CDC Director Walensky says Reports “Suggest increased Risk Of Severe Disease Among Those Vaccinated Early”
Back in April, the Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky faced backlash after she said that “vaccinated people do not carry the virus, don’t get sick. The CDC later walks back the claim that vaccinated people do not carry covid saying that the “The Evidence Isn’t Clear.”
Now Walensky just confirmed what many have been saying for months. In a Press Briefing by White House COVID-19 Response Team and Public Health Officials held on August 18, Walensky said “reports from our international colleagues, including Israel, suggest increased risk of severe disease amongst those vaccinated early.”
“Additionally, reports from our international colleagues, including Israel, suggest increased risk of severe disease amongst those vaccinated early. Given this body of evidence, we are concerned that the current strong protection against severe infection, hospitalization, and death could decrease in the months ahead, especially among those who are at higher risk or who were vaccinated earlier during the phases of our vaccination rollout.”
Walensky also confirmed that the data the CDC is about to publish “demonstrate the vaccine effectiveness against SARS-CoV-2 infection is waning.” She also added that the CDC is “concerning evidence of waning vaccine effectiveness over time and against the Delta variant.”
“The data we will publish today and next week demonstrate the vaccine effectiveness against SARS-CoV-2 infection is waning. And even though our vaccines are currently working well to prevent hospitalizations, we are seeing concerning evidence of waning vaccine effectiveness over time and against the Delta variant,” Walensky said.
Surgeon General Murthy also said that “recent data makes clear that protection against mild and moderate disease has decreased over time. This is likely due to both waning immunity and the strength of the widespread Delta variant.”
Meanwhile, Walensky also cautioned:
“The overwhelming majority of hospitalizations and death continue to occur among the unvaccinated.”
Update 9:15 PM EST: Title updated to add context.
Old Title: CDC Director Walensky Says There is “Increased Risk Of Severe Disease Among Those Vaccinated Early”
New Title: CDC Director Walensky says Reports “Suggest increased Risk Of Severe Disease Among Those Vaccinated Early”
Below are some of the excerpts from the briefing.
“Press Briefing by White House COVID-19 Response Team and Public Health Officials
11:10 A.M. EDT
MR. ZIENTS: Good morning, and thank you for joining us. Today, the main topic of our briefing is our plan for booster shots. So I’ll turn to Drs. Murthy, Walensky, and Fauci in just a moment.
First, I want to provide a brief update on our fight against the virus. We continue to see a rise in cases driven by the more transmissible Delta variant, with cases concentrated in communities with lower vaccination rates.
So this remains a pandemic of the unvaccinated.
We know getting more people vaccinated is the best way to end this pandemic. And thanks to our relentless efforts to get more shots in arms, we are making progress.
In the last two weeks alone, nearly 7 million Americans have rolled up their sleeves and gotten their first shot. Seven million. That’s that highest two-week total since the beginning of June.
And over the past month, we’ve also seen a 75 percent increase in the average daily number of 12- to 15-year-olds getting vaccinated — particularly important as adolescents begin going back to school.
And once the numbers from today are reported, we will have reached 200 million Americans with at least their first shot. Two hundred million Americans with at least one shot. That’s a major milestone.
SURGEON GENERAL MURTHY: Well, thanks, Jeff. And it’s good to be with all of you again today. Today, I want to update you about where we are regarding boosters for fully vaccinated individuals.
Our top priority has always been protecting people and their families with COVID — from COVID-19. And we have been fortunate to have safe and effective vaccines that offer outstanding protection against the worst outcomes of this virus — severe disease, hospitalization, and death.
The COVID-19 vaccines that are authorized in the United States have been remarkably effective, even against the widespread Delta variant. But we know that even highly effective vaccines become less effective over time.
Our goal has been to determine when that time might come for the COVID-19 vaccines so we can make a plan to take proactive steps to extend and enhance the protection the vaccines are giving us.
Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for COVID-19 boosters is now.
Recent data makes clear that protection against mild and moderate disease has decreased over time. This is likely due to both waning immunity and the strength of the widespread Delta variant.
Even though this new data — even though this new data affirms that vaccine protection remains high against the worst outcomes of COVID, we are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization, and death.
That is why, today, we are announcing our plan to stay ahead of this virus by being prepared to offer COVID-19 booster shots to fully vaccinated adults 18 years and older. They would be eligible for their booster shot eight months after receiving their second dose of the Pfizer or Moderna mRNA vaccines. We plan to start this program the week of September 20th, 2021.
