Fact check: Novavax is safe and effective against Omicron.
It is probably no safer than the other vaccines, but there is no evidence at all that it's effective against Omicron.
IS NOVAVAX SAFER? UNKNOWN. AND IT MAY BE INEFFECTIVE AGAINST OMICRON
When I heard Novavax was available in Australia I considered getting vaccinated to keep my job. It is not an mRNA vaccine. But at that stage, they had not allowed Novavax to be used as a booster, which meant I would still have had to take an mRNA booster shot, something I have been very reluctant to do, not wishing to be coerced into being an experimental test subject.
In early March Novavax was approved as a booster by the TGA in Australia.
But looking at the third phase trials which took place before June 2021, the Novavax vaccine may actually be less safe than the other vaccines, because out of 7500 people who took the vaccine there was actually one case of myocarditis; though it was not a serious adverse event, according to the study authors.
Of course, this assumes that the reported rates of myocarditis from the other vaccines are the actual rates, and are not underestimated or under-reported as Steve Kirsch thinks they are.
The main question still remains, though, for the current wave: Novavax’s effectiveness against Omicron is completely unknown.
NOT MUCH INFORMATION
There were actually not many studies into Novavax safety and efficiency that I could find on google scholar. By the time I got to the third page they were all citations.
In Novavax’s third phase trials, though, one of only a handful of studies, there was one death from Covid seven days after the first dose, and one death from Covid in those people who took the placebo.
I know they say it takes 14 to 21 days for the vaccine to kick in, but I think there is a large question about whether any or all of the vaccines might cause people to be more likely to catch Covid in the first 21 days, which is a possibility with the vaccines that hasn’t been ruled out to my knowledge, not just with Novavax; and is supported by the suppressed Pfizer trial data.
WE KNOW NOTHING ABOUT NOVAVAX’S EFFECTIVENESS AGAINST OMICRON
But the biggest limitation of the Novavax third phase trials in retrospect is that they do not tell us anything about how effective Novavax is against Omicron; indeed, not even against Delta or Beta, for in their third phase trials the virus variants were not even sequenced and a proxy was used instead to distinguish between Alpha and other unnamed/unknown variants.
MYOCARDITIS
According to various studies the reported rate of myopericarditis caused by the vaccines (temporarily associated) is somewhere around 1 in 10,000 (see links to studies in the references) although some people believe it to be higher in fact; many cases might not be reported, particularly if the person is sedentary (my hypothesis is that the myocarditis tends to be noticed particularly in people who are highly athletic). The Novavax third phase trial gave the vaccine to 7500 people, and this resulted in 1 case of myocarditis in which “the participant had a full recovery after 2 days of hospitalization”. In the study they say this myocarditis case was not a serious adverse event; nonetheless 1 in 7500 though indicates a higher rate of myocarditis than the reported rate of other vaccines, including the Pfizer trial data that was initially suppressed. What would be interesting to know is the age of the myocarditis case in the Novavax trials - myocarditis caused by the vaccine occurs most commonly in teenagers. Myocarditis in the general population occurs more frequently in the general population aged 20-40, although the timing of the case indicates the vaccine is the probable cause.
They followed the participants for 3 months after the second dose; it would also be interesting to know follow up they did on their patient with myocarditis to ensure it was actually a mild adverse event and not something that proved to be a chronic ongoing condition.
The initial trials showed the vaccine while effective against Alpha was only 60% effective against the “South African variant” - but this refers to the Beta variant first discovered in South Africa - not the Omicron variant.
Novavax themselves reported the results of the third trials of their vaccines, first published in June 2021 but for some reason in the journal is dated September 2021, both dates before the emergence of Omicron.
A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups.
They found the vaccine was 86.3% effective against Alpha and 96.4% against ‘other variants’ - but they apparently never sequenced the variants, instead using a proxy. Since they did not sequence the viruses, they do not even know how many people had Delta; all they knew was how many people had Alpha, and how many had something else that was not exactly Alpha.
A further limitation of the current trial is the lack of sequencing data on viral isolates, although the use of S-gene target failure, as detected by the TaqPath assay, has proved to be a reliable proxy for the presence of B.1.1.7 variants.
Also since there are only 7500 people who actually took the vaccine…
This trial has several limitations. Although approximately 7500 participants received NVX-CoV2373, it is not possible to exclude the occurrence of rare adverse events. However, such events may be captured through the ongoing follow-up of participants, which is planned to continue until 12 months after the administration of the second dose of vaccine and is also being assessed in the larger PREVENT-19 phase 3 trial (ClinicalTrials.gov number, NCT04611802. opens in new tab). The PREVENT-19 trial was also able to enroll a larger number of participants in racial and ethnic minority groups, whereas only 5.7% of participants in the current trial were non-White. Similarly, the efficacy estimates reported here are derived from a relatively short duration of observation (median, 3 months after dose 2). Thus, the ongoing follow-up will provide data regarding the durability of vaccine efficacy, a continued assessment of severe cases, and an assessment of efficacy against asymptomatic disease.
