We want to help you understand the science,
risks, and benefits of getting immunized!
risks, and benefits of getting immunized!
Q1. “THESE VACCINES WERE DEVELOPED PRETTY FAST, WERE CORNERS CUT?”
Steps were not skipped in the development of the COVID-19 vaccine.To speed up the process, steps were completed simultaneously instead of sequentially. For example, companies starting manufacturing the vaccine at industrial scale before demonstrating vaccine efficacy and safety. This increased the financial risk, but not the product risk.
The traditional clinical trial process was also followed.
>>In phase 1, the vaccine was given to a small number of healthy people to assess safety.
>>In phase 2, it was given to hundreds of people to determine: how effectively it stimulates immune responses; how much/how many doses need to be given to protect against COVID; and if there are any side effects.
>>In phase 3, it was given to thousands of people to test whether it protects large populations from COVID and check if there are any uncommon or serious side effects.
As of Feb 5, 1,000,000+ vaccines have been given in Canada, with no safety flags raised.
Q2. “IS THIS NEW MRNA TECHNOLOGY SAFE?”
mRNA vaccines are new but not unknown, researchers have been studying and working with mRNA vaccines for decades. mRNA vaccines do not affect or interact with your DNA in any way. In simple form, the COVID mRNA vaccine provides instructions to your immune cells to make a harmless piece of what is called the “spike protein.” The spike protein is not COVID! It is found on the surface of the virus that causes COVID-19. And, after the protein piece is made, your cell breaks down the mRNA instructions and gets rid of them. Your cell then displays the spike protein on its surface (“Hey You! I’m Over Here!”). Your immune systems recognize that the protein doesn’t belong there and builds an immune response to kill the spike.
Voila! Your body learns how to protect against future infection, without ever being exposed to the COVID
Q3. “AT WHAT POINT AND FOR HOW LONG WILL I BE PROTECTED BY THE COVID-19 VACCINE?”
Q4. “I HAVE LUPUS, WHICH HAS BEEN UNDER CONTROL FOR MANY YEARS, I AM ON PLAQUENAIL. I DO WANT TO HAVE THE VACCINE, LOOKING FOR ADVICE ON IF IT IS SAFE FOR PEOPLE WITH AUTOIMMUNE ISSUES?
People with autoimmune disease or immunosuppression either from drugs or disease were not included in the original vaccine approval trials. However, based on the way they work, the mRNA vaccines (Moderna and Pfizer) are felt to be safe for people with autoimmune disease and for those on immunosuppressive medications. There is no increased risk of side effects or adverse reactions from the vaccine in people with autoimmune diseases. There is a theoretical concern that people on immune-suppressing medications might not make as strong of a reaction to the vaccine (because their immune system is suppressed in general). However, we don’t know for sure if this is true or not. Fortunately, as the vaccine is very effective (94-95% after two doses), even if the vaccine is a little less effective in this group, it will still provide a lot of protection. The vaccine guidelines recommend that people with the autoimmune disease be offered the vaccine and it has been given to many people in this group since the vaccine distribution has begun. As always, if you have particular questions, your primary care provider is a great person to talk to. The BCCDC site and ImmunizeBC also have lots of good information.
The above article published 2 days ago indicates those with or without the autoimmune disease have the same levels of vaccine willingness. So no hesitancy.
Q5. IS THERE A CLEARINGHOUSE THAT WILL BE REVIEWING THE LONG TERM EFFICACY, MONITORING OF ANY TERATOGENIC EFFECTS, POSSIBLE UNKNOWN RISK FACTORS ASSOCIATED WITH THE VACCINE (EG. SAFETY WITH IMMUNOCOMPROMISED CONDITIONS, AUTO IMMUNE DISORDERS OTHER GENETIC FACTORS THAT IMPACT VACCINE SAFETY OR EFFICACY)?