I want to be very clear: This plan is pending the FDA conducting an independent evaluation of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and the CDC’s Advisory Committee on Immunization Practices issuing booster dose recommendations based on a thorough review of the evidence.
The plan ensures that people who were fully vaccinated earliest in the vaccination rollout will be eligible for a booster first. This includes our most vulnerable populations, like our healthcare providers, nursing home residents, and other seniors. We will also begin delivering booster shots directly to residents of long-term care facilities.
For people who received the Johnson & Johnson vaccine, we anticipate vaccine boosters will likely be needed. The J&J vaccine was not administered in the U.S. until March of 2021, and we expect more data on J&J in the coming weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots.
I want to emphasize that this decision was not made lightly. It was made with careful consideration by the top medical and public health experts and the Department of Health and Human Services. It was informed by data, thoughtful analysis, and by our collective years of experience addressing illness and epidemics.
As always, we will continue to follow the science on a daily basis, and we’ll take whatever steps are necessary to protect our nation from COVID-19.
This plan to administer booster doses does not change our commitment to vaccinating those who are not yet vaccinated here in the U.S. and around the world.
The overwhelming majority of hospitalizations and death continue to occur among the unvaccinated. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines and access to vaccinations.
We will also continue to expand our efforts to increase the supply of vaccines for other countries, building on the over 600 million doses we have already committed to donate globally.
We understand well that global pandemics require a global response and strong leadership. And we will not stop until America and the world are vaccinated against COVID-19.
I’m speaking to you today as your Surgeon General, but most importantly as fellow American who has felt the pain of losing family members to this disease and who hears, each day, the stories of people whose lives have been upended and forever altered by COVID-19 — the brave doctors and nurses in our hospitals, the teachers working to get our kids back to school, and the frontline workers who have put themselves on the line to make sure we can get groceries and supplies.
We all want this pandemic to be over. And right now, our quickest path to getting COVID-19 under control, once and for all, is getting vaccines to those who need them as quickly as possible.
So, here’s what you need to know: If you are fully vaccinated, you still have a high degree of protection from the worst outcomes of COVID-19 — severe disease, hospitalization, and death — so we are not recommending that you go out and get a booster today. Instead, starting the week of September 20th, fully vaccinated adults could begin getting their booster shots eight months after their second shot of an mRNA vaccine.
And finally, all of us must do everything we can to protect our communities from COVID-19. That means encouraging our family and friends, our patients and students, our coworkers and neighbors to get vaccinated. That is our path to ending this pandemic.
I’ll now turn it over to Dr. Walensky who will walk us through some of the data that helped inform our decision to take action now.
DR. WALENSKY: Good morning, Doctor. Good morning, everyone. And Dr. — as Dr. Murthy mentioned, I want to provide an update on vaccine effectiveness.
Today, we are releasing three articles in MMWR with data I will now describe that are helping to inform our booster plans. Recognizing that for most vaccines there is a reduction in protection over time, we have been analyzing the data closely from a number of cohorts in the United States and around the world to understand how long protection from the initial COVID-19 vaccine series will last.
Examining numerous cohorts through the end of July and early August, three points are now very clear. First, vaccine-induced protection against SARS-CoV-2 infection begins to decrease over time. Second, vaccine effectiveness against severe disease, hospitalization, and death remains relatively high. And third, vaccine effectiveness is generally decreased against the Delta variant.
So, let’s jump into the data. On this slide, you will see two studies — one from New York and one an analysis of data from the Mayo Clinic. From May 3rd through July 25th, New York examined COVID-19 tests and linked them to individuals’ vaccination status based on the state’s vaccine records. This allowed New York to study vaccine effectiveness against infection over time for more than 10 million New Yorkers of all ages.
Vaccine effectiveness in May, during — early, during the vaccine rollout in the state, was 92 percent. In the later months, further from vaccination, vaccine effectiveness declined to 80 percent. These data will be published in the MMWR today.
The Mayo Clinic analysis looked at vaccine effectiveness for both the Pfizer and Moderna vaccines among over 80,000 vaccinated and unvaccinated individuals across all age groups with data through July 16th.
