COVID Vaccination for Aging Adults:
What to Know & Do

COVID is an important issue for older adults: they are more likely to be severely affected by COVID, and they represent most COVID deaths.

Luckily, COVID vaccines are effective and significantly reduce the risk of hospitalization and death in older adults. In particular, I want to offer science-based information to help with common questions, such as “Which COVID vaccine is better for seniors?” or “Which COVID vaccine for a 90-year-old?”

This page covers my older science-based updates on COVID vaccines.

For my latest update, see here: Covid & Aging Adults: Current Vaccines & Updates

 

COVID fall vaccine update October 1, 2024

 

In this video, I talk about the impact of COVID on older adults so far this year, and I explain the available vaccines for the three respiratory viruses likely to be very active this fall and winter: COVID, influenza, and RSV.Also: the CDC announced a few weeks ago that new COVID vaccines are available for the 2024-2025 season.

They are recommended for everyone over the age of 6 months, and are especially recommended for adults over the age of 65.

This year, three vaccines are available for people aged 12 and older:

• Moderna mRNA COVID vaccine: based on KP.2 variant, 50 microgram dose
• Pfizer mRNA COVID vaccine: based on KP.2 variant, 30 microgram dose
• Novavax Adjuvanted COVID vaccine: based on JN.1 variant

Unless you’ve had COVID in the last six months, I highly recommend getting your fall COVID vaccine within the next few weeks, especially if you are over age 50.

Now, which one to get? Any of them should be fine, but there are some small differences to consider:

• The mRNA vaccines (Moderna and Pfizer) are based on a more recent COVID strain, and so are more likely to provide better protection against whatever strain might be circulating around Thanksgiving and Christmas.
• Moderna is a somewhat higher dose. This might be more likely to stimulate an aging immune system. (A higher-dose vaccine is a strategy that has been effective in flu vaccines.)
• Novavax tends to give fewer systemic side-effects. So, if you’re one of those people who tends to feel lousy after COVID vaccination, consider Novavax instead of an mRNA vaccine.

Now, what if you’ve had COVID this past summer, as many people have?

The CDC’s guidance at this time is that it’s ok to wait 3 months before your next COVID vaccination, but also says that people who are very high risk can get it sooner.

Last but not least: remember that it’s ok to get your COVID vaccine at the same time as your fall flu shot.

COVID winter update December 20, 2023

As anticipated, we are seeing a substantial rise in COVID activity this month. This can be seen in wastewater and we’re also seeing a rise in hospitalizations.

What is a little more worrisome is that a new variant, JN.1, now seems to be taking off in the US. This variant has been active in Europe, where it is causing a marked exponential spike in COVID wastewater levels.

We are also seeing a fair amount of RSV circulating, plus some influenza.

For more on the state of these respiratory viruses, I highly recommend reading this update by epidemiologist Katelyn Jetelina, MPH PhD: State of Affairs: Dec 19, 2023.

All three of these viruses (COVID, RSV, influenza) can hospitalize vulnerable older adults 🙁

So as you consider holiday travel and gatherings, here are my recommendations:

• Avoid gathering with others inside if you have cold symptoms (or anything worse). If you need to gather, consider wearing a mask and be sure to ventilate the space with a HEPA air filter (or open windows).
• Consider rapid tests for COVID before having a gathering with vulnerable older adults.
• Wear a N95 or KN95 when traveling on planes or other forms of crowded public transit. 
  • Consider a mask when in malls or other crowded indoor spaces.
• People over age 65 should get the 2024 COVID vaccine (if they haven’t yet had it), for renewed protection against hospitalization.
  • The exception is if you’ve actually had COVID within the past few months; that’s like getting a booster but much more effective.
• Paxlovid still works. Older adults should request it if they test positive for COVID.

COVID fall vaccine update September 21, 2023

The CDC announced recently that new COVID vaccines are available for the 2023-2024 season.

They are recommended for everyone over the age of 6 months, and are especially recommended for adults over the age of 65.

This fall, the COVID vaccine is a monovalent vaccine based on the XBB.1.5 subvariant of Omicron (which was the most prevalent variant at the beginning of the summer). Although there are different Omicron subvariants currently circulating, the XBB.1.5 is expected to provide good protection against hospitalization and deaths.

If you are a details and data person, you can find the slides presented at the 9/12/23 CDC meeting here.

Learn more about the new fall COVID vaccines here: CDC: Stay Up to Date with COVID-19 Vaccines.

I highly recommend that adults aged 65+ get this updated COVID vaccine, especially if they have not had COVID in the past 4 months.

I also recommend that aging adults get their annual flu shot (get one of the stronger ones recommended for older adults) and consider the new RSV vaccine for older adults.

Otherwise, my recommendations for how to stay safe in regards to COVID have not changed since my most recent video update from August, which you can view below.

From August 14, 2023:

In this update, I discuss the latest COVID news for August 2023, including the recent rise in COVID cases, whether to get boosted again now or later, what we know about the upcoming fall COVID vaccine, and more. 

In this episode:

• What to know about the new COVID wave
• Update on the EG.5 subvariant
• Whether vaccines work against the newest variants
• Update on the upcoming 2023 COVID vaccine booster
• Answers to FAQs
  • Should you get boosted again now or wait?
• Symptoms of COVID & what to do if you catch it
• What will really help us live with COVID

Note: For the masks I recommend, you can get the 3M V-flex here https://amzn.to/3OxrsRY, and the Powecom KN95 here https://amzn.to/3W9frXf

These are Amazon affiliate links, so any purchases will help support Better Health While Aging, thank you!

