Novavax , Your Heart and Pregnancy
After seeing this I did a very quick scan of the
FDA Briefing Document for Novavax COVID-19 Vaccine
https://www.fda.gov/media/158912/download#page=75
There are a few interesting nuggets here.Like with J&J’s Janssen and Astra Zeneca Vaccines, FDA will sometimes do its job in a limited hangout fashion if it can make its favorite sons (Pfizer and Moderna) look better by comparison
The primary source of clinical data to support the EUA request is from Study 2019nCoV-301, which provides safety, immunogenicity, and efficacy data from a total of approximately 30,000 adult participants (including from the United States) randomized 2:1 to receive 2 intramuscular injections of either NVX-CoV2373 (n=19,735) or placebo. NVX-CoV2373 vaccine drug product (DP) administered in this study was manufactured at Par Sterile Products, LLC.
The first point is this is a sub-unit vaccine meaning it uses 5 micrograms of spike protein with 50 micrograms of an adjuvant. Its basically a traditional vaccine. No transfection of cells from LNP/virus and no genetic material (mRNA or DNA). Sounds good except we know the spike protein is a nasty bugger.
An interesting observation is that while we know how much mRNA is in the Pfizer (30 micrograms) and Moderna (100 micrograms) vaccines for adults in the primary series. We still don’t know how much spike protein gets made with each dose.
Certainly the mRNA makes at least its weight in spike protein since it makes multiple numbers of protein before its degraded. This means they should have far more spike protein than Novavax.
On the surface, Novavax looks like it should be far safer than mRNA vax although the adjuvant is the big unknown.
The adjuvant is what triggers the alarm bells for your immune system to go into action against the spike protein (otherwise it would just ignore it or at least not mount a sufficient response to make antibodies).
mRNA vaccines supposedly do not need an adjuvant since it transfects your cells. However, the LNP is believed to operate as an adjuvant due to the fact it causes inflammation, and is probably needed because the pseudouridine in the modified mRNA is opaque to the cells TLR’s which dampens the immune response.
Myocarditis.
Somehow while Pfizer and Moderna could not detect much if any myocarditis in its Clinical Trials, Novavax did. Six cases of Myocarditis/Pericarditis for the Vax vs 1 for the Placebo. Comes out to 1/3500 participants for the Vax group vs 1/10,000 for the placebo group (if I read it right).
This passes the sniff test since its about whats seen from Pfizer and Moderna in use (too bad their trials missed it, maybe a Grand Jury can be convened to find out if fraud was involved).
Here is what the FDA says
“The Spike protein antigen can induce antibodies to SARS-CoV-2 spike glycoproteins that cross-react with myocardial contractile proteins, including myocardial α-myosin heavy chain (Vojdani and Kharrazian, 2020). It has been postulated that the effect of these antibodies, influenced by hormonal differences, immune–genetic background, age, and sex are potential mechanisms of myocardial injury associated with SARS-CoV-2 infection or COVID-19 vaccination (Heymans and Cooper, 2022)
Nothing new there, it was just refreshing to hear them say so directly
Medically Attended Adverse Events (MAAE’s).
That means you need a Doctor or hospital. Not good.
“MAAEs and related MAAEs was comparable across the treatment arms (5.8% and 0.5%, respectively, in the NVX arm and 5.7% and 0.3%, respectively, in the placebo arm).”
So you have a 5% chance of needing a Doctor after taking a shot to prevent an infection which rarely requires a Doctors visit for most people?
Death
“As of September 27, 2021, 11 (<0.1%) participants in the NVX arm and 5 (<0.1%) participants in the placebo arm died in the pre-crossover period.
One death in the placebo arm (myocardial infarction) was assessed by the investigator as related to trial vaccine, and no deaths in the NVX arm were assessed by the Sponsor as related to trial vaccine.”
There were twice as many in the vax group as the placebo group so double the death rate in the vax group is expected. However, the background death rate over 3 months in a group representative of the population at large would be 50 for the vax group and 25 for the placebo group. So these groups are much healthier than the population at large
How the investigator rules the vaccine is not responsible for death without autopsy is not explained . How they determined the placebo was responsible in one case is also of interest, assuming it was saline (they don’t seem to say so maybe it wasn’t saline)
Deaths in the NVX arm included cardiac arrest (n=5), myocardial infarction, toxicity to various agents, accidental overdose, cerebrovascular accident (CVA), gunshot wound, and septic shock. Deaths in the placebo arm included cardiac arrest (n=3), myocardial infarction, and COVID-19 pneumonia.
Pregnancy
Now for the most important finding IMO, although its cleverly disguised.
A summary table of pregnancy outcomes was provided by the Sponsor in their briefing document; however, source data was not provided, and FDA is unable to verify this data.According to the Sponsor, as of 15 March 2022, a total of 147 pregnancies were reported across the entire period of the clinical studies in participants who received NVX-CoV2373.
I don’t understand. How hard would it be for FDA to say fine. Lets put all this on hold until you show us the FOOKING data.
You can be sure that if the data was supportive of use in pregnancies it would already have been provided .
I’ll explain later why this is important.
See anything alarming?
