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A Brief History of Vaccines in the United States
September 1, 2021 | 3DhealthWhere We Are Today
As of this writing, about 75% of Americans age 12 and older are at least partially vaccinated against COVID-19. While this is certainly encouraging, this means that more than 70 million eligible Americans have not received a single dose of a COVID-19 vaccine.
As an industry, and a country, we have not had the time to take full stock of the impact of COVID-19. We know that more than 43 million Americans have contracted COVID, more than 700,000 have died from the virus, our Hospitals are full, our ICUs are more than full, our healthcare workers are beyond stretched, preventable COVID-19 hospitalizations among unvaccinated adults cost over $5 Billion from June through August of 2021, and the life expectancy among men fell by 2.2 years in 2020, the largest drop since World War II.
History
The history of battling over whether to enforce mandatory vaccination actually pre-dates the formal organization of our country. In early colonial America, the Smallpox virus spread quickly among growing populations, killing as many as half who caught it. When one of the earliest forms of immunization was introduced in the West, called “inoculation,” colonizers fought over whether it was safe. Today, many historians give General George Washington credit for deciding to inoculate his soldiers, helping the Continental Army win the Revolutionary War.
The next routinely recommended vaccines were developed in the early 20th century. These included vaccines that protect against Pertussis (1914), Diphtheria (1926) and Tetanus (1938). By the late 1940s, scientific knowledge had developed enough that large-scale vaccine production was possible and modern disease control efforts began in earnest. Recommended vaccines in the late 1940s included Smallpox, Diphtheria, Tetanus and Pertussis, the latter three given as a DTP combination.
During this time, parents were petrified of the Polio epidemics that occurred each summer – they kept their children away from swimming pools, sent them to stay with relatives in the country, and scrambled for an understanding of the spread of Polio. Parents waited for a vaccine, closely following vaccine trials and sending dimes to the White House to help the cause. When the Polio vaccine was licensed in 1955, the country celebrated, and Jonas Salk, its inventor, became a national hero.
In 1963, the Measles vaccine was developed, and by the late 1960s, vaccines were also available to protect against Mumps (1967) and Rubella (1969). These three vaccines were combined into the MMR vaccine by Dr. Maurice Hilleman in 1971. During the 1970s, one vaccine was eliminated. Because of successful eradication efforts, the Smallpox vaccine was no longer recommended for use after 1972. While vaccine research continued, new vaccines were not introduced during the 1970s.
The coming decades saw the introduction of vaccines for Haemophilus Influenzae type B (Hib), Hepatitis B, Varicella (chickenpox), Rotavirus, Hepatitis A, DTaP, Intranasal Influenza, Pneumococcal, Influenza, HPV and Meningococcal Serogroup B, to name a few.
Our Pioneering Spirit vs. The Greater Good
As a citizen, I love almost everything about our pioneering spirit in the U.S. But, sometimes this spirit causes individuals to act not only against their own good, but also against the well-being of the whole. As the Smallpox epidemic tore through the Northeast in 1901, The Boston and Cambridge Boards of Health ordered the vaccination of all residents. Some refused to get the shot, claiming the vaccine order violated their personal liberties under the Constitution.
A Swedish-born pastor named Henning Jacobson took his anti-vaccine crusade all the way to the U.S. Supreme Court. The nation’s top court issued a landmark 1905 ruling that legitimized the government’s authority to “reasonably” infringe upon personal freedoms during a public health crisis by issuing a fine to those who refused vaccination. The Jacobson decision was upheld in 1922 when a Texas student was barred from attending public school because her parents refused to have her vaccinated. The Supreme Court found that the Jacobson case had settled that it is within the police power of a State to mandate compulsory vaccination.
Quite a bit has changed since 1905, including how the Supreme Court decides if certain laws violate an individual’s Constitutional rights. Starting in the second half of the 20th century, the Court began to recognize certain Constitutional rights as fundamental, including the freedoms of speech and religion, and personal decisions about marriage, contraception and procreation.
