Control Group Eliminated in Study Funded by Vaccine Maker Novavax

On June 7, FDA’s Vaccines and Related Biological Products Advisory Committee will discuss an EUA request for a COVID-19 vaccine manufactured by Novavax.  If the EUA is granted, Novavax will become the fourth vaccine maker permitted to distribute vaccine in the United States.  

The “Novavax COVID-19 Vaccine, Adjuvanted” (aka NVX-CoV2373) claims to be different from any other vaccine on the market. It’s not mRNA, and therefore, not gene therapy.  Instead, it’s a “nanoparticle” covered in spike protein.  The nanoparticle, Novavax’s proprietary protein “Matrix-M,” is thought to better resemble virus than current vaccines.  According to a company press release, “This arrangement mimics nature, helping your immune system recognize that target protein from different angles—the same way that your immune system would see the details of a real pathogen.”

A study recently published in the New England Journal of Medicine, together with its supplementary appendix, presents results of a U.S. phase 3 clinical trial for Novavax vaccine conducted by dividing 25,000 participants into two groups.  One group received the full two-shot vaccine series, and the other group received two placebo injections.

To determine vaccine efficacy, participants were tested for SARS-CoV-2 infection after receiving vaccine or placebo.  Subsequent infection was identified in 77 individuals; most of these were in the placebo group.  Only 14 of these infections were considered “moderate-severe COVID,” and all of these were in the placebo group.  All infected patients recovered.  There were no deaths attributed to COVID in the study.

To study vaccine safety, the researchers solicited reports of adverse effects from participants.  Adverse effects were experienced by nearly 80% of vaccine recipients, four times the rate of placebo.  Most of these adverse events were mild.  The report claims that Novavax is not associated with the types of complications associated with other COVID vaccines:

“No episodes of anaphylaxis, no evidence of vaccine-associated enhanced Covid-19, and no events that triggered prespecified pause rules were observed. No episodes of the Guillain–Barré syndrome and no imbalance in myocarditis or pericarditis or in vaccine-induced immune thrombosis with thrombocytopenia were observed during the relatively short safety follow-up period reported here.”

How short was that safety follow up period?  A mean of two months.

Despite the promise to continue the safety review for 24 months, the authors admit:

“We implemented a blinded crossover approximately 3 to 4 months after the first vaccination series to allow all trial participants to receive NVX-CoV2373, after vaccine efficacy and required safety had been established and reviewed by the data and safety monitoring board.”

This crossover hides any potential long term adverse effects in the control group by eliminating the control group.  To make up for this deficiency, “hazard models have been proposed for subsequent analyses.”

The authors then conclude “NVX-CoV2373 was safe and effective for the prevention of Covid-19.”

The study fails to report an honest cost-benefit analysis.  Although the study legitimately claims Novavax reduces susceptibility to a mild disease, it ignores data showing that cost of this reduction is the likelihood of short-term adverse effects, and it erases the possibility of finding long-term adverse effects which may be more serious than any benefit of taking the vaccine. 

Oh, one more thing.  Guess who is first on the list of supporters funding this study?  Novavax.

Surprised?  Me neither.