Biologics, Know What You are Signing
When it comes to signing papers in the clinic, hospital or emergency room, medical jargon can sometimes be confusing and even overwhelming. This is especially true if you or a loved one ends up needing emergency care. Papers are thrust into your hands, with pressure to immediately sign, not comprehending what you are agreeing to.
Medical terms can be deceptive. The term “biologics” is one of those medical terms that many aren’t familiar with.
You may see the term “biologics” and not given it much notice. However, this term covers many different treatments and medications.
The focus of this paper is on biologic vaccines, the review process of vaccines, how vaccines are fast tracked and a review of the PREP act.
What are biologics? (AKA as biologic therapies, biopharmaceuticals)
Biologics are a class of drugs derived from living organisms or contain components of living organisms. They include a wide range of products such as:
- Vaccines
- Blood and blood components,
- Allergenics,
- Gene therapy,
- Tissues
Examples of Biologics
- Humira (adalimumab): Used to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, ulcerative colitis, ankylosing spondylitis, and uveitis.
- Enbrel (etanercept): Used to treat psoriasis and rheumatoid arthritis.
- Biologic vaccines are a subset of biologic drugs that are designed to elicit an immune response to prevent or treat infectious diseases. These vaccines are derived from living organisms and can include a variety of types, such as inactivated or live-attenuated viruses, protein subunits, and more recently, mRNA vaccines.
Examples of Biologic Vaccines
- Measles, Mumps, Rubella (MMR) Vaccine:
- Varicella (Chickenpox) Vaccine
- Influenza Vaccine
- Hepatitis B Vaccine:
- Human Papillomavirus (HPV) Vaccine
- mRNA Vaccines: COVID-19 Vaccines (Pfizer-BioNTech and Moderna): These vaccines use mRNA technology to instruct cells to produce the spike protein of the SARS-CoV-2 virus. (2)
Approved mRNA Vaccines
- Pfizer-BioNTech COVID-19 Vaccine (Comirnaty):
Initially granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) in December 2020.
Received full FDA approval for individuals aged 16 and older in August 2021.
Updated versions of this vaccine have been approved to target new variants, including the Omicron variant XBB.1.5 for the 2023-2024 season
- Moderna COVID-19 Vaccine (Spikevax):
Initially granted EUA by the FDA in December 2020.
Received full FDA approval for individuals aged 18 and older in January 2022.
Other mRNA Vaccines in Development
In addition to the approved COVID-19 vaccines, there are numerous mRNA vaccines in various stages of development for other diseases, including:
- HIV: mRNA vaccines for HIV are in clinical trials
- Influenza mRNA Vaccine: Currently in clinical trials
- Zika Virus mRNA Vaccine: In development to prevent Zika virus infections,
- Rabies mRNA Vaccine: Being researched as a potential new method to prevent rabies
- Cancer: Personalized mRNA cancer vaccines are being developed to target specific tumor antigens. (2)
Vaccine Approval Process
The average timeline to have a vaccine approved for use is anywhere between 10 and 15 years.
(Unless the vaccine has been Fast Tracked-see below)
- Discovery Research: (2-5 years)
- Preclinical Stage: (2-3 years)
The vaccine is tested in laboratory settings and on animals to assess its safety and potential efficacy.
- Clinical Development:
- Phase I: (1-2 years) Tests the vaccine on a small group of 20-80 healthy volunteers to assess safety and dosage.
- Phase II: (2-3 years) Involves several hundred volunteers to further evaluate safety and the immune response.
- Phase III: (5-10 years) Conducted on thousands of participants to confirm efficacy and monitor for adverse reactions.
- Regulatory Review and Approval: (up to 2 years)
- The regulatory body, such as the FDA in the United States or Health Canada in Canada, reviews all the data from the clinical trials.
- Manufacturing and Distribution:
Once approved, the vaccine is manufactured in large quantities and distributed.
- Post-Marketing Surveillance:
- After approval, the vaccine undergoes monitoring for safety and effectiveness through systems like the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink.
