limit of Detection than Metrix’s combo test:

  • Visby SARS2: 20 copies/swab
  • Metrix SARS2: 500 GE/swab
  • Visby Influenza: 90-270 copies/swab
  • Metrix Influenza: 1,000-2,000 GE/swab

However, the clinical sensitivity still ended up being roughly equivalent to Metrix )actually very slightly lower, but the confidence intervals sort of make that a moot point):

  • Visby SARS2: 93.6%
  • Visby Flu A: 92.0%
  • Visby Flu B: 94.4%
  • Metrix: 95.2% to 95.8% for all three

This test has been in development since 2021 when Visby received a $12.3M grant from HHS’s BARDA, and is subsequent to Visby’s OTC STI panel (FDA authorized 2025) and point-of-care PCR COVID-19 test (EUA September 2020).

As far as I’m aware, no information is available yet on distribution channels, availability, or pricing.

Press release: https://www.businesswire.com/news/home/20260702443381/en/Visby-Medical-Receives-FDA-Clearance-for-the-First-At-Home-PCR-for-Multiple-Respiratory-Viruses

FDA documents:

u/Jazzlike-Cup-5336 — 15 hours ago

Just curious: For anyone with specific knowledge of Burger King’s refund process, does anyone know how it might impact employees or future service?

So, the Burger King app, as far as I know, offers the quickest and easiest refunds in fast food, so I’m pretty frequently taking advantage of that. If they give me an incorrect item or forget an item, I’ll always go in the app and tell the chat bot, and I always receive a coupon for greater than the item’s value every time. And it happens a lot, because, well, they mess up a lot, just like any fast food restaurant in 2026. But at any other restaurant, where the refund process isn’t as easy as spending 60 seconds with a chatbot, I’ll usually just ignore the minor issues.

Anyway, I’m just wondering, since I end up doing it fairly frequently:

  • Do individual stores or employees ever get contacted/notified about refunds?

  • Can employees specifically see when you use a customer support coupon for an order (and would they potentially think anything of that)?

  • Are there ever any consequences for individual employees for refund-related issues?

I doubt that those things would be an issue, but I would just hate to be known by local staff as a “problem customer”, or even worse, cause someone to get in trouble, because fast food is never that serious. So I just wanted to get a vibe check on the situation

reddit.com
u/Jazzlike-Cup-5336 — 1 day ago
▲ 149 r/fastfood

My 9/11: The McDouble increase from $2.50 to $2.89, just weeks after the new menu introduction, has now hit even my extremely-low-COL midwestern area today

u/Jazzlike-Cup-5336 — 13 days ago

What antihistamines make the most sense to take for an acute COVID infection?

By now, you’ve probably seen at least some information floating around over the past few years that over-the-counter antihistamines could be a beneficial addition to COVID treatment protocols.

The science behind H2 blockers is more robust, and picking a product is also a much easier task. There’s really only one on the market that makes sense, which is Famotidine/Pepcid. In 2022, we got this small randomized clinical trial suggesting that Famotidine during an acute infection can improve the rate of symptom resolution: https://gut.bmj.com/content/71/5/879

For H1 blockers (the more common antihistamines that you probably think of (eg. Benadryl)), there is also speculation that they may be beneficial in treating acute COVID, however, the choice of selecting a product is a lot more complicated, with close to a dozen potential options on the market.

The theory that H1 blockers may be beneficial mainly stems from this 2024 paper, which demonstrates that the H1 histamine receptor can act as an alternative receptor for SARS-CoV-2 entry, in addition to ACE2: https://journals.asm.org/doi/10.1128/mbio.01088-24. Therefore, an H1 blocker that competitively binds to H1 should theoretically work to prevent SARS2 entry.

From what I’ve been able to identify, there are 3 options that likely stand out above the others:

  • Fexofenadine (Allegra)

  • Cetirizine (Zyrtec)

  • Levocetirizine (Xyzal), the active, purified component of cetirizine

That 2024 paper also studied the IC50 of 11 different antihistamines, which is the concentration that would be required to inhibit SARS2 binding by 50%. Their choices of antihistamines, though, aren’t very helpful, because those 11 only included a couple of OTC options that would make sense for outpatient COVID treatment, like Benadryl and Claritin. However, the takeaway is still important - although there was some slight variation, the IC50 of all 11 antihistamines fell into the range of 1.6 to 3.6 micromolars (μM). For the sake of making a choice, since it’s the only thing that we can really do, we can assume that most available OTC antihistamines will also likely fall within that same range, or at least be similar.

