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Another COVID-19 Vaccine Approved!

Another COVID-19 Vaccine Approved!

The Pfizer-BioNTech vaccine was approved by the FDA on December 11, 2020 for any person aged 16 years and older. This vaccine requires everyone to receive two doses (the initial dose and the second dose 3 weeks later). On Sunday, December 13th the first COVID-19 vaccines were shipped from Michigan; on Monday, December 14th the vaccines were distributed to all 50 states to be administered to healthcare providers and long-term care facility residents. In New York, a critical care nurse received the first COVID-19 vaccine. On December 17, 2020 the US Food and Drug Administration (FDA) voted unanimously, with one abstention, to recommend use of the Moderna vaccine. This is the second COVID vaccine to receive US authorization. The Moderna vaccine is about 94% effective at preventing COVID-19 and is approved in people 18 years and older. Two other COVID-19 vaccines will be reviewed by the FDA for approval soon, in fact, the reviews for some are already underway.

The CDC and FDA have created an additional layer of safety monitoring to evaluate the COVID-19 vaccine safety in real-time called V-safe. V-safe is a smartphone-based, post-vaccination health checker for recipients of the COVID-19 vaccine. V-safe will send vaccine recipients a text message or web survey from the CDC to check-in, send reminders for the second dose, and will follow-up with anyone who reports adverse effects. Recipients may call their healthcare provider and report that they are experiencing symptoms such as pain, swelling at the injection site, tiredness, headache, fever, and/or chills. Although these are adverse effects that are expected, if they persist for more than 24 hours, patients should follow up with a healthcare provider.

Some helpful tips to provide the recipient after vaccination:

  • To reduce pain and discomfort:
    • Apply a clean, cool, wet washcloth over the area
    • Use or exercise the arm that received the injection
    • Take OTC ibuprofen or acetaminophen
  • To reduce discomfort from fever:
    • Drink plenty of fluids
    • Dress lightly
  • Contact healthcare provider:
    • If the redness or tenderness where the vaccine was administered increases after 24 hours

Remind the recipient that they need both shots—even if they had side effects after the first dose—unless the healthcare provider (you) tells them not to get the second dose. All adverse effects should be reported to the Vaccine Adverse Events Reporting System (VAERS) after receiving the COVID-19 vaccine. Information on how to submit a report to VAERS is available at vaers.hhs.gov/index.html or 1-800-822-7967.

Patients maybe concerned about these mRNA COVID-19 vaccines. The CDC highlights these key points to share with your patients:

  • Like all vaccines, mRNA COVID-19 vaccines have been rigorously tested for safety before being authorized for use in the United States
  • Though newly approved, mRNA technology is not unknown. It has been studied for more than a decade
  • mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person
  • mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person's DNA

A webinar hosted by the CDC that I recently attended contains additional helpful information on differentiating vaccination symptoms from COVID-19 symptoms and how to manage them when there is overlap or confusion. Other helpful information regarding the vaccine and information for healthcare personnel can be found on the CDC website, as well as on the PCE COVID-19 Resource Page.

Remember, regardless of vaccination status, you should continue to cover your mouth and nose with a mask when around others, stay at least 6 feet away from others, avoid crowds, and wash your hands often.

Be safe everyone and thank you for all you do.

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Filed under: Infectious Diseases, Public Health

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