By: Kevin Mensah
Whether you are a freshman, sophomore, junior, senior, parent, or staff member, I am convinced that you have pondered about the development and distribution of the COVID-19 vaccine. At the moment there are no vaccines approved by the FDA: The Food and Drug Administration. The FDA is the administration responsible for protecting public health when it comes to guaranteeing the safety and efficiency of drug-related products. When will it be developed? How will it be distributed? How will it be made? Are we required by law to take it? Will it be free? You’ve come to the right place. And don’t be perturbed with all the complex articles depicting this vaccine. This article (The first edition of What Would Happen if…?) is dedicated to all your inquiries about the vaccine and how it will affect our daily routines. I have gone through these complex articles so you can get the simple and straight-forward information you desire.
What is the process?
In the previous Vice Presidential Debate, Vice President Mike Pence stated “The reality is we are going to have a vaccine Senator, in record time, in unheard-of time in less than a year. And we are right now producing tens of millions of doses.” (Keep note that there are just over 331 million people in America, and the fastest vaccine developed to date has been for mumps, and that took four years!) Pence accused Senator Kamala Harris of undermining the success of the COVID vaccine after stating that there are 5 companies in Stage 3 Clinical Trials producing tens of millions of doses. Is this fake news? Let’s break this down. First of all, there are six stages to produce a vaccine. The Exploratory Stage, The Pre-Clinical Stage, The Clinical Development Stage, The Regulatory Review and Approval Stage, The Manufacturing Stage, and the Quality Control Stage. We are currently in the Clinical Development Stage which is the third stage.
The Clinical Development Stage is a 3 phase process. In phase 1 of this stage, small groups of healthy people were given the vaccine. In phase 2, the vaccine was given to people of specific groups that varied between age and physical health to expand the research for the safety, effects, and dosage of the vaccine. In phase 3 (the final phase), the vaccine was given to thousands of people to test if the vaccine was effective. Phase 3 began on July 27. Since then, 44 vaccines have been in clinical trials on humans, and at least 92 preclinical vaccines are under constant examination in animals.
When will it be developed?
There has been controversy on when the vaccine will be developed. President Donald Trump constantly reassures the public that the vaccine will be available by the end of 2020. He quoted, “We are delivering life-saving therapies and will produce a vaccine before the end of the year, or maybe even sooner.” Trump has even hinted that the vaccine might be ready before election day, which is even sooner than the end of the year being set for Tuesday, November 3rd. In realistic time, it could be 12 to 18 months before the vaccine is open to the public due to constant trial and error. There is not a certain timestamp to when the research for this vaccine will be completed. After all, the development of these vaccines does take vigorous hours of dedication. Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, announced that a COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results.
In the meantime let us hope for the best and acknowledge our health care workers and our hard-working scientists for handling this crisis. Let us be mindful of others and wear our masks. If you are one of the people who say, “If your mask works, why do I have to wear mine?” Why wouldn’t you take the initiative to limit the spread of this disease? It is scientifically proven that although one mask can limit the spread of COVID, more masks can drastically decrease the spread. Being uncomfortable for a few hours is nothing like dying. Our healthcare workers at the front lines will most likely receive the vaccine first. BARDA, a department of health has received more than $6.5 billion from Congress for countermeasures and so far has partially funded five vaccine developers: Merck and IAVI, AstraZeneca, Moderna, Sanofi’s Protein Sciences, and Janssen.
What is the Science behind this vaccine?
The research began in January, with the configuring of the SARS-CoV-2 genome. It is a protein in which stimulates the immunity of the virus through the vaccine. Scientists have been using Adenoviruses to transport DNA. Adenoviruses are viruses that cause the common cold and are found in monkeys and in other animals. DNA provides instructions for such proteins. This is how the Coronavirus affects the body: Coronavirus virions, (or particles) latch themselves to the surface of an infected host’s cell. Using their spikes, they pierce the cell and the cell releases a strand of RNA. The genetic code hijacks the cell’s mechanism to make more virions, which then search for new targets. Hopefully, scientists can prevent this by providing a vaccine that can limit and prevent infection.