Like we saw in the New York data, vaccine effectiveness against infection declined over time — in this case, from 76 percent to 42 percent for those who received the Pfizer vaccine, and from 86 percent to 76 percent for those who received the Moderna vaccine. These data are currently available on a preprint server.
Today, CDC will also publish data from our National Healthcare Safety Network, a nursing home cohort where we analyzed more than 85,000 weekly reports from more than 14,900 facilities.
Weekly COVID-19 case counts were used to evaluate vaccine effectiveness over time. These data demonstrate that vaccine effectiveness declined over time — from 75 percent in March, to 53 percent as recently as August 1st, 2021.
This represents a substantial decline in vaccine effectiveness against infection among those who are most vulnerable, including during months where Delta was the predominant circulating variant.
Taken together, you can see that while the exact percentage of vaccine effectiveness over time differs depending on the cohort and settings study, the data consistently demonstrate a reduction of vaccine effectiveness against infection over time.
Importantly though, despite waning vaccine effectiveness against infection, data analyzed through July continued to demonstrate the stable and highly effective protection against severe illness and hospitalization for people who are vaccinated. Included in the same reports described before, data from New York State and Mayo Clinic also show that vaccine effectiveness against hospitalization remains relatively high, both over time and during periods when the Delta variant was surging.
CDC will also publish, today, in the MMWR, data from the IVY network, which examines data over 3,000 adults admitted to 21 hospitals across 18 states, between March and mid-July. This report compares vaccine effectiveness against hospitalizations early after vaccination, within 2 to 12 weeks, and later after vaccination, between 13 and 24 weeks, and found that vaccine effectiveness against hospitalization remained high. However, in this study, only about 7 percent of samples sequenced were the Delta variant.
Taken together, these data confirm that while protection against infection may decrease over time, protection against severe disease and hospitalization is currently holding up pretty well.
As we make decisions about boosters, though, we also have to look at vaccine effectiveness in the specific context of the Delta variant.
Preliminary data through August 6th from two of our vaccine effectiveness cohort studies that include more than 4,000 healthcare personnel, first responders, and other frontline workers in eight locations across the country show waning effectiveness against symptomatic and asymptomatic infection in the context of the Delta variant: from 92 percent prior to Delta, to 64 percent with Delta. Notably, this analysis did not show difference over time, which suggests effectiveness is also decreased against Delta, independent of when you were vaccinated.
These data suggest full vaccination in the context of the Delta variant may be correlated with less protection against SARS-CoV-2 infection than against prior variants.
To be clear, our top priority is to save lives and prevent severe infections. The data we will publish today and next week demonstrate the vaccine effectiveness against SARS-CoV-2 infection is waning. And even though our vaccines are currently working well to prevent hospitalizations, we are seeing concerning evidence of waning vaccine effectiveness over time and against the Delta variant.
Additionally, reports from our international colleagues, including Israel, suggest increased risk of severe disease amongst those vaccinated early. Given this body of evidence, we are concerned that the current strong protection against severe infection, hospitalization, and death could decrease in the months ahead, especially among those who are at higher risk or who were vaccinated earlier during the phases of our vaccination rollout.
In the context of these concerns, we are planning for Americas — Americans to receive booster shots, starting next month, to maximize vaccine-induced protection. Our plan is to protect the American people and to stay ahead of this virus.
Before I turn things over to Dr. Fauci to share the immunologic data informing our decisions, I want to emphasize one final thing: Our vaccines continue to offer the best protection against severe COVID illness. While we are still learning about how these vaccines perform over time and how long they will last against emerging variants, one thing is very clear: Getting vaccinated can keep you out of the hospital; getting vaccinated can save your life.
In areas with low vaccination coverage, we continue to hear far too many heartbreaking stories of people who did not get vaccinated only then to get severe COVID-19. In these areas, the data are showing us that the more people who are in the hospital, and tragically more people are dying of COVID-19.
We are currently averaging over 500 COVID-19 deaths per day, and these remain largely preventable. If you are still unvaccinated, please get vaccinated. The single best action you can take to protect yourself and others is to simply get vaccinated in the first place.
And now I will turn things over to Dr. Fauci.
DR. FAUCI: Thank you very much, Dr. Walensky. What I’d like to do over the next couple of minutes is provide you with the immunological basis that would support a third booster mRNA immunization. I will make four points and show you representative data from each of these.
First, antibody levels decline over time. Second, higher levels of antibody are associated with higher levels of efficacy of the vaccine.
