At last, at last. After an excruciating year of coronavirus pandemic, an amazing milestone has been reached: COVID vaccination has begun!
On December 11, 2020, the FDA granted an emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine. So now, it’s possible to vaccinate people who are not part of a trial studying the new vaccine. (Moderna’s vaccine is expected to get its EUA very soon, as well.)
Of course, it doesn’t mean that everything will be back to normal within the next few weeks. But vaccination is what will enable us to eventually pull out of the danger and disruption the pandemic is causing.
Although it’s exciting to see COVID vaccination start to take place in the U.S., it also raises a lot of questions for people.
In this article, I’ll summarize what I think is most important for older adults and families to know about coronavirus vaccination.
In particular, I want to address the question of efficacy (does it work?) and safety (is it dangerous?), specifically for older adults.
So I’ve recorded a short video presentation about how I assess whether the COVID vaccine (or other treatment) is effective in older adults, especially those over age 85 and those in nursing homes. I also have summarized some key vaccine information below.
In this video, I review the data for Pfizer’s vaccine, and I show you how you can assess the data on older adults when the data for upcoming vaccines is released.
What’s Most Important to Know About COVID Vaccination
What COVID vaccines are currently available?
You can see which COVID vaccines have been approved for use in the U.S. on the FDA’s COVID-19 Vaccines page: FDA COVID-19 Vaccines.
As of December 17, 2020, only Pfizer’s vaccine has received an Emergency Use Authorization (EUA). However, the FDA has recommended that Moderna’s vaccine be granted an EUA as well, which will likely happen soon.
Dozens of other vaccines are under development worldwide, of which some are in “Phase 3,” in which the vaccine is given to thousands of people to test it for efficacy and safety. You can see a list of vaccines in Phase 3 on the NYTimes Coronavirus Vaccine Tracker page, which also includes a helpful summary of the vaccine approval process.
Once a vaccine receives the FDA’s Emergency Use Authorization, it still needs to be distributed before it can be available to individuals. Manufacturing the millions of necessary doses is also a challenge. For the time being, many of us will find that an authorized COVID vaccine is still not easily available to us.
How the Pfizer and Moderna COVID vaccines work
The Pfizer and Moderna vaccines use a new approach for vaccination: messenger RNA (“mRNA”). This technology has never before been used in a licensed vaccine. But it seems to offer several advantages over pre-existing vaccine technology.
Whereas most vaccines work by injecting a person with a killed virus or portion of virus, mRNA vaccines use a totally different approach: they contain limited instructions that prompt the body’s cells to create copies of the COVID spike protein component (but not the whole virus).
The body’s immune system then recognizes the COVID spike protein as foreign, and builds up immunity. This means that when the body later encounters the complete COVID virus during an infection, it can ramp up quickly and defeat the virus before the person feels ill, or becomes seriously ill.
So, it’s impossible to get COVID from the mRNA COVID vaccines, because they don’t inject killed or weakened COVID, and the injected instructions cannot cause the body to create complete functioning COVID virus.
Another advantage of the new mRNA technology is that vaccine doses can be manufactured much more quickly.
You can learn more about these mRNA vaccines here: CDC: Understanding mRNA COVID-19 Vaccines
For the Pfizer and Moderna vaccines, two doses are required (3 and 4 weeks apart, respectively).
COVID Vaccine Efficacy in Older Adults: What we know from the trials so far
To date, the best information publicly available comes from the Pfizer phase 3 trial data, which was published in the New England Journal of Medicine (NEJM) on December 10, 2020.
As was widely reported by the press, the trial included about 43000 participants, who were randomized to get the Pfizer COVID vaccine or a placebo injection. During a follow-up period of a few months, there were 8 cases of Covid-19 among vaccine recipients and 162 cases among placebo recipients. The authors concluded that the vaccine was 95% effective in preventing Covid-19.
But before you assume that you — or your aging parent — will be 95% protected by the vaccine: it’s extremely important to take a good look at the study data, to find out: how many people like you were studied, and what were the results in that group?
