Safety

Safety Questions

Great question!

RNA are like post-it notes (or, for the younger crowd, Snapchat messages that expire!). At any moment, a human cell has 5000+ different RNA messages. They are read by the cells and then destroyed within minutes to hours.

Because they are temporary, they do NOT become a permanent part of your body. In fact, they do not enter the nucleus of the cell and they never interact with a person’s DNA.

These temporary RNA messages instruct the cells of the body to make proteins. In the case of the mRNA COVID-19 vaccine, they message for one single coronavirus protein: the spike protein. This is the protein that the virus needs to enter the cells. So by developing antibodies to block it, you prevent COVID!

Now: remember — it takes 25 different proteins to make a coronavirus. So your body is NOT making a coronavirus with the RNA vaccine!

This is a great question because we knew that we would learn more about the mRNA vaccines as they rolled out.  And the FDA discussed the data to date at the J&J hearing on February 26th, which covered over 55 million people having received a dose of either the Pfizer (over 28 million) or Moderna (over 26 million).  They have data on nearly 4 million who completed at least one v-safe health check in.  What they have found is that there was no difference in the safety data between Pfizer and Moderna, with most people reporting injection site pain, fatigue, headaches and myalgias within 24 hours of their injections.  They also found no increased risk of any serious adverse outcome as detailed in the data they presented here:  https://www.fda.gov/media/146269/download.

Category: Safety

Yes! It’s an incredible scientific achievement!  But realize—research on the technology behind the new COVID-19 vaccine has been underway for at least the past 10+ years.  We’ve had prototypes for influenza, rabies and other types of viruses.  This pandemic pushed scientists across the world to be really motivated and focused on a single virus and utilized the knowledge they already with significant resources. In the US, we had Operation Warp Speed, a federal partnership between the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), Department of Defense (DOD), and private companies to develop, manufacture, and distribute 300 million doses of the COVID-19 vaccine. It was incredibly fortunate that they picked the spike protein of SARS-CoV-2 to focus on, as it turned out this was the right protein to target!

These vaccines have been tested in clinical trials enrolling tens of thousands of people, just like other vaccines. The timeline was accelerated, but steps were not skipped. You can see the FDA briefing materials that provide a comprehensive overview of the safety and efficacy data.

Category: Safety

So far, there have been less than 20 severe allergic reactions that have been reported with the Pfizer and Moderna vaccines. It is important to remember that this is out of >1 million people worldwide who have been vaccinated. In all cases, people have successfully been treated for the allergic reaction. These events are being evaluated to determine exactly what reactions have occurred and what (if any) allergies these people have had.

The CDC is currently recommended a 15-minute monitored waiting period after the vaccine; but if you have had a serious of severe anaphylaxis, they are recommending you have 30 minute monitored waiting period after your vaccine.

Additional recommendations will be forthcoming or change, so check back here!

Category: Safety

No! Currently there are no underlying medical conditions that preclude you from getting the vaccine. That is because getting COVID is so much worse, especially for people with underlying chronic conditions.

If you do have a significant allergy history, or believe you are allergic to any of the ingredients in the vaccine, you should let your provider know. You may be monitored more closely following the vaccine.

Category: Safety

Great question! The only people who should NOT get the vaccine are those with a history of severe reactions to the vaccine ingredients. Those ingredients are listed on page 2 of this document: https://www.fda.gov/media/144414/download

We do strongly recommend you also discuss your allergy concerns with your doctor!

Category: Safety

None of the vaccines are live vaccines. The mRNA vaccines (Pfizer, Moderna) are simply mRNA vaccines, which are like temporary notes that tell the cell what to do—in this case, make antibodies to the spike protein of SARS-CoV2.

 The J&J vaccine uses an adenovirus—another type of virus—as a carrier of DNA coding for the spike protein, so the cells can make antibodies to it.  Many have worried about this adenovirus component of the vaccine and if this is a “live” vaccine—but it’s very important to understand that this adenovirus component has had both its replicative and survival abilities erased from its genome.  So it’s really just scaffolding for the DNA coding the spike protein—no live virus involved. It is therefore safe for those patients with suppressed immune systems, either through medications or due to underlying medical conditions.

Category: Safety

mRNA vaccines contain no human or animal in them — they are just made with a few salts, sugar, water, a lipid capsule and mRNA.

Category: Safety

It appears that people who get the COVID vaccines are more likely to get some mild flu-like symptoms: sore arm, muscle aches, fatigue, GI discomfort, etc. This appears to happen a bit more with this vaccine than with (for example) the flu vaccine; and it appears to be more common after the second dose of the vaccine, and can last up to 24–36 hours.

But please remember: this is a GOOD thing! It means your body is responding to the vaccine and building up the defense you need to protect you from COVID! (Think of it like working out — you have to get a little sore to build up that muscle!)