SELF-COMMENDATION IS NO RECOMMENDATION.
The greatest limitation of this study is obviously that it was conducted by Novavax themselves, who were desperate to get their drug onto the market at this stage.
One could perhaps be forgiven for suspecting that the outcome of the third phase trials was predetermined to make the 60% effectiveness towards the beta variant signal disappear, that was noted in the initial trials. Since they didn’t sequence the variants, what variant other than Alpha was present is completely unknown.
That there was one death from Covid in both the vaccine group and the placebo group calls into question the effectiveness of the vaccine, although the death in the vaccine group occurred within 7 days.
But the other main limitation of this study is that it was conducted before the emergence of the Omicron variant; something the study authors obviously couldn’t help.
There was another study with 2878 participants that looked at third booster shots; none of the participants had taken Novavax as shot 1 or shot 2, and this was published in December 2021 and Omicron variant was not tested for either.
NOVAVAX SHOULD BE SAFER
Novavax should theoretically be safer, because it is a sequenced protein based vaccine, not an mRNA vaccine. It contains the whole spike protein, though, unlike Petrovsky’s vaccine which contains only part of it with some protein from a different part of the virus. Happily the scientists who made Novavax mutated the furin cleavage site, which is the part of the spike protein that made the Alpha and Delta variant particularly efficient at binding with cells in the lungs and airway, and is the most dangerous part.
The SARS-CoV-2 S-gene (MN908947.3, nucleotides 21563–25384) encoding the full-length 1273 amino acid spike protein was used as a backbone to produce spike protein variants. The BV2365 single mutant was generated by mutating the putative furin cleavage site 682-RRAR-685 to 682-QQAQ-685, and the NVX-CoV2373 double mutant was generated with 682-QQAQ-685 and two proline substitutions at residues K986P and V987P (Fig. 1a). Synthetic full-length wild-type (WT), the single mutant BV2365, and double mutant NVX-CoV2373 genes were codon optimized for insect cells and cloned into recombinant baculovirus for expression in Sf9 cells.
WHY TAKE IT IF IT IS NOT KNOWN WHETHER IT CAN PREVENT OMICRON?
But despite being safer theoretically speaking, this is not necessarily demonstrated in the data.
And the initial trial begs the question, why even take a vaccine that might only be 60% effective against the Omicron variant, or maybe even less, since it’s way further down the Covid family tree than Beta?
BIBLIOGRAPHY
THE DESIGN OF THE NOVAVAX VACCINE
https://www.nature.com/articles/s41467-020-20653-8
NOVAVAX INITIAL TRIALS
Covid-19: Novavax vaccine efficacy is 86% against UK variant and 60% against South African variant BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n296 (Published 01 February 2021)
THIRD PHASE TRIALS
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine Paul T. Heath, F.R.C.P.C.H., Eva P. Galiza, M.B., B.S., David N. Baxter, M.D., Ph.D., Marta Boffito, M.D., Ph.D., Duncan Browne, M.D., Fiona Burns, Ph.D., David R. Chadwick, Ph.D., Rebecca Clark, M.B., Ch.B., Catherine Cosgrove, Ph.D., James Galloway, Ph.D., Anna L. Goodman, D.Phil., Amardeep Heer, M.B., Ch.B., et al., for the 2019nCoV-302 Study Group* Originally published June 2021 N Engl J Med 2021; 385:1172-1183 DOI: 10.1056/NEJMoa2107659
OVERVIEW OF THE JOURNEY OF THE VACCINE
https://www.bmj.com/content/375/bmj.n2965.full
A STUDY LOOKING AT THIRD SHOT BOOSTERS.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02717-3/fulltext
PHILLIPINES CLINICAL ASSESSMENT OF NOVAVAX EFFECTIVENESS
MYOCARDITIS RATES
estimates the rate of myocarditis:
possible incidence of 0.008% in adolescents aged 16-17 years and 0.01% in those aged 12-15 years following the second dose
https://www.nejm.org/doi/full/10.1056/NEJMoa2110475
https://jamanetwork.com/journals/jama/fullarticle/2782900
https://jamanetwork.com/journals/jamacardiology/fullarticle/2781602
https://jamanetwork.com/journals/jamacardiology/fullarticle/2783052
https://jamanetwork.com/journals/jama/fullarticle/2788346
https://nationalpost.com/news/canada/university-of-ottawa-heart-institute-myocarditis-study
PFIZER DOCUMENTS RELATING TO SIDE EFFECTS
https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf