Let’s discuss the AstraZeneca vaccine. I am just going to give you some facts. You can make your own decision about the AstraZeneca vaccine.
On March 29th, Canada’s National Advisory Committee on Immunization (NACI) recommended provinces pause on the use of the AstraZeneca-Oxford COVID-19 vaccine on those under the age of 55 because of safety concerns. NACI’s priority is vaccine safety. Their decision came after the European Medicines Agency ( EMA), Europe’s Health Canada equivalent, investigated 25 cases of very rare blood clots out of about 20 million AstraZeneca vaccines given. On March 18th the EMA concluded that the benefits of the AstraZeneca vaccine far outweigh this risk if there is a true increased risk of the blood clots.
Most of these rare blood clots occurred in women under the age of 55 ( 18 out of 25). Thus, NACI’s recommendation to halt the use of the AZ vaccine in this age group pending further review of the ongoing real-time research.
So, 25 cases out of 20 million vaccinations is a risk of about 1 in a million. That means that if there actually is an increased risk, the risk is 1 case of the rare blood clots out of 1 million vaccines given. One in a million.
Let’s shed some light on that: The risk of blood clots developing among new users of oral contraceptive pills ( birth control pills) is 8 out of 10,000. Thirty four out of 10,000 women who use hormone replacement therapy ( HRT ) will develop a blood clot at some point. And, the risk of developing a blood clot in women in general is is 16/100,000.
The Canadian maternal mortality rate ( the rate of death in women during childbirth) is 8.3 deaths per 100,000.
No medical intervention is without risks. The question is, should we take that risk? That is what NACI will try to figure out in the coming weeks. Let’s balance that risk of 1 in a million with the risk of COVID-19.
A new briefing note from a panel of science experts advising the Ontario government on COVID-19 shows a province at a tipping point. Variants that are more deadly are circulating widely, new daily infections have reached the same number at the height of the second wave, and the number of people hospitalized is now more than 20 per cent higher than at the start of the last province-wide lockdown.
These variants are more dangerous and more easily transmitted. They cause 2.5 to 4.1 deaths per 1000 detected cases. That’s deaths. The risk of serious complications with the variants is double the risk of the original COVID-19 virus: 20 out of 100.
Here’s a quote that scared me. “Right now in Ontario, the pandemic is completely out of control,” Dr. Peter Juni, the scientific director and a professor of medicine and epidemiology with the University of Toronto and member of Ontario’s COVID-19 science advisory table.
The AstraZeneca vaccine is over 70% effective up front and almost 100% effective at preventing deaths and hospitalizations from COVID-19. Breathe. It is not time to throw out the baby with the bath water. No blood clots have occurred in people over 60. We should continue using the AstraZeneca vaccine in this age group which is most at risk of serious complications and death from COVID-19.
Canada now has 4 different vaccines to help us fight COVID-19, BioNtech/Pfizer, Moderna, AstraZeneca and Johnson and Johnson. While that’s a (very) good thing, this has led to some inevitable questions about which vaccine is “better” and whether people should wait for one or the other. An email from a friend who questioned the AstraZeneca vaccine inspired me to write this.
First, to re-iterate once again, while is true that all of these vaccines were developed at a rapid pace, the reality is that they all have been thoroughly tested. The shortcuts that were made were made in the bureaucracy, not the human trials. You can read my thoughts on that here, or see my colleague Dr. Greg Rose explain it better here.
There will likely never, ever be a vaccine (of any kind) that is 100 per cent safe (ever), but overall these vaccines are extremely safe for the general population.
The difficult part in sorting out information about the COVID vaccines is two fold. First, there is a whole lot of information that comes out, almost on a daily basis. It’s hard for not just physicians to keep track of it all, but also members of the general public. Second, some of the information that is released is extremely premature, without a full analysis being done. First impressions being lasting impressions, this often times creates an incorrect perception of a vaccine, that is hard to refute later on.