For all links and resources mentioned in the update, see the related podcast page here.

June 6, 2023 Update:

In this update, I cover what’s going on with COVID as of Summer 2023, including the current COVID situation in the US, how to get COVID data now that the public health emergency has ended, updates on COVID boosters, how to know if you still should take precautions, and more.

In this episode:

• What’s changed since February
• Updates on the COVID bivalent booster
• What’s happening now with COVID
• How to decide if you should worry about COVID
• What are the risks of catching COVID now?
• How to avoid catching COVID this summer
• COVID booster FAQs
• COVID symptoms now
• What to do if you catch COVID & how to get Paxlovid

Note: For the masks I use, you can get 3M Aura here https://amzn.to/3PJJyRO, the 3M V-flex here https://amzn.to/3OxrsRY, and the Powecom KN95 here https://amzn.to/3W9frXf.  

These are Amazon affiliate links, so any purchases will help support Better Health While Aging, thank you!

For all links and resources mentioned in the update, see the related podcast page here.

February 23, 2023 Update:

In this video update, I cover what aging adults and their families should know about COVID being better but not yet gone, including what to know about the new COVID 2023 variant XBB.1.5, what to expect when the public health emergency ends in May, and how to get Paxlovid (it’s the best treatment!) if you do catch COVID. This update addresses many COVID FAQs including:

• Is COVID over now?
• Is there a new COVID variant in 2023?
• Does the bivalent COVID booster work?
  • If I haven’t gotten it yet, should I still get the COVID bivalent booster?
• Can you still get COVID if you’ve had Omicron before?
• What are symptoms of COVID now?
• What should I do if I (or my aging parent) gets COVID?
• What’s the best treatment for COVID and how to get Paxlovid if your doctor doesn’t want to prescribe it
• How to know what’s safe in 2023?

Note: For the masks I use, you can get 3M Aura here https://amzn.to/3PJJyRO, the 3M V-flex here https://amzn.to/3OxrsRY, and the Powecom KN95 here https://amzn.to/3W9frXf.  

These are Amazon affiliate links, so any purchases will help support Better Health While Aging, thank you!

For all links and resources mentioned in the update, see the related podcast page here.

December 8, 2022 Update:

In this video update, I cover what all older adults & families should know about the COVID and flu situation this winter, including what to know about the new BQ.1 subvariants, and how to stay safer during winter gatherings. This update addresses many FAQs, including:

• Does the fall COVID booster work?
  • Does it work against the newest Omicron subvariants
• What are symptoms of COVID now?
• Can you still get COVID if you’ve had Omicron before?
• How can you tell if it’s COVID, flu, or something else?
• How worried should I be?

I also cover which masks and HEPA air purifiers I recommend, and what to do if you catch COVID.

Note: you can get the CO2 monitor I refer to here: https://amzn.to/3yhDtq8. For the masks I use, you can get 3M Aura here https://amzn.to/3PJJyRO, the 3M V-flex here https://amzn.to/3OxrsRY, and the Powecom KN95 here https://amzn.to/3W9frXf.  The HEPA air purifier I use in my home is here https://amzn.to/3Y96crN.

These are Amazon affiliate links, so any purchases will help support Better Health While Aging, thank you!

For all links and resources mentioned in the update, see the related podcast page here.

September 7, 2022 Update:

In this video update,  I explain what to know about the new fall COVID boosters, the latest Omicron variants, and more. I also cover the data on who died of COVID this summer and how older adults can know if they remain at high risk of severe COVID. This update addresses many FAQs, including:

• What’s in the new COVID booster and who should get it?
• Is the new COVID booster safe and effective?
  • Will it wane?
  • Will it work against upcoming variants?
• When should you get your COVID Omicron booster?
• Which booster is better for older adults: Pfizer or Moderna?
• What if you’ve already had Omicron?
• Who is still at risk of dying from COVID?
• Does Paxlovid work? Should you take it if you get COVID?

For all links and resources mentioned in the update, see the related podcast page here.

July 21, 2022 Update:

In this video update, I cover the current high COVID levels, the related risks for aging adults, what to know about Omicron BA.5, the data on boosters, and the most effective ways to take sensible precautions this summer.

This update addresses many FAQs, including:

• Is COVID on the rise again?
  • The current COVID situation and how high cases really are
• Is BA.5 worse than previous Omicron variants?
• What to know about COVID hospitalization numbers
• Do vaccines and boosters still work for aging adults?
• Should I get a second booster? Should my aging parent get one?
  • The data on first and second boosters
• How the new Novavax COVID vaccine works
• How to test for COVID and whether tests still work with BA.5
• How long to isolate if you get COVID
• What to know about Paxlovid and relapsing after Paxlovid
• What masks I recommend and why
• How to take reasonable precautions

Note: you can get the CO2 monitor I refer to on Amazon here: https://amzn.to/3yhDtq8. The masks that I’m currently using include 3M V-flex N95, and 3M Aura N95. These are affiliate links, so any purchases will help support Better Health While Aging, at no extra cost to you.

For all links and resources mentioned in the update, see the related podcast page here.