From that starting point, we can look at the Cmax of available OTC antihistamines, which is the maximum plasma concentration that they achieve in the body, and comparing them to the IC50 range that the study lays out. At the typical oral dose, these are the Cmax concentrations of some popular OTC options:

  • Fexofenadine (Allegra) - 0.98μM

  • Cetirizine (Zyrtec) - 0.80μM

  • Levocetirizine (Xyzal) - 0.69μM

  • Diphenhydramine (Benadryl) - 0.27μM

  • Dimenhydrinate (Dramamine) - 0.15μM

  • Chlorpheniramine - 0.055μM

  • Loratadine (Claritin) - 0.020μM

As you can see, the 3 that I mentioned are the only options that come anywhere close to reaching the desired concentrations.

Since any theoretical benefit is based solely on the mechanism (ie. no trials yet), combined with the fact that none of the options actually do reach the required Cmax, I probably definitely wouldn’t suggest H1 blocking antihistamines as a blanket treatment that everyone infected should automatically take. But it’s certainly a legitimate pathway to consider, and is fairly low-risk.

So, if you do want to add an antihistamine, why not just select the best performing in Cmax, which is Fexofenadine (Allegra)? Well, there are some other individual characteristics to consider.

Fexofenadine (Allegra) is the one option that comes with essentially no risk of drowsiness, while both Cetirizine (Zyrtec) and Levocetirizine (Xyzal) do both typically come with with at least slight drowsiness, the caveat being that they’re also slightly more potent at their job of H1 blockade. Allegra is more polar, meaning that it’s less “membrane sticky”, which means that it crosses the blood brain barrier less, which is why we get the benefit of no drowsiness. However, that relative lack of concentration at membranes also means that it may not perform as well in the SARS2 cell entry context, since that area is where the viral entry is happening. This could theoretically increase the IC50 of Allegra, making it more similar (or even a slightly worse option) when compared to Zyrtec or Xyzal. Our best guess is that it probably wouldn’t increase the IC50 dramatically, but it’s still something that should be considered.

So, TLDR, my recommendation would be:

  • If you want the safest bet with an all-around favorable profile, and you don’t mind some drowsiness or plan to take it at bedtime, then the best options are either Cetirizine (Zyrtec) or Levocetirizine (Xyzal).

  • If you don’t tolerate drowsiness at all, or if you want the option that may perform better, but does have some question marks surrounding its mechanism for blocking SARS2 cell entry, then the best option is Fexofenadine (Allegra).

reddit.com
u/Jazzlike-Cup-5336 — 17 days ago

A progress update 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

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.

The Hummingbird trial listing on ClinicalTrials.gov was indeed updated on that same projected date (May 22nd), for the first time since December 2024, to shift from “Active, not recruiting” to “Completed.”

It finally looks like some real progress is happening, 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, according to former ACIP member Robert Malone (https://x.com/rwmalonemd/status/2065474465492779158?s=46), is that RFK Jr. himself might not be far behind. 

Here is my previous update on the status of pediatric Nuvaxovid:https://www.reddit.com/r/Novavax\_vaccine\_talk/comments/1se2jgn/hummingbird\_pediatric\_trial\_updates/oengpbd/

FDA PMC database:https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

Hummingbird trial listing:https://clinicaltrials.gov/study/NCT05468736

u/Jazzlike-Cup-5336 — 23 days ago

Results from ACTIV-6, the 2nd RCT evaluating metformin for the prevention of Long COVID: Risk of symptoms on day 180 was 0.8 percentage points lower with metformin (not significant, 95% credible interval -2.2 to 0.6). Much more underwhelming than the first RCT.