For example, the BioNtech/Pfizer vaccine was initially plagued by concerns that it caused Bell’s palsy (based on a report that 4 people got it after taking the vaccine) and that death was a side effect (based on report in Norway of 33 people over the age of 80 dying after taking the vaccine). It wasn’t until later that a through review showed that the Bell’s palsy issue was actually the same or less than the background rate. Essentially, you would expect about 12 people a year in the vaccine group to get Bell’s palsy anyway, regardless of whether they got the vaccine or not, so the fact that 4 got it didn’t mean it was linked to the vaccine, just that they were going to get it anyway. As for the 33 deaths, turns out that was in keeping with Norways normal death rate for their population of over 80 year olds, so again, not related to the vaccine.
Think of it this way. The most common time to get a heart attack is actually three hours after you wake up. Does this mean eating breakfast causes a heart attack? Of course not. Just because those two things happen close together, doesn’t mean that one caused the other. In statistics this is referred to as “correlation does not imply causation.” Sadly, there is rather a lot of correlation that is brought up about all of these vaccines, and the assumption is made that they are causing problems.
It was initially claimed the Moderna vaccine had more side effects than the BioNtech/Pfizer one. But it was only after studying it more that people realized that these aren’t really side effects, but proof that the vaccine is working. Your second shot of the Moderna vaccine made your immune system mount a response to what it viewed as a foreign body. Thus the muscle aches, fever and headaches that went along with it.
Now most recently there is some sub-optimal information circulating around the AstraZeneca vaccine. First, there was concern that they would not work against certain strains of COVID19, particularly the South African strain. Second is concern about blood clots.
The South African strain issue was particularly overblown. “Only 10% effective” screamed out some headlines. South Africa even stopped using this vaccine as a result. The full story is somewhat different.
Turns out the study that suggested AstraZeneca wouldn’t work against the SouthAfrica variant was very small (2,000 people), and not well done. Further more, what really matters, is preventing deaths, hospitalizations and severe disease and AstraZeneca works for this with the South African strain. Perhaps you may get a mild case of COVID19 (cough, fever, mild muscle aches for a couple of days). But the point of the vaccine is prevention of severe cases and deaths.
Similarly, the blood clot issue again appears to be one of correlation, not causation. The background rate of blood clots in the population would explain the ones found in Europe. Health Canada and Thrombosis Canada is not worried, and you shouldn’t worry either.
So back to the question at hand. Which vaccine should you get? My personal feeling is the J&J one would be the best simply because, logistically it’s much easier. Get one shot and it’s done. The problem with that one is that we have an effete Prime Minister who’s totally botched vaccine procurement for Canadians. There’s a reason #trudeauvaccinefailure is on twitter. Last I checked we are 61st in the world for procurement of vaccines (and for a G-7 country, that’s just embarrassing).
While happily announcing the approval of the J&J vaccine, Trudeau and the Liberals neglected to emphasize the fine print. Namely that the vaccine would likely not start to arrive until the end of April or early May, and that would only be in small amounts. The bulk of this vaccine won’t be in Canada until September.
Of course, right on queue, a few days after boasting about J&J, it was announced there would be production delays. Why the media isn’t talking about the outright incompetence of Trudeau and his government in protecting Canadian lives is beyond me.
Therefore, the best thing you can do is get the first vaccine that you are offered. When you get notified to get your shot, don’t ask which one, just get it. For what matters the most (keeping you out of hospital or dying from COVID19), they all work roughly the same.
I urge you all to do your part, protect yourself, protect others, and let’s get ourselves out of this pandemic, and back to a normal life.
A Great Cause.
As an addendum I would like to encourage all of my readers to consider buying some merchandise from Conquer Covid 19. This all volunteer group did yeoman’s work providing PPE to physicians, health care workers and others in need. Last year they raised $2.4 million and donated around 3 million (!) pieces of PPE.