May 5, 2022 Update:

In this video update, I explain what to know about the current rise in COVID cases, the related risks for aging adults, what to know about the newest Omicron variants BA.2 and BA.2.12.1, and the most effective ways to take sensible precautions.

This update addresses many FAQs, including

• Where we are at with COVID now, and the impact on aging adults
• What do we know about the latest Omicron variants: BA.2, BA.2.12.2, BA.4, and BA.5
• What’s changed (& hasn’t) with COVID
• The latest on COVID vaccine efficacy during Omicron
• What to know about first and second boosters
• The latest on how COVID is being transmitted
• What to do for masking to be effective
• Ventilation & checking CO2 levels
• Does rapid testing still work?
• What to know about COVID treatments and possible Paxlovid relapses
• Whether to mask on airplanes
• My top recommendations for taking reasonable precautions right now

You can get the CO2 monitor I refer to on Amazon here: https://amzn.to/3yhDtq8. This is an affiliate link, so any purchases will help support Better Health While Aging, at no extra cost to you.

For related links, see the podcast page for this update, which is here.

March 29, 2022

The CDC approved a second COVID booster, for adults aged 50+ and for people who are moderately or severely immunocompromised.

For more information: CDC: COVID-19 Vaccine Boosters

I will discuss the data on boosters in an upcoming video update…for now, the main thing to know that getting a first booster is what is most important. Getting a second one is most likely to benefit those at highest risk (e.g. those age 80+). It’s unclear that it’s very beneficial to healthy adults in their mid-50s…especially the effect is likely to be temporary.

Feb 25, 2022:

The CDC has just released new guidance re COVID, including a revised version of calculating whether local “COVID-19 community levels” are low, medium, or high. The new method combines the number of cases in the past 7 days with hospitalization rates and hospital capacity, as the CDC explains here.

Note that their method considers whether the new cases in 7 days (per 100k population) are fewer or more than 200. 200 cases/100k/7 days corresponds to 28.5 cases/100k/day. This is not a horribly high case level, but their previous approach considered less than 10 cases/100k/day low transmission, with moderate transmission being 10-50 cases/100k/day, so we are definitely moving the goal posts here.

I also have mixed feelings about heavily relying on hospitalization rates. They are a seriously lagging indicator of COVID taking off; people get hospitalized 1-2 weeks after they catch COVID. Also, you can have pretty high levels of transmission among children and young people before you see hospitalizations moving (because the younger people are extremely unlikely to be hospitalized for COVID), and those high transmission levels are riskier for older adults than for the general public. So, I plan to keep an eye on local case counts, at least for the next few months.

Whereas yesterday we were almost all living in high transmission areas, now many parts of the US have been reclassified into moderate or low. Does it matter? Regardless of the numbers, the masks and precautions are being dialed back. In my latest video update (recorded yesterday), I explain what I think we need to focus on now, and also what we can learn from Denmark (which removed all restrictions on 2/1/22).

Personally, I think a level of 10 cases/100k/day sounds better for relaxing all the masking and precautions. (This is the level that Dr. Bob Wachter is going with, as I explain in the video.) At 30 cases/100k/day, I would still be considering rapid testing before indoor encounters with vulnerable elders, and a few other precautions.

February 24, 2022 video update:

In this video update, I discuss the tapering of the Omicron surge, what to know about the “stealth” Omicron BA.2 (it has taken over in Denmark and is growing here), how to “live with COVID” safely, and more.

This update covers:

• Why current COVID numbers are better but still not low enough
• What we’ve learned about vaccines & boosters during the Omicron surge
• What we can learn from Denmark lifting all COVID restrictions
• How to compare US COVID data to that of other countries, and why our outcomes are worse
• What to know about the Omicron sister variant BA.2
• What it would mean for COVID to be “endemic”
• The ideal approach to living with COVID
• Wastewater & other ways to monitor COVID in your local area
• What older adults can do to keep themselves and their families safer

For related links, see the podcast page for this update, which is here.

January 6, 2022 update:

This video update covers the latest on the ongoing Omicron surge, including whether it’s milder in older adults, what’s we’ve learned about rapid testing for Omicron, what to know about the current hospital situation, how to stay safer during the surge, and more.

The update addresses these FAQs:

• But isn’t Omicron supposedly “milder”?
• Do COVID tests (PCR and rapid) work against Omicron?
• Do the COVID vaccines still “work”, and will they work against Omicron?
• Are the COVID vaccines effective in older adults?
• Why get vaccinated/boosted if you’re just going to get COVID anyway?
• What about those new COVID treatments?
• Shouldn’t we just “let it rip”?
• And if I test positive for COVID?
• Is it safe to ….

Related links (including my favorite COVID Twitter sources) are posted on the podcast page for this update, which is here.

From Dec 16, 2021:

This video update covers Omicron, COVID boosters, plus how to search the CDC data to see just how well vaccines have worked, even in older adults. I also show the data demonstrating that vaccinated people age 80+ are still at higher risk of serious COVID than unvaccinated people under age 50; this is why fully vaccinated older adults should take precautions during the current surge!

The update addresses these FAQs:

• What do we know about Omicron so far, and will the vaccines remain protective
• Should I get vaccinated against COVID?
• Should my 90-year-old mother get the COVID vaccine?
• How well does the vaccine work in older adults? How well does it work over time, and against Delta?
• Should I worry that the vaccine might harm me (or my frail older parent)?
• Who should get a COVID booster and why?
• How to stay safer during the holidays.