Being a geriatrician, I always want to know how many older adults were included in a study, what was the age breakdown of older participants (because the average 65-year-old is medically fairly different from the average 85-year-old), and what happened with those participants.
Here’s what I found out:
- The median age of participants was 52 years, and 42% of participants were older than 55 years of age. The age range of participants was 16-91.
- COVID cases and vaccine efficacy results are reported for four age ranges (see Table 3):
- 16-55 years (19852 people) –> 5 cases (vaccine) vs 114 cases (placebo) –> 95.6% efficacy (statistically likely range: 89.4–98.6%)
- >55 years (15043 people) –> 3 cases (vaccine) vs 48 (placebo) –> 93.7% (statistically likely range: 80.6–98.8%)
- >65 years (7728 people) –> 1 case (vaccine) vs 19 (placebo) –> 94.7% efficacy (statistically likely range: 66.7–99.9)
- >75 years (1559 people) –> zero cases (vaccine) vs 5 cases (placebo) –> 100.0% efficacy (statistically significant range: −13.1–100.0%)
Please note that it’s not a typo: for participants aged 75 years or older, they are reporting a statistically likely efficacy range of negative 13% to 100%. (!)
What does this result mean? Since the statistically likely efficacy range includes the number zero, it means it’s possible the vaccine has zero efficacy.
But honestly, that’s unlikely. The data right now is showing this large efficacy range because in practical terms, they didn’t have enough people aged 75+ catch COVID during the study period. (This may be because everyone in this age group was being careful to minimize their COVID exposure.) So, there was not enough data to determine how well the vaccine works in this age group.
It also means that for the time being, we don’t know how well the Pfizer vaccine works in older adults aged 75+. And we really don’t know how well it works in people aged 85-90+. We don’t even know how many people aged 85+ were in the study, but probably it was a small number.
Most vaccines, such as the influenza vaccine, tend to work less well in older adults because of an aging immune system. (This is why vaccine makers have designed flu vaccines specifically for older adults.)
At this time, I think it’s likely that the Pfizer vaccine is effective in the most vulnerable older adults (e.g. those in nursing homes and those over age 85). It won’t be AS effective as in younger people, but it’s likely better than not being vaccinated at all.
The vaccine also appears to be safe — certainly safer than catching COVID.
In my opinion, the biggest risk in vaccinating frail older adults is that people may overestimate the associated protection and then take fewer precautions around these older adults. So even if all residents of a nursing home are vaccinated, I hope that all the staff will agree to be vaccinated as well, and that everyone continues to take precautions until the levels of COVID community transmission finally drop down.
Is the Pfizer COVID vaccine safe?
In general, it appears to be quite safe and there were very few true severe problems noted in the study.
Now, it’s important to note that it was quite common for vaccine recipients to feel unwell after vaccination, especially after the second dose. The most common symptoms were fatigue and headache, and some people experienced fever, as well.
These are signs that the immune system is responding to the vaccine! (Which is why they occurred less often in older participants than younger ones.) So these should not be taken as a sign that the vaccine is dangerous, or not worthwhile.
For more on the Pfizer vaccine’s safety data, see my video above.
Who shouldn’t be vaccinated against COVID?
At this time, there are not many specifics on who should not be vaccinated, provided a vaccine is approved for your age group. (Neither the Pfizer or the Moderna vaccine have an emergency authorization for children.)
As of December 18th, there have been a very small number of severe allergic reactions, which the FDA is investigating. So people with a history of anaphylactic allergic reactions should probably check with their health providers before pursuing vaccination.
That said, with millions of vaccine doses being distributed over the next few weeks, guidelines are likely to rapidly evolve, regarding who should not be vaccinated, or who should be vaccinated with caution. For accurate information on this topic, I recommend reputable information sources, such as the FDA and the CDC’s COVID information pages. (See Resources, below.)