It is absolutely fine to take Tylenol or ibuprofen (Motrin, Advil) to treat these symptoms if they occur; but it is currently NOT recommended to take those medications to prevent these symptoms before they start because it is unclear at this time if they will interfere with the antibody response and vaccine effectiveness.

And don’t worry if you don’t have these symptoms — some people do, some people do not!

Category: Safety

Yes! The CDC absolutely recommends that people who are immunosuppressed or have high-risk medical problems get vaccinated.  Please remember: none of the vaccines are live vaccines.  And these vaccines protect against severe COVID-19 or dying from COVID-19.

Category: Safety

This is not true. It is recommended that even if you have had COVID in the past you get vaccinated. We have not seen an increased number of autoimmune flares with either the vaccine or with COVID.

Category: Safety

People with autoimmune disorders have not been reported to have “flares” after receiving the COVID vaccines or after having active COVID-19 infections.

Category: Safety

Yes vaccines can contain metals; and so do blueberries, eggs and bananas! Metals are part of nature. Your body needs certain types of metals for appropriate function; and your body can handle these micro doses of metals and excrete them appropriately — including those in the foods you eat AND in vaccines.

Category: Safety

Bell’s Palsy is a facial paralysis, usually on one side, that causes drooping of the face. It is usually temporary but can rarely become permanent.  The CDC has been monitoring this, along with a number of other outcomes, with the COVID vaccines and have not found any increased risk with the COVID vaccines. For more on this research, please see the informational slides here.

Category: Safety

Initially with the Pfizer and Moderna vaccines, there was concern regarding allergic reactions. As we have accumulated millions more people receiving these vaccines, it appears there is no increased risk of an allergic reaction.  However, for ALL the vaccines (the Pfizer, Moderna and J&J vaccine), the CDC recommends a 15-minute monitored waiting period after the vaccine; and a 30-minute monitored waiting period if you have any history of serious allergies to medications.

Category: Safety

Per the CDC, a delayed local injection-site reaction after the first mRNA vaccine dose is not a contraindication or precaution to the second dose. You will also want to discuss with your health care provider.

Category: Safety

No—none of the approved vaccines are live vaccines. You do not have to quarantine after getting the vaccine.  You SHOULD continue to wear a mask and physically distance for 2 weeks after you receive either the J&J vaccine or the second dose of the Pfizer or Moderna vaccine.

Category: Safety

The FDA and CDC wanted to evaluate a total of 15 rare events of cerebral venous thrombosis (a very rare type of clotting disorder) and low platelet count.  One of these people died; and another was hospitalized.  This syndrome (large vessel blood clots with low platelet count) was deemed to be biologically plausible to be associated with this type of vaccine.

The pause also afforded the opportunity to provide clarity to providers on a) who appears to be at increased risk and b) how to treat it appropriately if there is concern that it happened in someone who received the J&J vaccine.

The conclusion that they came to was that these rare events were in fact quite rare; and the benefits of the J&J vaccine greatly outweighed the risks of these events.

Category: J&J Vaccine Pause

The complication was a combination of a rare type of clotting disorder called a cerebral sinus venous thrombosis and a low platelet count.  

It is important to note that this is different from the regular blood clots we are used to thinking about.  In this case, the blood clot is the result of an immune-mediated phenomenon that causes destruction of the platelets (clotting cells) but also causes production of clots itself.  

The typical risk factors for blood clots are NOT associated with this type of clots.

Category: J&J Vaccine Pause

With only 15 of these outcomes, it’s very hard to tell if something is truly a pattern.  However, analysis did not find any particular risk factors other than all of the people who had this complication were women and the majority (13/15) were under the age of 50.

It is important to understand, however: this vaccine is NOT restricted from women or pregnant women.  It is just important to be aware of this potential rare risk.

Category: J&J Vaccine Pause

 Yes! And that is part of the reason pause: to really look at all the information and, if it is related, to get appropriate information back to health care providers about exactly what this is, what to look for, and how to appropriately treat it.

Category: J&J Vaccine Pause

This complication seems to happen a median of 9 days after vaccination—so it’s not an immediate side effect. And none of the cases occurred after 3 weeks of vaccination.

Symptoms include: severe headache, difficulty breathing, abdominal pain, swelling in the legs and easy bruising.  If you have had these symptoms and recently (within the last 3 weeks) had the J&J vaccine, you should contact your doctor or go to an emergency room to be evaluated.

Category: J&J Vaccine Pause

It is important to remember that this is an extremely rare side effect—6 people out of an estimated 7 million people who have received the J&J vaccine.  To put this into perspective, it is twice as rare as getting hit by lightening!

It is also important to remember that despite being so rare, the FDA and CDC still paused vaccination with the J&J COVID vaccine when seeing this.  This shows how seriously they take even rare serious side effects and how important it is for them to investigate these fully before allowing them to be given to Americans.

Category: J&J Vaccine Pause
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