21 USC 360bbb-3 stipulates the rules for the authorization of emergency use of the unapproved products that are still under clinical trial i.e.:
Pfizer, May 2nd 2023;
Moderna, Oct 27th 2022;
AstraZeneca, Feb 14th 2023.
Johnson & Johnson, Jan 2nd 2023.
The Secretary of Health & Human Services is required to:
1. declare SARS-CoV-2 & COVID to be a public health emergency that affects national security or the security & health of citizens overseas www.phe.gov Latest Renewal
2. assess that the products provide more benefits (against SARS-CoV-2 & COVID) than risks
3. determine that the vaccines are the only means to address SARS-CoV-2 & COVID
4. provide the scope of authorization
5. inform
(I) the health care professionals, providing the product
(II) the individuals, receiving the product
of the following:
(a) the products' emergency use authorization
(b) the products' benefits & risks (known, potential & the extent of the unknowns)
(c) available alternatives & their benefits & risks
(d) that individuals have the option to accept or refuse the products
& of any consequences of refusing the product
6. appropriately monitor and report adverse events associated with the emergency use of the product
7. periodically review the circumstances and the appropriateness of the EUA.
8. revise or revoke an authorization under this section if:
(a) the circumstances no longer exist;
(b) the criteria are no longer met; or
(c) other circumstances make such revision/revocation appropriate to protect public health/safety.
Post-EUA, we now have more information as well as questions:
- Gain of function ie Bioweapon research
- Pandemic statistics
- Spike protein effects
Chimeric Recombinant Virus & Spike Protein?
Furin Cleaves Spike Protein & FREES S1 - What happens to Free S1?
Does it travel & cross the blood brain barrier?
Do free S1s become enveloped by exosomes and get breathed out & transmitted to other people?
mRNA / DNA vaccine platform
- track record: year research began
- no. of products approved prior to 2020
- any issues in bringing products to market prior to 2020?
Ingredients
eg PEG LNPs
-GO-coated=cytotoxic?
-allergenic?
mRNAs for producing spike proteins
-bio-distributed?
-"Off" switch?
Spike proteins
-cytotoxic?
-bio-distributed?
-cleared after x months?
Sterilizing vs non-sterilizing immunity
-Boosters?
-Marek's Disease
ADE risks?
Adverse Effects
Israel Myocarditis Data
Among 304 persons with symptoms of myocarditis,
21 had received an alternative diagnosis.
142/283 the remaining cases occurred after receiving the BNT162b2 vaccine;
of these cases, 136 diagnoses were definitive or probable.
The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal.
The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among
male recipients aged 16 - 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46).
As compared with the expected incidence based on historical data,
the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients aged 16 and 19 years (13.60; 95% CI, 9.30 to 19.20).
The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons,
was 2.35 (95% CI, 1.10 to 5.02);
the rate ratio was again highest in
male recipients aged 16 - 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.
Link to Writings On The Wall
there doesn't seem to be anything here