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COVID Vaccines: The Lowdown & Answers to Common Questions

COVID Vaccines, the Lowdown

COVID Vaccines: The Lowdown and Answers to Common Questions, by Erin Stair MD, MPH (Dr. Eeks)

Hi guys, Dr. Eeks here. I decided to write a simplified write-up on the COVID vaccines, because they are a little complicated. And they are new, so it’s completely normal to have concerns. We’ve never used mRNA vaccines in humans, at least not on a wide scale outside of clinical trials. The traditional vaccines use actual parts from live or dead viruses to stimulate the immune system, so this is brand new territory. I also want everyone to know that I value your autonomy in making decisions about your health. You have to do your own risk/benefit comparison and decide if the vaccine is right for you. The purpose of me writing this blog is to present the information as I understand it. I also wrote down some of the common questions I receive on social media and answered them to the best of my ability. If I don’t have an answer, I say that.

I broke this blog down like a “cheat sheet,” and I’ll try to update it as information evolves and/or more vaccines are approved for emergency use. I know people are frustrated by the seemingly constantly changing information, but such is the nature of a new virus and pandemic. I also want to stress that these vaccines are not FDA-approved. I’ve seen people write that on social media, but it’s incorrect. These COVID-19 vaccines are approved for emergency use. That’s a different category, and I stress that, because we are continually gathering data on the safety and effectiveness of these vaccines, especially in sub-populations, like pregnant people, the elderly and folks with comorbidities. So maybe…, let’s start there:

What is the difference between FDA-Approved and Emergency Use Approval (EUA)?

EUAs are used in emergency situations, like pandemics. The FDA makes a drug or product available to the public based on the available evidence, while weighing the risks against the benefits. EUAs are ONLY valid for the period of emergency declaration. Beyond that, they are not valid, and the FDA reserves the right to pull the EUA at anytime. A drug that is FDA-approved has undergone more rigorous studies, have been studied for a longer period of time and has a more solid evidence base than those given EUAs. All drugs with EUAs are still undergoing further investigation under an Investigational New Drug Application. Approval is granted only after a greater review of efficacy, a greater assurance of safety in larger numbers and a greater review of manufacturing takes place. The FDA will also be actively evaluating the durablity of these vaccines, or how long immunity lasts, because at the moment, no one knows.

Okay, first up, the lowdown on the mRNA Vaccines for COVID:

What is mRNA, in simple terms?

It stands for Messenger RiboNucleic Acid. It’s essentially a code that our cells translate into proteins. Right now, there are 2 mRNA vaccines approved for COVID-19: Pfizer-BioNTech and Moderna. Pfizer is approved for people 16 and older and Moderna is approved for people 18 and older.

What are the ingredients of the 2 mRNA COVID-19 Vaccines:

Pfizer-BioNTech:

1.mRNA

2.Fats:

  1. ALC-0315 (4-Hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate): This is a synthetic fat. When used in combination with other synthetic fats, it helps our cells take up mRNA
  2. 2 [(polyethylene glycol)[PEG]-2000]-N,N-ditetradecylacetamide ): Also called macrogols or polyether compounds and used in a variety of drugs, personal hygiene products, cosmetics and foods. Allergies to this can be diagnosed via an IDT ( intradermal skin test)
  3. 1,2-Distearoyl-sn-glycero-3-phosphocholine: A phospholipid used to form a liposome- a “fat” vesicle used to deliver drugs to cells
  4. Cholesterol: A lipoprotein

3.Potassium Chloride: Potassium Salt. Used in medicines, food processing, and also known as food additive E508. Often used as a substitute for table salt

4.Monobasic Potassium Phosphate: An inorganic compound often used as a food additative or buffering agent. It’s used in both Gatorade and Powerade

5.Sodium Chloride: Salt. The edible version is table salt

6.Dibasic Sodium Phosphate Dihydrate: Salt. Used in foods and water-softening treatment. Used in foods to adjust pH. Used in desserts/pudding and also as an anti-cake addititve

7.Sucrose: Table sugar

Moderna

1.mRNA

2.Fats

  1. SM-102: A proprietary lipid- formula: C4H87NO5
  2. Polyethylene glycol [PEG] 2000 dimyristoyl glycerol: Also called macrogols or polyether compounds and used in a variety of drugs, personal hygiene products, cosmetics and foods. Allergies to this can be diagnozed via an IDT ( intradermal skin test)
  3. 2000 Dimyristoyl Glycerol (DMG): Lipid used for drug delivery- used in some cancer delivery drugs
  4. Cholesterol: A lipoprotein

3.Tromethamine: An organic amine proton acceptor. Used to make pharmaceuticals. Used as an emulsyifing agent in skin products and used as a biological buffer ( pH regulator)

4.Tromethamine Hydrochloride: A biologically inactive amino alcohol that buffers Carbon Dioxide & Acids and helps control pH

5.Acetic Acid: A weak acid. Acetic Acid makes up most of  Vinegar

6.Sodium Acetate: The salt version of Acetic Acid. Used commonly in foods to prolong shelf life, used in heating pads and hand warmers. When used with Acetic Acid, acts as a buffer to keep a constant pH level

7.Sucrose: Table sugar

What about allergies to these ingredients?

The CDC’s current guidelines state that if you have an allergy to any ingredient listed above, do not get the vaccine. The allergy does NOT have to be severe. Also, if you are allergic to Polysorbate, an ingredient which is NOT in the vaccine, the recommendation is to NOT get the vaccine. This is because Polysorbate is very similar to the PEGs in the vaccine. Both vaccines are given as 2 shots (covered below). If you have an immediate reaction to the 1st shot, you shouldn’t get the 2nd shot.

What about cosmetic fillers? 

You might have heard about facial swelling in people who had cosmetic fillers in their face? That happened to a few people in the Moderna vaccine trial, but not the Pfizer trial. Dermatologists say this “can” happen with vaccines in general, and can be treated with antihistamines and/or steroids. The swelling goes away, but if you have facial fillers, it’s something to keep in mind.

What about Bell’s Palsy?