In 2020 the Supreme Court ruled against broadly applying the logic of the Jacobson decision to all COVID-19 lockdown restrictions. In Roman Catholic Diocese of Brooklyn, NY vs. Andrew M. Cuomo, the Court decided that the State of New York violated the Constitutional rights of citizens wanting to gather in churches and synagogues during the pandemic.
The Vaccine Approval Process
Before any vaccine is licensed by the Food and Drug Administration (FDA), it is tested extensively in the lab and with human subjects to ensure safety. First, researchers use computers to predict how the vaccine will interact with the human immune system. Then the researchers test the vaccine on animals including mice, guinea pigs, rabbits and monkeys.
Vaccine development and approval follows the same general pathway as for drugs and other biologics:
- Basic Research
- Discovery
- Pre-Clinical Studies, with the Investigational New Drug Application submitted
- Phase 1 Clinical Trials – Safety
- Phase 2 Clinical Trials – Effectiveness
- Phase 3 Clinical Trials, with the Biologics License Application submitted
- FDA Review and Potential Approval
- Advisory Committee on Immunization Practices (ACIP) Review and Recommendation
- Phase 4 – Post-Approval Monitoring and Research
The FDA has found that the three COVID-19 vaccines authorized for use in the U.S. are safe and effective in helping prevent serious disease or death due to the coronavirus. These vaccines were granted an emergency use authorization, or EUA, by the FDA. The Pfizer/BioNTech COVID-19 vaccine received full approval by the FDA on Aug. 23, 2021.
What, if Anything, was Different About the COVID-19 Vaccine Process?
Vaccines for COVID-19 became available in less than a year. In the past, it’s taken many years to create a vaccine that’s ready for public use. So, how did the COVID-19 vaccines happen so quickly? In short, the global pandemic caused scientists and governments to rally globally, dramatically speeding the timeline while largely following the typical process. The following made the biggest difference:
- Researchers have been watching and studying coronaviruses for decades. They are a very common type of virus and number in the hundreds. In addition, scientists had seen 2 other serious types of coronaviruses affect humans just in the past 20 years – SARS and MERS.
- Decades of research into DNA also made the process faster. The DNA genome (genetic code) for COVID-19 was mapped within 2 weeks and shared globally.
- mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein, or even just a piece of a protein, that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.
- America’s COVID-19 vaccine initiative, previously called Operation Warp Speed, had spent around $12.4 billion supporting vaccine development through March of 2021. This investment allowed the vaccine manufacturers to produce the vaccine prior to FDA approval for distribution.
- There was also waiting time recouped from the U.S. Food and Drug Administration’s review process. Typically, it takes the FDA 10 months to review a new drug. However, with the COVID-19 death toll rising, the FDA rushed all coronavirus vaccines to the front of the review lines. The Pfizer vaccine got reviewed and authorized for emergency use only 21 days after submission and the Moderna vaccine in just 19 days. Compared with a more typical 10-month wait time, that’s about 283 days saved.
Where Does this Leave Us?
The topic of vaccine hesitancy, resistance and misinformation is tricky. The conversation has become wildly polarized, political and sometimes religious with global experts dismissed. Following are our top observations as of now:
- Virtually everyone you know has been vaccinated against anywhere from 8 to 14 deadly viruses, not counting the COVID-19 vaccine.
- The process used to develop and distribute the COVID-19 vaccine utilized superior science and technology in its development – i.e., it was better than the process used for the vaccines that we have all already taken.
- While many unvaccinated seem entrenched in their view, the vaccinated population seems increasingly frustrated and angry with the unvaccinated.
- Employers will likely lead the way in reducing the number of unvaccinated in the country.
- The potential exists for more extreme measures to “encourage” vaccination – health insurance companies excluding COVID hospitalization coverage for the unvaccinated, life insurance companies denying death claims for the unvaccinated, travel restrictions for the unvaccinated and vaccination passports becoming commonplace.
For questions or more information, please contact Ron Flower at RFlower@3Dhealthinc.com or Shane Foreman at SForeman@3Dhealthinc.com.