For related links specific to this update, see the related podcast show notes page.

What’s Most Important to Know About COVID Vaccination

As of December 17, 2021, what is most important to know is:

• There is currently a COVID surge in the US, involving both Delta and the newer Omicron variant. Very high case numbers are expected. Unvaccinated older adults are at quite high risk of hospitalization or death due to COVID (as explained in 12/16/21 video update). Even vaccinated older adults are at some risk, and should take extra precautions during the surge, to avoid being exposed to COVID.
• The COVID vaccines are safe and remain very effective at preventing hospitalization or death from COVID (especially the mRNA vaccines from Pfizer and Moderna). Even after 5-6 months, the vaccines continue to provide excellent protection against hospitalization and death due to COVID, even in older age groups.
• After several months, the vaccines do become less effective at preventing mild COVID infections and breakthrough infections can happen. These are unlikely to become serious.
  • The small number of breakthrough infections that become very serious are mostly in people who are older or have serious chronic medical conditions. (Note: General Colin Powell, who died of a breakthrough COVID infection, was 84 and had a very serious blood cancer.)
• The Omicron variant is very contagious and its mutations enable it to cause breakthrough infections in people who are vaccinated or have previously had COVID. Vaccination is expected to continue providing good protection against hospitalization and severe COVID.
• Both Omicron and Delta are causing symptoms and (usually) mild COVID illness in fully vaccinated people. There is also evidence that fully vaccinated people can transmit the Omicron and Delta COVID variants to others. Many COVID cases in vaccinated people are asymptomatic, as well.
  • This means you should not assume that you can’t get COVID from a fully vaccinated person.
  • If you are vaccinated, you should be careful about the possibility you could transmit COVID to another vulnerable person, such as an unvaccinated child or frail older person.
• Getting vaccinated is safe, will protect you personally from serious illness due to COVID, and helps reduce the impact of COVID in our communities. I recommend vaccination for all adults. I have personally vaccinated my own children (ages 13 and 11), to reduce risk to our family members who are in their 90s.
• I also recommend resuming wearing masks indoors and taking COVID exposure precautions (ventilation, minimize time indoors with people outside your household), at least until COVID case rates decline.
• Getting a booster dose of the vaccine does seem to reduce the risk of a vaccinated person getting a breakthrough infection.  I recommend getting a COVID booster.

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, 2021, in the U.S., three COVID-19 vaccines are in use: Pfizer, Moderna, and Janssen (which is the pharmaceutical branch of Johnson & Johnson).

On December 11, 2020, the FDA granted an emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine. Moderna was granted a similar EUA on December 18, 2020.

On February 27, 2021, the FDA granted emergency use authorization to Johnson & Johnson’s COVID vaccine. Unlike the Pfizer and Moderna vaccines, which require two injections spaced about a month apart, the J&J vaccine only requires one injection.

On August 21, 2021, the FDA authorized an additional dose of COVID vaccine for people who are moderately to severely immunocompromised.

On August 23, 2021, the FDA granted full authorization to Pfizer’s vaccine.

On Sept 22, 2021, the FDA authorized a single booster dose for Pfizer COVID vaccine recipients who are age 65 or older, plus for a few other select groups.

On October 20, 2021, the FDA authorized a booster dose for older Moderna COVID vaccine recipients (plus for a few other at-risk groups) and for Johnson & Johnson vaccine recipients (all).

On December 16, 2021, following a review of the effectiveness and safety of the Johnson & Johnson vaccine, the CDC announced that it’s preferred that adults receive one of the mRNA vaccines (Moderna or Pfizer).

Many other vaccines have been approved in other countries, such as the Oxford AstraZeneca vaccine in the U.K. You can see a list of COVID vaccines on the NYTimes Coronavirus Vaccine Tracker page, which also includes a helpful summary of the vaccine approval process.

Vaccines were initially prioritized for frontline health workers and nursing home residents, and then were prioritized in most areas for older adults. As of May 2021, vaccinations are available in most parts of the US to all adults who wish to be vaccinated.

The Pfizer vaccine received emergency approval for children ages 12 and older in May 2021, and a pediatric dose for children ages 5-11 received approval in November 2021.

About the mRNA COVID Vaccines (Pfizer and Moderna)

How the Pfizer and Moderna COVID vaccines work

The Pfizer and Moderna vaccines use a new approach for vaccination: messenger RNA (“mRNA”). This technology had never before been used in a licensed vaccine. But it was under development at the NIH about 10 years prior to the pandemic, and it offers 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

Unfortunately, there has been a lot of misinformation spread about the mRNA COVID vaccines. An excellent article debunking the false claims is here: Irish Professor Makes Unfounded Claims About Long-Term Effects of mRNA Vaccines

For the Pfizer and Moderna vaccines, two doses are required (3 and 4 weeks apart, respectively).

mRNA COVID Vaccine Efficacy in Older Adults: What we know so far

What we know about how well these vaccines work is based on two types of information: randomized trial data submitted to the FDA to get emergency use authorization, and then observational analyses conducted over the past several months.

CDC data indicate that since vaccination began, COVID case rates and death rates have fallen dramatically in nursing home residents and among people aged 85+. A UK study also noted a significant drop in COVID hospitalizations among older adults after their vaccine rollout. (See the video here for an explanation of where to find this data.)

