Bivalent Vaccines Up to Bat: a Swing and a Miss

SARS-CoV-2 Easily Mutates Away from Newest mRNA Products

By Peter A. McCullough, MD, MPH

The US government vaccine program led by the CDC and FDA selected mRNA vaccines that contained genetic code for the original (long extinct) Wuhan wild-type strain (50%) and Omicron BA4/BA5 subvariant (50%).  These products were purchased before the failed animal studies were completed.  The FDA who is conflicted as a sponsor of the vaccine program, approved the products based upon a surrogate antibody elevation against BA4/BA5.  Within a few short months, as depicted by the CDC Nowcast system, BA4/BA5 are on their way out giving way to BQ.1 and BQ1.1.[i] 

This has been an accurate and helpful part of the CDC’s effort to inform the public and scientists on the outbreak: “To identify and track SARS-CoV-2 variants, CDC uses genomic surveillance. CDC's national genomic surveillance system collects SARS-CoV-2 specimens for sequencing through the National SARS-CoV-2 Strain Surveillance (NS3) program, as well as SARS-CoV-2 sequences generated by commercial or academic laboratories contracted by CDC and state or local public health laboratories. Virus genetic sequences are analyzed and classified as a particular variant. The proportion of variants in a population are calculated nationally, by HHS region, and by jurisdiction. The thousands of sequences analyzed every week through CDC’s national genomic sequencing and bioinformatics efforts fuel the comprehensive and population-based U.S. surveillance system established to identify and monitor the spread of variants.” 

So Nowcast is telling us the emerging dominant strains are BQ.1 and BQ.1.1 subvariants, known to have enhanced ability to fuse with the human ACE-2 receptor, dictated by the N460K mutation which is the principle site for antibody neutralization.[ii]   Qu et al have recently demonstrated that sera from patients with BA4/BA5 had very poor antibody defenses against BQ.1 and BQ.1.1.  The authors concluded: “The perpetual emergence of SARS-CoV-2 variants with enhanced immune escape continues to threaten public health. Monitoring the immune escape of emerging variants will be critical to improving mRNA vaccine reformulation, assessing new broader coronavirus vaccine candidates, as well as directing ongoing public health measures.” 

This is a politically correct way of saying the new vaccines are essentially obsolete just a few months after their debut.   Is it possible the bivalent vaccines prompted this mutational shift?   Given the low public (<10.1%) uptake, it is unlikely they have applied ecologic pressure on the virus. 

To summarize, the US government just stuck out with a big expensive swing and a whiff against SARS-CoV-2 mutating away with BQ.1/BQ.1.1!

If you find “Courageous Discourse” enjoyable and useful to your endeavors, please subscribe as a paying or founder member to support our efforts in helping you engage in these discussions with family, friends, and your extended circles.

---

[i] CDC Nowcast System Accessed November 14, 2022

[ii] Qu P, Evans JP, Faraone J, Zheng YM, Carlin C, Anghelina M, Stevens P, Fernandez S, Jones D, Lozanski G, Panchal A, Saif LJ, Oltz EM, Xu K, Gumina RJ, Liu SL. Distinct Neutralizing Antibody Escape of SARS-CoV-2 Omicron Subvariants BQ.1, BQ.1.1, BA.4.6, BF.7 and BA.2.75.2. bioRxiv [Preprint]. 2022 Oct 20:2022.10.19.512891. doi: 10.1101/2022.10.19.512891. PMID: 36299423; PMCID: PMC9603827.