Four people who received the vaccine in the Pfizer vaccine trial developed Bell’s Palsy and 3 in the Moderna trial. In the Pfizer trial, no one in the Placebo group developed it and in the Moderna trial, 1 person in the Placebo group developed it.  However, it’s inconclusive that it is linked to the vaccines. Bell’s Palsy is a condition in which the facial nerve is compressed or inflamed. It affects around 40,000 people in the US/year and causes paralysis of the facial muscles, giving one a droopy appearance and the inability to open or close the eye on the affected side. Symptoms come on fast, usually 1-2 weeks after a viral infection, and usually symptoms start to resolve after 2 weeks and are completely gone by 3-6 months. It’s mostly associated with viruses, like Lyme, The Common Cold, Mono, Herpes…, and is like a post-viral syndrome. It’s also associated with stress, though they don’t know if stress “causes” it. (Random trivia: Angelina Jolie developed the condition after her breakup with Brad Pitt and said that acupuncture helped her recover!)
Right now, some experts speculate that the Bell’s Palsy was coincidental, since the trial included thousands of people, and the rate of incidence in the trial wasn’t significant from the population-level rate. I believe they are still looking into it, though. Also, I did a fast literature sweep to see if Bell’s Palsy is associated with being infected with the COVID-19 Virus. There is an association. There is an article in the Journal of Neurovirology about the neurological manifestations of COVID-19, and Bell’s Palsy is listed as one. In some folks infected with COVID-19, it was one of the earlier symptoms.

What about Guillain-Barre Syndrome (GBS)?

This is a very rare syndrome in which the immune system attacks the peripheral nerves. It often presents as ascending muscle weakness or paralysis, meaning it starts in your lower legs and moves up. In most cases, it resolves on its own. On average, there are less than 20,000 cases per year in the US. GBS has been known to happen after both viral illnesses and vaccines.

In relation to the COVID vaccines, I would follow the advice of the GBS/CIDP foundation. They believe there is no contraindication for someone who had GBS to not get the vaccine nor do they believe this vaccine poses a higher risk of GBS. No cases of GBS have been linked to the COVID vaccines, and none were reported in the clinical trials. While Dr. Fauci originally said that people who developed GBS after past vaccinations should avoid getting the COVID vaccine, he retracted that statement based on expert advice from neurologists, including the doctors who are part of the GBS foundation. Historically, GBS was associated with the Swine flu vaccine ( 1 additional case for every 100,000 people vaccinated) and the influenza vaccine (2 additional cases for every 1 million people vaccinated.) However, GBS is more common after recovering from the actual flu. GBS doesn’t seem to have increased with COVID-19 either. One study in the UK shows that its rate of incidence has actually fallen during the pandemic.

I’ll note that some doctors say “it’s too soon” to know for sure, and we need much more data beyond the clinical trials, especially to evaluate risk of already rare events.

How do the vaccines work?

mRNA vaccines deliver instructions to our cells on how to make proteins. In the case of COVID-19, the mRNA vaccines deliver instructions on how to make a specific protein on COVID-19 called Protein S. (Protein S helps COVID-19 get inside our cells, take over our cellular machinery and cause disease.) Our cells “read” these instructions and use their protein-making machinery to make Protein S. They then show Protein S to the cells that make up the immune system and wander around the body detecting harmful invaders. The immune system recognizes Protein S to be an invader and responds by making protective cells. (These protective cells include things called antibodies and T cells.) The good news is that these protective cells stick around inside your body, so if in the future COVID-19 tries to infect you, you’ll have an army of cells ready to fight it.

If you are a VISUAL LEARNER, I created a video here, using my leg warmers, forks and random stuff in my kitchen to explain how they work and why they don’t affect your DNA.

Can you get COVID-19 from the mRNA vaccines?

No, you cannot, because it doesn’t use any part of the actual virus. It uses ONLY the code for Protein S on the virus.

Do the COVID vaccines change your genetic code?

To change someone’s genetic code, you have to get into the nucleus of a cell. The nucleus is like the central processing unit. mRNA vaccines never enter the nucleus. After they deliver the instructions on how to make Protein S, cellular enzymes break down the mRNA molecule and get rid of it. And since I’m on the subject, I should note that what alot of viruses do IS get inside the nucleus of our cells. People are very concerned about vaccines doing this, but, um, lots of viruses do this already!! Here’s a good piece on how they do it, if you are concerned.

How many doses is the vaccine?

Both Pfizer and Moderna are 2 doses. The Pfizer doses are given 21 days apart and the Moderna doses are given 28 days apart.

Is it okay to wait longer than 21 days or 28 days or mix/match vaccines?

Lots of experts are arguing these points at the moment. My opinion is that we should try to stick to the protocol that was tested in the trials. To me, that’s the most scientific thing to do. I know a pandemic is an emergency situation, and decisions may be made that don’t have a strong evidence base, but I still think it’s important to follow a tested protocol. Others don’t agree with me, I’m sure.

How effective are the vaccines after 2 doses?

Approximately 30,000 people were enrolled in the Moderna trial, so you can assume half got the vaccine and half didn’t. The Moderna vaccine was 95% effective at reducing cases of symptomatic COVID-19, 14 days out from the second dose. It was 87% effective in people 65 and older. The Pfizer trial involved around 44,000 people, so you can assume half got the vaccine, and half didn’t. The vaccine was 95% effective at reducing cases of symptomatic COVID-19, 7 days out from the second dose. It was 94% effective in people 65 and older.

How effective are the vaccines after just 1 dose?

I don’t trust these numbers, entirely, because they were based on small numbers and an mITT analysis, which is a modified intention to treat analysis that can create bias. But based on one source, the Moderna vaccine was 80% effective after 1 dose, with a median time of 28 days out. The sample size used to determine this was small and non-random, so take it with a grain of salt. ( Source: FDA, Page 28)  The Pfizer vaccine was 52% effective between the 1st dose and the 2nd dose, starting at 12 days after the 1st dose. ( Source: NEJM)

How long does immunity last from the vaccines? 

This is still being determined.

Will you need a booster?

My feeling is probably, given how fast the coronavirus family mutates and the fact that immunity wanes, but this is still being determined.

How long does immunity last from a natural infection of COVID-19? 

