The beginning of the end?

So this post is a bit overdue…As much as I would like to turn this into a reel, I honestly don’t have the mental capacity to sit down and make a video, so blog post it is!

Fair warning! This post is extremely heavy so I have opted to make a second post with more FAQs.

It comes as no surprise that the number of COVID-19 cases have increased following the Thanksgiving holiday. Anyone working in healthcare KNEW and dreaded this as we’re are trying to mentally prepare for the weeks to come now that we’re also in the middle of flu season.

So at this point, you’ve heard that the FDA on 12/10 met up with the scientific panel and approved the Pfizer COVID-19 Vaccine for EUA (Emergency Use Authorization) in individuals 16 years of age and older. This allows the FDA to assist and protect people during public health emergencies either through treatment options or vaccinations.  Moderna (the second vaccine you’ve heard on blast)  should follow suit with Pfizer and  be granted approval for use later this week as well. 

Now you’re probably asking yourself, “Should I get it? Should I not?” If you’re still uncertain about the vaccine…read on!

Part of the reason why I’m writing on this is because I TOO was hesitant. As a public health professional AND infectious disease provider, how can I be so uncertain!?

I honestly just wished someone would sit me down and give me the facts (I mean, isn’t that why we turn to social media for quick updates on info? Baaaaad, bad Ngan! As someone who’s been trained to use evidence based medicine (EBM)  – I KNOW better, but I’m totally guilty!)

So what do these 2 vaccines (Moderna vs. Pfizer) have in common? Well, for starters, they’re what we call mRNA vaccines. Historically, vaccines can either be live, attenuated (MMR, varicella), inactivated/killed (polio, Hep A), inactivated toxin, or conjugated (containing pieces of the pathogen – Hep B, TdAP, influenza)

mRNA vaccines are getting a lot of attention just because they are “newer” on the market and historically have been used for gene therapy, cancer treatment, or other epidemic emergencies such as ebola and chikungunya!

How does a mRNA vaccine work?

Well, let’s start with some basics first. What is a mRNA? Messenger RNAs or mRNA, is a molecule that works in the cell to carry a code or protein.  

COVID has 29 main proteins, the main protein on the outer layer is known as the “Spike protein” (pay attention, because this is important later on). This particular mRNA carries the code to produce a part of the spike protein (THEREFORE, IT CANNOT CREATE AN ENTIRE VIRUS). I REPEAT! You cannot replicate the SARS-CoV-2 virus!

The isolated protein is then packaged in a lipid nanoparticle, allowing it to fuse into our human cells.

The vaccine/mRNA can now enter and recruit additional initiation factors (ribosomes, amino acids..etc) to build it’s own version if you will of the spike protein. So say, you’re now newly infected with COVID-19, your antibodies recognizes the spike protein, and illicit an immune response (B cells and T cells) to bind to the antigen on the surface of SARS-CoV-2 and responds before the virus can destruct your cells.

Now let’s talk more about the research of these vaccines.

What is known:

  • We only have 2 months of post-vaccination data
  • Data were analyzed from Pfizer Phase 3 Trials (July 27,2020 – November 14, 2020
  • We understand that most side effects are known and reported within a 6 month time frame
  • Herd immunity projected for COVID-19 is 70-80% of the population
Pfizer Vaccine: Moderna Vaccine:
95% Effective
Enrolled approx. 44,000 participants
21 days in between dosages
94.1% Effective
Enrolled approx 30,000 participants
28 days in between dosages
Pfziver Vs. Moderna COVID-19 Vaccine comparison

Common Side Effects Reported:

  • Headache, arthralgia, myalgia, injection site pain (83%)*, redness (51%)*, Swelling (6%)* fatigue, fever, chills
    • Compared to Dose #2: injection site pain (78%)*, redness (50%)*, swelling (6%)*
  • *Local reactions reported within 7 days after each Pfizer vaccination, 18-55 YO – – I will add those >55 YO had less reported SE

Adverse Effects

  • Lymphadenopathy, Bell’s Palsy**
    • I keep hearing this over and over again. The reported data shows bell’s palsy occurred on day 3, 9, 37, 48 after vaccination… but what’s important here is it is consistent with the expected rate in the general population.
      • MEANING… these individuals were probably going to get Bell’s palsy with or WITHOUT the vaccine. Remember, correlation DOES NOT equal causation!

Serious Adverse Effects:

  • Deaths: 2 in vaccine group, 4 in placebo group
  • Appendicitis (0.04%), Heart attack (0.02%), Stroke (0.02%)

Efficacy:

  • The data suggests 52% efficacy after Dose 1 and  95% efficacy overall at 7 days after Dose 2
  • Data suggestive there is no evidence of waning immunity 2 months after Dose 2

Special populations/Consideration:

  • Immunocompromised – may still receive COVID-19 vaccine unless otherwise contraindicated
  • Pregnancy: There are no current data on the safety of COVID-19 vaccines in pregnant women
  • Breast Feeding/Lactating Women: There are no data on the safety of COVID-19 vaccines in lactating women or the effects of vaccines on the breastfed infant or milk production/excretion
  • UPDATED (1/10/ 2021) Women’s health professional academies ( ACOG, ASRM, and SMFM) are ALL RECOMMENDING COVID-19 vaccination for pregnant women and lactating mothers.
  • It is absolutely safe for the majority of women to receive a vaccine if they are pregnant, breastfeeding or consider becoming pregnant in the immediate future.” – Kurt R. Wharton MD, FACOG
  • History of Anaphylaxis reaction
    • Due to reports of anaphylactic reactions vaccinated outside of clinical trials, persons who have had a severe allergic reaction to any vaccine or injectable therapy should NOT receive the Pfizer-BioNTech vaccine at this time
    • If you have any history of anaphylaxis – you should be observed for 30 minutes, all other persons..15 minutes for the first dose.

That’ll conclude part 1 of this most likely 2 part – COVID-19 Vaccine blog posts.
Next up! FAQs and my take on what’s to come with this pandemic.

If you have questions or concerns about whether or not the COVID-19 vaccine is right for you, please consider having a discussion with your medical provider.

Until next time… stay safe and well!
Xx,
Ngan

http://ACOG Pregnancy Statement
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html

Disclaimer:  These opinions and views expressed are not related to any hospital, health practice or any other institution. The information and other content provided in this blog are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.


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