This year they are selling their extremely boring merchandise (check Ryan Reynolds take on it here) and proceeds will go to LTCfrontline foods, providing hot meals to those workers who are struggling in long term care homes and Call Auntie, an organization that helps Indigenous people navigate issues around COVID19.
Disclaimer: As always, the information I present here is meant to be an overall summary of what we know, and not specific medical advice for one person. If you have questions, please talk to your doctor.
As I write this blog, almost 52 million doses of the new COVID vaccines have been delivered to people around the world. Our knowledge about COVID (and the vaccines) continues to increase almost exponentially, and while we don’t know everything yet, here’s what we’ve learned so far.
Time to put the whole “Guinea Pig” argument to rest.
Many people have told me they don’t want to be a human “guinea pig” to test the vaccine on. The clinical trials on the vaccines (while quick) were thorough. More people have gotten their first dose of the vaccine than the entire population of Canada. If you get it now, you won’t be first. In fact you’ll be after this guy:
I’m Worried About a Sore Arm and Other Symptoms After
Sore arm, fever, and muscle aches are all symptoms people can get after any vaccine. However, what’s important to note is that these are not side effects. A vaccine works by stimulating your immune system. If you get a cold, your immune system activates to fight the virus, and as part of that, will often give you a fever, and muscle aches. You may feel crummy, but your immune system is doing its job.
If this happens to you after a vaccine, it may be miserable to experience but at least you can take it as a sign your immune system is working, and you are getting a response to the vaccine.
It’s off label but I ensured that all of the resident of Bay Haven Nursing home got 1,000 mg of Acetaminophen three times a day the day before, the day of and the day after the vaccine. We have had no reports of flu like illnesses after the vaccine. I intend to take this myself before my second shot, and you may want to consider this as well.
I Am Pregnant or Trying to Get Pregnant
There were women of child bearing age in both the Moderna and Pfizer studies (although no pregnant women). The vaccine did not appear to cause issues. We routinely give other vaccines (like the flu shot) to pregnant women and it is felt to be safe.
But I Still Have to Wear a Mask/Get Swabbed/Get Screened!
Alas, yes you do. I share the frustration on this one. Health Canada only approves what it knows. The evidence from the studies on the vaccines was very strong that they would reduce your chance of getting COVID. However, to study whether the vaccine will reduce the risk of transmission is much more complicated. It requires a high level contact tracing which we don’t have in Canada.
However, every other successful vaccine in the past has reduced the ability to transmit whatever disease we were protecting against. That’s why we no longer have small pox, and until the rise of the renowned neurobiologist/brain surgeon Jenny McCarthy, had almost eliminated measles. I’m hoping that Health Canada will lift the requirement to wear masks for people vaccinated in the near future.
This should at least show you how much confidence they have in the Covid vaccines. I mean if an organization that historically takes it’s time to approve things moved so quickly when they saw the evidence for the Covid vaccines.
Are You Sure These Vaccines Were Tested Properly? They Were Approved Awfully Fast.
There was good reason to be approved quickly. As I mentioned in a previous blog, there was a significant reduction in bureaucracy. Everybody (drug companies/regulatory bodies/politicians) agreed we needed a vaccine as soon as possible, so the five years (!) of red tape was cut.
The second thing to keep in mind is that to test a vaccine, you have to expose people who had the vaccine to the illness. For a condition like shingles, you often times have to wait for years to see if the virus is effective, because as painful and awful as it is, Shingles is still relatively rare. It takes a LOT of time to accumulate the data needed to see if enough people benefited.
For COVID, one perverse benefit of the fact that the United States has one of, if not the worst responses to the pandemic in the world is that the virus is, well everywhere. That means the over 70,000 people in the studies could be exposed to the virus very quickly, and we could see very quickly if the vaccine worked.
Moreover, it’s a myth that all the drug companies who developed a vaccine were approved. There are 14 vaccines for COVID that were being developed. But if flawed, the trials were halted (like CSL in Australia or Sanofi-Glen‘s vaccine).