The answer to this will change ( and get closer to the truth) as more evidence gets published. Research is ongoing in this area, and it depends on the types of immune cells produced upon recovery and the antibody test being used. Not all antibody tests are created equal. If you are getting your antibodies tested, ask the clinic what test they are using and make sure it’s one of these on the FDA’s frequently updated approved list and not one on their “Remove” list. The answer to this question not only depends on the number of antibodies being produced, but the type of antibodies. In short, you want more neutralizing antibodies, or ones that prevent COVID-19 from reinfecting you, rather than binding antibodies that may not prevent reinfection. In the earlier part of the pandemic, it was suggested that antibodies didn’t last long…only 3 months, for example. Research conducted later in the pandemic has suggested that the level of neutralizing antibodies remains high for longer. For example, this study analyzed levels of neutralizing antibodies in over 30,000 NYC patients with mild to moderate COVID-19 and concluded that they last for at least 5 months. To assess the level of neutralizing antibodies they used the Mount Sinai Hospital enzyme-linked immunosorbent assay (ELISA) that is specific for neutralizing anti SARS-CoV-2 spike protein antibodies. A study from Iceland on over 30,000 patients used six different antibody assays to measure antibodies and concluded that they last at least 4 months.

Some researchers have stressed the importance of  “immune memory” over the antibody test. Simply put, immune memory includes immune cells other than antibodies. To assess immune memory, you want to measure the quantity of other cells, such as T cells ( CD4 and CD8 T cells). One study analyzed immune memory from samples taken from 188 COVID-19 patients and determined that immune memory was retained in 95% of patients, 6 months after recovery.

Can you get reinfected? 

The short answer is yes, but it seems rare. BUT…the real-world prevalence of reinfection is not known, because of lack of widespread surveillance and testing. For example, someone might have a mild case of  infection and/or reinfection and never get tested, so we wouldn’t know about it. Dr. Iwasaki did a great breakdown in the Lancet on four confirmed cases of reinfection. The patients’ ages were 25, 33, 46 and 51. All had a mild first case of COVID-19. We don’t know how good the antibody response was for 2 of the patients following the 1st infection, but it was not good for the other 2. Days to reinfection were 48, 63, 93 and 142. Just recently, a first happened: A 58 yo man in France with a history of asthma had a confirmed case of mild COVID-19 in September and recovered. In January, he was reinfected with the South African variant and had a much more serious infection. He is currently in critical condition and on a ventilor.

If you hear about cases of COVID-19 in people who got vaccinated, does that mean the vaccine is not working as well as it should? 

No, it does not mean that. First, expect “breakthrough” cases. Nothing is 100%, remember that. It’s possible that people who get vaccinated will still get COVID-19. The idea is to make sure that number is statistically SMALL, and the exception not the norm. Even the trials indicate this. It’s also important to remember that the current vaccines were designed to work against the original COVID-19 viral strain. More and more variants are popping up and making up a significant portion of new cases, meaning that it is most likely easier for those variants to “escape” the vaccine and cause disease. ( I discuss variant and vaccine effectiveness below.)

Why are they saying that we’ll still have to wear a face mask?!?

Every clinical trial has a primary outcome. When researchers determine the primary outcome, they design and power the study to correctly assess the primary outcome. In these trials, the primary outcome was how well the vaccines prevent symptomatic COVID-19 infection. The trial did not test how well the vaccine prevents someone, including someone who has COVID-19 but is showing no symptoms, from spreading COVID-19 to another person. Hence, that is why experts are telling us that we need to continue to wear face masks. They need to collect more data on how well the vaccines reduce spread. I know, it’s a complete and total drag…, but it won’t be forever. Remember, the effectiveness of face masks is the role they play in “source control”, or keeping an infected person from spreading COVID-19, not so much the role they play in preventing someone from getting COVID. While some experts are now saying to wear 2 face masks instead of 1, the CDC is still saying to only wear 1, but make sure it’s tight and fitted. There are no randomized controlled trials comparing the effectiveness of wearing 2 face masks vs 1, and my opinion is that folks should focus on wearing 1 right, in situations where they can’t social-distance. Otherwise, why not wear 3, 4, 5… you get the drill. Not that anyone cares, but I’ve been wearing 1 surgical mask since March of 2020 in situations where I can’t social-distance, and I definitely walk and run outside without it when no people are around. It’s healthy to aerate the lungs! ( For an interview I did with a face mask researcher in Hong Kong, click here.)

Do the vaccines cover the variant COVID-19 strands?

Viral mutations are normal. Some mutations are beneficial for the virus and some are not. The  most concerning variants, right now, are the UK one ( B.1.17)  the South African one (B.1.351), the Brazil one (P1), the New York one, the California one…and new ones are bound to pop up. All of the variants appear more transmissible. The variants, such as P1, might be more deadly in younger people, as early data in Brazil indicates. The New York one ( and it’s still very early) may be more deadly.

But do the vaccines work against the variants!?

This is an ongoing, million-dollar question, so be prepared for a lot of fluctuations in answers as more data comes in. The thinking is that the vaccine should provide some coverage against the variants, and even enough to prevent the variant from causing disease. However, it’s possible that a variant “escapes” immunity from a vaccine. I just read a study in NEJM ( March 24, 2021) that measured decreases in the vaccine’s ability to neutralize ( or stop a virus variant from causing disease) a viral variant.

For the B.1.17 variant: Ability of Pfizer to neutralize virus decreased by a factor of 2; Ability of Moderna to neutralize it decreased by a factor of 1.8.

For the B.1.351 variant: Ability of Pfizer to neutralize virus decreased by a factor of 6.5. Ability of Moderna to neutralize it decreased by a factor of 8.6.

For the P1 variant: Ability of Pfizer to neutralize virus decreased by a factor of 6.7. Ability of Moderna to neutralize it decreased by a factor of 4.5.

An important thing to keep in mind: Just because a vaccine had reduced activity against a viral variant, does NOT mean that the variant will escape the vaccine, and cause disease. To put the above numbers in comparison, from the same study, the AstraZeneca vaccine showed a reduction in neutralizing activity against the B.1.351 variant by a factor of 86! That is not good.

 

What about all the old people who died in Norway? 