Also, in May 2021, researchers published an updated study of the Pfizer vaccine efficacy in Israel. This found a real-world overall vaccine efficacy of 94% (93% in over 65 age group). Table 3 of this study report also reported vaccine efficacy in 3 older age groups (over 65, over 75, and over 85). (I explain this data in my COVID update video from 5/14/21.)

This data found that vaccine efficacy dropped in the older age groups for asymptomatic infection (83% in people over age 85) but remained around 97% for symptomatic COVID and severe COVID, with no drop seen in the older age groups. This suggests that although the risk of passing on COVID or having a breakthrough infection may go up as people get older, even those over age 85 should expect to get excellent vaccine protection from serious COVID illness.

A CDC report published in early May of 2021 found that getting either the Pfizer or Moderna vaccine was 94% effective against COVID-19 hospitalization among fully vaccinated adults aged 65 and older.

At this time, research and observational data overall supports the efficacy of the mRNA vaccines, even in the very old. The main group that seems to be an exception is those with significant immunocompromise, such as those taking certain immune medications, those who’ve had transplants, and those with a history of hematological malignancies (“blood cancers”) or other conditions affecting their B cells and T cells. For more on this, see Researchers Tie Severe Immunosuppression to Chronic COVID-19 and Virus Variants.

The CDC recently began reporting COVID cases and deaths based on vaccination status. This NY Times article includes graphics based on the CDC data, showing how vaccination reduces cases (and deaths) for every age group: Who Had Covid-19 Vaccine Breakthrough Cases?

For these reasons, I highly encourage COVID vaccination for adults of all ages, and especially for older adults.

What we know about COVID vaccine protection weakening over time

Several observational studies indicate that the three COVID vaccines become less good at preventing mild infection after a few months. However, so far they have continued to provide excellent protection against hospitalization, especially in people under age 65.

• CDC: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021 (Published Sept 2021)
• COVID-19 Vaccine Effectiveness by Product and Timing in New York State (pre-print posted Oct 9, 2021)
• Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study (Lancet, Oct 2021, about the Pfizer vaccine)

Most studies show that after several months, Moderna remains more effective than Pfizer, and both are more effective than Johnson and Johnson.

For this reason, COVID boosters are now being recommended for all adults, and especially for older adults or those at risk of severe COVID. For more on COVID boosters:  CDC: COVID-19 Vaccine Booster Shots

For data on how boosters increase antibody levels, see  Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report.

Note: A COVID vaccine booster is not technically the same as getting a “third dose,” which was approved by the FDA on 8/21/21 for certain people who are immunocompromised and unlikely to mount sufficient response to the usual COVID vaccine schedule. For more on who qualifies for this type of extra dose, see CDC: COVID-19 Vaccines for Moderately to Severely Immunocompromised People.

What we know from the COVID trial data submitted to the FDA

The Pfizer phase 3 trial data was published in the New England Journal of Medicine (NEJM) on December 10, 2020, and the Moderna phase 3 trial data was published on December 30, 2020.

The Pfizer 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 vaccine trial data: 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 is the short video presentation I recorded in December 2020, 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.

Here’s what I found out, for the Pfizer trial:

• 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, the initial Pfizer trial data reported a statistically likely efficacy range of negative 13% to 100%. (!)

Why is this? 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.)

In short, when Pfizer’s vaccine was authorized, it wasn’t clear just how effective it was in older adults aged 75+, much less those aged 85-90+. They also didn’t report just how many people aged 85+ were in the study, but probably it was a small number.

As a geriatrician, this concerned me. 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.)

That said, in February 2021, researchers published a study of the Pfizer vaccine efficacy under real-world conditions in Israel, which noted a real-world vaccine efficacy of over 90%. The study did exclude nursing home residents from the study, and did not specify effectiveness in people over age 80. But it was excellent to see the vaccine demonstrating such good results overall.

Also, as noted earlier in this article, in May 2021, researchers published an updated study of the Pfizer vaccine efficacy in Israel, which reported vaccine efficacy in 3 older age groups (over 65, over 75, and over 85).

This data found that vaccine efficacy dropped in the older age groups for asymptomatic infection (83% in people over age 85) but remained around 97% for symptomatic COVID and severe COVID, with no drop seen in the older age groups. This suggests that although the risk of passing on COVID or having a breakthrough infection may go up as people get older, even those over age 85 should expect to get excellent vaccine protection from serious COVID illness.

For the most recent information on what data from Israel shows (including why they decided to give boosters), see my latest video update.

What about the efficacy of the Moderna vaccine?

The Moderna phase 3 trial data was overall similar to the Pfizer data. They also had a limited number of participants over age 75, and so could not draw statistically significant conclusions regarding the efficacy of the vaccine in people over age 75.  The peer-reviewed Moderna vaccine study results published in the New England Journal are here.

The data that Moderna submitted to the FDA when requesting emergency approval can be viewed here.

• In Table 17 (page 29), you can see that in people aged 65+, the point estimate for vaccine efficacy was 86.4% (95% likely range of 61.4 – 95.5%), compared to an efficacy of 95.6% (range 90.6%, 97.9%) in people age 18 to under 65.
  • This is overall excellent vaccine efficacy.
• You can see the number of participants aged 75+ and the vaccine efficacy results in Table 10 (page 24).
  • The number of people over age 75 was quite small (about 1300 overall) and there were only 3 COVID cases in the vaccinated group.
  • So the posted efficacy rate of 100% is not statistically significant (which is why they don’t provide a range).

