Posted in Current Events & Politics, Health & Medicine

Pfizer-BioNTech COVID-19 Vaccine Explained From the FDA Document Released

A huge wave of skepticism and resistance against the COVID-19 vaccine flooded the internet a couple of days ago when countries began administering it to patients worldwide. Uncertainties continue to dominate as this new feat in medicine unfolds. Back when the pandemic hit a few months back and fatalities were increasing month after month, everyone wished for a vaccine. Everyone prayed that scientists could develop one to end this madness. So, here it is, I believe this extraordinary milestone is to be celebrated as the much awaited vaccine has started to rollout.

Hence, why the skepticism? Misinformation and too much information. As a result, it created another worldwide havoc. The death rates continue to increase and hospitalizations rise daily. Also, mental health issues and economic struggles engulf mankind. Where do we go from here? It starts with research. Although Google provides a lot of data, we should be keen in deciphering which information is factual and evidence-based. So here’s what we know about the Pfizer-BioNTech COVID-19 Vaccine and FDA briefing document released. This is what we found out.

The vaccine efficacy outcome was more than 93% across demographic subgroups. Approximately 44,000 participants is currently ongoing to evaluate the vaccine’s safety and efficacy. They used randomized and placebo-controlled trial for the vaccine trials. Additionally, a two-month follow up after the completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate post vaccination period. Adverse events may start 6 weeks of vaccine receipt.

ADVERSE EVENTS

  • Localized reactions: Injection site redness and swelling occur after each dose on participants 18 to more than 55 years old and lasted 1-2 days.
  • Systemic and unsolicited adverse events: Most common for ages 18 to more than 55 years old: fever, fatigue, headache, chills, vomiting, new/worsened muscle pain
  • Bell’s palsy was seen in 4 participants that appeared after 3, 9, 37 and 48 days after vaccination. One resolved in 3 days, and the others with a duration of 10, 15 and 21 days respectively.
  • Appendicitis appeared in 8 participants.
  • Three participants reported shoulder injury, ventricular arrythmia and lymphadenopathy and are considered by the investigator to be vaccine related.
  • Another participant between ages 16 to 17 years experienced facial bones fracture which was not considered related to study intervention.
  • A total of 6 of 43,448 participants died which account for 0.01%. 2 from vaccine group and 4 from placebo group. 2 of the vaccine recipients who died were >55 years old, one has baseline obesity and experienced cardiac arrest 62 days after vaccination #2. The other died of arteriosclerosis 3 days after vaccination #1. Of the 4 participants in the placebo group, 2 died of unknown causes and 2 died from myocardial infarction and hemorrhagic stroke.

DOSING REGIMEN

  • Administered intramuscularly, the vaccine is off white, sterile, and preservative free.
  • The vaccine is supplied as a multidose vial (5 doses) containing a frozen suspension (-80 to -60 degrees Celsius) that must be thawed and diluted with 1.8 mL of sterile 0.9 sodium chloride.
  • The 5 doses allows 0.3 mL each.
  • Administered in two doses, 21 days apart.

With this data yields a lot of uncertainties. Seeing deaths as a result in a vaccine trial is not plausible and that’s fully understandable. We’re scared. We don’t really know how it will affect us or how it will change our lives. The deaths resulting from the vaccine trial is 0.01%, which I don’t discredit. However, we have a known data that experts could work on and possibly find alternatives to counteract those adverse effects. This is very promising and exciting. We finally have a vaccine! As I’m writing, there are 12,867 deaths in Canada from COVID-19. Although humanity is still treading rough waters in the fight against this virus, one must look into the benefits and risks of this vaccine. For years, infectious diseases has been the leading cause of death worldwide. In Canada, they cause less than 5% thanks to immunization programs. We have to make a choice as to what really benefits us.

Understanding the true value of vaccines is difficult when a lot of misinformation, hoaxes and conspiracies are readily available. We know what’s more difficult: social distancing, mask wearing, plexi glass divisions, business bankruptcies, foreclosures, rise in mental health issues and suicide rates, overflowing hospitals, healthcare worker burnouts, travel bans and lockdowns; this virus has created horrific problems and it’s about time to change that. So, what is it going to be?

Author:

Filipino-Canadian. Lives in Ottawa, Ontario. Full time frontliner, part-time scribbler.

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