You might have heard about the 23 old people who died in Norway after receiving the Pfizer vaccine. They all lived in a nursing home. I’ve seen a lot of social media posts about it online, so figured I’d address it. First, the deaths are being investigated by the Norwegian Medicines Agency (NOMA). The British Medical Journal (BMJ) published a report on this in mid-January of 2021. Here is a direct quote from that report: “The agency has investigated 13 of the deaths so far and conclused that common adverse reaction of the mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients.”  All of the deaths were in frail and/or terminally ill patients. My thoughts on this are to keep a few things in mind when analyzing this data: 1) It’s possible that these deaths would have happened with or without the vaccine. There are approximately 45 Nursing Home Deaths/day in Norway normally, because this population simply has a higher death rate; 2) Once NOMA is finished analyzing all of the data, if there proves to be a significant association with the vaccine, then public health decisionmakers should take note and update the vaccine guidelines; 3) There are a lot of elderly people who received the vaccine and are doing fine. ( I will update this section as I learn more.)

What about the Miami doctor who died? 

A 56-year-old, healthy doctor received the Pfizer vaccine on Dec 18, 2020 and died 16 days later from a brain bleed. A few days after the vaccine, he noticed red dots on his hands and recognized them as “petechiae.” He went to the hospital, they drew blood and diagnosed him with ITP, or Idiopathic Thrombocytopenic Purpura, a rare condition where the immune system attacks your own platelets. This will lead to widespread clotting dysfunction in the body. Petechia is one sign, but so is easy bruising and bleeding of the gums. The CDC and Pfizer are currently investigating this casee and a few others like it. ITP is also linked to COVID-19 viral infections, however. I’m linking to one article here that showed that ITP was found in 20% of the patients with COVID-19, 3 weeks after symptoms first showed. Also, several cases of ITP have been reported in COVID-19 patients who are in the “recovery” stage.

What if you’re pregnant?

None of the vaccines for COVID-19 are tested well enough in pregnant people to make a definitive conclusion, but they also aren’t shown to cause harm. There are animal studies that suggest that the vaccine does not impact the fetus, but more data is needed overall. Currently, the CDC recommends that pregnant people discuss the risks vs the benefits with their healthcare provider. The WHO recommends that pregnant people who are high risk for COVID-19, such as healthcare workers or those with underlying conditions, get the vaccine.

Onto the viral-vector vaccines:

The viral-vector vaccines include Johnson and Johnson’s, AstraZeneca’s and Russia’s Sputnik V. I will focus on the J and J vaccine since that one just got approved for emergency use in the US.

First, what is a viral-vector?

A viral-vector is a common virus that is made harmless and turned into a vehicle for delivering messages to our cells. Scientists make the viral-vector harmless by removing its genes that allow it to cause disease. The viral-vector can be either replicating ( meaning it can reproduce) or nonreplicating. The J and J viral-vector is nonreplicating, meaning it cannot reproduce. The approved Ebola vaccine is an example of a replicating viral-vector vaccine. The J and J vaccine uses the Adenovirus, a common virus, as its viral vector.

So it’s a vehicle…what is it delivering?

Similar to the mRNA vaccines, the viral-vector delivers instructions to our cells on how to make Protein S on COVID-19. Scientists take the genetic code for this protein and stitch it into the viral-vector.

How does it work? 

After you’re given the vaccine, the viral-vector travels to your cells and delivers the code for how to make Protein S on COVID-19. Your cells “read” the code, make the protein and present it to the immune system. The immune system responds by making protective cells, including antibodies and T cells. If COVID-19 tries to infect you in the future, you have an army of protective cells ready to fight it.

Does it affect your genetic code?

No. It does enter the nucleus, but it stays outside of your chromosomes (genes).

Can it give you COVID-19?

No, it cannot, because it doesn’t contain any live virus.

How many doses is it?

The J and J vaccine is 1 dose. They are currently testing 2 doses, but those results won’t be available for a while. (Russia’s Sputnik V is 2 doses and AstraZeneca is also 2 doses.)

What’s in the J&J Vaccine?

It’s an Adenovirus vector that is made harmless and grown in the PER.C6 cell line. It includes the genetic code for the spike protein on COVID-19. It also includes the following inactive ingredients:

  1. Citric Acid MonoHydrate: An Organic Acid
  2. Trisodium Citrate DiHydrate: Often used as a buffer in solutions and certain medications. Also used as a food additive or a flavoring agent, like in club sodas and drink mixes
  3. Ethanol: A simple alcohol
  4. 2-Hydroxypropyl-B-Cyclodextrin: A cyclic oligosaccharide used to improve the solubility of various compounds.
  5. Polysorbate 80:  A compound used to lower the surface tension between compounds. It’s also used as an emulsifier to do things like make ice cream smoother. It’s used in lots of food products, as well as soaps, eye drops and mouthwashes.
  6. Sodium Chloride: Salt
  7. Sodium Hydroxide: A metal hydroxide “Lye” used in the manufacture of soaps, medicines, water, drain cleaner, detergents and paper. It’s a strong base.
  8. Hydrochloric Acid: A strong acid

How effective is it?

It’s 66% effective at preventing symptomatic COVID-19 14 days after vaccination and 66.1% after 28 days. It’s 76.7% effective after 14 days in preventing severe/critical disease and 85.4% effective after 28 days in preventing severe/critical disease. Some people have said that means it’s less effective than the mRNA vaccines, but I don’t interpret the results that way at all. For one, it’s only 1 shot and 85% effective at preventing severe disease (which is key for maintaing healthcare capacity), and the trials for this vaccine happened later, when the new variants started to pop up. Those variants may have impacted the efectiveness of the vaccine. As for the other two, AstraZeneca is between 62% and 90% effective at preventing symptomatic COVID-19. Remember, this was the trial with the dosing “error.” The pooled dosing regimen showed an effectiveness of 70.4%. Russia’s vaccine, which will probably never be used in the US but is being rolled out in several other countries, is said to have 91% effectiveness against COVID disease.

Can you sue the drug companies for any negative side effects from the vaccines? 

