By Lambert Strether of Corrente.
As readers know, I stan for nasal vaccines and mucosal immunity generally. So now that I’m sure I’m not gonna stroke out, I’m writing this short post to express my astonishment, dismay, revulsion, and anger that Anthony Fauci — he of the “noble lie” on masking, and the “moving goalposts” on so-called herd immunity — is jumping into nasal vaccine development with both feet, as evidenced by a recent article in Cell, for which Fauci is the corresponding author.[1]
From “Rethinking next-generation vaccines for coronaviruses, influenzaviruses, and other respiratory viruses,” by David M. Morens, Jeffery K. Taubenberger, and Anthony S. Fauci. I will quote the summary in full, interpolating comments:
Viruses that replicate in the human respiratory mucosa without infecting systemically, including influenza A, SARS-CoV-2, endemic coronaviruses, RSV, and many other “common cold” viruses, cause significant mortality and morbidity and are important public health concerns. Because these viruses generally do not elicit complete and durable protective immunity by themselves, they have not to date been effectively controlled by licensed or experimental vaccines.
Oops. Joe Biden, June 2, 2021: “If you’re vaccinated, you are protected.” Jeffrey Zients, June 10, 2021: “If you are fully vaccinated, you are protected.” Anthony Fauci, July 2021: “The broad overall CDC recommendation is that if you are vaccinated, you are protected….” The administration’s messaging was successful; the pervasive “vaxed and done” was the result. (To be fair to Biden, Zients, and Fauci, all of them used qualifying language that you are “protected” against hospitalization and death, but — assuming those hospital-centric, tranmission-encouraging metrics are appropriate, which they are not — “protected” was amplified, the caveats were not, and the public quite reasonably concluded that the Covid vaccines were sterilizing, like others with which they were familiar). More:
In this review, we examine challenges that have impeded development of effective mucosal respiratory vaccines…
Like not being included in Trump’s Operation Warp Speed — or Biden’s Operation Warp Speed 2… Oh, wait, let me correct that — losing precious years of development time, though even I can’t blame Fauci for that, having no evidence. More:
… emphasizing that all of these viruses replicate extremely rapidly in the surface epithelium [see an earlier Cell article] and are quickly transmitted to other hosts, within a narrow window of time before adaptive immune responses are fully marshaled. We discuss possible approaches to developing next-generation vaccines against these viruses, in consideration of several variables such as vaccine antigen configuration, dose and adjuventation, route and timing of vaccination, vaccine boosting, adjunctive therapies, and options for public health vaccination polices.
So, Fauci is pivoting to mucosal immunity hence nasal vaccines; presumably his Flex Net of allies, funders, and sycophants will do so as well.
On the one hand, Fauci’s imprimatur could be good for funding. The driver on “next-generation” vaccine, before Fauci big-footed everybody, was Eric Topol of Scripps Research Translational Institute. Here’s Topol in Science, back in July 2022:
As the virus continues its accelerated ability to evade our immune response and increase its transmissibility, we urgently need to achieve population-wide respiratory mucosal immunity. The objective of breaking the chain of transmission at the individual and population level will put us in a far better position to achieve containment of the virus, no less reducing the toll of sickness and long COVID-19. The prospect of achieving this with nasal vaccines is high but will only be possible with dedicated funding, priority, and breaking down of any regulatory hurdles. While we have waited far too long to take such initiative, a new operation at lightning speed could help us get ahead of the virus and build on the initial success of COVID-19 vaccines.
(Oddly, Topol is not cited in Fauci et al., supra., although there are plenty of other citations on policy.) If the effect of Fauci blessing nasal vaccines is funding for Topol’s “operation at lightning speed,” that can only be good, right?
On the other hand, Fauci has form, and there’s every indication that whatever he does will be a complete and utter debacle, thereby ruining (at least for the benighted population of the United States, as opposed to Big Pharma) a technology that could promise — crossed fingers, certainly — a way out of the pandemic. Shorter Fauci: “I got it badly wrong once. Now give me and my buddies more money!”
Because I am very pressed temporally, I cannot go through the Cell paper in full. However, this passage on public policy caught my eye. From Table 2:
(6) Public health considerations relating to next-generation respiratory vaccines [including those for SARS-CoV-2] must contribute to shaping vaccine design, including vaccine schedule, role of boosting, frequency of vaccination and duration/completeness of protection, side effects, and public acceptance
Because Fauci did so well on public acceptance the last time around, right? More importantly, this paragraph seems to envision starting United States nasal vaccine development from the ground up, ex nihilo, on a “green field,” in a clean room, or pick your own “blank slate” metaphor. But why do that? MR SUBLIMINAL ***cough*** So Big Pharma owns the IP ***cough*** Does NIH stand for “Not Invented Here”? Consider an alternative: Among the obvious “possible approaches” that could take place with immediate effect would be for the US government to purchase Bharat’s already developed and manufactured iNCOVACC nasal vaccines (see note 1) in bulk. Or — total dark horse, here — they might purchase Thailand’s already developed and manufactured COVITRAP “evening before” nasal spray. BWA-HA-HA-HA-HA- HA-HA!!!! Who am I kidding? (Oddly, neither iNCOVACC nor Bharat appear in Fauci et al.)