How will it be Distributed?
One factor in the distribution of this vaccine is the temperature. Pfizer Inc., BIOTECH, and Moderna Inc., use a new gene-based technology called mRNA to keep the shots at temperatures as low as minus 70 or minus 80 degrees Celsius. Many hospitals around the country do not have the capacity or mechanical requirements to store vaccines at such negative temperatures according to industry officials. Pharmacies and clinics are unlikely to become vaccination sites until a vaccine is authorized for the broader population, which is expected to happen next year. About 90,000 pharmacies, 230,000-plus physician practices, 1,200 health clinics, and 6,000-plus hospitals in the U.S are part of the distribution plan. We rely on these companies to distribute the vaccine successfully.
There is also a possibility that the COVID vaccine will be distributed at the same time as the Flu vaccine. This “twin-demic” is very likely to happen. It is possible to get COVID and the Flu (professionally known as Influenza) at the same time. Having both diseases in action at the same time will result in overwhelming tax to our health-care systems and puts lives at risk more than ever.
Another problem with this is the waste created. To minimize vaccine waste Dr. Soren Bo Christiansen, of Sharp Technology, has a plan. (Sharps Technology Inc. is a company that makes syringes). He says, “you can get a vaccine in two ways: in a vial, with typically 10 doses, or in a prefilled syringe with 1 dose. For COVID-19, the first approach will be vials because it’s faster and cheaper…”. Unfortunately, there is a catch with this plan. “The vaccinator will then withdraw a dose from the vial, change the needle, and inject the patient. In all currently available syringes, there is a waste when you are done with the injection,” he explained. Usually, manufacturers overfill the vial and there is built up waste after every injection. A different syringe that can prevent waste can increase available doses by 10 percent. This is a great increase especially when looking at the 10 million doses that need to be produced. Hopefully, this will be worked out soon.
Are WE Required by Law to Take it?
You cannot be forced to take the vaccine yet but you can certainly be fined or taxed if the law requires it. There is the possibility that refusing the vaccine could result in a 1,000 dollar fine in some states. States can use mandates to control the public. Mandates are commands carried out by the government to accomplish and enforce certain orders. Mandates can also be given in schools. States and cities in the United States have the authority to manage public health. Universities and schools may mandate students to take the vaccine. Younger children are especially more likely to be required to take the vaccine.
Businesses might be able to turn you away and deny you service for refusing to get the vaccine. It might come to the point where it is totally legal for your employers to fire you for endangering the safety of other workers but only if the law requires everyone to get the vaccine. If you are unable to take the vaccine due to medical reasons, you would need an accommodation from your employer. The accommodation might require you to keep your distance from others in the workplace and wear a mask. The inability to get a vaccine can be considered a disability under the Americans with Disabilities Act. The Civil Rights Act of 1964 might protect people who have a religious opposition to the vaccine. These laws generally only affect companies with 15 or more employees. Small businesses are usually excused. Dr. Fauci has announced that he is investigating the durability of the vaccine as it may be ineffective after a while.
The Trump administration announced that the Vaccine would be free of charge for any American who is “vulnerable, who cannot afford the vaccine and desires the vaccine, we will provide it for free.” World leaders came together and pledged a total amount of $8 billion from Japan, Canada, South Africa, and dozens of other countries in May to help pay for the vaccinations worldwide.
I hope this article gave you an idea of what is happening with the production of this vaccine. In the meantime let us wear our masks in school and public places. Remember to wash your hands for at least 20 seconds. Make sure to take all the necessary precautions. Keep your distance and stay safe! Stay tuned for the next version of What Would Happen If….? Thank you for reading, I hope you have a great day!
Very well written. Very detailed. Great