Third, higher levels of antibody may be required to protect against the problematic Delta variant.
And finally, a booster mRNA immunization increases antibody titers by at least tenfold and likely much more.
So, let’s take the first concept: that antibody levels decline over time — in this case, following two mRNA immunizations. And that’s regardless of the variant.
So, if you look at the horizontal axis, at day 29 is when you get your second shot. You can see the level of antibodies go up at 43 days. But look what happens at 119 and 209 days: Regardless of the variant involved, the antibody levels against those variants decline over time.
Next concept: that higher levels of antibody are associated with higher levels of vaccine efficacy. This is often referred to as an “immune correlate.” And this is a paper recently published in a preprint server. And what it shows is that a model of vaccine efficacy — in this case, based on the Moderna phase three trial — showed that four weeks after the second dose, that what you have is a serum neutralization titer of 1 to 100 — which goes up from the vertical red line — that gives you an efficacy of 91 percent.
But if you look at the dark black line going from left to right: As you go further up, you get a higher degree of efficacy. So, the higher the neutralization titer, the higher degree of efficacy of the vaccine in this model.
Third issue: Higher levels of antibody may be required to protect against Delta. And I’m showing you data now both from Moderna, on the left, and a paper in the New England Journal — has very similar data from Pfizer.
So, if you look at the left panel, what you’re measuring is neutralization titer after two doses of the immunization. And the open circles are the same people as in the pink circles. And you’re looking at the fact that the immuniza- — the neutralization titer required to neutralize the standard prototype D614G, which was the original variant, is — clearly, the titer is much lower — as you see it all goes down in pink when you’re dealing with Delta.
The next concept — and that gets to the booster: The booster mRNA immunization increases antibody titers by at least tenfold. These are data from Moderna, but Pfizer has announced very similar data.
The bottom line is: If you look first at the left panel, the first column is looking at the antibody — the antibody titers just before the third dose, and then 15 days after the third dose is shown right next to it, that says “D15.” As you can see a remarkable increase in titers against the 614G, the B.1.351, the P.1. And in the Pfizer data, which you’d expect would be very, very similar to the Moderna, it was also against the Delta variant.
So, you get a dramatic increase in antibody titers when you do a third immunization dose.
And so, in summary, the current immunological data that indicate that antibody levels decline over time; higher levels of antibody are associated with a higher level of efficacy; higher levels of antibody may be required to protect against Delta; and, as I showed you on this former slide, a booster mRNA immunization increases antibody titers by multiple-fold.
All of this support the use of a third booster mRNA immunization to increase the overall level of protection.
We’ll go back to you now, Jeff.
MR. ZIENTS: Thank you, Drs. Murthy, Fauci, and Walensky.
I want to be clear: The President’s whole-of-government vaccination effort is ready to get every American who needs one a booster shot.
Pending FDA and ACIP approvals, boosters will be available starting the week of September 20th.
The plan is for the rule to simple: Get your booster shot eight months after you got your
first [sic] — second shot. I apologize.
So, if you got your second shot on February 1st, you can get a booster starting on October 1st. If you got your second shot on March 12th, you can get your booster starting on November 12th, and so on.
Thanks to the aggressive actions we have taken to establish our vaccination program, it will be just as easy and convenient to get a booster shot as it is to get a first shot today.
We have enough vaccine supply for every American. And you’ll be able to get a booster at roughly 80,000 places across the country, including over 40,000 local pharmacies. In fact, 90 percent of Americans have a vaccine site within five miles of where they live.
And importantly, boosters will be free, regardless of immigration or health insurance status — no ID or insurance required.
So, the bottom line is that we are prepared for boosters and we will hit the ground running.
In the weeks ahead, we’ll continue working closely with states, healthcare providers, pharmacies, and national and community-based organizations to ensure Americans know they should get a booster shot eight months after their second shot.
And we will be laser-focused on getting boosters to long-term care facilities to make sure residents and staff get their shots and are safe and protected.
Importantly, as we continue to vaccinate Americans, we will maintain our focus abroad, as we know this virus knows no borders.
We have already shipped more than 115 million vaccine doses to 80 different countries — more vaccine doses donated than all the other countries in the world combined. And just this week, we started shipping the half a billion Pfizer doses that the U.S. pledged to purchase and donate to 100 low- and lower-middle-income countries in need.
