How mRNA COVID-19 vaccines were developed | American Academy of Pediatrics (AAP)

Summary

COVID-19 vaccines have been rigorously tested and proven to save lives. Scientists have spent over 30 years developing mRNA vaccine technology, leading to extensive trials with thousands of participants. The process includes multiple phases to ensure safety and efficacy, with constant monitoring even after approval. Emergency use authorizations are granted in times of crisis, and children have also been included in clinical trials. Vaccines are a critical tool in protecting public health, and their continued safety is assured through ongoing oversight by medical professionals and agencies.

Takeaways

• 😀 mRNA vaccine technology has been in development for over 30 years, contributing to the effectiveness of COVID-19 vaccines.
• 😀 COVID-19 vaccines were tested in large clinical trials before being authorized for use in the U.S.
• 😀 The vaccine development process ensures safety through rigorous testing phases, including lab tests, small group trials, and large-scale clinical trials.
• 😀 The first phase of clinical trials involves testing the vaccine in fewer than 100 healthy volunteers.
• 😀 In the second phase, vaccines are tested in hundreds of people, and in the third phase, thousands are involved to ensure its safety and effectiveness.
• 😀 The top priority in vaccine testing is safety, as vaccines are preventive and held to higher safety standards than most medicines.
• 😀 Data from earlier testing phases must show the vaccine is safe before moving to the next phase of trials.
• 😀 If a vaccine is proven safe and effective during trials, it can be authorized for emergency use by the FDA during health crises like the COVID-19 pandemic.
• 😀 The vaccine approval process is similar for both adults and children, though scientists account for differences in children's immune systems and vaccine needs.
• 😀 Over 10,000 children aged six months and older participated in vaccine trials, with millions of children receiving the vaccine safely.
• 😀 Vaccines continue to be monitored after approval to ensure ongoing safety and effectiveness, providing a trusted defense against diseases like COVID-19.

Q & A

How long have scientists been developing mRNA vaccine technology?

Scientists have been developing the technology for messenger RNA (mRNA) vaccines for over 30 years.

What is the first step in ensuring a vaccine is safe and effective?

The first step is testing the vaccine in cells to determine early on whether it will be safe to test in people.

How does the clinical trial process for vaccines work?

The clinical trial process involves testing the vaccine in three phases: first in a small group of healthy volunteers, then in hundreds of people, and finally in thousands of people.

What happens if a vaccine does not appear safe during clinical trials?

If a vaccine seems unsafe at any point, it does not move forward to the next phase of testing.

Why are vaccines held to a higher safety standard than most medicines?

Vaccines are given to healthy people to prevent disease, unlike medicines which treat specific problems, so they must meet higher safety standards.

What is Emergency Use Authorization (EUA) for vaccines?

EUA allows the distribution of a vaccine during a medical crisis, such as the COVID-19 pandemic, after proving it is safe and effective in clinical trials.

How did the clinical trials for COVID-19 vaccines ensure safety for children?

Clinical trials for children considered differences in their immune systems, testing different doses with older children first before moving to younger kids.

How many children participated in COVID-19 vaccine trials?

More than 10,000 children aged six months and older participated in COVID-19 vaccine trials.

How many children ages 12 and older are eligible to receive the Pfizer vaccine?

Children aged 12 and older were eligible to receive the Pfizer-BioNTech vaccine starting in May 2021.

What is the role of monitoring after a vaccine is authorized or approved?

After a vaccine is authorized or approved, scientists, health agencies, and doctors continue to monitor its use to quickly identify and address any potential problems.