Immunizations: Protecting the world from the ravages of disease
Robert Kleiman, MD – VP, Cardiology & Chief Medical Officer at Clario
August is National Immunization Awareness Month (NIAM), a month dedicated to highlighting the importance of vaccinations for all ages. Clario recognizes the success of immunizations, including the more than 100 vaccines it has helped to develop in its 50-year history.
Vaccinations have effectively eliminated diseases that ravaged the world just two generations ago. In 1976, the smallpox vaccine eradicated the virus estimated to have killed 300 million people during the 20th century. And since 1979, the United States has been polio-free thanks to the vaccine that attacks the devastating viral disease that once paralyzed 15,000 American children each year. Vaccines have also dramatically reduced the prevalence of tetanus, pertussis (whooping cough), rubella (German measles), measles, varicella (chickenpox), and mumps.
This NIAM is critical given the focus COVID-19 has placed on vaccinations. We have proven to ourselves and the industry that we can safely accelerate the development of vaccines when necessary. In its 50-year history, Clario has participated in developing more than 100 vaccines across its eCOA, Cardiac Safety, Imaging and Respiratory product lines. We are particularly proud of how our electrocardiogram (ECG) and eCOA solutions helped facilitate the speedy approval of COVID-19 vaccines. Clario has supported in six COVID-19 vaccine studies, including Johnson & Johnson, Pfizer, GSK and AstraZeneca.
The vaccine approval process
New vaccines go through a thorough approval process to ensure safety and efficacy. After lab testing, volunteers receive the vaccine in closely monitored clinical trials. There are three phases of clinical trials when developing a vaccine:
- Phase I: 20-100 volunteers receive the vaccine, and researchers study efficacy, safety, dosage and side effects.
- Phase II: Hundreds of volunteers receive the vaccine, and researchers dive deeper into short-term side effects and how volunteers’ immune systems respond.
- Phase III: Results from hundreds to thousands of volunteers are compared to volunteers who receive another vaccine or no vaccine (for the COVID-19 vaccines, the Phase III trials each included 30,000-45,000 participants).
Which vaccines are needed and when?
Medical professionals recommend immunizations throughout our lives for various reasons. Below, we touch on the different types of immunizations (including boosters) and why and when they are needed.
Routine vaccinations: administered incrementally from the time we are born through the rest of our lives. The Centers for Disease Control and Prevention (CDC) publishes the following recommended immunization schedule for children and adults:
- Recommended child and adolescent immunization schedule for ages 18 years or younger
- Children whose health insurance does not cover vaccinations can receive them at no cost through the Vaccines for Children (VFC) program when working with health care providers enrolled in the program.
- Routine childhood vaccinations are also critical for preventing infection from outbreaks, such as measles and mumps, which we have seen in the past few years.
- Recommended adult immunization schedule for ages 19 years or older
- For additional help identifying which vaccines you need, adults can use the Adult Vaccination Assessment Tool.
Vaccinations for travelers: recommended to protect you from serious diseases that are rare in your native country and, thus, do not require vaccinations. Some countries even require proof of vaccination. The CDC recommends discussing the vaccines and medicines needed with your doctor at least one month before your trip. For a full list of recommended vaccinations for travel, visit the CDC’s complete list of vaccinations.
Seasonal vaccines: recommended for most people over the age of 6 months (including pregnant women) every season to protect from seasonal influenza. The flu vaccine has been shown to reduce the risk of illness, hospitalizations and flu-related death.
COVID-19 vaccine: several vaccines are approved globally to protect against COVID-19. In the U.S., the Pfizer, Moderna and Johnson & Johnson vaccines are approved under the emergency use authorization pathway (they are likely to have full approval shortly); in the EU and other areas, the AstraZeneca vaccine is also approved. The CDC provides frequent updates to answer all of your vaccine-related questions.
Written by
Robert Kleiman, MD
VP, Cardiology & Chief Medical Officer at Clario