This is called Phase 4. All uncommon adverse vaccine reactions are reported and followed up on. There is an entire agency dedicated to doing this. BC Women’s Hospital has a registry for pregnant women who receive the vaccine and they are being followed to continue to monitor for any unexpected reactions/effects.
So far the monitoring has shown similar side effects to other non live vaccines. Although there were those initial reports of anaphylaxis, as the vaccine has been given to millions world wide, we have not seen a higher rate of allergic reaction to this vaccine than to other vaccines.
The following information comes from the BCCDC Website:
More information about the Canadian vaccine safety surveillance system is contained in the Canadian Immunization Guide, Part 2 – Vaccine Safety, Vaccine safety and pharmacovigilance.
At the current time the only absolute contraindication (reason not to get the vaccine) is a history of anaphylaxis to this vaccine or one of the vaccine components.
Q6. THE VACCINE WAS INITIALLY TESTED AND APPROVED BASED ON THE MODEL OF THE 2ND VACCINE BEING ADMINISTERED WITHIN 21 DAY ( 3 WEEKS) IS THE MANUFACTURER AND RESEARCH NOW SUPPORTING AND ADVISING BASED ON PROVEN CLINICAL RESEARCH THAT WE HERE IN BC CAN HAVE OUR OWN MODEL OF SECOND VACCINATION OCCURRING NOW AT 16 WEEKS WAS THE EFFICACY NOT BASED ON A 2 DOSE – 3 WEEK MODEL? DO WE REALLY NEED A SECOND DOSE IF THE FIRST ONE IS GIVING >95% PROTECTION?
This is a great question and one that many people, including doctors, are asking.
You are correct, the Pfizer vaccine was tested with a 3 week booster and the Moderna with a 4 week booster. A single dose of either of these vaccines seems to be giving a “real world” 90% protection rate, 2-2.5 weeks after vaccination. Remembering that these vaccines were testing the protection from people getting seriously ill or dying. The studies did not test whether the vaccine would prevent mild illness or being a carrier who does not have symptoms. It might prevent this, but that was not what was studied, so we do not know for sure.
I don’t have a lot of details or data to answer your question. We are told that the Provincial Medical Health Office (the people who made the decision about the vaccine schedule in BC) have been following evidence as it is building that shows the immunity generated from the initial vaccine is continued for 3-4 months (at least) and that evidence is being built and shared across this country and internationally. However, as physicians, we really have not yet received the detailed information that supports this understanding. I hope that this will be shared with us in time. Of course this is all happening very fast, so sometimes information distribution lags a bit.
I think the consensus is that we will need a second dose to provide lasting immunity, but the best timing for that second dose is under debate. The vaccine companies were basically looking at how close together they could be given, now BC is looking at how far apart they can be given. Only time is going to tell us what the perfect window is.
I do understand the decision - it makes sense to give twice as many people 90% coverage. The gamble is that we don’t know for sure how long that coverage lasts. But I believe Dr. Henry has made this choice carefully and with the best interests of BC residents in mind.
I would add that the rationale for a second shot/booster is to prime the memory cells (B cells) which keep a lasting memory for antibody production to start immediately upon a re exposure to the antigen ( Covid spike protein). This step is important. Doctor Fauci and other immunology experts clearly state that the 2nd dose of an mRNA vaccine should not be skipped. Only in time will we know what the true safe interval is, and how to balance that with the need to extend coverage to as many people as possible.
Q7. IS THE COVID-19 VACCINE SAFE TO GET IF YOUR AUTOIMMUNE IS COMPROMISE AND YOU HAVE AN ALLERGY TO EGGS?
Part A: Yes, immune compromised persons can get this shot and any other non-live/attenuated vaccine.
Part B: I do not know about eggs, it depends on which vaccine. As mRNA vaccines are not grown in eggs it would not be issue.