Needless to say, the participants in the vaccine trials who were aged 75+ are overall much younger and healthier than people in nursing homes, and should be assumed to have a better immune system response to vaccines than even a healthy 90 year old will have.

If you are wondering why there weren’t more people aged 75+ in the trials, see this interview with geriatrician Dr. Sharon Inouye, of Harvard: Why Aren’t Highest-Risk People Better Represented in COVID Vaccine Trials?

When the Pfizer and Moderna vaccine were released, my concern was that 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, it’s important for staff to be vaccinated as well, and that everyone continues to take precautions until the levels of COVID community transmission finally drop down.

For the latest information on the efficacy of the Moderna vaccine (which in many studies appears to be more effective than the Pfizer vaccine), see my latest video update above.

Do the Pfizer and Moderna vaccines protect against the new variants of COVID?

The CDC is monitoring several COVID variants, some of which appear to be more contagious than usual. These seem to have originated overseas but appear to be circulating in the United States. The variants include:

• Alpha, (B.1.1.7, first identified in the U.K.)
• Beta (B.1.351, first identified in South Africa)
• Gamma (P.1., first identified in Brazil)
• Delta (B.1.617, first identified in India) — As of October, 2021, this has proven to be extremely transmissible . It was implicated in a breakthrough cluster of cases among vaccinated airport workers in Singapore and has become the dominant COVID variant in many parts of the world.
• Omicron (B.1.1.529, first identified in South Africa) — This one has an exceptional number of mutations and as of Dec 2021, seems to be rapidly spreading.

The vaccine makers are actively studying how well their vaccines protect again these variants. In July 2021, a study published in the New England Journal of Medicine concluded that the Pfizer vaccine and AstraZeneca vaccines were effective against the Delta variant, provided two doses were administered.

To date, no COVID boosters have been designed specifically for any COVID variants, but it is possible that this will be developed in the future.

To find out if the COVID variants are causing cases near you, see this CDC page: US COVID-19 Cases Caused by Variants.

Are the Pfizer and Moderna COVID vaccines safe?

In general, they appear to be quite safe and there were very few true severe problems noted in the study.

As of March 26, 2021, over 130 million doses of these vaccines have been administered. To date, the primary safety issue that has emerged is the possibility of severe allergic reactions. However, these are uncommon and only affect a handful of people per every million doses administered. For more on this, see this CDC page.

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.

About the Johnson & Johnson COVID Vaccine

The Johnson & Johnson vaccine requires only a single injection. A good summary of the J&J vaccine, including how it’s different from the Pfizer and Moderna vaccines, is here: How does the Johnson & Johnson vaccine work? When is it available? What to know about the new shot.

Reviewing the J&J vaccine data is more complicated in that the Phase 3 trial was conducted in three regions (the US, South Africa, and 6 Latin American countries), and also took place in the winter of 2020-2021, when some areas had COVID variants spreading.

The trial data submitted to the FDA can be viewed here:  FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19.

In reviewing the J&J data, I noted:

• Vaccine effectiveness (VE) overall, by region was:
  • US: 72% (95% confidence interval 58-82%)
  • Latin America 61% (95% confidence interval 47-72%)
  • South Africa 64% (95% confidence interval 41-79%)
• 35% of participants were over age 60
  • 3.7% over age 75
• VE after 28 days against moderate-severe COVID:
  • Age 18-59: 66% (95% CI 53-76%); 64% if comorbidities
  • Age 60+: 66% (95% CI 37-83%); 42% if comorbidities
• VE after 28 days against hospitalization/ICU/death
  • No cases were noted among vaccine recipients; VE 100% (31-100%)

The bottom line is that although the posted overall efficacy rate appears to be lower (72% in the US) than that of the mRNA vaccines, the J&J vaccine is still quite effective overall and after 28 days, it had good efficacy (83%; see table 16) in preventing severe/critical COVID.

It is perhaps a little bit concerning that it was less effective among older adults with comorbidities, but it is still better than being unvaccinated.

There was no very detailed data on the vaccine efficacy in people over age 75; they are mentioned in some results tables (e.g. table 12) but there does not seem to be enough data to draw an efficacy conclusion.

The vaccine also appeared to be safe overall. Similar to the previously approved COVID vaccines, many vaccine recipients did experience side effects such as headache, fatigue, and body aches, and these were more common in younger recipients.

There has been some concern about a rare but serious side effect involving clots: as of December 17, 2021, 57 people have experienced clots associated with the J&J vaccine. These all occurred in people under the age of 59. Given 16 million doses have been administered, this appears to be a very rare side-effect.

Although it is better to be vaccinated with J&J than to be unvaccinated, as of December 2021, it has become clear that the Pfizer and Moderna vaccines are more effective, and potentially safer. For these reasons, on December 16, the CDC announced that the mRNA vaccines are now preferred over J&J.

COVID Vaccination and Nursing Homes:

CDC data indicates that since vaccinations began in nursing homes in December 2020, COVID case rates and death rates have fallen dramatically in nursing home residents and among people aged 85+. A UK study also noted a significant drop in COVID hospitalizations after their vaccine rollout.

You can view current counts for COVID cases and COVID deaths in nursing homes here:
CDC: Nursing Home Covid-19 Data Dashboard

The numbers have improved a lot since the winter of 2020-2021. However, in December 2021, there were still 4000 cases per week in nursing homes nationwide, along with nearly 400 deaths per week.