A quick comparison of both trials:

COVID-OUT:

  • Dec 30, 2020, to Jan 28, 2022

  • n = 1,126

  • Symptomatic COVID for <7 days

  • Outpatients aged 30-85, either overweight or obese

  • 55% with at least 2 prior SARS2 vaccines

  • No prior SARS2 infection

  • Percent with PASC symptoms (cumulative) by day 300: 6.3% with metformin vs. 10.4% with placebo

  • Hazard ratio [HR]: 0.59 (95% CI 0.39 to 0.89)

  • When started within 3 days of symptom onset: Hazard ratio [HR]: 0.37 (95% CI 0.15 to 0.95)

ACTIV-6:

  • Sept 19, 2023 to May 1, 2024

  • n = 2,983

  • Symptomatic COVID for <7 days

  • All outpatient adults aged 30+

  • 54% with at least 1 prior SARS2 infection

  • 68% at least 2 prior SARS2 vaccines

  • 83% either prior infection or vaccine

  • Percent with PASC symptoms on day 180: 2.3% with Metformin vs. 3.0% with Placebo

  • Adjusted risk of symptoms on day 180 was 0.8 percentage points lower with metformin (95% credible interval [CrI] -2.2 to 0.6)

  • Risk ratio [RR]: 0.79 (95% CrI 0.474 to 1.230)

reddit.com
u/Jazzlike-Cup-5336 — 1 month ago

A new randomized controlled trial evaluated the effects of 3x daily green tea gargling on COVID-19 prevention: 22.8% reduction, but no statistical significance

Perhaps a long time coming, we finally have a randomized controlled trial evaluating green tea (via 3x daily gargling) for the prevention of COVID-19: https://www.sciencedirect.com/science/article/pii/S277306542600043X

For the group gargling with green tea, there was a 22.8% reduction in COVID infections. However, the result did not come close reaching significance - the 95% confidence interval spanned all the way from a 58% reduction to a 55% increase.

In my opinion, though, it’s still a fairly impressive result. There are some pretty obvious mistakes in the methodology of the trial, and there are also many problems outside of the protocol itself that would all be expected to contribute to an underwhelming result.

To start, why would we think that gargling with green tea would be beneficial for COVID prophylaxis? EGCG, or epigallocatechin gallate, the most abundant catechin found in green tea, has long been understood to be implicated in viral binding to ACE2. From 2021: EGCG from green tea effectively blocks infection of SARS-CoV-2 and new variants by inhibiting spike binding to ACE2 receptor: https://pmc.ncbi.nlm.nih.gov/articles/PMC8404181/

For the trial, about the only thing I like is that they used a high-quality product - a pre-measured powder mix of green tea & matcha from a reputable manufacturer, where the catechin concentration is readily available and standardized. If someone wanted to use green tea for this purpose, that’s exactly the type of product I would recommend. For anyone interested, this is the specific product (2 packets worth) used in the trial: https://japanesetaste.com/products/itoen-oi-ocha-japanese-instant-green-tea-matcha-blend-powder-100-sticks

But there are quite a few major problems:

  • As a control group, they used 3x daily gargling with water, which seems like a poor decision to make in a study that is incapable of being blinded anyway. It’s possible that the act of gargling itself, even with water, has prophylactic effect, similar to what we see with saline nasal rinses. There is already evidence of this, like this 2023 RCT evaluating viral load and infectivity that compared a saline placebo to various mouthwashes: https://pmc.ncbi.nlm.nih.gov/articles/PMC10030878/ Contrary to expectations, it was discovered that gargling with saline alone was almost as effective as the mouthwash.
  • They only used 1.6g of green tea dissolved in 13oz of water, which is…a very puzzling concentration. Working with measured powder, they had free rein to easily make the concentration as high as they liked, but their stated intention was to only “match the catechin concentration of commercially available green tea bottles.” Uh, what? For some context, folks will typically use about 2g of tea for a a typical cup of matcha much smaller than 13oz.
  • There were significantly higher rates of mask wearing (84.26% vs. 79.87%) and vaccine uptake within the past 6 monrhs (21.6% vs. 17.4%) in the water gargling group compared to the green tea group.
  • The study ended up undersized to attempt to make a conclusion. By their own estimation, they needed about 550 participants in each group, but only ended up with 403 and 386 after removing 214 due to lack of adherence (gargling rate below 80%).
  • Since blinding is not possible for a trial like this, it’s expected for the green tea group to become more comfortable taking risks, which would increase their COVID incidence. This is what we -also commonly see with some COVID vaccines, and why they often end up with a “negative effectiveness” after several months, because vaccinated individuals take more risks after overestimating their level of protection.
  • The trial, being based in Japan, already included high rates of green tea consumption in both groups. 64–67% of participants from both groups had habitual tea drinking behavior, so the water gargling group were also receiving any benefits inherent to EGCG consumption.