No, you cannot. Under the PREP Act the companies were granted immunity. The PREP act grants immunity to companies that create drugs or countermeasures to a disease that is considered a public health emergency. There is, theoretically, a “Covered Countermeasures Process Fund” designed to compensate individuals who are seriously injuried directly by the vaccines, but Congress must first approve money for this fund. “Serious physical injuries” include injuries that warrant hospitalization or led to significant loss of function or disability. (My gut feeling is to not rely on this fund for compensation.) Some of you are more familiar with the National Vaccine Injury Compensation Program (VICP) that was formed in the 1980s. That was created to provide compensation to people injured by certain vaccines, with the goal of protecting drug companies from law suits and ensuring that they continue to make vaccines. In 1988, a group of British researchers alerted the public to a possible link between the pertussis portion of the diphtheria-pertussis-tetanus (DPT) vaccine and serious neurological harm in kids. ( The pertussis vaccine prevents against whooping cough, a respiratory illness caused by the bacteria, Bordetella pertussis.) While this link remains debatable, British parents stopped giving their kids the pertussis vaccine. As you can imagine, a lot of infants developed whooping cough and many died. A similar trend happened in the US. Parents sued the drug companies that made DPT and received sizeable financial awards. As a result, drug companies threatened to stop making vaccines altogether since they were costing them a lot of money, which led to the government creating the VICP.

Watch my video on this topic here!

How were these vaccines developed in less than a year?

The short answer is that they weren’t. Researchers have been studying mRNA vaccines and viral-vector vaccines for many years now. Just to give you an idea, here’s an article describing advances in mRNA vaccines published in Trends in Molecular Medicine in 2013. Here’s a study that was published in 2004. The point is that scientists did not start with a blank slate in 2020. What did change, however, is Operation Warp Speed. Operation Warp Speed gave the drug companies a ton of money, along with immunity, to make these vaccines as fast as they could. Without that financial boost, we’d never see these vaccines in a year’s time. That said, these vaccines are not licensed for use. They are only approved for emergency use, and that is because of the current level of evidence.

Were any steps skipped?

No, no steps were skipped. However, usually animal trials are conducted before the human trials. Animal trials make up the “pre-clinical stage,” and if something looks unsafe during the animal trials, it doesn’t progress to the human trials. Here we see animal trials being conducted in parallel with the human trials, something that not ever ethicist is happy about.  STAT did a great article on this topic that is worth checking out.

What vaccines use cell lines from aborted fetuses?

As far as the vaccines approved for emergency use, the Pfizer/BioNTech and Moderna vaccines do not use cell lines from aborted fetuses. AstraZeneca ( approved in the UK) and Johnson & Johnson do use stem cells from aborted fetuses. AstraZeneca uses HEK-293, a kidney cell line from a fetus aborted in 1972 and Johnson & Johnson use cell line PER.C6, retinal cells from a fetus aborted in 1985.

What was your biggest concern? 

My biggest concern about the vaccines was something called Antibody Dependent Enhancement, or ADE. In really simple terms, it means that unhelpful or non-neutralizing antibodies are formed after a vaccine that end up helping a virus infect cells and create a more serious disease state. It’s like when the exact opposite of what you want to happen, happens. I read about it derailing past attempts to create a safe vaccine for a Coronavirus. For example, a viral-vector vaccine for SARS, another coronavirus, was tested on macaques. It didn’t see the light of day, because it was shown to lead to severe lung inflammation and acute respiratory failure when the macaques were given SARS. An inactivated whole virus vaccine for SARS and a virus-like-particle vaccine were shown to create the same type of reaction in mice and ferrets. 

Other animal studies show a mixed picture for risk of Antibody Dependent Enhancement. The literature is painfully complex, so I made sure to ask Dr. Fleming, an ID doctor here in NYC who did research on antibody responses to COVID-19, about it on my podcast, Causes or Cures. I specifically asked what measures were being taken to prevent Antibody Dependent Enhancement or if it was even something we had to worry about. If you’re interested in learning more, please listen to it.

The FDA and CDC are currently monitoring, and will be for several months, for signs of ADE in the population, as this is something that won’t manifest immediately after receiving a vaccine.

**Important Update: More recently I’ve interviewed a vaccinologist and one of the original inventors of DNA vaccinations, Dr. Robert Malone, on this issue. I highly, highly recommend listening to it. He explains it very well, in an easy-to-understand way and provides a very honest answer about risk. Here is the podcast with Dr. Malone.

What about side effects?

When you get any vaccine, you’re triggering an immune response, and that can feel like a viral illness. These vaccines have similar side effect profiles to FDA-approved vaccines: fatigue, sore arm, fever, sweating, and headache…that go away in a short amount of time. In the trials, for the most part, there were similar side effects in the vaccine group as the placebo group, which is a good thing. From the mRNA vaccine trials, side effects seem stronger after the 2nd dose, including for people who had COVID-19 and recovered. On an anecdotal level, I have heard people complain of longer-lasting headaches. That struck me, because headaches are super annoying and get in the way of daily functioning. Places of employment may want to consider paid time-off for their employees who get vaccinated. A few other people talked about longer-lasting fatigue and one person mentioned swollen lymph nodes. An article on WebMD highlighted the swollen lymph nodes, as they may mimick breast cancer symptoms. ( A good one for women to know, as that can scare a lot of people.) In general, most people I talked to reported very minor symptoms and the vaccines didn’t interfere with their functioning at all. That said, these vaccines are still in an experimental stage, and the FDA/CDC will be actively monitoring side effects going forward in a much larger population. This includes the monitoring of vaccine-induced antibody-dependent enhancement of disease. Anyone who has side effects, should report them to VAERS.

Specifically, from the trials:

For the Johnson and Johnson Vaccine: 

In the trial, there were numerical imbalances between the vaccine and placebo groups in regard to the following adverse events: Tinnitus ( 6 in Vaccine group, 0 in Placebo group); Thromboemboli or clots ( 15 in the Vaccine group, 10 in the Placebo group) and Urticara, or hives ( 5 in the Vaccine group and 1 in the Placebo group). While very small, the FDA couldn’t conclude that these imbalances were/weren’t caused by the vaccine, and Johnson and Johnson has set up a Pharmacovigilance Plan to monitor them in the population.

