After nine months of the COVID-19 global pandemic, a vaccine has finally been developed and begun to be administered. Multiple pharmaceutical companies have been a part of the race for a vaccine, but as of December 19, only Pfizer-BioNTech and Moderna’s vaccines have been granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and are recommended by the Center for Disease Control and Prevention (CDC). Other companies that are in Phase III clinical trials (the last phase before submission for approval to the FDA) are AstraZeneca and Janssen.
To be authorized, a vaccine must undergo pre-clinical trials (which includes animal testing), Phase I trials with a small group of people, Phase II trials with more people to test safety, and Phase III trials with a larger group to test efficiency. For EUA, a pharmaceutical company is allowed to skip pre-clinical trials.
From December of 2020 to spring of 2021, Phase 1 vaccinations will take place and from spring to summer, Phase 2 vaccinations will take place. Phases 1 and 2 will include healthcare workers (including Emergency Medical Service (EMS) workers), long-term care facility staff, adults in congregate settings (such as homeless shelters, group homes, and prisons), law enforcement, teachers and childcare workers, essential services or critical industry workers, seniors, and adults of any age at high-risk. Phase 3 will take place during and after the summer, and will include the general population. Two doses are needed.
The Covid-19 vaccine can be received for free because it is being paid for by U.S. taxpayer dollars. Vaccination providers can charge an administration fee, which can be reimbursed by insurance companies or the Health Resources and Services Administration’s Provider Relief Fund. This will ensure that the cost is not a barrier to vaccination.
The Pfizer-BioNTech Vaccine
The FDA consulted with the Vaccines and Biological Products Advisory Committee (VBPAC) to decide whether or not the Pfizer-BioNTech Vaccine is effective and safe. It is currently only approved for people over the age of 15.
The Pfizer-BioNTech vaccine is proven to be 95% effective; however, it is currently unknown how long the immunity from this vaccine will last. The data from Phase III of the vaccine trial are available to the public. The trial involved 44,000 people. 162 of the 170 COVID-19 cases were in the placebo group, including 9 of the 10 severe cases. The vaccine did not disproportionately affect any demographic.
Recipients of this vaccine reported pain at the injection site, moderate fatigue, headache, chills, or fever. Most of these symptomatic cases lasted no longer than 48 hours.
The Moderna Vaccine
The FDA also consulted with the VBPAC to decide whether or not the Moderna vaccine is effective and safe. It is currently only approved for people over the age of 17.
The Moderna vaccine is proven to be 94.1% effective, but it is also unknown how long immunity from this vaccine will last. Their Phase III trial involved 30,400 people. 185 of the 196 COVID-19 cases were in the placebo group, including all 3o of the severe cases. The vaccine did not disproportionately affect any demographic.
Recipients of this vaccine reported side effects of pain at the injection site, fatigue, headache, muscle pain, joint pain, and chills.
The authorization of two COVID-19 vaccines and the prospect of more to come marks the beginning of the end of the pandemic. Although Pfizer-BioNTech and Moderna were allowed to skip pre-clinical trials for EUA, the pharmaceutical companies still ensured that their vaccines would be safe and effective for all demographics. Both companies and the federal government are playing a part in guaranteeing affordability for all U.S. residents. As more and more people continue to be vaccinated, life will slowly return to normal.
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