Despite all of those problems…the green tea group still saw a 22.8% reduction in COVID incidence, which doesn’t sound too shabby to me, there could’ve very easily been no effect noted at all. We obviously need more (and better) trials in this space, but it’s also a zero-risk (and pretty tasty) intervention that anyone can institute now if they would like.

u/Jazzlike-Cup-5336 — 1 month ago

A recent study from Emory University compares the performance of all available SARS-CoV-2 / Influenza multiplex rapid test brands (including against JN.1-lineage SARS2)

The two main takeaways:

  • Don’t waste your money on a more expensive brand or overthink your purchase. No single brand consistently performed better than all other tests - The lowest detected concentrations were achieved by different tests for each of the 4 viruses. 
  • It’s essential to wait until the END of the time window listed on the instructions to read the results. “We found that at low viral concentrations, many OTC tests were interpreted as negative at the start of the stated interpretation window but converted to a positive result by the end of the interpretation window.”

 

They looked at the 8 SARS-CoV-2 / Influenza combo rapid tests that were available in the U.S market as of fall 2025. Unfortunately, they didn’t include the Aptitude Metrix molecular combo test, or the newer 4-in-1 rapid tests that include RSV from Flowflex and iHealth, because they were not yet available at the time. 

They tested the following 8 brands: 

  • ACON Flowflex
  • iHealth
  • OSANG BinaxNOW*, QuickFinder
  • CorDx Tyfast
  • Healgen Rapid Check*, InBios, statID, Equate, INDICAID, GenaCheck, Consult, RiteAid, ACCUBIO, healthconfirm, RapidResponse, RapidGo, Walgreens, CVS
  • SEKISUI Osom
  • Watmind SpeedySwab 
  • Wondfo WELLlife*, INDICAID, Hough, 2San

*Specific test used in this study 

For the main portion of the study, to determine sensitivity, they examined the lowest concentration of virus at which each of the test brands would reliably (3 out of 3 tests) show a positive result. For H1N1, WELLlife and Osom performed the best. For H3N2, Healgen and SpeedySwab performed the best. For influenza B, Osom performed the best. And for SARS-CoV-2, Flowflex performed the best. As the authors point out, there isn’t really any sort of a clear pattern here, and the results are indicative of all tests having about equivalent capabilities.

Next, they examined whether the readability of the results changed from the start to the end of the timed viewing window listed in the test instructions. The answer was consistently “yes”. In the 2nd image, all of the solid bars were positives that were able to be read at the end of the window, but were missed at the beginning of the window. It was a major issue across all tests - but especially with SARS-CoV-2, and especially with some brands (eg. WELLife, Osom, BinaxNOW). 

Link: Analytical comparison of over-the-counter multiplex tests for influenza A, influenza B, and SARS-CoV-2: https://journals.asm.org/doi/10.1128/spectrum.00110-26

u/Jazzlike-Cup-5336 — 1 month ago

FDA vaccine committee recommends for updated 2026-2027 vaccines to target the XFG variant; all three manufacturers have indicated preparedness to produce an XFG vaccine for fall release (Sanofi has already started manufacturing of XFG Nuvaxovid)

Link to today’s VRBPAC meting: https://youtube.com/live/3wU0NWzXvZY

The vote was 8 Yes, 0 No, and 1 Abstain for the question “For the 2026-2027 Formula of COVID-19 vaccines in the U.S., does the committee recommend JN.1-lineage XFG variant as the preferred variant for an updated monovalent vaccine?”