My current recommendation for COVID vaccination
As of December 18th, 2020, I think that for most people, it’s best to accept vaccination for COVID, if you have the opportunity to do so.
That’s because:
- The Pfizer vaccine appears to be quite effective, especially in people up to age 75.
- Even though it’s unclear how effective it is in people over age 75, it almost certainly provides some protection.
- Remember, this is the age group in which COVID is mostly likely to cause hospitalization or death; 60% of all US COVID deaths have occurred in people over age 75.
- So far there is no reason to believe the vaccine is unsafe or likely to cause harm.
- Until COVID rates drop way, way, down, the risks of catching and transmitting COVID should vastly outweigh the potential discomfort of vaccination or very small risk of an adverse reaction.
What to remember if you — or your loved one — is over age 75:
I do think you should accept vaccination, but please please do not assume you will be 95% protected from COVID.
Until adequate research is done, we will not know how effective the vaccine is for our most vulnerable older adults. So it’s important to keep taking precautions and continuing efforts to reduce COVID exposure, such as masks, physical distancing, and avoiding indoor gatherings.
We can also protect nursing home residents and other vulnerable older adults by encouraging all younger adults around them to accept vaccination.
Please take care, stay safe, and consider vaccination once it’s available to you!
Resources:
- FDA (Food & Drug Administration):
- CDC:
- CDC advisory panel’s lone dissenter on why long-term care residents shouldn’t receive Covid-19 vaccine first
- New England Journal of Medicine:
- Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (12/10/20 publication of the Pfizer vaccine phase 2/3 trial data)
- New York Times:
What about people who have had covid and are now well?
That’s a good question that is touched on on the CDC FAQ page about the vaccine, here https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
Right now, it’s not clear how long natural immunity will last after having coronavirus infection, so there is no clear recommendation about whether those individuals need a vaccination yet. I hope we have more information soon.
What is your commentary on the debate from Dr. Wolfgang Wodarg and Dr. Michael Yeadon about how the vaccine can cause permanent infertility?
I haven’t delved into this debate in detail, but there is definitely a lot of discussion about vaccine safety. The consensus from leading experts in health is that the vaccine is safe and is an important part of promoting public health during the pandemic.
Thanks, Dr. Leslie. An excellent summary I’ve not seen anywhere else.
Thanks for reading!
do covid + people who get ccp automatically become negative? are they retested after infusions?
I’m not sure what you mean by “CCP”, so I’m sorry if I can’t answer your question in more detail.
Whether or not a person with COVID is retested when they are no longer showing symptoms depends on the person’s other health issues and lifestyle (for example, do they need to go back to work in a healthcare setting or to care for a person at high risk? are they severely immunocompromised?). Here’s what the CDC has to say about when to stop isolating: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/end-home-isolation.html
Thank you Dr. Kernisan. Very Helpful! I agree with you, that there needs to be much more done to study these vaccines in older adults.
I also agree, that it is the staff of long term care facilities and family caregivers who really need to be vaccinated, since this is who has been exposing most seniors, especially those in congregate care, where visitors have been severely restricted since mid March.
It would have been so helpful if the researchers had recruited participants living in congregate senior communities, such as Independent and Assisted Living facilities, since those residents are all over the age of 65. I am sure that many would have willingly participated in the research trials, had they been asked.
Relieved, there are vaccines being rapidly developed and deployed, (Michigan is now being shorted 24,000 doses of the Pfizer vaccine, why?), but saddened that we may not know for quite sometime, if they are actually “effective” in a larger senior population.
Sad, since restrictions on family visitors to long term care facilities, and extended family gatherings will most likely continue for months and months more, until the general public can get vaccinated…prolonging the severe isolation seniors have been enduring.
When it is available, I will sign off for my soon to be 85 yrs old mom, to get the vaccine despite already having had Covid-19. Although she survived Covid-19, she is forever changed by the lasting/permanent effects of the virus, the effects of severe isolation imposed by restrictions to family visitors and group meals/activities at her Assisted Living facility…or both!