And in the coming weeks and months, we will do even more to lead the global vaccination efforts, accelerating our work to build vaccine manufacturing and production capacity both here in the U.S. and in other countries.
Our wartime effort will continue doing everything we can to get even more people vaccinated both here at home and around the world. We can and must do both at the same time because that’s what it’s going to take to end this pandemic. And we will not stop until we get the job done.
With that, let’s open it up for questions.
MODERATOR: Thanks, Jeff. And as a reminder, please keep your question to one question. There are many today.
First, let’s go to Lev Facher at STAT News.
Q Hi, folks. Thanks, as always, for doing the briefing. This is a Mike Ryan quote from a WHO briefing earlier today about booster shots. “If we think about this in terms of an analogy, we’re planning to hand out extra lifejackets to people who already have lifejackets.”
And I’m curious — I know you’ve emphasized — all of you — that this is a false choice: vaccinating Americans versus vaccinating the rest of the world. But could you explain how there isn’t finite vaccine capacity and how booster shots for Americans does not, at this moment, come at the expense of first vaccine or second vaccine doses for folks elsewhere in the world?
MR. ZIENTS: So, let me — let me go first, and then, Dr. Murthy, if you want to add anything.
Look, to end this pandemic, we have to protect the American people and we have to continue to do more and more to vaccinate the world. Both are critical. And we’re already proving that we can protect our own people here at home as we help others.
Just to give you some data here: In the months of June and July, the U.S. administered 50 million shots here in the United States and we shipped more than 100 million to other countries.
As I said, the 115 million doses that we’ve already donated is more than all the other countries combined. And during the coming months, when we talk about booster shots, we expect to give about 100 million boosters in the United States. And at the same time, we will be donating more than 200 million — twice that number — additional doses to other countries on our way to donating more than 600 million vaccine.
So, we are continuing to serve, as the President has said, as an arsenal for vaccines for the world. And you’ll see us do more and more. This builds on our support of the TRIPS waiver; our commitment to COVAX, where we are the largest contributor; the QUAD partnership, which we helped to establish, which is on track to produce at least a billion doses of COVID vaccine in India for the Asia region by the end of 2022; and our work to support vaccine manufacturing in Africa by providing financing to a South African business to bolster manufacturing capacity to produce more than 500 million doses. And we’re just going to keep going and going and going.
So, this is a situation where we’re going to do both: We’re going to both protect the American people and we’re going to do more and more to help vaccinate the world.
SURGEON GENERAL MURTHY: Well, thanks, Jeff. And, Lev, good to hear your question. I appreciate it.
Look, I do not accept the idea that we have to choose between America and the world. We clearly see our responsibility to both, and that we’ve got to do everything we can to protect people here at home while recognizing that clamping down the epidemic — the pandemic across the world and getting people vaccinated is going to be key to preventing the rise of future variants. We know that. We see that clearly. And we believe we have to work on both fronts, as we have been.
But, Lev, when we see data that is giving us, essentially, indications that protection is starting to diminish — in terms of mild to moderate disease — when we recognize that if this trajectory continues, that people who are well protected today may see more vulnerability in the future, we have to act. The science tells us that, our clinical judgment tells us that, and that was the collective decision of the top public health and medical experts in this administration.
So, again, we will do everything possible to protect people in our country. That’s why we’re announcing this booster plan. But we will also continue to accelerate our efforts to vaccinate the rest of the world. We take that responsibility very seriously.
MR. ZIENTS: Next question please.
MODERATOR: Cheyenne Haslett at ABC News.
Q Hi. Thanks for taking my question. How realistic is that September 20th launch date, given that we haven’t seen the official EUA requests from Pfizer or Moderna yet?
MR. ZIENTS: That is the date that we’re working toward. And as we’ve said, that is obviously pending both the FDA’s approval and the ACIP’s recommendation. So that is the date that we are prepared for, the beginning of the week of September 20th
MODERATOR: Jeremy Diamond. CNN.
Q Hey there. Thanks for taking my question. First of all, why did you guys decide not to limit this to older and more at-risk Americans, and simply say that “all vaccinated people will need a booster shot after eight months”?
And secondly, you say in the statement that the protection against severe disease, hospitalization, and death could diminish. How certain are you about that? And are you saying over time that you do not believe these vaccines will continue to be highly effective at preventing hospitalization and death? Thanks.
MR. ZIENTS: Let’s start with you, Dr. Murthy.