Slide decks, for anyone interested:

Previous post about former meeting materials: https://www.reddit.com/r/Novavax_vaccine_talk/comments/1toftl6/fda_has_published_meting_materials_agenda_roster/

reddit.com
u/Jazzlike-Cup-5336 — 1 month ago

FDA has published meting materials (agenda, roster, voting questions, discussion topics, etc.) ahead of Thursday's VRBPAC meeting to select the strain for 2026-2027 vaccines

Voting question and discussion topic:

  • For the 2026-2027 Formula of COVID-19 vaccines in the U.S., does the committee recommend JN.1-lineage XFG variant as the preferred variant for an updated monovalent vaccine?

  • Please discuss circumstances that may warrant recommendation of a non-JN.1 lineage variant (e.g., BA.3.2) for COVID-19 vaccine use in the U.S.

So, perhaps as expected, we’ll very likely be getting a recommendation for an updated XFG vaccine. Which I think is the most obvious and correct choice, but I still wish they would leave the issue a bit more in the hands of manufacturers, by issuing a wider recommendation (like what essentially was the case with JN.1 last year). We’re also still going to need to figure out, which I’m sure will be discussed at the meeting, what constitutes an “XFG variant” vaccine, since XFG has now progressed to the point of essentially being an entire lineage on its own - with variants like XFG.1, XFG.14.1, and especially XFG.1.1, etc. becoming more dominant lately.

Briefing document:

> All licensed manufacturers have indicated that they are prepared to produce an XFG vaccine for COVID-19 vaccines (2026-2027 Formula).

Meeting roster:

There are 4 temporary voting members (3 of them returning from previous terms serving on VRBPAC) that are being brought on for this meeting in addition to the 6 permanent members who will be attending. That isn’t very surprising, that’s the same approach that was used for the flu selection meeting back in March. I wasn’t thinking we’d get any new permanent member announcements this close to the meeting, anyway, even though there are now 9 vacancies listed on the roster.

It's notable that this is the first year where Sanofi is attending on their own (with no Novavax speaker) after the Nuvaxovid license transfer. Last year, it was a joint effort (Novavax’s CMO Robert Walker, and, just like this year, Tonya Colpitts from Sanofi).

That makes me a bit wary, honestly…it’s anyone’s guess as to whether Sanofi will continue to have as advantageous of an approach to strain selection as Novavax did. I would personally like to see it continue to be a joint effort.

That said, the change is not surprising. At the Cantor global healthcare conference last September, Novavax was asked about strain selection duties, and the comment was:

> Moderator: “When it comes to future strain selection and so forth, whose responsibility is that? Is it joint? Is it…”

> Novavax: “So, of course, as Sanofi’s going to take over, that decision is going to belong to Sanofi more and more. For this transition year, we have worked together for the strain selection.”

But it’s notable that the tech transfer, where manufacturing of Nuvaxovid is transitioned from Novavax to Sanofi, is still not yet complete, just the global marketing transfer. Tech transfer was originally expected to be completed by now, but on the February earnings call, Novavax mentioned that the timeline had been extended because Sanofi made the pivot to produce Nuvaxovid in the United States, which was not the plan originally (presumably, due to the current admin’s efforts in that area).

Meeting agenda: https://www.fda.gov/media/192691/download

Previous post on the meeting announcement, public comment is still open until midnight Thursday for anyone who would like to leave one: https://www.reddit.com/r/Novavax_vaccine_talk/comments/1sxw993/the_fdas_vaccines_and_related_biological_products/

reddit.com
u/Jazzlike-Cup-5336 — 1 month ago

FDA has published meting materials (agenda, roster, voting questions, discussion topics, etc.) ahead of Thursday’s VRBPAC meeting to select the strain for 2026-2027 vaccines.

Voting question and discussion topic:

  • For the 2026-2027 Formula of COVID-19 vaccines in the U.S., does the committee recommend JN.1-lineage XFG variant as the preferred variant for an updated monovalent vaccine?

  • Please discuss circumstances that may warrant recommendation of a non-JN.1 lineage variant (e.g., BA.3.2) for COVID-19 vaccine use in the U.S.

So, perhaps as expected, we’ll very likely be getting a recommendation for an updated XFG vaccine. Which I think is the most obvious and correct choice, but I still wish they would leave the issue a bit more in the hands of manufacturers, by issuing a wider recommendation (like what essentially was the case with JN.1 last year). We’re also still going to need to figure out, which I’m sure will be discussed at the meeting, what constitutes an “XFG variant” vaccine, since XFG has now progressed to the point of essentially being an entire lineage on its own - with variants like XFG.1, XFG.14.1, and especially XFG.1.1, etc. becoming more dominant lately.