The Vaccine Is Genetic and Will Affect My DNA
Simply not true. The mRNA used in the vaccine will not affect your DNA. DNA is the stuff that makes you, well you. I can’t explain it any better than Dr. Abdurrahman:
I Don’t Trust Big Pharma/Bill Gates is Injecting Nanochips Into My Body/It’s an Illuminati Conspiracy
………. I got nothing. If you really believe this there’s nothing I can do to convince you otherwise.
Should I Get The Vaccine (Whichever one) When It’s My Turn?
YES! The lockdowns and economic harm caused by this pandemic are having a terrible toll on us. The social isolation, job loss, economic harm, mental illness and much, much more is devastating society.
If we want to visit our friends, if we want to go to a restaurant, if we want to go to Church/Mosque/Synagogue/Temple, if we want to travel, if we want to……..simply live a normal life again, we need to get everyone possible immunized. Without this, the pain we all suffer from this pandemic will continue.
Note: The following is a letter I sent to all the staff of Bay Haven Seniors, a joint Retirement and Nursing Home. There has been rather a lot of variable information about the new Covid vaccines out there, and I wanted to address that up front. Some of this information may help you as well, so I’m copying it here.
To: All Staff at Bay HavenFrom: Dr. M. S. Gandhi, Medical Director Re: New Vaccines for COVID19
As I think all of you are now aware, Bay Haven has been fortunate to have our staff given the opportunity to immunize early with the new vaccines for COVID19. There has been much written about the vaccines in print and on Social Media (unfortunately!!) . I wanted to let you know about some information on the development of the vaccine, and why I do strongly encourage people to get the vaccine.
In “normal” times (remember those?), when a drug company thinks about whether it’s a good idea to develop a vaccine for a certain disease, there is a bit of convoluted process that has to happen first. Some officious bureaucrat at the drug company does a cost analysis on how much it will cost to make the vaccine and how much profit could be made from it. Then it goes to a regulatory body in the host country where some other pointy headed bureaucrat looks at how widespread the disease is and whether it’s worth while to approve a trial. Then it goes back to the company where some lawyer reviews the cost/benefit ratio, whence it goes back to the officious bureaucrat and then back to the pointy headed one. Amazingly enough (and I’m not kidding here) this process can take 2,3, even 5 years before a trial even begins.
This time, every body agreed right off the bat that it was good idea to have a vaccine for COVID19, and so the up to five years of paperwork was eliminated. Seriously, that bureaucratic bafflegab can take that long.
The next step after the paper work is done is for a vaccine to undergo three phases of trials. It’s important to know that both the Pfizer and Moderna vaccines DID undergo all three phases of trials. Given the catastrophic situation around COVID, the trials were done quickly, but they were fully completed. The Pfizer trials had about 42,000 people (by the way about 35% were people of colour ). The Moderna vaccine had over 30,000 people (also with 35% people of colour). The trials were extremely successful (94-95% effectiveness).
The main side effects are the same as you would get from just about every other vaccine (pain at the injection site, fatigue, muscle pain, joint pain, fever). These side effects are rare and and if they occur, go away in a couple of days.
There has also been a lot of talk about the fact that these are the first vaccines to be developed using “mRNA” technology. I appreciate that when people talk about genetics, it can cause many people to have second thoughts. But, mRNA technology has been studied for something like 30 years now in the oncology field. Additionally, mRNA cannot and will not affect your genes. It’s your genes that make mRNA in your body. Your mRNA can’t go backwards and affect your genes.
In short mRNA vaccines are an efficient, safe process. They actually herald a new era of vaccine development that promises rapid and effective prevention for new pandemics in the future. This is a good thing.
