| OCTOBER <strong>2020</strong> | PAGE 2 theMIRROR AMERICAN TEENAGER
theMIRROR | C U R R E N T E V E N T S | | OCTOBER <strong>2020</strong> |3 How far away are we from a covid-19 vaccine? By OWEN MITCHELL & SHAAN BHATIA THE MIRROR STAFF As covid-19 related deaths exceed one million worldwide, six vaccines have been approved for limited use, while 45 vaccines are being tested in clinical trials on humans. Before a vaccine can be approved for limited or full public use, it must undergo three phases of testing. Prior to Phase 1, scientists test a new vaccine on cells and then give it to animals like mice to see if it produces an immune response. Scientists then move onto Phase 1 which is a small study performed on volunteers to test the safety and dosage and to determine the effects of the drug on cells including how it is absorbed, metabolized and excreted. Phase 2 expands the vaccine to hundreds of people split into groups, such as children and the elderly, to study how the drug performs differently in them. This phase continues to test the vaccine’s safety and ability to stimulate the immune system. Phase 3 is large-scale testing conducted with thousands of people to observe how many become infected, compared with volunteers who received a placebo. Phase 3 trials will determine if the vaccine protects against the coronavirus. <strong>The</strong> Food and Drug Administration (FDA) has advised scientists that they should see evidence that the vaccines can protect at least 50 percent of those who received it. Phase 3 trials also reveal side effects that may have been missed in earlier trials. 11 vaccines are currently in Phase 3 trials around the world right now. Pharmaceutical company Johnson & Johnson and Boston-based Beth Israel Deaconess Medical Center are currently approved for Phase 3 after testing their vaccine on monkeys showed signs that it offered protection against coronavirus. Further testing of Johnson & Johnson’s vaccine was abruptly stopped on Oct. 12 after a study participant became sick with what the company called an “unexplained illness.” <strong>The</strong> U.S. government has already invested $450 million of taxpayer money into developing the vaccine, under the Administration’s Warp Speed program, which has distributed billions of dollars in funding to companies to quickly get a vaccine to market. In the wake of Johnson & Johnson’s announcement, another American-based drug manufacturer, Eli Lilly, announced on the following day that it was also pausing the trial of its experimental covid-19 vaccine. It is unclear what safety issues prompted the pause. Eli Lilly’s vaccine is similar to a drug currently in trials ISTOCK | STEFANAMER developed by Regeneron, which President Donald Trump received after his diagnosis with covid-19, and has been touting as a cure, even though most scientists are highly skeptical. Regeneron and Eli Lilly’s treatments use monoclonal antibodies which theoretically mimic the natural immune response to the virus. Another promising vaccine in Phase 3 testing is being developed by Moderna in partnership with the National Institutes of Health. <strong>The</strong>ir approach relies on messenger RNA (mRNA) to produce viral proteins in the body. <strong>The</strong> U.S. government has provided the company nearly $1 billion in support. Moderna will be awarded an additional $1.5 billion from the government in exchange for 100 million doses if the vaccine is safe and effective. Pharmaceutical company Novavax is developing a vaccine that increases proteins produced by the immune system to fight infections and enhances immunity. After promising results from preliminary studies in monkeys and humans, Novavax launched a Phase 3 trial, testing up to 10,000 volunteers in the United Kingdom and is preparing to bring phase 3 testing to the United States later this month. <strong>The</strong> company has also partnered with the Serum Institute of India, a vaccine manufacturer, and if the vaccine is approved for use, that would allow for production of up to 2 billion doses of the drug a year. Pfizer, the frontrunner in developing a vaccine for the United States, said its results won’t be ready until mid- November at the earliest. This dims any expectations of a vaccine by election day as promised by President Trump, whose prospects had already been dismissed by most doctors and researchers as wishful thinking. “I am willing to do my part in order to make my community safe. I want to go back to normal life and if vaccines are the answer, then I think everything should be done to make it happen and cure this disease,” senior Steven Kim said. Chinese groups have also made progress on developing vaccines. CanSino Biologics has begun Phase 3 testing, running trials in Saudi Arabia, Pakistan and Russia. <strong>The</strong> Wuhan Institute of Biological Products has also developed a vaccine that is clinical testing and is approved for Phase 3 trials in the United Arab Emirates, Peru and Morocco despite volunteers experiencing side effects such as fevers. A partner company has a promising second vaccine that could be available in 2021. <strong>The</strong> Chinese government gave its approval to provide the two experimental vaccines to hundreds of thousands of its citizens. German and Swedish-based companies are also working on developing treatments that are in Phase 2 and Phase 3 trials. Last August, Russian President Vladimir Putin announced that healthcare regulators had approved a vaccine named Sputnik V before Phase 3 trials had even begun. After testing the vaccine, Russian scientists found that Sputnik yielded antibodies to the coronavirus, but causes mild side effects such as weakness and muscle pain. Students feel that covid-19 vaccinations are a necessary step to lowering cases, but would be hesitant to receive the vaccine in its first round of approval for the public. “Personally I wouldn’t be one of the first people to get the vaccine if it was released right now due to the fact that I live with people with weaker immune systems,” junior Kristine Shahbazyan said. “Once more people get the vaccine and it is deemed safe I would a hundred percent get it. Vaccines are important in lowering covid cases but wearing masks is the first step. If everyone wore a mask and started social distancing our cases would drop.” “If the vaccine was released right now I would be slightly skeptical about the safety of it. However, if enough people received it and walked out with only minor side effects, I would get it, no questions asked,” junior Nicole Gasparian said. STEPS TO A SAFE VACCINE Before any vaccine gets final approval from the Food and Drug adminstration, it must undergo a series of rigorous tests and ultimately shown to be safe, effective and beneficial. PRETRIAL TESTING Immune response determined in animals Drug is tested on cell and and given to mice and rats to see if it produces an immune response. PHASE 1 Safety and dosage: 100-200 volunteers Determines vaccine’s effect on cells, whether it works, whether there are side effects and the correct dosage. PHASE 2 Response simulation: Several hundred volunteers Determines immune system response and short-term side effects. <strong>The</strong> FDA reports only 33% of treatments make it to the next phase. PHASE 3 Large scale testing: Thousands of volunteers Compares how people who get the vaccine compare to those who don’t and determines the most common side effects. THE MIRROR | INFOGRAPHIC SOURCE | CENTERS FOR DISEASE CONTROL
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