(By the way, the most reported VAERS was the Pfizer COVID-19 vaccine to have the most adverse reactions.
Adverse reactions included pain at the injection site, fatigue, headache, and dizziness. Serious adverse events included anaphylaxis, myocarditis, and pericarditis.)
Fast Track Designation
Fast Track is a designation by the FDA to expedite the development and review of drugs and vaccines that address unmet medical needs for serious or life-threatening conditions. The Fast Track process includes:
Rolling Review: Allows the submission of sections of the BLA as they are completed, rather than waiting for the entire application to be finished.
Frequent Communication: Early and frequent interactions between the FDA and the sponsor to resolve issues quickly and efficiently.
Priority Review: The application is usually reviewed within six months
Circumstances for Fast Tracking
A vaccine can be fast-tracked if it meets the following criteria:
Serious Condition: The vaccine is intended to treat or prevent a serious or life-threatening condition.
Unmet Medical Need: There are no existing treatments, or the new vaccine shows potential to offer significant improvement over existing treatments.
Examples of Fast-Tracked Vaccines
COVID-19 Vaccines:
- Pfizer-BioNTech (Comirnaty): Received Fast Track designation in July 2020 and full FDA approval in August 2021
- Moderna (Spikevax): Received Fast Track designation in July 2020 and full FDA approval in January 2022
Other Vaccines:
- GSK's Investigational Vaccine for Gonorrhea: Received Fast Track designation in June 2023 to address the rising incidence and antimicrobial resistance of gonorrhea.
- Pfizer and BioNTech's Combined Influenza and COVID-19 Vaccine: Received Fast Track designation in December 2022. (3)
Fast Track Designation and Liability Protections
Know your rights (or lack of)
The FDA's Fast Track designation is intended to expedite the review of drugs and vaccines that address serious or life-threatening conditions, (I guess they determine what is serious and/or life threatening) and fill an unmet medical need. (4)
Public Readiness and Emergency Preparedness (PREP) Act:
The PREP Act provides broad liability immunity to manufacturers, distributors, and administrators of vaccines and other medical countermeasures during a public health emergency. This immunity covers claims of loss related to the administration or use of the countermeasures, except in cases of willful misconduct.
The PREP Act was invoked for COVID-19 vaccines, granting manufacturers like Pfizer and Moderna immunity from lawsuits related to vaccine side effects until October 2024.
Willful Misconduct:
Liability protections under the PREP Act do not apply in cases of willful misconduct. To prove willful misconduct, it must be shown that the manufacturer acted with intent to cause harm or with reckless disregard for known risks, which is a high legal standard to meet.
Fast-Tracked Vaccines and Liability Protections
COVID-19 Vaccines:
Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) received Fast Track designation and were granted immunity under the PREP Act. This protection is in place until October 2024, shielding these companies from most lawsuits related to vaccine side effects. (5)
Individuals compensated under the PREP act
Under the PREP act, the total compensation amount for COVID-19 vaccine-related claims as of May 1,2024 is $6,121,395.
For more information on vaccines, their uses, and more, visit the National Vaccine Information Center (NVIC). “The National Vaccine Information Center (NVIC) is dedicated to preventing vaccine injuries and deaths through public education and advocating for informed consent protections in medical policies and public health laws.”
Citations
- (n.d.). Biologics: Definition, side effects, uses & drug list. Retrieved from https://www.medicinenet.com/biologics_biologic_drug_class/article.htm
- National Center for Biotechnology Information. (2023, July 18). Recent advancement in mRNA vaccine development and ... Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10384963/
- Centers for Disease Control and Prevention. (2023, March 30). How vaccines are developed and approved for use. Retrieved from https://www.cdc.gov/vaccines/basics/test-approve.html
- Kettering Health. (2021, September 2). Understanding the FDA's fast track. Retrieved from https://ketteringhealth.org/pfizer-fast-track-fda
- (2023). Public Readiness and Emergency Preparedness Act. Retrieved from https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx
Written by Brooke Lounsbury