SURGEON GENERAL MURTHY: Well, thanks, Jeremy, for that question. Look, first, I would say that when we look at the data, we see a reduction in protection against mild to moderate disease across age groups, and that was an important part of why we made this recommendation for all adults. We want to protect all adults in our country from the worst effects of COVID-19.
But our plan does prioritize the most vulnerable. If you look at how we began vaccinating people, Jeremy, over the — at the beginning of the vaccination effort, we prioritized healthcare workers, long-term care facility residents, and the elderly. And those are exactly the same populations that we will be starting with.
So, we do prioritize the most vulnerable, and we think that’s going to be essential, you know, in our goal to ultimately to protect the country and save the most lives.
MR. ZIENTS: Next question.
MODERATOR: Alice Park at Time.
Q Yes, just wanting to ask again, Jeff, if you could just provide some more details on the plan for administering the booster shots. You’re going to have to reach the same number of people as in the current campaign, and yet many of the federal mass vaccination sites have closed. So, does that mean we can expect to see more doses shipped to doctors’ offices, pharmacies, smaller clinics? And will states continue to be the intermediary for managing that and distributing that?
And secondly, for Dr. Fauci, can you tell us — you focused a lot on the data looking at antibody responses to vaccines. Can you tell us what we’ve learned about the T cell response and what role that plays in any decision to recommend boosters — or, you know, continue to recommend boosters in the next year or even years to come?
MR. ZIENTS: So, the first question: You know, there are 80,000 sites across the country. As I mentioned, 90 percent of Americans live within five miles of a site. The booster will be administered at the eight-month mark — beginning at the eight-month mark.
We’re going to be working very closely, as we have throughout, with governors and local and state officials to make sure that we have the number of places to — for people to get vaccinated in a convenient way, enough vaccinators in the field. FEMA stands ready to help in any way. As I mentioned, that reimbursement has been extended — 100 percent reimbursement.
So, we will make sure that it is convenient and easy for all Americans to get their free vaccine, their booster shot at their eight — at or around their eight-month mark.
Over to you, Dr. Fauci.
DR. FAUCI: Yeah, thank you for that question, Alice. There — no doubt T cells will play a role — very likely — in not preventing initial infection, but in the progression of disease in the — in the situation that T cells usually do in eliminating or blocking against infected cells.
The issue is that they are not as easy, at all, to measure in the standpoint of large volumes of cohorts, and we will continue to study the T cell response.
But the important slide that I showed was the correlate of protection slide where you show there, no doubt, was an increase in protection of the antibody as you got the titer higher and higher.
So, based on that, that would be the most easily — and actually most common and, very likely, the most appropriate measurement of a correlate of immunity. And for that reason, that was one of the issues that swayed us towards the relationship between titer of antibody and linking that to the next-to-last slide, where I showed you could dramatically increase the titer of antibody by a boost that is at the third boost months later. And if you looked at that, the increase was really rather substantial.
But again, not to downplay the ultimate potential importance of T cells, but if you look at the relationship between antibody titer and vaccine efficacy, it looks pretty good.
MR. ZIENTS: Next question, please.
MODERATOR: Weijia, at CBS.
Q Hi, thanks so much for taking my question. If — it sounds like effectiveness begins to wane sooner than eight months. And please correct me if I’m wrong. So, if the supply is not an issue, can you walk us through the science of how you landed on eight months, please? Thanks.
MR. ZIENTS: Why don’t we start with you, Dr. Murthy? And then, Dr. Walensky or Dr. Fauci, if you have anything to add.
DR. MURTHY: Sure. So, thank you, Weijia, for that — for that question. So, let me talk you through how we were looking at this.
We did see that around the six-month mark in the data, you start to see increases in mild-to-moderate infection. But we know that the most important purpose of the vaccine is to keep us out of the hospital and to save our life. It’s to prevent against hospitalizations and death.
And fortunately, we’re seeing that still holding at a high level, which is good news. But our anticipation is that if the trajectory that we are seeing continues, then we will likely see, in the future, an increase in breakthrough hospitalizations and breakthrough deaths. And that’s why we used our judgement, Weijia, to see when to make a determination of what that point may be, and that’s how we came to the eight-month mark.
I want to be clear, though, there is — there’s nothing magical about this number. Could it have been one week earlier, one week later? This is where judgment comes in, and it’s why we’ve put so much time and thought into this decision, and why we pulled the best public health and medical minds from together around the department to look at the data and discuss it a number of times, and then, ultimately, to come to that determination.