Briefing document:

> All licensed manufacturers have indicated that they are prepared to produce an XFG vaccine for COVID-19 vaccines (2026-2027 Formula).

Meeting roster:

There are 4 temporary voting members (3 of them returning from previous terms serving on VRBPAC) that are being brought on for this meeting in addition to the 6 permanent members who will be attending. That isn’t very surprising, that’s the same approach that was used for the flu selection meeting back in March. I wasn’t thinking we’d get any new permanent member announcements this close to the meeting, anyway, even though there are now 9 vacancies listed on the roster.

It's notable that this is the first year where Sanofi is attending on their own (with no Novavax speaker) after the Nuvaxovid license transfer. Last year, it was a joint effort (Novavax’s CMO Robert Walker, and, just like this year, Tonya Colpitts from Sanofi).

That makes me a bit wary, honestly…it’s anyone’s guess as to whether Sanofi will continue to have as advantageous of an approach to strain selection as Novavax did. I would personally like to see it continue to be a joint effort.

That said, the change is not surprising. At the Cantor global healthcare conference last September, Novavax was asked about strain selection duties, and the comment was:

> Moderator: “When it comes to future strain selection and so forth, whose responsibility is that? Is it joint? Is it…”

> Novavax: “So, of course, as Sanofi’s going to take over, that decision is going to belong to Sanofi more and more. For this transition year, we have worked together for the strain selection.”

But it’s notable that the tech transfer, where manufacturing of Nuvaxovid is transitioned from Novavax to Sanofi, is still not yet complete, just the global marketing transfer. Tech transfer was originally expected to be completed by now, but on the February earnings call, Novavax mentioned that the timeline had been extended because Sanofi made the pivot to produce Nuvaxovid in the United States, which was not the plan originally (presumably, due to the current admin’s efforts in that area).

Meeting agenda: https://www.fda.gov/media/192691/download

Previous post on the meeting announcement, public comment is still open until midnight Thursday for anyone who would like to leave one: https://www.reddit.com/r/ZeroCovidCommunity/comments/1sxvsyr/the_fdas_vaccines_and_related_biological_products/

reddit.com
u/Jazzlike-Cup-5336 — 1 month ago

WHO TAG-CO-VAC Statement on the antigen composition of COVID-19 vaccines: Recommends monovalent LP.8.1 for 2026-2027 formulas, but that other antigens (e.g. XFG, NB.1.8.1) that demonstrate broad and robust nAb responses or efficacy against circulating SARS2 variants could also be used.

Link to statement: https://www.who.int/news/item/16-05-2026-statement-on-the-antigen-composition-of-covid-19-vaccines

Key points:

  • The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) held its twice-yearly decision-making meeting in May 2026 to review the evolution of SARS-CoV-2, the effectiveness of currently approved COVID-19 vaccines and the implications for COVID-19 vaccine antigen composition.

  • The objective of any update to COVID-19 vaccine antigen composition is to enhance vaccine-induced immune responses to circulating SARS-CoV-2 variants, when needed.

  • Following this meeting, the TAG-CO-VAC advises vaccine manufacturers that monovalent LP.8.1 is the recommended vaccine antigen.

  • Other antigens (e.g. XFG, NB.1.8.1) or other approaches that demonstrate broad and robust neutralizing antibody responses or efficacy against currently circulating SARS-CoV-2 variants could also be used.

  • Vaccination remains an important public health countermeasure against COVID-19 and vaccination should not be delayed in anticipation of access to vaccines with an updated antigen composition. As per the March 2026 WHO Strategic Advisory Group of Experts on Immunization (SAGE) recommendations, Member States should consider routine COVID-19 vaccination of groups at highest risk of severe COVID-19 disease.

Personal thoughts:

This conservative approach of what is essentially multiple recommendations is a continued philosophy that they’ve also exhibited at their last 2 meetings. This essentially tosses the issue to the individual vaccine manufacturers to use their specific platform to what they feel is the best of its ability, as well as for local governing bodies (eg. EMA in Europe, FDA in the US) to make more specific recommendations based on their geography.