For the Pfizer Vaccine:

In the trial, there was a numerical imbalance between the vaccine and placebo groups regarding appendicitis ( 8 in the Vaccine group and 4 in the Placebo group). Right now, there is inconclusive evidence to say that the imbalance was caused by the vaccine. As mentioned earlier, there was a numerical imbalance in relation to Bell’s Palsy ( facial paralysis): ( 4 in the Vaccine Group and 0 in the Placebo group). There is inconclusive evidence to suggest that this was caused by the vaccine. There was also a higher number of lymphadenopathy: Vaccine group (64) vs. the placebo group (6).

For the Moderna Vaccine:

In the trial, there was a numerical imbalance between the vaccine and placebo group regarding Bell’s palsy (3 in the Vaccine group and 1 in the Placebo group.) The current available data on Bell’s palsy makes it insuffient to determine if the vaccine played a causal role. There were 2 cases of facial swelling related to facial implants, as discussed above. There was more lymphadenopathy (swollen and/or painful lymph nodes) in the Vaccine group ( 1.1 percent) vs the Placebo group (.6%).

Will taking Benadryl beforehand lower my risk of an allergic reaction?

I’ve received this question from friends and family members, because there is mixed advice floating around online. An article from WebMD, which interviewed practicing immunologists, made the most sense to me. Basically, the recommendation is to not take Benadryl before getting the COVID vaccines unless you already take it as part of your normal routine. One doctor made a good point: Benadryl might suppress the body’s reaction and make it harder to detect an anaphylactic reaction early-on. Personally, I’d rather detect an anaphylactic reaction as fast as possible so I can get a shot of Epinephrine and not die. Along the same vein, the experts interviewed in the WebMD article don’t recommend taking pain medication before getting the vaccine, because they don’t know for sure how it reacts with the vaccine.

Will the vaccine ever be mandatory? 

I don’t think so. Remember, it’s approved for emergency use only. It’s not FDA-approved, so I think making it mandatory would be very difficult. I started this post by saying how much I value your autonomy when it comes to making decisions about your health. I would never support a vaccine being made mandatory for that reason. I just hope that you use facts and solid science to make your decision and not misinformation or lies from the Internet.

I hope this “cheat sheat” on the COVID vaccines was helpful. I will update it as more information comes to light and/or add more questions and answers as I get them. As a reminder, opinions on this page are my own and not reflective of anyone I work for.

Thanks,

Erin (Eeks)

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COVID-related blogs and/or Expert Interviews from my Causes or Cures Podcast:

Antibody-Dependent Enhancement and the COVID-19 Vaccines with Dr. Robert Malone

The Story of Ivermectin & COVID-19, with Dr. Kory

How and Why Obesity makes COVID so much Worse, with 2 Infectious Disease Doctors

Why it’s Safe for Kids to be in Schools, with Dr. Jonas Ludvigsson

How COVID causes Strokes in People, with Dr. Ricardo Jose 

The Effectiveness of Face Masks: With Dr. Benjamin Cowling 

COVID-19 and Blood Type: Does Your Blood Type Matter? With Dr. Chris Latz 

Early At-Home Treatment for COVID: Why aren’t we talking about this more?  With Dr. McCullough

The Mental Health Toll of COVID-19 on Adults and Kids, with Psychiatrist Dr. Farren

COVID-19’s effect on the Opioid Epidemic, with Addiction Doctor Dr. John Kelly

Why the US Couldn’t Respond like Singapore Did ? ( Singapore has a much lower death rate.)

Inconsistent Public Health Messaging in the Age of COVID

Not COVID-related, but Appreciate the Support:

My current books:

(Please leave a review too, if you have the time!)

Manic Kingdom. a True Story of Breakdown and Breakthrough

Yours in Wellness, Krystal Heeling: A Short, Comedic Parody on the Wellness Industry 

And…

ZENBands from our shop, if you want comfortable ears & help relaxing.  🙂

 

19 Responses to “COVID Vaccines: The Lowdown & Answers to Common Questions”

  1. Thank you. Perfect cheat sheet for talking RJ concerned faculty and staff. I’ll be sharing.

  2. Please address Celeste Solumn’s concerns (20-year FEMA Veteran) with the vaccine. It would also be helpful to hear your thoughts on DARPA Hydrogel and alleged nano-particle use in this vaccine.
    Thanks!

  3. Thank you, this is a great summary resource!

  4. I have heard of you’ve had Guillian Barre that you should not have the COVID vaccine. Then I heard it was safe. I don’t know if I should chance it or our not??????

    • Hi Caryl… I updated the blog to answer this question. Below is what I wrote. I also suggest visiting the GBS community page ( linked in the blog) because I feel they, above anyone, know what they are talking about when it comes to GBS.

      “What about Guillain-Barre Syndrome (GBS)?

      This is a very rare syndrome in which the immune system attacks the peripheral nerves. It often presents as ascending muscle weakness or paralysis, meaning it starts in your lower legs and moves up. In most cases, it resolves on its own. On average, there are less than 20,000 cases per year in the US. GBS has been known to happen after both viral illnesses and vaccines.

      In relation to the COVID vaccines, I would follow the advice of the GBS/CIDP foundation. They believe there is no contraindication for someone who had GBS to not get the vaccine nor do they believe this vaccine poses a higher risk of GBS. No cases of GBS have been linked to the COVID vaccines and none were reported in the clinical trials. While Dr. Fauci originally said that people who developed GBS after past vaccinations should avoid getting the COVID vaccine, he retracted that statement based on expert advice from neurologists, including the doctors who are part of the GBS foundation. Historically, GBS was associated with the Swine flu vaccine ( 1 additional case for every 100,000 people vaccinated) and the influenza vaccine (2 additional cases for every 1 million people vaccinated.) However, GBS is more common after recovering from the actual flu. GBS doesn’t seem to have increased with COVID-19 either. One study in the UK shows that its rate of incidence has actually fallen during the pandemic.

      I’ll note that some doctors say “it’s too soon” to know for sure, and we need much more data beyond the clinical trials, especially to evaluate risk of already rare events.”