And last thing, let me just say this, Weijia: We have said, over the last several months, that we are looking at the data closely and, when we see a signal, that we will let the public know and tell them what our plan is. And that’s exactly what we’re doing today.
We put the best minds together in the administration, and we looked at the best data that we had. We saw a signal, and now we’re sharing our assessment with the public with a plan for how to make sure that the protection people still have today from the vaccine will continue in the future.
DR. WALENSKY: And, maybe, if I might, Jeff, just add: You know, another piece of data that we’ve been looking at is our international colleagues who are ahead of us both in the Delta surge as well as have vaccinated large — a few weeks ahead of us in terms of large portions of their population that have been vaccinated. And data we’re seeing from our international colleagues, specifically — and especially Israel — have demonstrated a worsening of infections amongst vaccinated people over time.
And so, we are — we remain concerned about that, as we see in the context of Delta variant, some breakthroughs that are occurring and decreased vaccine effectiveness that is occurring in the context of infection. We are watching other countries — the experience of other countries carefully, in concern that we, too, will see what Israel is seeing with — which is worsening infections over time.
DR. FAUCI: Yeah. And, Jeff, one other thing: It has been such a — almost reproducible phenomenon with COVID-19. If you wait for something bad to happen before you respond to it, you find yourselves — you’re considerably behind your real full capability of being response. So, as Vivek said in the introduction, you want to stay ahead of the virus.
And if you look at the indications that we’ve had, including with what Dr. Walensky just mentioned, you don’t want to find yourself behind, playing catch-up. Better stay ahead of it than chasing after it.
MR. ZIENTS: Next question, please.
MODERATOR: Felicia Schwartz at the Wall Street Journal.
Q Hi. Thanks. What will it mean to be fully vaccinated once people are eligible for boosters? Will it be three shots or two shots?
MR. ZIENTS: Dr. Murthy.
DR. MURTHY: Well, so, on that question, right now, I think what’s very important for people to know is that if you’ve gotten both shots of your mRNA vaccine, you are fully vaccinated right now; you have full — you have a high degree of protection against the worst outcomes of COVID-19.
But our recommendation — and down the line, again, pending the advice and the review of the FDA and ACIP — the Advisory Community on Immunization Practices — is that we believe that that third dose will ultimately be needed to provide the fullest and continual extent of protection that we think people need from the virus.
MR. ZIENTS: Next question.
MODERATOR: Josh Wingrove, Bloomberg.
Q Hi, there. Dr. Walensky, you addressed this earlier a little bit, but I’d like you to expand on what has changed.
I mean, five days ago, with the decision on immunocompromised people for whom this is pretty different scenario — those are people who didn’t have great protection in the first place — as opposed to having waning protections, you made a point of saying, repeatedly, that booster shots weren’t needed for the time. And now, five days later, not only are they being announced, but they’re being announced for everyone. Is it the Israeli data, in particular, that changed your mind? Why the change of position over five days?
And can you also clarify — Dr. Murthy said that this is only adults. Pfizer was EUA for 16-plus in December, so we’re not that far away from 16- and 17-year-olds being eligible. Should they get a booster when they are at eight months, or should they not get a booster when they are at eight months? Thank you.
DR. WALENSKY: Thank you, Josh. And thanks for actually noting that clarification.
So we made — based on the FDA review and ACIP and, exactly as you said, the note that immunocompromised people actually never got, really, a good immune protection to begin with, we noted that, as of now, we should be offering a third dose of vaccine to our immunocompromised pe- — anyone immunocompromised is eligible for vaccination.
However, what we’ve seen over the data that really has been analyzed over the last week or two from data through July — because it was important to really understand the impact of the Delta variant here — we are starting to see waning immunity with regard to symptomatic infection. Not severe infection, but symptomatic infection.
So we’re staying ahead of this virus. And what we are saying is: We are planning for — for a time in — you know, September 20th — to say: As we are following, symptomatic infection is waning. We have not yet seen that severe disease and hospitalizations is really waning. That’s remaining relatively stable. But we’re looking at other countries, and as we do so, we’re seeing worsening outcomes in other countries.
And in the context of all of these studies — different cohorts, different settings across the country, and our international colleagues — we’ve made the decision to plan for these booster doses.
