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Mahi Wants You Healthy and Happy – A column using science to focus on physical health and myths associated with disease.
On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to begin distribution in the United States. This vaccine is used for the prevention of COVID-19, caused by SARS-CoV-2, in individuals who are at least 12 years of age.
Approval
The Pfizer COVID-19 vaccine meets the criteria to be issued (EUA) status. However, it has not undergone the intense review to become an FDA-approved product. The FDA EUA’s decision is based on scientific evidence that shows the product may be effective to prevent COVID-19 and “that the known and potential benefits of the product outweigh the known and potential risks of the product.” Unless revoked or terminated, the COVID-19 EUA declaration justifies the emergency use of the Pfizer vaccine.
Vaccine Distribution
The Pfizer vaccine has received the FDA’s emergency use authorization to prevent COVID-19 for patients 12 years of age and older. The Pfizer vaccine should not be administered to anyone who has experienced a severe allergic reaction from a previous dose of the vaccine or any of its individual ingredients. The Centers for Disease Control and Prevention (CDC) recommends the initial phase of the vaccinations “be offered to healthcare personnel and residents of long-term care facilities.” Both governors and jurisdictions will decide the timeline of vaccine recipients and the Vaccine Allocation Planner for COVID-19 will assist the state and county decision-makers by approximating the size of the highest priority populations across the United States and predicting the percent vaccine coverage depending on different scenarios.
Pfizer Inc. is supplying the vaccine directly as directed by the government, and it will be administered by vaccination providers. An individual prescription for each vaccine recipient is not necessary for the Pfizer vaccine at this stage.
Communicating with a Vaccination Provider
Upon receiving the first dose, you will receive a vaccination card that shows when to return for the second shot. It is important to bring the card with you to receive the second dose. The FDA emphasizes the importance of communicating to the provider if you have a fever, bleeding disorder, or are on blood thinners or medication that affect your immune system. You must also let your provider know if you have any allergies, are pregnant or planning to become pregnant, are breastfeeding, or have received another COVID-19 vaccine. For reference, the CDC’s Pre Vaccination Checklist for COVID-19 vaccines displays questions that are asked prior to vaccine administration.
What to Expect: Symptoms and Side Effects
The Pfizer vaccine is administered in two doses, 21 days apart, in which each shot is a 0.3 mL injection into the deltoid muscle. The duration of the side effects is currently unknown.
After receiving the vaccine, certain symptoms may arise depending on the severity of your conditions; however, the majority of side effects are felt after receiving the second dose. FDA reports that “the most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.” Other common symptoms include nausea, swollen lymph nodes, and injection site swelling or redness.
In the case of an allergic reaction, call 9-1-1 or go to the nearest hospital. According to the FDA Pfizer Vaccine Fact Sheet, a severe allergic reaction could occur within a few minutes to one hour after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine. If this happens to you, your vaccination provider may request that you stay at the place where you received the vaccine to monitor your conditions. Allergic reactions include difficulty breathing, swelling of your face and throat, fast heartbeat, body rashes, dizziness, and weakness. Since the vaccine is still being studied in clinical trials, there may be additional reactions and symptoms.
COVID-19 – the pandemic
Combatting misinformation about vaccines has never been more important. The return of COVID-19 urges the development and widespread usage of a vaccine. Please share this article and help us in our effort to educate others and save lives!
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Mahi Ravi is a senior at Saratoga High School who is dedicated to getting more vaccinators in line for the COVID shot. In her free time, Mahi leads a website The Corona Page that offers simplified research on COVID.
Shreya Kakade is a sophomore majoring in Biological Sciences. She established an ambition for supporting non-profit healthcare organizations through working with teams to research and coordinate successful community outreach. In her free time she enjoys hiking, martial arts, experimenting in the kitchen, and looking for the perfect cup of coffee!