  5. This cheat sheet is so informative! I have been reading on some FB epidemiologists pages that they count the people who have had Covid + those getting the vaccine in their calculations to “herd immunity”. Why are they then suggesting someone who has had Covid get the vaccine? This is confusing. Their statement makes it appear that those who have had the virus are helping the virus not spread person to person… but then no…. get the vaccine!? If someone has immunity by natural infection, why get the shot?

    • That is confusing, Michele. Herd immunity DOES include people who have recovered from a natural infection and have a robust supply of antibodies, as well as 95% of people who are vaccinated ( based on the trial effectiveness.) The reason they are telling someone who had the infection and recovered to get the vaccine is because they are unsure of the antibody/immune memory response, which will vary from person to person. There were people who had recovered from COVID-19 in the vaccine clinical trials, and they did not have a hyper immune response or anything like that. But you’re right in the sense that if some epidemiologists are using those recovered in their herd immunity equation, they might be double counting or confused somewhere along the way.

  6. **UPDATES ADDED 15’FEB, 2021:

    What about Guillain-Barre Syndrome (GBS)?

    This is a very rare syndrome in which the immune system attacks the peripheral nerves. It often presents as ascending muscle weakness or paralysis, meaning it starts in your lower legs and moves up. In most cases, it resolves on its own. On average, there are less than 20,000 cases per year in the US. GBS has been known to happen after both viral illnesses and vaccines.

    In relation to the COVID vaccines, I would follow the advice of the GBS/CIDP foundation. They believe there is no contraindication for someone who had GBS to not get the vaccine nor do they believe this vaccine poses a higher risk of GBS. No cases of GBS have been linked to the COVID vaccines, and none were reported in the clinical trials. While Dr. Fauci originally said that people who developed GBS after past vaccinations should avoid getting the COVID vaccine, he retracted that statement based on expert advice from neurologists, including the doctors who are part of the GBS foundation. Historically, GBS was associated with the Swine flu vaccine ( 1 additional case for every 100,000 people vaccinated) and the influenza vaccine (2 additional cases for every 1 million people vaccinated.) However, GBS is more common after recovering from the actual flu. GBS doesn’t seem to have increased with COVID-19 either. One study in the UK shows that its rate of incidence has actually fallen during the pandemic.

    I’ll note that some doctors say “it’s too soon” to know for sure, and we need much more data beyond the clinical trials, especially to evaluate risk of already rare events.

    How long does immunity last from a natural infection of COVID-19?

    The answer to this will change ( and get closer to the truth) as more evidence gets published. Research is ongoing in this area, and it depends on the types of immune cells produced upon recovery and the antibody test being used. Not all antibody tests are created equal. If you are getting your antibodies tested, ask the clinic what test they are using and make sure it’s one of these on the FDA’s frequently updated approved list and not one on their “Remove” list. The answer to this question not only depends on the number of antibodies being produced, but the type of antibodies. In short, you want more neutralizing antibodies, or ones that prevent COVID-19 from reinfecting you, rather than binding antibodies that may not prevent reinfection. In the earlier part of the pandemic, it was suggested that antibodies didn’t last long…only 3 months, for example. Research conducted later in the pandemic has suggested that the level of neutralizing antibodies remains high for longer. For example, this study analyzed levels of neutralizing antibodies in over 30,000 NYC patients with mild to moderate COVID-19 and concluded that they last for at least 5 months. To assess the level of neutralizing antibodies they used the Mount Sinai Hospital enzyme-linked immunosorbent assay (ELISA) that is specific for neutralizing anti SARS-CoV-2 spike protein antibodies. A study from Iceland on over 30,000 patients used six different antibody assays to measure antibodies and concluded that they last at least 4 months.

    Some researchers have stressed the importance of “immune memory” over the antibody test. Simply put, immune memory includes immune cells other than antibodies. To assess immune memory, you want to measure the quantity of other cells, such as T cells ( CD4 and CD8 T cells). One study analyzed immune memory from samples taken from 188 COVID-19 patients and determined that immune memory was retained in 95% of patients, 6 months after recovery.

    Can you get reinfected?

    The short answer is yes, but it seems rare. BUT…the real-world prevalence of reinfection is not known, because of lack of widespread surveillance and testing. For example, someone might have a mild case of infection and/or reinfection and never get tested, so we wouldn’t know about it. Dr. Iwasaki did a great breakdown in the Lancet on four confirmed cases of reinfection. The patients’ ages were 25, 33, 46 and 51. All had a mild first case of COVID-19. We don’t know how good the antibody response was for 2 of the patients following the 1st infection, but it was not good for the other 2. Days to reinfection were 48, 63, 93 and 142. Just recently, a first happened: A 58 yo man in France with a history of asthma had a confirmed case of mild COVID-19 in September and recovered. In January, he was reinfected with the South African variant and had a much more serious infection. He is currently in critical condition and on a ventilor.

    What vaccines use cell lines from aborted fetuses?
    As far as the vaccines approved for emergency use, the Pfizer/BioNTech and Moderna vaccines do not use cell lines from aborted fetuses. AstraZeneca ( approved in the UK) and Johnson & Johnson do use stem cells from aborted fetuses. AstraZeneca uses HEK-293, a kidney cell line from a fetus aborted in 1972 and Johnson & Johnson use cell line PER.C6, retinal cells from a fetus aborted in 1985.

  7. March 3, 2021, UPDATES Added:

    1. LINKS to podcasts on experts discussing COVID-related topics were added at the end of the blog.

    2.What’s in the JandJ Vaccine?