I am generally a fan of that approach, even though I absolutely disagree with the outright preferential recommendation of LP.8.1 here. LP.8.1 has not been detected in US wastewater since August 2025 and represents a dead-end branch on the SARS2 evolutionary tree (https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00308-1/fulltext), while XFG and NB.1.8.1 have continued to dominate and result in the creation of countless fitter variants.

As I’ve said before (https://www.reddit.com/r/ZeroCovidCommunity/comments/1sxvsyr/the_fdas_vaccines_and_related_biological_products/), I will be advocating for manufacturers to update to XFG or NB.1.8.1 at the upcoming May 28th FDA VRBPAC meeting, which I still think makes the most sense for our specific situation by far.

Also, this is what I was expecting, but I’m very relieved to see confirmation that they are not recommending a BA.3.2 component to the vaccines. That would’ve been a big mistake, since BA.3.2 remains a pretty irrelevant development for the time being.

reddit.com
u/Jazzlike-Cup-5336 — 2 months ago

NEJM: Ensitrelvir for Covid-19 Postexposure Prophylaxis in Household Contacts (Full peer-reviewed publication of SCORPIO-PEP, the Xocova trial supporting Shionogi’s post-exposure prophylaxis application to the FDA)

nejm.org
u/Jazzlike-Cup-5336 — 2 months ago

Over the past couple weeks, most companies have been releasing their Q1 earnings reports. Here is a brief summary from 3 of the companies that I routinely follow in the infectious disease space (Novavax, Sanofi, and Vaxart). There isn’t much groundbreaking news here that would’ve really necessitated a single post on its own, but I figured that there are enough nuggets of information that it might be useful for someone when combined.

Sanofi:

  • Highlighted the recent COMPARE study, where Nuvaxovid showed better tolerability (reactogenicity/side effects) than Moderna’s mNEXSPIKE in a head-to-head study

  • Highlighted the recent NIRSE-GAL study, which showed that a single dose of Beyfortus, their pediatric monoclonal antibody for RSV, generated an 85.9% reduction in hospitalizations during the first season and remained largely effective throughout the second season, reducing hospitalizations by 55.3%.

  • Confirmed that they’ve submitted an application to the FDA to expand the indication of their high-dose influenza vaccine, FluZone HD, down to 50 years of age (currently 65+).

Vaxart:

  • Reiterated that the first data (n=400) from the phase 2b trial of their oral COVID-19 vaccine is still expected very soon, within the next couple of months.

> In the first quarter of 2026, our team remained focused on the operational execution of our Phase 2b COVID-19 trial . . . We are currently finalizing the topline 12-month safety and efficacy data from our 400-person sentinel cohort and are working to release these data as soon as our partnership protocols and contractual data-sharing guidelines permit.”

  • Shifted the release timing for the full results from the 5,000-person trial slightly, from late 2026 to early 2027.

Novavax:

  • Highlighted the continued and substantial interest across the pharmaceutical industry in their saponin-based Matrix-M adjuvant. 4 of the top 10 pharma companies have now signed a material transfer agreement (MTA) to evaluate Matrix-M for use in their company’s vaccine products. Companies are now actively experimenting with the use of Matrix-M in 30 unique fields across infectious diseases and oncology.
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u/Jazzlike-Cup-5336 — 2 months ago

Today, the Department of Justice has indicted David Morens, former NIAID advisor to director Anthony Fauci, “for his role in a scheme to evade FOIA requests in connection with COVID-19 research grants.”

Allegedly, he pledged to help a co-conspirator get their bat coronavirus grant restored and “counter the lab leak narrative”, and then attempted to hide those communications.

Selected text:

> A former National Institute of Allergy and Infectious Diseases (NIAID) employee is facing indictment for his role in a scheme to evade Freedom of Information Act (FOIA) requests in connection with COVID-19 research grants.

> David M. Morens, 78, of Chester, Maryland, is charged with conspiracy against the United States; destruction, alteration, or falsification of records in federal investigations; concealment, removal, or mutilation of records; and aiding and abetting. Morens served as a senior advisor in NIAID’s Office of the Director from 2006 through 2022.