Here is what they say
“For each time period of vaccine exposure relative to the last menstrual period, the rate of miscarriage appears consistent with expected background rates in the general population; however, information on the timing of pregnancy loss and risk factors was not provided by the Sponsor. The available data are insufficient to establish the presence or absence of vaccine- associated risk during pregnancy.”
Are they kidding me?
“timing of pregnancy loss and risk factors was not provided by the Sponsor. “
Why not?. The trial has a 2 year follow up.So follow up and get the data.
The rate of miscarriage that appears consistent with expected background rates in the general population is generally accepted to be somewhere between 11-22%. Its a pretty wide range for some reason but almost all miscarriages occur in the first 20 weeks
Ignoring voluntary termination and ectopic pregnancy, we have 122 pregnancies.
So 25/122 gives 20.4% miscarriage rate. Thats pretty close to the upper limit of acceptability but thats only assuming all 122 were vaccinated within the first 20 weeks of pregnancy and with 56 pregnancies with live births as of March 15, 2022 thats unlikely. Its reasonable to assume most of the 56 ongoing pregnancies were not vaccinated in the first 20 weeks of pregnancy.
That means of 81 pregnancies, 56 of which are ongoing, with 41 live births (many of whom likely had been vaxxed early in term) and those ongoing pregnancies likely vaccinated late in term (so ignored), we have a possible miscarriage rate up to 38% (25/[41+25] )
Information of the timing not being provided is quite a convenient excuse . Again, how hard could it be to get it?
Also, where is the data for the placebo group? Only the blinded vaccine group could get pregnant? What exactly was in that placebo? An anti HcG vaccine?
Breakthrough Transmission
And lastly they acknowledge this:
Available data for COVID-19 vaccines currently in use has demonstrated that effectiveness against asymptomatic infection is lower and less durable than effectiveness against symptomatic COVID-19.
Available data also do not indicate high-level or durable effectiveness against transmission of SARS-CoV-2 from vaccinated individuals with breakthrough infections.
Data for these outcomes are not currently available for NVX-CoV2373, it is more likely than not that the observations with other COVID-19 vaccines (with similar antigens and routes of administration) will apply to this vaccine as well.
I am sure there are more interesting things here if I had the energy to look, but I dont.
Now why do we need the Pregnancy data?
Many pregnant women are getting vaccinated despite the manufacturers never stating the vax was safe and effective for pregnant women. Neither has FDA although they cleverly state there is no evidence to contraindicate it.
CDC originally left it up to the patient and Doctor. But now:
Of course, many hired guns also went out and did the dirty work while FDA, Pfizer and Moderna kind of danced around the issue
And the “American College of Obstetricians and Gynecologists” (ACOG) recommends that all eligible persons aged 12 years and older, including pregnant and lactating individuals, receive a COVID-19 vaccine or vaccine series.
Another Non-Profit telling Doctors what to recommend.
According to the CDC about 20% of pregnant women are getting vaccinated during Pregnancy.
https://media.nature.com/original/magazine-assets/d41586-022-00031-8/d41586-022-00031-8.pdf
Thats lower than I expected. Good job Moms.
While data and studies on recent miscarriage rates are hard to come by we do have a small safety signal something is happening
The preterm birth rate rose 4% in 2021 to 10.48%, from 10.09% in 2020. The 2021 rate is the highest reported since at least 2007 (10.44%). The percentage of infants born preterm (births at less than 37 completed weeks of gestation) fell 8% from 2007 (the first year for which national data are available based on the obstetric estimate of gestation ) to 2014, rose 7% from 2014 (9.57%) to 2019, and declined 1% from 2019 to 2020 .
Increases of 4% were observed in both early preterm births (less than 34 completed weeks of gestation) and late preterm births (34–36 weeks) from 2020 to 2021 . The early preterm rate rose from 2.70% to 2.81%, the highest level reported since 2011 . The late preterm rate rose to 7.67% from 7.40%, the highest level reported since at least 2007
https://www.cdc.gov/nchs/data/vsrr/vsrr020.pdf
There is one study worthy of note.
Receipt of mRNA Covid-19 Vaccines and Risk of Spontaneous Abortion
In the sensitivity analysis, under the extreme assumption that all 65 participants (lost to follow up) with most recent contact during the first trimester had a spontaneous abortion, the cumulative risk of spontaneous abortion from 6 to less than 20 weeks of gestation was 18.8% (95% CI, 16.6 to 20.9); after age standardization, the cumulative risk was 18.5% (95% CI, 16.1 to 20.8).
About 10–15% of all natural pregnancies end in recognized spontaneous abortions ( Wilcox et al ., 1981 ; Risch et al ., 1988 ; Nybo Andersen et al ., 2000 ; De La Rochebrochard and Thonneau, 2002)
The study claimed 11-22%
https://www.nejm.org/doi/full/10.1056/NEJMc2113891
So if you believe 11-22% is the correct number it seems ok ignoring the preterm birth increases (although we don’t know if the development is affected).
If the true maximum is closer to 15% then we may be looking at up to 40% increase in spontaneous abortion (miscarriage) rates
There is still the unknowns as regard to affects on fertility. That will take some time and Monkey Pox no doubt might reduce Fertility Rates and confound any analysis depending on how much Fear Porn they sell.