learn about COVID-19, its impact, and what you can do about it.
Optimistic results were reported from initial findings of Pfizer’s phase III clinical trial on November 9th as well as Moderna’s phase III 30,000 person clinical trial. Pfizer is a company based in New York City that co-developed this vaccine along with a company in Germany called BioNTech. Both Pfizer’s and Moderna’s vaccine are a mRNA vaccine, and Pfizer’s would be taken in two doses. They are currently running the vaccine through the last phase of human testing. The interim results from these trials provide hope that an effective prevention of COVID-19 is on the horizon. So what exactly are these vaccines?
This vaccine is based on mRNA, a form of genetic information, and teaches the immune system to recognize the Sars-CoV-2 virus. When this specific mRNA sequence is inserted into the immune system, spike proteins are produced causing an immune response. By causing an immune response, when the immune cells are facing the SARS-CoV-2 virus molecules they will be able to defend against the virus more effectively.
Beginning in mid-March of 2020, the Pfizer clinical trial for the COVID-19 vaccine reached Phase 3 in mid-July, and recent data has revealed that the vaccine is 90% effective. The Moderna clinical trial, which began phase 3 around the same time as Pfizer, has also revealed the results of their trial so far. Their vaccine has been shown to be 94.5% effective. Clinical trials, which can take up to 10 years, are series of medical tests that help determine the effectiveness of a drug in question involving large groups of people. Clinical trials are made up of three total phases, and each successive phase involves an increasing number of test subjects. Before COVID-19 vaccine trials began, scientists quickly developed vaccine candidates that were ready to be tested with the help of previous research knowledge on ebola and vaccines other pathogens. In each phase of the trial, around half of the participants receive the actual vaccine and the remainder receive a placebo. Phase I of most clinical trials involves a group of less than 100 healthy adults, and lasts several months to a year. However, with the issue of Operation Warp Speed, phases I and II were combined in COVID-19 trials to save time, and scientists started working with over 1,000 individuals. This phase I/II, which began around the end of May for both Moderna and Pfizer, focused on finding the correct dosage and observing symptoms and side effects. When phase 3 began for both companies, they began to involve tens of thousands of volunteers around the US and Europe. Usually lasting years, phase 3 of COVID-19 clinical trials lasted short of 3 months, leaving many questioning the longer-term safety and efficacy of the vaccine.
Like many other vaccines, the Pfizer vaccine includes some minor side effects that patient Glenn Deshields describes in a “Fox and Friends” interview. Deshields is one of the 43,000 volunteers who received Pfizer’s COVID-19 vaccine. He received two injections to complete the vaccination experiment and developed antibodies to the virus just after the second injection. After the first injection, Deshields states that he had headaches, fatigue, and pain around the injection location. After the second injection, the side effects were not as severe and over the counter anti-inflammatory drugs like Advil quickly diminished these symptoms. After developing the antibodies and representing a fairly successful experiment, Deshields urges the public to receive the vaccine. He recognizes that although there are some side effects, he has not contracted the coronavirus and that is what is most important.
The Pfizer vaccine is an mRNA based vaccine. It is referred to as the BNT162b2 vaccine to researchers and scientists. This vaccine utilizes a specific mRNA for the spike proteins that cover the virus. By thorough research from scientists, they were able to find the exact mRNA that codes for the spike proteins. When this mRNA is injected into the body, human cells evaluate this mRNA and create spike proteins. Most importantly, there are only spike proteins created, no other COVID-19 virus particles. Human cells don’t normally create spike proteins so when the mRNA is introduced to the system, the immune system springs into action and annihilates the spike proteins. The immune system creates antibodies against these spike proteins, so if the real COVID-19 was to enter the body, the antibodies could quickly remove the virus. This mRNA vaccine has to be stored in a -80 degree Celsius freezer. In addition, each person who wishes to be vaccinated must take two doses, leading to many issues.
The first clinical trial to test the safety and effectiveness of Moderna’s mRNA-1273 vaccine tested 45 people, all of whom received two doses of the vaccine between March and April. The second dose was given 28 days after the first, different people getting different amounts of the vaccine. All participants exhibited anti–SARS-CoV-2 immune responses and no trial-limiting safety concerns were identified. Some participants after receiving the second vaccination experienced adverse side effects, such as fatigue, chills, headache, myalgia, and pain at the injection site. These adverse events occurred more in the participants with higher doses, although the antibody responses were also higher.
Additionally, CanSino Biologics, a Biotech company based in Shanghai, China, is currently in phase 1 Clinical Trial. Along with Beijing Institute of Biotechnology, they have developed a recombinant novel coronavirus vaccine which is an adenovirus type 5 vector (Ad5-nCov). Preclinical animal studies show that this vaccine candidate induces successful immune system responses in these animals.
After FDA approval, Pfizer is working to get the first doses available by December.(for emergencies), although the safety portion of trials will go on for another 2 years
“The Moderna vaccine reduced the risk of COVID-19 infection by 94.5%. There were 95 cases of infection among patients in the company’s 30,000-patient study. Only five of them occurred in patients who developed COVID-19 after receiving Moderna’s vaccine, mRNA-1273.”
The United States has a 1.525 billion dollar contract with Moderna given through Operation Warp Speed in order to provide the United States with 100 million doses of the vaccine.
According to the Los Angeles Times, state and federal health officials have largely agreed that frontline healthcare workers who are in contact with COVID-19 patients daily should have accessibility to the vaccinated first. There is also an opinion that nursing home residents and the elderly at other long-term care facilities should be targeted in the initial immunization push. This is due to a majority of COVID-19 deaths being people 85 years of age or older.
Written by Jennifer D, Sarah W, Lian H, Daniel S, Soultana T, and Jake M
Authors and Editors