Q8. I HAVE A ONE-TIME HISTORY OF UNEXPLAINED IMMUNE THROMBOCYTOPENIA 2 YEAR AGO, NO OTHER HEALTH HISTORY. WOULD I POTENTIALLY BE PUTTING MYSELF AT RISK BY RECEIVING THE VACCINE? WOULD I BE AT MORE RISK IF I CONTRACTED COVID-19? IS ONE VACCINE FAVOURABLE OVER THE OTHER IN THIS CASE (MRNA VS. NON MRNA)?
I don’t know if I have enough expertise to answer your question about if your risk of severe illness with Covid is higher based on your history of ITP. The answer is maybe? I would be concerned that you have a higher risk of severe illness based on the fact that you have had an unusual illness in the past that involved your immune system acting in a “wonky” way. But I have no hard data to support this. Just a gestalt feeling on my part.
With respect to vaccination, none of the guidelines I have seen would suggest that one type of vaccine would be better for you than the other. From my reading, I do not think your past history of ITP makes you more at risk for an adverse reaction to any of the vaccines. Overall, the only absolute contraindication (reason that you SHOULD NOT get a vaccine) is a history of anaphylaxis to any component of the vaccine. People with autoimmune disease were included in the vaccine trials, but the numbers were relatively small, so it is hard to draw strong conclusions.
This is some further information that has been provided to us by the BCCDC: Although participants with autoimmune conditions who were not immunosuppressed were not excluded from trials, they constitute a very small proportion of trial participants and represent a very narrow range of autoimmune conditions. The spectrum of autoimmune conditions is diverse. The relative degree of autoimmunity in individuals with autoimmune conditions is variable depending on the underlying condition, the severity and progression of disease, and use of medications that impact immune function. Therefore, the balance of benefits and risks must be made on a case-by-case basis. Other applications of mRNA technologies for the treatment of cancer required anti-self immune response, which raised a theoretical concern that mRNA vaccines for infectious diseases would behave similarly. Previous mRNA vaccine technologies may have elicited inflammation and theoretically exacerbated existing autoimmune disease. Current applications of mRNA technology for COVID-19 vaccines have been optimized to reduce this risk. (NACI)
A complete COVID-19 vaccine series may be offered to individuals in the authorized age group if a risk assessment deems that the benefits outweigh the potential risks for the individual, and if informed consent includes discussion about the absence of evidence on the use of COVID-19 vaccine in these populations.
Advise those with autoimmune disorders to have a discussion with the care provider who knows their condition the best, as they would be most familiar with the client’s disease and treatment. If such a client presents for immunization and indicates that they have had this discussion with their care provider and they understand the benefits and risks and absence of evidence on the use of COVID-19 vaccine in these populations, this would be sufficient for the immunizer to proceed with vaccination.
Please note that as we gain more experience with these vaccines, more information may become available to help guide your decision around vaccination.
Q9. ARE THE VACCINES SAFE FOR PREGNANT WOMEN AND/OR WOMEN TRYING TO CONCEIVE?
The SOGC (Society of Obstetricians and Gynecologists of Canada) is recommending vaccination for breastfeeding and pregnant women after discussion with their care provider around their personal risks. The vaccines are felt to be safe based on how they work and real world data has so far not shown any concerns. Of course, pregnant and breastfeeding women were not included in the original vaccine trials (this is normal, pregnant women are never included in medication trials) so we are always left getting data from the real world. The bottom line is that the risk of Covid in pregnancy is real and there is no expected risk from taking the vaccine. In BC, there is a registry for pregnant women who receive the vaccine so that they can be followed. I should add that the uptake of covid vaccine by pregnant physicians is very high. I have included the link to the SOGC statement below:
For women who are trying to conceive, there is absolutely no reason not to get the vaccine.