Many seniors have survived having Covid-19, but we haven’t even begun to process the lasting effects they may be dealing with afterward. I know seniors aren’t alone in being “long haulers”, but it’s my hunch that they are disproportionately effected.
Thank you so much for sharing your thoughts about the vaccine. You highlight the challenges and limitations of testing a new vaccine very well in your comment.
I also appreciate you sharing how hard the pandemic restrictions have been for your family. That echoes what I’m hearing from many patients and families right now. There will definitely be a reckoning when all of this has passed, and it has prompted us to take a long, hard look at how we treat our elders in society. I know there is a lot of research going on in this area right now and I’m looking forward to learning more.
Thanks again for your comment and for reading the article!
Apparently the vaccine does not prevent people from catching the virus. Instead, the vaccine stimulates the immune response to the virus, so that when the person does catch the virus, their symptoms will be less severe, or they may even have no symptoms at all, but still be capable of transmitting the virus.
My mother and all 10 other people in her secured memory care building caught the virus in June.
Science now says that a second infection is extremely unlikely. There have been about 20 recorded cases of a true second infection, among the tens of millions around the world who have already survived the virus.
Given these facts, why should my mother and the other residents in her building receive the vaccine? It certainly doesn’t seem medically necessary, especially since they all already survived the virus.
thanks!
You are correct that a person who’s been vaccinated could still get COVID, and could potentially transmit it, although would do so at a much lower rate than a non-vaccinated person with COVID exposure. That’s part of the reason we need to remain vigilant with other infection control measures like handwashing and social distancing.
The question about vaccination in someone who has had COVID is touched on on the CDC FAQ page about the vaccine, here https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
Right now, it’s not clear how long natural immunity will last after having coronavirus infection, so there is no clear recommendation about whether those individuals need a vaccination yet. I hope we have more information soon.
I wish that those of us who are over the age of 80 would not have to wait until all the essential workers are vaccinated. But it appears that reopening the economy is more important than saving lives.
I understand your concerns about having to wait to be vaccinated. It’s such an unprecedented situation with vaccine supply being limited and need being universal, and it’s hard to imagine that there wouldn’t be some delay in getting everyone vaccinated.
Here in Canada, those who live and work in long-term care will be first, followed by those over 80, those over 70, healthcare workers and persons in Indigenous communities. Next will be other health workers and essential workers.
There may be a great deal of regional variation in vaccine prioritization, so I would check with your local public health unit for more information.
Thank you for such excellent information!
I am 73 years old and have been diagnosed with ME/CFS. At this point my varies from moderate to moderate/severe. Is it okay to proceed with the vaccine when it becomes available to me? (Most doctors here know very little about ME/CFS, so can’t discuss with them.
I’m so glad that you enjoyed the article!
A person with a diagnosis of ME/CFS (Myalgic encephalomyelitis/chronic fatigue syndrome) is still eligible for a COVID vaccine, unless they have an allergy to the vaccine components.
Having said that, many of the symptoms of ME/CFS can be mistaken for vaccine side effects, and I would be careful about that if possible. That is, if there’s a symptom after the first dose of the vaccine, I would carefully consider if it is related to the vaccine or to the ME/CFS, and not avoid the second dose of the vaccine which is necessary for immunity to develop.
What is your opinion now that we have some information about the frail seniors passing in Norway after their Pfizer booster?
I don’t have all of the details about this story, but from what I’ve read, it sounds like this could have been a coincidence that these frail individuals, who resided in nursing homes, passed away after getting immunized (and I believe it was after their first shot). Right now, there’s no indication that we’re being told to not offer the vaccine to frail adults.
What about taking tylenol before or after the Covid vaccination? I understand that anti-inflammatory medications (NSAIDs) should not be taken before, because they may blunt the effects. But what about non-anti-inflammatory drugs, such as acetaminophen?
The recommendations that I’ve read suggest that acetaminophen is reasonable to take, but most are recommending the avoidance of ibuprofen.