> As a senior advisor, Morens counseled Senior NIAID Official 1 and other senior-level NIAID staff on senior-level policies, developed recommendations and solutions for issues impacting the National Institutes of Health (NIH), and wrote and edited manuscripts. Morens also provided guidance and expertise to senior staff members on epidemiological studies and issues related to infectious disease planning and management. Additionally, Morens gathered information from grantees and others in the scientific community to establish facts about the nature of COVID-19. This enabled Morens to understand NIH and NIAID’s historical activities in coronavirus research, assist in formulating policy and procedures, and brief Senior NIAID Official 1 so he could then relay information to the President of the United States, Congress, and the public.

> According to the indictment, Morens, Co-Conspirator 1, Co-Conspirator 2, and others conspired during the COVID-19 pandemic to defraud and commit several offenses against the United States after NIH terminated Co-Conspirator 1’s grant. NIH terminated the grant, Understanding the Risk of Bat Coronavirus Emergence (bat coronavirus grant), based on allegations that COVID-19 emerged from the Wuhan Institute of Virology (WIV) in Wuhan, China. NIAID awarded the grant to Company #1 and Co-Conspirator 1, who made a subaward to the WIV.

> Following the termination, Morens and Co-Conspirator 2 pledged to help Co-Conspirator 1 restore the termination of the bat coronavirus grant and counter the narrative that COVID-19 leaked from a lab. In anticipation that their communications would be requested through a FOIA Request, Morens, Co-Conspirator 1, and Co-Conspirator 2 agreed in writing to intentionally hide from public view their communications by corresponding using Morens’s personal Gmail account, rather than his official NIH email account.

> The indictment alleges that the conspirators used Morens’s personal Gmail account to exchange non-public NIH information; correspond about their efforts to influence NIH to fund Company #1; exchange edits to drafts of letters addressed to NIH leadership for Company #1 and Co-Conspirator 1; and “back-channel” information to Senior NIAID Official 1. According to the indictment, each of these matters fell within Morens’s role as senior advisor and constituted federal records that needed to be created, maintained, and exchanged on government systems.

> Additionally, the indictment further alleges that Morens and Co-Conspirator 1 conspired to pay illegal gratuities. The indictment states that Co-Coconspirator 1 gifted Morens wine for his “behind-the-scenes shenanigans,” and arranged for its delivery to Morens’s residence in Maryland. Morens then allegedly identified an official act that he could perform to “deserve” the gift, which was a scientific commentary in a prominent medical journal advocating that COVID-19 had natural origins. The indictment further alleges that Co-Conspirator 1 suggested he would provide Morens with additional things of value, including meals at Michelin-starred restaurants in Paris, New York, and Washington, D.C.

Full press release: https://www.justice.gov/opa/pr/former-senior-niaid-official-indicted-concealing-federal-records-during-covid-19-pandemic-0

u/Jazzlike-Cup-5336 — 2 months ago
▲ 90 r/Novavax_vaccine_talk+1 crossposts

Meeting announcement:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-meeting-may-28-2026-announcement

Public Comment link:

https://www.regulations.gov/document/FDA-2026-N-3962-0001

Public comment is open until May 27th, 11:59 PM EDT, but only comments received on or before May 21st will be provided to the committee.

Some ideas on talking points, which I’ll personally be making:

  • All COVID-19 vaccines should be made available universally, with labeling not limiting use to high-risk populations, and free of cost.

  • Manufacturers should once again target a monovalent JN.1 lineage, preferentially XFG or NB.1.8.1. Any JN.1 lineage would be acceptable, due to similar antigenic grouping, but current evidence does not suggest that emerging BA.3.2 should be an antigen target at this time.

  • The strain selection process should be more frequent (at least twice per year, the same schedule as the WHO’s TAG-CO-VAC). Considering COVID-19’s lack of seasonality, it should also be scheduled earlier in the spring (in ~March, like influenza strain selection) and it should be a goal to release updated vaccines before children return to school in late summer.

  • Nuvaxovid’s indication should be expanded to include pediatric use, and Nuvaxovid’s shelf life should be extended from 6 to 9 months, in line with other COVID-19 vaccine products.

Of course, it’s best practice to always use your own words in your comments.

u/Jazzlike-Cup-5336 — 2 months ago