The VACCINES which are APPROVED UNDER 'ACCELERATED' APPROVALS. What is that? It is approved based on a 'surrogate endpoint.'

This is a approved based on a surrogate endpoint with NO MEASURE OF CLINICAL BENEFIT.

“The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit.’

https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program#:~:text=The%20FDA%20instituted%20its%20Accelerated,based%20on%20a%20surrogate%20endpoint.

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit.

BUT IF NO BENEFIT IS DETERMINED THERE ARE PROCEDURES THAT COULD LEAD TO DELISTING THE VACCINE.

ok.

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

Infectious Disease Indications Accelerated Approvals

• Ongoing (excluding vaccines)

• Verified Clinical Benefit (excluding vaccines)

• Ongoing (vaccines)

• Verified Clinical Benefit (vaccines)

• Withdrawn

Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals

• Ongoing

• Verified Clinical Benefit

• Withdrawn

Cancer Accelerated Approvals

• Ongoing

• Verified Clinical Benefit

• Withdrawn

• Other

I will list below the Vaccines which got this ‘ACCELERATED APPROVAL’ BELOW.

CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)

For active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.

IXCHIQ (Chikungunya Vaccine, Live)

Active immunization for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus

IXCHIQ (Chikungunya Vaccine, Live)

Active immunization for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus

Prevnar 20 (pneumococcal 20-valent conjugate vaccine)

For active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older and the prevention of pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)

To add prevention of oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV)

Fluad Quadrivalent (influenza vaccine, adjuvanted)

For active immunization of persons 65 years of age and older against influenza disease caused by seasonal influenza virus subtypes A and types B

Fluad (influenza virus vaccine, adjuvated)

For active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.

Vigiv 2 (vaccinia immune globulin intravenous (human))

Treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination: eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions, aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.

https://www.fda.gov/drugs/accelerated-approval-program/ongoing-infectious-disease-accelerated-approvals-vaccines

Thank-you for your continued support. Please share with those school administrators pushing Gardasil 9 on our youth.

Based on a ‘surrogate endpoint’.