5 Things to Know About the FDA Approved Pfizer’s COVID-19 Vaccine

Here’s what we need to know about the vaccine.

Disclaimer: All information quoted here in this story is supported by appropriate citations and not made up.

The news is out.

People are ecstatic and relieved.

The vaccine is on our way!

On December 11, 2020, FDA (U.S Food and Drug Administration) approved the first emergency use authorization (EUA) vaccine for the immunization against the COVID-19. Through EUA, the government bodies will distribute the Pfizer-BioNTech COVID-19 vaccine throughout the U.S in the next couple of weeks.

The FDA commissioner Stephen M. Hahn, M.D writes:

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.

Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

The tireless work to develop a new vaccine to prevent this novel, serious and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

This vaccine is a result of path-breaking research that has been developed after the rigorous work of eleven months. Though it immunizes us against the deadly virus, there’s a lot of things that we need to know about this vaccine.

1. the Vaccine Comes With Side-Effects

We all know this famous quote:

“There’s no such thing as a free lunch.”

The immunization shot is also the same.

According to the FDA, there can be some side effects after getting immunized. They are:

  • Pain at the injection site for several days.
  • Tiredness
  • Headache
  • Muscle aches
  • Chills
  • Joint
  • Body pain
  • Fever

Besides these mild symptoms, there are also remote chances that Pfizer-BioNTech COVID-19 Vaccine could cause severe allergic reactions. These allergic reactions may initiate within a few minutes to one hour of getting a shot of this vaccine.

Symptoms may include:

  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

What you should do in case of allergic reactions:

  1. First of all, call 9–1–1 or head to the nearest hospital if you see these symptoms mentioned above in you.
  2. Call the vaccination provider or the healthcare aid that injected you with the vaccine to seek emergency aid.
  3. Report the side effects of the vaccine to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) by calling a toll-free number (1–800–822–7967)
  4. You can also report online to https://vaers.hhs.gov/reportevent.html. While filing a report online, please include “Pfizer-BioNTech COVID-19 Vaccine EUA” in the first line of box #18 of the report form.
  5. You can also file a report at Pfizer's online facility:https://www.pfizersafetyreporting.com/.
    Fax: 1–866–635–8337
    Telephone Number: 1–800–438–1985

2. The Vaccine Hangs in Uncertainty for Severe Allergic Individuals

FDA posted a fact sheet regarding the vaccine trials that suggests, “in one of the tests, 0.4% of people got the vaccine immunization had a severe adverse event compared with 0.3% of those who received a placebo.”

Moreover, FDA has mentioned in their fact sheet that advises that:

“Individuals with a severe allergic reaction history (e.g., anaphylaxis) must not be given any component of the Pfizer-BioNTech COVID-19 Vaccine.”

This warning does not apply to 1.6% of people with severe allergic reactions to foods or something in the environment.

However, there have been strong allergic reactions in people residing in the United Kingdom who have a significant history of severe allergies. So, the UK’s health regulator has advised not to give this vaccine to allergic individuals.

What you should do:

Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, advises the allergic individuals to talk to their family doctor first before getting this immunization.

He further added that the doctors, while assessing your medical history, would be able to tell if the vaccine components are harmful to you or not.

3. Not Everyone Is Getting the Vaccine

To ensure faster delivery of million doses of vaccine by January 2021, the U.S government has initiated an Operation Warp Speed.

However, the CDC (Centers for Disease Control and Prevention) has recommended that the doses be given to the healthcare workers, residents, and staff of nursing homes in the first phase of distribution.

According to CNBC, it might take a few months (third quarter of 2021) for the entire nation’s population to get this vaccination, unless you are in a high-priority group (elderly or high-risk patients).

4. Vaccine Isn’t for Pregnant Women and Children Under 16

According to the FDA fact-sheet, pregnant women and children under sixteen have been excluded from getting immunized.

The trials of this covid vaccine on pregnant women and children are likely to begin in late January 2021 as per the FDA. The American Academy of Pediatrics is still inviting younger people for the vaccine clinical trials.

5. Cost of Getting the Pfizer Vaccine

As per the CDC guidelines (Center for Disease Control and Prevention), the government will be providing vaccines for free.

However, healthcare providers will have a free hand to charge a basic fee for these shots, which individuals can recoup from private and public insurance plans or government funds for uninsured citizens.

Last Thoughts

Despite the Pfizer vaccine's fantastic results, we must continue following the safety guidelines to keep the virus at bay.

While we wait for the vaccine to reach us, let’s cover our mouth and nose with a mask in public places and avoid close contact with people who are sick.

Also, let’s not forget the 6 feet away rule and washing our hands often.

✦A positive-minded guy with a peaceful heart ✦ I write about Life and Spirituality to solve the riddle of WhatIsInsideMe ✦ Connect on Social Media@watisinsideme

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