MR. ZIENTS: Dr. Murthy, do you want to address the 16-, 17-year-olds?
SURGEON GENERAL MURTHY: Sure. So it’s a good question. And when it comes to 16- and 17-year-olds and minors in general, we are going to let the FDA weigh in on that; obviously, do their thorough review; and then, based on their recommendations, on ACIP’s recommendations, we will have guidance to share for those who are under 18.
I also just want to underscore one thing, to your question, about the last five days and our message. I want to be very clear that what we have said before, which is still true today, is we do not believe that the general population needs booster shots today. That was true yesterday. It was true five days ago. It was true a few — a few weeks ago.
We are announcing a plan for the future, and that’s extremely important. We want people to understand that this is a plan for the future, and it’s based on an assessment of data, including recent data that we have just come across in — over the last few days.
We have said from the beginning, “When we see a signal, we will tell you,” and that is what we are doing.
MR. ZIENTS: Next question.
MODERATOR: Last question. Let’s go to Shannon Pettypiece at NBC.
MR. ZIENTS: Kevin, we’re not hearing a question.
MODERATOR: We are not. All right, sorry, Shannon. We’ll go to Brenda Goodman at WebMD, and circle back.
Q Oh, hey, can you guys hear me now? Oh, I’m sorry. It’s —
MR. ZIENTS: You’ve got to a bit of —
Q I found myself (inaudible).
MR. ZIENTS: You’ve got a bit — bit of an echo. Go ahead, please.
Q Okay. Sorry about that, guys. I just wanted to find out — and I think, maybe, you answered this a bit — but why are you sort of skipping the typical FDA review process? I know you’re saying this is pending FDA review, but not — why not wait until the FDA has reviewed the safety, the efficacy, and we’ve gotten that Advisory Committee recommendation?
And are you worried at all about adding to vaccine hesitancy by trying to get ahead of that by making this announcement now?
MR. ZIENTS: Dr. Murthy.
SURGEON GENERAL MURTHY: Well, I’m glad — I’m glad you asked that question. And I want to be very clear: We are not skipping the very important FDA and ACIP process here. They have an incredibly important role to play in evaluating safety and making recommendations for vaccines.
We respect that, we honor that, and that will be a part of this process as well. But the reason that we are not waiting for many more weeks to announce this — and it falls into two — two buckets — one is transparency.
We have told the public: When we see a signal in the data, we will tell them about when we are concerned, when we think boosters may be required down the line. And we are fulfilling that promise today.
The second reason is we also want to ensure that people and states and localities and the public more broadly can plan. You can’t turn on a booster effort, you know, with a flip of a switch. You know, you have to lay the groundwork. We’ve got to make sure people understand this, that we communicate often about it, and so on. When we’re ready to go and start offering boosters, everybody understands what has to be done and who needs to be boosted. And that is why we are announcing this plan in advance today.
DR. WALENSKY: Maybe I’ll just add that we are very much following what ACIP provided. Because they initially advised us on who should be getting vaccinated first, and it is those people who will be — the long-term care facilities, healthcare workers, vulnerable populations — it is those people who will be first eligible again.
MR. ZIENTS: Okay, so why don’t we take the last question, Kevin.
MODERATOR: All right, Brenda.
Q Thanks. I just have a question a little bit to do with the rationale here. So, do you have any evidence from the U.S. or from other countries that waning immunity is playing a role in transmission of Delta because it’s so highly contagious? Do you anticipate that boosters will help to slow the spread?
MR. ZIENTS: Dr. Fauci, you want to go first there?
DR. FAUCI: Yeah. Thank you, Jeff, and thank you for that question.
Transmissibility is a bit more tricky than looking at a clinical phenomenon such as infection, seriousness of disease, and hospitalization.
It is entirely conceivable — and we will be looking at that — that when you boost and have a high level — and as I showed you on the next-to-last slide, the increase with a boost is really quite striking: multiple-fold increase — that it is conceivable that that would be important in lowering the level of virus in the nasopharynx, which could have an impact on transmission.
I certainly hope that’s the case. If it is, then you could really get multiple benefits from doing this. You can get benefits for disease, severity of disease, and then, ultimately, infection and transmission.
But the bottom line, with full transparency: We don’t know that right now.
MR. ZIENTS: Well, we appreciate all the good questions, and we look forward to the next briefing.
11:59 A.M. EDT”
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