Q10. ARE THE VACCINES SAFE FOR PREGNANT WOMEN AND/OR WOMEN TRYING TO CONCEIVE? WITH THREE VACCINES IN THE MIX AND POTENTIALLY MORE BEING DEVELOPED - WILL THERE BE ASSURANCES THAT CLIENTS WILL BE RECEIVING THE SAME VACCINE 4 MONTHS DOWN THE ROAD? THIS IS MORE OF A PRODUCT ACCESS/DISTRIBUTION QUESTION BUT I'M CURIOUS TO KNOW IF THIS HAS BEEN CONTEMPLATED. WOULD BE A SHAME TO GET TO 4 MONTHS AND THE VACCINE IS NOT AVAILABLE.
Response 1. Interchangeability of COVID-19 vaccine products - Any currently authorized COVID-19 vaccine can be used when indicated; ACIP does not state a product preference. However, COVID-19 vaccines are not interchangeable. mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) The safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product. In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the 2nd dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
Response 2. As far as I know there is definitely a plan that people receive the booster dose of the same vaccine that they got the first time. This was discussed at a big presentation on Covid Vaccination that was put on by the Public Health Office. Which vaccine you get is entered into a public health registry, so that even if a person relocates and doesn’t remember what vaccine they got, the information can be obtained. They were quite clear there was no intention to mix vaccines. Of course we can’t predict the future, but I think it is anticipated that there will be supply from all of the vaccines to allow for a second dose of the same vaccine. The delay just allows time for that vaccine to be produced. If you are interested in reading the information on the BCCDC website about second doses, here is the link: http://www.bccdc.ca/Health-Info-Site/Documents/COVID-19_vaccine/Public_health_statement_deferred_second_dose.pdf
Q11. BETWEEN THE PFIZER AND THE MODERNA VACCINES, IS THERE ONE THAT IS MORE SAFE AND EFFICIENT TO RECEIVE?
Q12. CAN YOU EXPLAIN WHY THESE SIDE EFFECTS ARE HAPPENING WITH THE VACCINE AND WHY THEY ARE WORSE FOR SOME WITH THE SECOND DOSE? (IE.FEVER AND CHILLS/RIGORS, HEADACHE, BODY ACHES X 2 DAYS POST IMMUNIZATION). IT SEEMS THESE SYMPTOMS ARE MORE SEVERE THAN OTHER IMMUNIZATIONS.
Response 1. An immunologist is an appropriate person for this question, we have none nearest is Kelowna or Vancouver. Why some people get a stronger 2nd dose response than others is unknown. The second dose response is normal and expected. It is due to activation of T cells, cytokine release ans possibly programming of Memory B cells, cells that remember the 'spike' protein.The secondary downstream T and B cell inflammation that is temporary...interferons are largely responsible for the ache-y flu-like symptoms.Here is what to expect (updated Mar 11 2021)http://www.bccdc.ca/health-info/diseases-conditions/covid-19/covid-19-vaccine/getting-a-vaccine#after No one knows why some have more reactions & others have none? However these are temporary generally 24 hrs or less. There is no long term or long Covid reported from the vaccine!BTW the temporary after vaccine symptoms do not correlate with how strongly our immune response is or how well tne vaccine has worked.
Response 2. Basically these symptoms are the immune system responding to the vaccine. Other vaccines have a similar response - the current Shingrix vaccine for shingles is known for this and a few years ago we had a flu vaccine that caused these types of symptoms as well. I don’t know the exact science behind why some people get no reaction and other people get the aches, chills etc. I just view it as part of the wide variability of humans. The response is typically worse with the second dose because the immune system has already been primed by the first dose.
Q13. I CURRENTLY TAKE IBRANCE/LETROZOLE COCKTAIL FOR METASTATIC BREAST CANCER. I'M CONCERNED THAT I SHOULD NOT TAKE THE ASTRA ZENNICA VACCINE BECAUSE OF DOUBLE BLOOD CLOT JEOPARDY AS CLOTS ARE ALSO A SIDE EFFECT OF THE MEDICATIONS MENTIONED.