Past investigations suggest that some nursing homes are experiencing outbreaks related to unvaccinated staff members, and “breakthrough” COVID cases in vaccinated residents are occurring. Most of these breakthrough cases are mild or asymptomatic, fortunately.

To date, vaccination rates are much higher among nursing home residents than among the staff who work in the facilities.

The CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed COVID vaccine safety data in a meeting on January 27, 2021.  You can view the meeting slides and safety data here. This meeting included data on the immunization of nursing home residents (slides 39-41). These vaccinations used Pfizer and Moderna vaccines.

The safety data, for nursing home residents, were reassuring. As the slides explained, after the vaccination campaign in nursing homes, there was no sign that people were more likely to die within after vaccination, compared to nursing home residents who are not vaccinated.

Especially given the risk of COVID exposure due to those staff members who have chosen to not be vaccinated, I highly recommend COVID vaccination for all nursing home residents. I also recommend vaccination for visiting family members, as this helps protect nursing home residents, who may be more vulnerable to breakthrough COVID cases after vaccination.

I also recommend a booster dose for older adults and especially for nursing home residents, since recently published CDC data finds that the mRNA vaccines efficacy against COVID infection has dropped over the past few months:
Effectiveness of Pfizer-BioNTech and Moderna Vaccines in Preventing SARS-CoV-2 Infection Among Nursing Home Residents Before and During Widespread Circulation of the SARS-CoV-2 B.1.617.2 (Delta) Variant — National Healthcare Safety Network, March 1–August 1, 2021.

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. (None of the available vaccines have an emergency authorization for children under the age of 5.)

As of December 2021, there have been a relatively 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. There have also been some very rare cases (28 out of 9 million doses given) of serious clots in people who receive the Johnson and Johnson vaccine, as noted above.

That said, with millions of vaccine doses being distributed over the next several months, 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 17, 2021, I am urging all adults to get vaccinated for COVID, unless your own health provider advises you otherwise. Although any vaccine is better than no vaccine, the mRNA vaccines have proven to be more effective than Johnson & Johnson, so I would recommend one of those. There is also evidence that the Moderna vaccine is a little “stronger” and more effective, which can be good for aging immune systems.

I recommend vaccination against COVID because:

• The Pfizer and Moderna vaccines appear to be quite effective in preventing hospitalization, even in older adults.
  • See my December 2021 video update in which I walk through the CDC data showing how COVID cases, hospitalization, and deaths are much higher in unvaccinated people, especially in older age groups
  • Data from Israel suggests good effectiveness in people over age 85, as well. Although there does seem to be some recent waning of vaccine protection against breakthrough infections (esp in older adults), vaccine protection against hospitalization remains quite good.
• Even though it’s unclear exactly how effective these vaccines are in people over age 75, COVID case numbers and deaths in this age group have fallen as older adults have been vaccinated.
  • Remember, this is the age group in which COVID is mostly likely to cause hospitalization or death; 75% of all US COVID deaths have occurred in people over age 65.
  • COVID cases and deaths in US nursing homes have dramatically decreased since the vaccination campaign started.
• So far there is no reason to believe these vaccines are unsafe or likely to cause lasting 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.

I also recommend that previously vaccinated older adults get a booster COVID vaccine dose. Younger adults should get a booster as well, as it’s now recommended for all adults and helps reduce transmission to older adults and other vulnerable people.

What is an older person’s risk of dying from COVID?

To get an estimated answer to this question, in March 2021, queried the CDC’s COVID-19 Case Surveillance Public Use Data set, which is available online.

In reviewing available data for COVID cases from 9/1/20 to 3/25/21, I calculated the following:

• For people aged 80+
  • 16.4% mortality overall
  • 43% mortality if hospitalized
  • 67% mortality if admitted to the ICU
• For ages 70-79
  • 6% mortality
• For ages 60-69
  • 2% mortality

Note that these figures are pre-Delta. The Delta variant does seem to cause more severe illness, so the risk of serious COVID illness in the unvaccinated is probably higher now.

For a more recent estimate of COVID mortality, see this part of my December 2021 COVID update.

What to remember if you — or your loved one — is over age 75:

I strongly urge you to get vaccinated! Moderna is likely better for older adults, but Pfizer is good too. Studies are finding that both mRNA vaccines offer superior protection compared to the Johnson & Johnson vaccine, and so I would recommend getting an mRNA two-dose vaccine if at all possible.

I also recommend that previously vaccinated older adults get a booster COVID vaccine dose. This will hopefully help reduce the chance of catching Omicron.

Please note that vaccination will make you much safer from COVID, but it often does not make you 95% safer and I especially urge caution for those who are frail, immuno-compromised, or over age 85.

Although most breakthough COVID infections in older adults are not severe, some are. Most deaths due to breakthrough COVID infections have been in people over age 65. It is hoped that boosters will reduce serious COVID breakthroughs in older adults.

There continues to be relatively little research published on vaccine efficacy in people over 85, which makes it challenging to know just how effective these vaccines are for our most vulnerable older adults. That said, the nursing home outbreaks we’ve had since residents were vaccinated show that although breakthrough infections can definitely happen, vaccinated nursing home residents are MUCH less likely to die of COVID.