    It’s an adenovirus vector grown in the PER.C6 cell line that includes the genetic material for the spike protein on COVID-19. It also includes the following inactive ingredients:

    Citric Acid MonoHydrate: An Organic Acid
    Trisodium Citrate DiHydrate: Often used as a buffer in solutions and certain medications. Also used as a food additive or a flavoring agent, like in club sodas and drink mixes
    Ethanol: A simple alcohol
    2-Hydroxypropyl-B-Cyclodextrin: A cyclic oligosaccharide used to improve the solubility of various compounds.
    Polysorbate 80:  A compound used to lower the surface tension between compounds. It’s also used as an emulsifier to do things like make ice cream smoother. It’s used in lots of food products, as well as soaps, eye drops and mouthwashes.
    Sodium Chloride: Salt
    Sodium Hydroxide: A metal hydroxide “Lye” used in the manufacture of soaps, medicines, water, drain cleaner, detergents and paper. It’s a strong base.
    Hydrochloric Acid: A strong acid

    3. How Effective Is It?

    It’s 66% effective at preventing symptomatic COVID-19 14 days after vaccination and 66.1% after 28 days. It’s 76.7% effective after 14 days in preventing severe/critical disease and 85.4% effective after 28 days in preventing severe/critical disease. Some people were saying that means it’s less effective than the mRNA vaccines, but I don’t interpret the results that way at all. For one, it’s only 1 shot and 85% effective at preventing severe disease (which is key for maintaing healthcare capacity), and the trials for this vaccine happened later, when the new variants started to pop up. Those variants may have impacted the efectiveness of the vaccine. As for the other two, AstraZeneca is between 62% and 90% effective at preventing symptomatic COVID-19. Remember, this was the trial with the dosing “error.” The pooled dosing regimen showed an effectiveness of 70.4%. Russia’s vaccine, which will probably never be used in the US but is being rolled out in several other countries, is said to have 91% effectiveness against COVID disease.

    4. What About Side Effects from the Vaccines?

    When you get any vaccine, you’re triggering an immune response, and that can feel like a viral illness. These vaccines have similar side effect profiles to FDA-approved vaccines: fatigue, sore arm, fever, sweating, and headache…that go away in a short amount of time. In the trials, for the most part, there were similar side effects in the vaccine group as the placebo group, which is a good thing. From the mRNA vaccine trials, side effects seem stronger after the 2nd dose, including for people who had COVID-19 and recovered. On an anecdotal level, I have heard people complain of longer-lasting headaches. That struck me, because headaches are super annoying and get in the way of daily functioning. Places of employment may want to consider paid time-off for their employees who get vaccinated. A few other people talked about longer-lasting fatigue and one person mentioned swollen lymph nodes. An article on WebMD highlighted the swollen lymph nodes, as they may mimick breast cancer symptoms. ( A good one for women to know, as that can scare a lot of people.) In general, most people I talked to reported very minor symptoms and the vaccines didn’t interfere with their functioning at all. That said, these vaccines are still in an experimental stage, and the FDA/CDC will be actively monitoring side effects going forward in a much larger population. This includes the monitoring of vaccine-induced antibody-dependent enhancement of disease. Anyone who has side effects, should report them to VAERS.

    Specifically, from the trials:

    For the Johnson and Johnson Vaccine: 

    In the trial, there were numerical imbalances between the vaccine and placebo groups in regard to the following adverse events: Tinnitus ( 6 in Vaccine group, 0 in Placebo group); Thromboemboli or clots ( 15 in the Vaccine group, 10 in the Placebo group) and Urticara, or hives ( 5 in the Vaccine group and 1 in the Placebo group). While very small, the FDA couldn’t conclude that these imbalances weren’t caused by the vaccine, and Johnson and Johnson has set up a Pharmacovigilance Plan to monitor them in the population.

    For the Pfizer Vaccine:

    In the trial, there was a numerical imbalance between the vaccine and placebo groups regarding appendicitis ( 8 in the Vaccine group and 4 in the Placebo group). Right now, there is inconclusive evidence to say that the imbalance was caused by the vaccine. As mentioned earlier, there was a numerical imbalance in relation to Bell’s Palsy ( facial paralysis): ( 4 in the Vaccine Group and 0 in the Placebo group). There is inconclusive evidence to suggest that this was caused by the vaccine. There was also a higher number of lymphadenopathy: Vaccine group (64) vs. the placebo group (6).

    For the Moderna Vaccine:

    In the trial, there was a numerical imbalance between the vaccine and placebo group regarding Bell’s palsy (3 in the Vaccine group and 1 in the Placebo group.) The current available data on Bell’s palsy makes it insuffient to determine if the vaccine played a causal role. There were 2 cases of facial swelling related to facial implants, as discussed above. There was more lymphadenopathy (swollen and/or painful lymph nodes) in the Vaccine group ( 1.1 percent) vs the Placebo group (.6%).

    5. The FDA and CDC are currently monitoring, and will be for several months, for signs of ADE in the population, as this is something that won’t manifest immediately after receiving a vaccine.

    **Important Update: More recently I’ve interviewed a vaccinologist and one of the original inventors of DNA vaccinations, Dr. Robert Malone, on this issue. I highly, highly recommend listening to it. He explains it very well, in an easy-to-understand way and provides a very honest answer about risk. Here is the podcast with Dr. Malone.

  8. March 10, 2021, UPDATE Added:
    I wanted to give an update on vaccine effectiveness against variants. A study that has been peer-reviewed and accepted into Nature, a well-respected medical journal, shows that the the Pfizer and Moderna vaccines are effective against the UK variant, meaning there was no loss of neutralizing activity. ( Neutralizing activity refers to the ability of vaccine-induced immune cells to bind to the virus and prevent it from infecting cells.) However, there was significant loss of neutralizing activity when it came to the South African variant, or B.1.351. There was a 10.3 fold reduction in neutralizing activity for the Pfizer vaccine and a 12.4 fold reduction in neutralizing activity for the Moderna vaccine. This means that the vaccines are significantly less effective against the South African variant, which could be a significant roadblock on the road to herd immunity. 

  9. Donald Callahan March 13, 2021 at 9:24 am

    Dr. EeKs – thanks for taking the time to author this article, it’s the most comprehensive and best ‘plain speaking’ resource I’ve found yet on this important topic!

  10. Thank you for the excellent information. I am looking for information about vaccination and its effects on those with post-viral syndrome, and specifically how effective each vaccination is for long-haulers. Do you have any information about this?

    • Hi Cici,
      I know they are actively studying this in trials that are ongoing.
      There are anecdotal reports that the vaccine is helping Long-Haulers. Just recently, there was an article in NPR about that. But to be honets with you, I wasn’t that impressed with the article, because its premise was based on subjective measures only, and not objective measures. The placebo effect could be at play there. Once studies with more objective measures get published, I will be sure to upate here!

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