Response 1. No one has definite evidence for the A-Z vaccine and thromboembism, it is being explored in Europe after events that could be isolated; causality is NOT established at this time. Out of abundance of caution, however, I suggest this be discussed with your oncology team.
Response 2. I encourage you to speak with your oncology team as this is a very specific question that would best be answered by someone who knows your health well.
Q14. INFORMATION FOR PATIENTS WITH AUTOIMMUNE DISEASES – ADVICE IS ALL SHOULD HAVE VACCINATION FOR COVID
Underlying immune dysregulation and inflammation is a higher risk for complications from Covid for this patient population. This is the case for patients with lupus, RA, psoriatic arthritis etc as well as MS. Registries throughout world have not picked up any signals of danger in these groups, though the studies were not specifically done for autoimmune diseases.
Q15. IS A PERSON WITH AN ALLERGY TO PENICILLIN SAFE TO GET THE VACCINE?
Short answer: yes! Long answer: Having an allergy to penicillin, or anything else, does not increase your risk of having an allergic reaction to the covid vaccine. The only allergy that is a concern is if you have had an allergic reaction to the covid vaccine (ie a first dose) or if you have an allergy to PEG (polyethylene glycol) which is a component of the vaccine. People who have a history of anaphylaxis reaction to anything in the past - whether medication or food, will be asked to wait for 30 minutes after vaccination, rather than the usual 15 minutes. Of note, the rate of allergic reaction to the mRNA covid vaccines is not higher than the rate of allergic reaction to all of our standard vaccines (it is very rare).
Q16. WHAT IS THE RISK OF A BLOOD CLOT FROM THE VACCINE VS GETTING COVID ESPECIALLY WITH A COMPROMISED IMMUNE SYSTEM FROM CHEMO ETC. ?
This is a common area of concern. There has been no signal of increased risk of getting a blood clot in people who receive the mRNA covid vaccines (Pfizer or Moderna). With the Astra-Zeneca vaccine there is a possible increase in the risk of getting a very rare type of blood clot. We do not know for sure yet if this is truly caused by the Astra-Zeneca vaccine. We do know that a prior history of blood clot does not seem to increase the risk as the blood clots of concern occur by a different mechanism than the typical type of clots that people get when they have a blood clot in their leg or lung. We also know that the risk of getting a blood clot with a Covid infection is much, much higher than the potential risk from the Astra-Zeneca vaccine. At any rate, as a precaution, this vaccine is currently not being given to people under age 55 (as the clots have occurred in people 50 and younger). This means that you will receive an mRNA vaccine which has not been linked at all to increased risk of clot. This is a long way of saying I would encourage you to be vaccinated as the risks are much, much higher if you are infected with COVID 19.
Q17. IF THE VACCINE GIVES ME SYMPTOMS IS IT STILL SAFE TO BE AROUND OTHERS?
Answer 1. Symptoms are generally self-limited to 24 hrs, and the vaccine cannot infect you. The symptoms are due to the immune system being tricked to react to the viral spike proteins, which the vaccine mimics. Being around others at that time has the same restrictions as per the public health officer recommendations, which is to keep the same bubble, and use same precautions with others eg.6 feet away, continue masking and washing hands. You cannot be infected and you cannot transmit the virus from vaccination.
Answer 2. You are fine to be around other people as these are expected symptoms to come from the vaccine. If you have COUGH or SHORTNESS OF BREATH, this is NOT from the vaccine. You need to isolate and arrange for a Covid-19 test. Of course, if you are significantly short of breath you should seek medical assessment.
want more information
On the vaccines Health Canada has approved:
On the vaccine approval process in Canada
On adverse vaccine events following COVID immunization in Canada
On mRNA Vaccines
On mRNA Vaccines (Video)
On vaccine information from the BC Centre for Disease Control
On vaccine information from the BC Centre for Disease Control
On frequently asked COVID vaccine questions from Immunize BC