COVID-19 Vaccine Update

Now that word of the new COVID-19 vaccine is spreading as fast as the pandemic itself, it’s important to educate ourselves on exactly what the vaccine entails. In the early stages of the COVID-19 vaccine, it will be administered under an Emergency Use Authorization (EUA) from the U.S. FDA (Food and Drug Administration). Although there will be a limited supply of the vaccine in early stages of use, its availability will increase as time goes on; the CDC stated that there will be “several thousand” vaccination providers available to help.

Due to the limited availability of the vaccine, certain groups will be eligible to receive the vaccine earlier than others. These groups include healthcare workers—including long-term care facility residents (the CDC made this recommendation on December 2, 2020 based on recommendations from the Advisory Committee of Immunization Practices, or ACIP)—as well as workers in essential industries, people at high risk for severe COVID-19 illness due to underlying medical conditions (such as autoimmune diseases), and people of ages 65 and older.

 As of now, early clinical trials of the COVID-19 vaccines only involved non-pregnant adults. Therefore, as clinical trials continue, researchers will hopefully release information about how the vaccine affects children, in order to determine if children should be inoculated. 

Since the vaccine doses are purchased with U.S. taxpayer dollars, the vaccine will generally be administered to the American people at no cost whatsoever, eliminating financial obstacles to inoculation. That said, certain vaccine providers can charge an administration fee; this fee can be reimbursed by the patient’s public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund.

Ethical principles identified by ACIP to guide their decision-making process in regards to limited supply are as follows:

  • Maximize benefits and minimize harms.
  • Decrease health inequities.
  • Promote justice.
  • Advance transparency.

Currently, there are two main companies in the limelight, Pfizer and BioNTech, and they both already applied to the Food and Drug Administration for emergency approval. The FDA is set to review the vaccine on December 10, 2020. Together, these companies came to an agreement with the U.S. government, pledging to supply 100 million doses. Federal officials have estimated about 20 million Americans will receive the vaccine in December alone.

According to the clinical trials, a patient must receive two doses of the Pfizer vaccine for complete protection. The FDA announced that there is a noticeable decline in the risk of catching COVID-19, with severe symptoms, any time after the patient receives the first dose. This risk declines even further after both doses. 

In the testing groups, the most common reactions to the vaccine were injection site reactions, fatigue, headache, muscle pain, chills, joint pain, and fever. Analysis of the data reveals that the vaccine does not seem to affect individuals differently based on race, age, ethnicity, or pre-existing medical conditions. 

The FDA announced that it would not grant a vaccine unless it diminished the rate of disease by 50% or more when compared with a placebo; Pfizer stated that its vaccine is 95% effective at protecting against symptomatic COVID-19. Additionally, half of the patients in their vaccine studies were monitored for least two months after inoculation to ensure that severe side effects do not occur. 

In addition to Pfizer’s vaccine, a second vaccine from Moderna Inc. is set for review later this week.

CDC source: Use this link to learn more about the vaccine on your own, if you are interested!