I also want to address some concerns about side effects circulating on social media. The first is with respect to Bell’s Palsy. There were four people in the Pfizer trials who developed Bell’s Palsy (now recovered) after getting a dose of the vaccine. This translates to a side effect rate of .01%. However, the “background rate” for Bell’s Palsy is .03%. Put another way, if we were to simply pick 40,000 people at random, and watch them for a year, we would expect 12 people to get Bell’s Palsy. This is why health professionals don’t feel that Bell’s Palsy is related to the vaccines.
Second, there is some talk about anaphylactic reactions (which can happen with any vaccines). With the Pfizer vaccine the concern is polyethylene glycol. Moderna has this in their vaccine too, but it seems in a different manner. There may be some concern about this for patients who have severe allergies (to the point that you carry an epi-pen). The best recommendation I could give is that if, and only if, you allergies are so bad that you need an epi-pen, it would be reasonable to wait for the Moderna vaccine (which just got approved today). We expect this vaccine to be available for distribution in February. If you do not need an epi-pen, then you should get the Pfizer one as it is out already.
Finally, I would like to thank all of you for all the hard work you have done this year. 2020 is a year that we will never forget, and I suspect a year that we are all anxious to give the boot too. Yet despite the hardship, the challenges and the seemingly unending (bad) surprises, you have continued to keep the residents safe, clean and comfortable. Providing this at the latter stages of peoples lives is the absolute minimum sign of respect we can show, and the staff have done that in spades this year.
Thank you again, and allow me to wish all of you a Merry Christmas and a Happy New Year!
Recently, many physicians offices have been inundated with requests for the so called “high dose” flu shot. I know I’ve had many patients ask in my own office, and this is the result of all the publicity around these shots. Pharmacies were specifically advertising that they had the high dose shots available. Heck some pharmacies even offered customers points for getting your shots. Until of course, they ran out. (Memo to pharmacies – unlike Teslas, generally not a good idea to advertise something you can’t deliver on time).
Of course once they ran out came the inevitable concerns expressed about why people couldn’t get a “high dose” shot themselves. I have also heard some isolated reports in my community about people waiting to get their flu shot until the high dose were back in supply.
But here’s the thing. There is no evidence to suggest that the high dose flu shot is actually better than the current standard dose shot. Seriously.
In 2014, a study was done looking at the high dose versus regular flu shots, particularly in older patients. The study clearly showed that there was a higher immune response in older patients with the high dose shot. But from a clinical perspective, it really only made a minor (although what statisticians will call a statistically significant) difference. 1.9% of people who got the standard flu shot went on to get the flu, and 1.4% of people who got the high dose flu shot went on to get the flu, for an effective difference of 0.5%. All this hype for 0.5%??
But more importantly, that study looked at what are called trivalent flu vaccines. In essence, both the standard and the high dose vaccines in the study were good against three strains of the flu.
However, in Ontario, our standard dose flu shot is a quadrivalent. It’s good against four strains of the flu. The high dose continues to be a trivalent. So the option for people in Ontario is to get a flu shot that has a regular dose against four strains, or a high dose shot that is good against three strains only.
Importantly, there has not been a head to head study between the high dose trivalent and the standard dose quadrivalent used in Ontario. Which means no one really knows which vaccine is better.
Heck even the Public Health Ontario Fact Sheet on flu vaccines states there is “insufficient evidence” to recommend one over the other. There is some supposition about the extra B strain that is covered in the quadrivalent vaccine not being as common in those over 65, and perhaps having a lower disease burden, but it’s not really clear cut.
So what should you do?
As I mentioned in my last blog, you should wait until November to get your flu shot. It now being November – GET IT! If you are over 65 and are unable to get the high dose, don’t sweat it, just get the standard one. Because frankly the protection you get from that is still really really good (I mean why all this fuss over a measly 0.5%??). But don’t put off getting your shot now just to wait and see if more high dose vaccines are coming.
It’s time to protect yourself and your loved ones. Both flu shots are good. Get whichever one you can, and let’s help each other stay safe.