Though it hurts me to be fair to Fauci, he did telegraph his punch. From Goverment Executive:
Fauci stated specifically, “I am not retiring” now. “After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field,” Fauci continued. “I want to use what I have learned as NIAID director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.” Fauci said he will assist with the transition over the coming months at NIAID.
And I guess we now know what the next phase of Fauci’s career will be. From Science, just after Fauci anounced his departure from public life both NIAID and his post as the chief medical adviser to President Joe Biden:
Q: What do you want to accomplish between now and December?
A: I’d like to guide the good research being done in the arena of both mucosal, nasal vaccines for respiratory diseases, as well as more durable vaccines that protect against entire families of viruses. I’m a pusher. We meet as a group at least three, four times a week and I go OK, what are we doing? I try to be not a pain in the ass, but I’d like to keep my foot on the pedal between now and then to keep that thing going.
< Fauci is a vile individual who lies freely without consequence (not, sadly, unknown in the public health field). Couldn’t Fauci have gone for walks in the woods and gotten plotzed on Chardonnay? At long last, has Fauci no decency?
NOTES
[1] Far be it from me to attribute a commercial motive to [genuflects] the good doctor, but finally we have a study on Bharat’s nasal vaccine, iNCOVACC, in a top-drawer Western medical journal. From the Lancet, “Immunogenicity and Tolerability of BBV154 (iNCOVACC®), an Intranasal SARS-CoV-2 Vaccine, Compared with Intramuscular Covaxin® in Healthy Adults: A Randomised, Open-Label, Phase 3 Clinical Trial” (January 31, 2023). Note that iNCOVACC is already being manufactured and distributed in India. From the Lancet:
Background: Unlike intramuscular vaccines, intranasal COVID-19 vaccines may generate mucosal immunity, which may be critical for to prevent infection and human-to-human transmission. We report interim immunogenicity and safety of an intranasal adenoviral vectored SARS-CoV-2 vaccine (BBV154, iNCOVACC®) in healthy adults compared with licensed intramuscular vaccine (Covaxin®).
Methods: In this open-label, multicentre, phase 3 clinical trial, healthy Indian adults were randomised to receive either two doses of BBV154 (n = 3,000) or Covaxin® (n = 160) 28 days apart. Primary immunogenicity outcome was geometric mean neutralisation antibody titres (PRNT50) against SARS-CoV-2 viruses; key secondary outcomes were safety and solicited adverse events, secretory-IgA and serum-IgA responses and cell-mediated immune responses.
Findings: We screened 3,209 volunteers between April 16 and June 4, 2022 and enrolled and randomised 3,160 to receive BBV154 (n = 2998) or Covaxin (n = 162). On Day 42, 14 days after the second dose, serum GMTs against ancestral (Wuhan) SARS-CoV-2 were 769 (95% CI: 665‒888) and 531 (426‒662) in BBV154 and Covaxin groups. The GMT ratio of 1·45 (95% CI: 1·11‒1·88) met the pre-defined superiority criterion for BBV154 over Covaxin. BBV154 also elicited a higher serum neutralising GMT [171 (137–213)] against Omicron BA.5 than Covaxin [82·4 (48·9–139)]. Similarly, at day 42 GMTs of secretory IgA were 12·3 (95% CI: 8·7 ‒17·4) and 6·6 (95% CI 4·6 ‒9·5) after BBV154 and Covaxin; BBV154 was superior to Covaxin with a GMT ratio of 1·9 (95% CI 1·1–3·0). BBV154 induced higher serum IgA titres and significantly higher levels of antibody-secreting plasmablasts on Day 42. Both vaccines induced equivalent T cell memory responses. Both vaccines were well tolerated, systemic adverse events were reported by 2·7% (82/2990) of BBV154 recipients and 6·2% (10/161) of Covaxin vaccinees. Nasal reactions were experienced by 4·9% (146/2990) of BBV154 participants, whereas 23·0% (37/161) of Covaxin® vaccinees experienced local injection site reactions.
Interpretation: Two intranasal doses of BBV154 were well tolerated with no safety concerns while eliciting superior humoral and mucosal immune responses compared with two intramuscular Covaxin injections. Further studies to assess the effect of BBV154 on infection and transmission are warranted.
Perhaps readers who can read The Great Runes better than I can will interpret the findings. However, what leaps out at me is that Bharat is willing to cannibalize its own intramuscular product in favor of a nasal vaccine. That, to me, implies confidence that Bharat can, well, eat Pfizer and Moderna’s lunch. It’s not hard to see that Fauci — who, let us remember, ramped both Gilead’s remdesivir (later shown to be inffective) and Pfizer’s vaccine as well (based on a press release ffs) — would regard this outcome as suboptimal, and would work to prevent it.
APPENDIX
For those who came in late, a collective portrait of our public health establishment, with Fauci at bottom right the allusion (“Easter egg”) in the headline:
