Before mRNA vaccines, such as the Pfizer-BioNTech and Moderna COVID-19 vaccines, were approved for emergency or full use, they underwent several rigorous stages of testing to assess safety and efficacy. Here’s an outline of the process:
1. Preclinical Testing (Lab and Animal Studies)
• Objective: To assess the safety, immune response, and potential efficacy of the vaccine.
• Process:
• Animal studies: Typically conducted in mice, rats, and non-human primates to evaluate whether the vaccine induces the desired immune response and does not cause harmful effects.
• The mRNA technology used in the COVID-19 vaccines had been previously studied in labs for other diseases (e.g., Zika, flu, cancer), but the COVID-19 vaccines were tested in animals before moving to human trials.
• Outcome: Encouraging results were obtained in animals, showing that the mRNA vaccines were effective at generating an immune response.
2. Phase 1 Clinical Trials (Initial Human Trials)
• Objective: To evaluate the safety and dosage of the vaccine.
• Process:
• Participants: A small group (often 20-100) of healthy volunteers.
• Testing: The focus was on safety, the immune response, and determining the appropriate dosage for further trials.
• Outcomes: This phase helped identify any immediate, severe side effects (e.g., allergic reactions) and the optimal dose that induces a good immune response.
• Duration: Typically 1-2 months.
3. Phase 2 Clinical Trials (Expanded Human Trials)
• Objective: To further assess safety, side effects, and immune response in a larger group of participants.
• Process:
• Participants: Hundreds of volunteers, including those from various age groups and risk categories.
• Testing: Vaccine doses were refined, and participants were monitored for side effects, immune responses, and any potential efficacy signals.
• Outcomes: This phase confirmed the safety and immune response induced by the vaccine.
• Duration: Usually several months.
4. Phase 3 Clinical Trials (Large-Scale Human Trials)
• Objective: To assess the vaccine’s efficacy and safety in a much larger population.
• Process:
• Participants: Thousands of volunteers (often over 30,000), including people from a wide range of demographics (e.g., elderly, people with underlying health conditions).
• Testing: This phase measured how well the vaccine protected against infection (or severe illness) and assessed side effects across a large group.
• Outcome:
• Efficacy: The mRNA vaccines showed high efficacy in preventing symptomatic COVID-19 (around 94-95% in early results for Pfizer-BioNTech and Moderna).
• Safety: Serious side effects were rare, and the vaccines generally had side effects similar to those of other vaccines (e.g., soreness at the injection site, fatigue, mild fever).
• Duration: Typically lasted several months to a year.
5. Emergency Use Authorization (EUA) / Approval
• After Phase 3 trials, Pfizer-BioNTech and Moderna submitted data to the U.S. Food and Drug Administration (FDA) and other regulatory bodies (e.g., the European Medicines Agency or EMA) for Emergency Use Authorization (EUA).
• Regulatory agencies conducted a thorough review of all data, including:
• Efficacy data showing that the vaccine effectively prevented severe COVID-19 illness.
• Safety data showing that the vaccines had a favorable risk-benefit profile.
• After the review, both vaccines were granted EUA by the FDA in December 2020, allowing them to be administered to the public while ongoing monitoring continued.
6. Post-Approval Monitoring (Phase 4)
• Objective: To continue monitoring the vaccine’s long-term safety and effectiveness in the general population.
• Process:
• Ongoing surveillance systems like the Vaccine Adverse Event Reporting System (VAERS) and V-safe were used to monitor adverse events, including rare or long-term side effects.
• The EUA was later converted to full approval (for Pfizer-BioNTech in August 2021) based on continued safety and efficacy data.
Summary:
• Preclinical studies and clinical trials (Phases 1-3) assessed safety, immune response, and efficacy.
• The mRNA vaccines were subjected to more rigorous testing than some other vaccine types due to the novel technology, but they followed standard protocols used for any vaccine approval.
• Post-approval monitoring continues to ensure safety in the wider population.
Hardly......"not tested at all"