COVID is also mutating and although so far the current vaccines appear protective against variants, that could change.

So I recommend erring on the side of taking precautions, such as being careful about crowded indoor spaces, especially if COVID cases are going up in your community.

Outdoor activity is in general low-risk for COVID exposure and transmission, and I believe that in most cases, it shouldn’t be necessary to wear a mask while outdoors.

You can find the CDC latest recommendations for fully vaccinated people here: CDC: When You’ve Been Fully Vaccinated

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 I hope you’ll get vaccinated once it’s available to you! 

And if it’s been more than six months since you were vaccinated please get a COVID booster soon!

Resources:

• • FDA (Food & Drug Administration):
    • COVID-19 Vaccines
    • FDA: Emergency Use Authorization for Vaccines Explained
    • FDA Briefing Document: Pfizer-BioNTech COVID-19 Vaccine (Dec 10, 2020)
    • FDA Briefing Document: Moderna COVID-19 Vaccine (Dec 17, 2020)
    • FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. (Feb 26, 2021)
  • CDC:
    • CDC COVID Data Tracker (to check your local transmission rates)
    • COVID-19 Vaccines for Moderately to Severely Immunocompromised People (CDC)
    • CDC: Who Is Eligible for a COVID-19 Vaccine Booster Shot?
    • Rates of COVID-19 Cases and Deaths by Vaccination Status
    • How CDC Is Making COVID-19 Vaccine Recommendations
    • Frequently Asked Questions about COVID-19 Vaccination
    • Provisional COVID-19 Death Counts by Sex, Age, and State
    • Effectiveness of Pfizer-BioNTech and Moderna Vaccines in Preventing SARS-CoV-2 Infection Among Nursing Home Residents Before and During Widespread Circulation of the SARS-CoV-2 B.1.617.2 (Delta) Variant — National Healthcare Safety Network, March 1–August 1, 2021
    • New Variants of the Virus that Causes COVID-19
    • CDC Advisory Committee on Immunization Practices (meeting slides on vaccine safety and efficacy topics are usually very informative; browse for the latest ones here)
      • Data and clinical considerations for additional doses in immunocompromised people (July 22, 2021)
      • COVID-19 Vaccine Effectiveness studies (May 12, 2021; includes some nursing home studies)
      • Update on thromboembolic events, COVID-19 vaccines safety surveillance (April 14, 2021)
      • COVID-19 vaccine safety update (January 27, 2021; covers initial nursing home safety data)
    • First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021
    • COVID-19 Case Surveillance Public Use Data
    • Nursing Home Covid-19 Data Dashboard
    • Suspected Recurrent SARS-CoV-2 Infections Among Residents of a Skilled Nursing Facility During a Second COVID-19 Outbreak
    • Risk for COVID-19 Infection, Hospitalization, and Death By Age Group
    • CDC: When You’ve Been Fully Vaccinated
    • Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021
    • Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021
    • Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19–Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance — Nine States, June–August 2021
  • Scholarly medical articles:
    • Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (12/10/20 publication of the Pfizer vaccine phase 2/3 trial data)
    • Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (12/30/20 publication of the Moderna vaccine phase 3 trial data)
    • BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting (Pfizer vaccine in Israel)
    • New SARS-CoV-2 Variants — Clinical, Public Health, and Vaccine Implications
    • Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data (Pfizer vaccine in Israel, May 2021)
    • Incident SARS-CoV-2 Infection among mRNA-Vaccinated and Unvaccinated Nursing Home Residents (May 2021)
    • Covid-19 Breakthrough Infections in Vaccinated Health Care Workers (July 2021)
    • Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant (July 2021)
    • Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence (Mayo Clinic pre-print Aug 2021)
    • Viral loads of Delta-variant SARS-CoV2 breakthrough infections following vaccination and booster with the BNT162b2 vaccine (Pre-print from Israel August 2021)
  • Other science articles:
    • Researchers Tie Severe Immunosuppression to Chronic COVID-19 and Virus Variants (May 2021)
  • Other news and media:
    • COVID-19 Vaccine Tracker (NYTimes)
    • Coronavirus Variant Tracker (NYTimes)
    • Israeli Data Suggests Possible Waning in Effectiveness of Pfizer Vaccine (July 2021)
    • What to know about booster shots if you received Johnson & Johnson’s COVID-19 vaccine (9/8/21)
    • So you got the J&J vaccine? Here’s what you should know about the delta variant, boosters, and more (8/18/21)
    • Highly Vaccinated Israel Is Seeing A Dramatic Surge In New COVID Cases. Here’s Why (NPR 8/20/21)
    • Health Officials Advise White House to Scale Back Booster Plan for Now (NY Times, 9/3/21)
    • The war has changed’: Internal CDC document urges new messaging, warns delta infections likely more severe (Washington Post, July 30, 2021)
    • Coronavirus vaccines may not work in some people. It’s because of their underlying conditions.
    • How does the Johnson & Johnson vaccine work? When is it available? What to know about the new shot.
  • MedPageToday “Track the Vax” Podcast Interview transcript: Why Aren’t Highest-Risk People Better Represented in COVID Vaccine Trials?
  • Uptodate.com COVID-19 Resources & Tools (Coronavirus Resources)
    • Coronavirus disease 2019 (COVID-19): Vaccines to prevent SARS-CoV-2 infection

This article was first published on Dec 18, 2020, and was last updated in October 2024.