The COVID-19 pandemic continues to wreak havoc around the world, and as of this writing, many countries are now in the midst of a long-feared “second wave.” For months, there has been an ongoing mission by researchers across the world to develop a COVID-19 vaccine hoping to slow the spread and enhance immunity to the disease. Dr. Anthony Fauci, Director of the U.S. National Institute of Allergy and Infectious Diseases, believes that many Americans may refuse to get vaccinated, reducing levels of immunity to quell the outbreak.1 In August 2020, a GALLUP® poll validated this concern, revealing that one in three Americans would not get the COVID-19 vaccine.2 In December, a new GALLUP poll suggested that 63% of Americans say they are willing to get the vaccine. With such widespread reported reluctance to this vaccine, let’s explore the concerns some people have for COVID-19 immunization.
Pharmaceutical manufacturing is a highly regulated industry, making products the world needs to combat life threatening diseases. For over a quarter of a century, Contec has worked closely with pharmaceutical manufacturers worldwide to help ensure their contamination control practices are as effective and robust as possible in the production of various types of vaccines. This article will focus on what a vaccine is, how it works, the approval process, and how some vaccines can be fast-tracked through the entire process.
What is a vaccine and how does it work? Vaccines contain the same organisms that cause a particular disease, but they have been modified, killed or inactivated, so they can’t make a person sick. Vaccines spark an immune response that help your body fight off and remember the organism so it can attack it if it ever invades again. Vaccines have been used to eradicate many serious diseases, including:
- Whooping cough4
Vaccines and the immune system: The immune system is a network of cells, tissues and organs that work together to defend the body from harmful organisms. When bacteria, viruses and other organisms invade your body, they multiply and attack. Your immune system stands in the way of these pathogens and protects you. When the immune system detects an invading organism, it attacks the organisms, initiating an immune response. Here is how an immune response works:
- The immune system lets the body know there is an infection trying to attack and multiply.
- The immune system begins releasing antibodies to fight the organism.
- The antibodies work to attack, weaken and destroy the organism.
- Afterwards, your immune system remembers the organism.
- This protection against certain diseases is called immunity.3
What is herd immunity? This term has been promoted and discussed since the onset of Covid-19 this past spring. It occurs when a sufficient proportion of the population is immune to an infectious disease, either through prior illness, or vaccination, so that the spread from person-to-person is unlikely. If enough people are resistant to a disease, it cannot be spread. Herd immunity protects at risk populations. There are two ways to achieve herd immunity:
Naturally developed immunity: your body is exposed to a virus and makes antibodies on its own to fight off infection.
Immunity through vaccination: make your body think you have already had a virus. You don’t get sick, and your immune system still makes protective antibodies.4
Why is it so hard to get a vaccine approved? Because vaccines are essential when it comes to combating widely spread and novel communicable diseases, they must go through extensive testing before approval for use, by the Federal Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and similar organizations in most other countries. Additionally, the safety of a vaccine must be monitored before and after administration to infants, children or adults prior to final approval. Before a vaccine is ever recommended for use, it is tested in labs. This process can also take years. During a clinical trial, a vaccine is tested on people who volunteer to get vaccinated. This step in the process usually has 20 to 100 volunteers, but eventually includes thousands of test subjects. These tests are done to answer important questions like:
- Is the vaccine effective?
- Does the vaccine have side effects?
- Can a person with underlying conditions take it??
- What dose (amount) works best?
- How does the immune system react to it?
- How long does protection last?
The company researching and developing the vaccine tests batches to make sure the vaccine is potent, pure, and sterile.
Testing a vaccine is divided into phases.
- Preclinical testing. Scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.
- Phase I Safety Trials. Scientists give the vaccine to a small number of people to test its safety and dosage, as well as confirm that it causes an immune response.
- Phase II Expanded Trials. Scientists administer the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.
- Phase III Efficacy Trials. Scientists give the vaccine to thousands of people and wait to see how many become infected compared to volunteers who received a placebo. These trials can determine if the vaccine is protecting against the disease.
- Approval. Regulators in each country review the trial results and decide to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.5
What’s next for the COVID-19 vaccines?
According to Pin Wang, professor of material sciences and biomedical and chemical engineering at the University of Southern California, it is possible to deliver a vaccine even sooner than the usual multi-year process.7
It usually takes about two years to bring new vaccines to market; however, priority vaccines can advance faster. There are three big advantages propelling progress to find a cure for COVID-19:
- The global research collaboration is unprecedented. Labs, companies and scientists worldwide are working closely together to tackle the problem.
- Scientists have tools available today to fight the pandemic that they lacked in previous outbreaks. Some of these technologies include genetic engineering, gene sequencing, electron microscopes, super computers, artificial intelligence, and expanded global communication.
- The novel coronavirus is “not very stealthy or tricky.” The virus does not have lots of defense mechanisms or evasive measures, unlike other challenging viruses like HIV and influenza.7
When speaking about how COVID-19 has changed science and vaccine production, Dan Barouch, director of the Center for Virology and Vaccine Research at Harvard Medical School in Boston, Massachusetts, said “It shows how fast vaccine development can proceed when there is a true global emergency and sufficient resources.” New ways of making vaccines, such as by using messenger RNA (mRNA), have been validated by the COVID-19 response, he adds. “It has shown that the development process can be accelerated substantially without compromising on safety.”8
Researchers have been studying related coronaviruses which cause SARS and MERS. The first two COVID-19 vaccines (Pfizer-BioNTech and Moderna) used a string of mRNA inside a lipid coat. RNA vaccines have benefited from 10-15 years of focused research making it ready to be used to combat COVID-19.8
On December 8, 2020, 90-year-old Margaret Keenan was the first Briton to get the Pfizer-BioNTech vaccine.9 On December 11, 2020, the United States FDA issued the first emergency use authorization for a vaccine, allowing Pfizer-BioNTech COVID-19 vaccine to be distributed in the US.10 This is a landmark achievement in the fight against COVID-19.
Back to the research: According to a poll by Pew Research Center in September 2020, of the roughly half of Americans who say they would not get a COVID-19 vaccine, 76% say side effects are a major concern.11 Other concerns included wanting to know more about how well it will work, or simply feeling they do not need it. More broadly, one could characterize these concerns as fear, based on a lack of information. In December, the poll numbers by Pew Research Center said that American’s plans to get vaccinated has risen to 60% who say they would definitely or probably get the COVID-19 vaccine.12
In the meantime, to learn more about the progress of the vaccine, check out The New York Times Coronavirus Vaccine Tracker. If you are still hesitant to get vaccines and want to know more, check out The Family Doctor's section on the importance of vaccines. This information goes into the significance and disproven myths about vaccines.
Note: This article is part one of a three-part series. Be sure to take your research further by checking out:
And, be sure to check out Contec’s COVID-19 Resource Center.