Happy Tuesday, Friends!
Note: I am not a medical provider and this column is not meant to constitute medical advice in any way. Please talk to a medical provider for any questions or concerns.
I know a lot of people were excited to hear that a FDA advisory panel voted 17-4 (1 abstention) to recommend that the FDA grant Emergency Use Authorization (EUA) for the Pfizer COVID vaccine. Another vaccine produced by Moderna should be having its hearing for EUA this week.
So, what does all this mean? There is a fact sheet for the Pfizer vaccine here and another 29-page one for providers. However – your friend Carol read both (and attended several seminars) so I’m going to try to summarize here.
- What is EUA? This is not full FDA approval. Instead, an expert panel has reviewed results from phase III clinical trials and has determined that the public benefit is great enough and that the vaccine has been shown effective and safe enough to warrant its use during this public health emergency.
- When will it be available? The first doses were shipped and administered in the US on Monday, December 14th.
- Who will get it? The Centers for Disease Control is still fully working out the full details, but the distribution of the vaccine will most likely be in a phased approach:
- Phase 1a (first 4-6 weeks after EUA) – Health care workers and nursing home residents.
- Phase 1b – Essential workers – Phase 1b Essential workers (examples: Education Sector, Food & Agriculture, Utilities, Police, Firefighters, Corrections Officers, Transportation)
- Phase 1c – Adults with high -risk medical conditions and adults over the age of 65.
- Phase 2 – other adults.
These phases do overlap somewhat, but tentative timelines I have seen has phase 1 a-c occurring over approximately 20 weeks. However, this is by no means definite.
- How effective is the vaccine? In the over 43,000 adults who received the vaccine during clinical trials in 6 countries, early data shows that the vaccine is 90-95% effective. What does this mean? In one study I saw, around 90-100 of the people who got the placebo (inactive) injection contracted COVID, but less than 10 people in the group that received the active vaccine got the disease. Given that early expectations were that this vaccine would be around 70% effective, this is very good news indeed.
- What is in the vaccine? The Pfizer and Moderna vaccines are given in 2 doses (injections) 3 weeks apart. The Pfizer vaccine consists of a fragment of genetic material (mRNA) for the viral Spike protein. It is enclosed in liposomes (little balls of fat) and injected under your skin. The liposomes help it enter your cells. The ingredient list I saw indicated it didn’t contain an adjuvant or preservatives. The Moderna vaccine is similar.
- How does it work? Once in the cells, your cell’s machinery uses the mRNA to produce this Spike protein and then the mRNA is quickly degraded. Your body’s immune system sees this Spike protein and works to produce antibodies that will attack and hopefully neutralize the virus should you ever be exposed to the virus.
- Can you get the virus from the vaccine? These vaccines only has genetic material for the Spike protein of the virus – which is the part of the virus that attaches to the cells and helps the virus enter cells. No full active COVID virus can be produced from this tiny piece of genetic material.
- What are the side-effects?
- In one study I saw, a few hundred (out of thousands) of vaccine recipients reported side effect which include: headache, fever, aches, and/or chills. These symptoms typically went away within a few days and are described as similar in type and frequency to the side effects seen with the flu vaccine. Some volunteers compare it to a ‘hangover’.
- There were no instances of severe allergic reactions during the clinical trials. However, there were 2 people in the UK with severe allergies who had severe allergic reactions after receiving the vaccine recently. There is not enough information to say why this happened.
Verdict – Is the vaccine safe? Data indicates yes. The side-effects seem to be generally what is seen for other vaccines, like the flu vaccine.
However – as the fact sheet says:
You should “tell the vaccination provider about all of your medical conditions, including if you:
- have any allergies • have a fever • have a bleeding disorder or are on a blood thinner • are immunocompromised or are on a medicine that affects your immune system • are pregnant or plan to become pregnant • are breastfeeding • have received another COVID-19 vaccine
WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in
individuals 16 years of age and older.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?
You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine”