11:03 A.M. EST
MR. ZIENTS: Good morning. Thank you for joining us. We got very good news over the weekend: The Food and Drug Administration issued an emergency use authorization for a third safe and effective vaccine, the Johnson & Johnson vaccine, which will help us defeat the pandemic.
While we have much work ahead of us on so many fronts, this is certainly a very encouraging development.
Today, we’ll get a state-of-the-pandemic update from Dr. Walensky. Dr. Fauci and Dr. Nunez-Smith will discuss the recently authorized J&J vaccine. And I’ll close with an update on our planning, logistics, and distribution of the J&J vaccine. And then we’ll open it up to questions.
With that, I’ll turn it over to Dr. Walensky.
DR. WALENSKY: Thank you, Jeff. I’m delighted to be back with you today. Let’s get started with the current state of the pandemic.
I remain deeply concerned about a potential shift in the trajectory of the pandemic. The latest CDC data continue to suggest that recent declines in cases have leveled off at a very high number. The most recent seven-day average of cases — approximately 67,200 — represents an increase of a little over 2 percent compared to the prior seven days.
Similarly, the most recent seven-day average of deaths has also increased more than 2 percent from the previous seven days to nearly 2,000 deaths per day.
These data are evidence that our recent declines appear to be stalling — stalling at over 70,000 cases a day. With these new statistics, I am really worried about reports that more states are rolling back the exact public health measures we have recommended to protect people from COVID-19.
I understand the temptation to do this. Seventy thousand cases a day seemed good compared to where we were just a few months ago. But we cannot be resigned to 70,000 cases a day, 2,000 daily deaths.
Please hear me clearly: At this level of cases, with variants spreading, we stand to completely lose the hard-earned ground we have gained. These variants are a very real threat to our people and our progress. Now is not the time to relax the critical safeguards that we know can stop the spread of COVID-19 in our communities, not when we are so close.
We have the ability to stop a potential fourth surge of cases in this country. Please stay strong in your conviction. Continue wearing you well-fitted mask and taking the other public health prevention actions that we know work.
Ultimately, vaccination is what will bring us out of this pandemic. To get there, we need to vaccinate many more people. Yesterday, the CDC’s Advisory Committee on Immunization Practices, or ACIP, endorsed the safety and efficacy of Janssen’s COVID-19 vaccine. After the ACIP met, I was heartened to sign their recommendations for use of this vaccine in people 18 or older.
This means we now have three safe and highly effective vaccines that prevent serious illness, hospitalization, and death from COVID-19. Importantly, ACIP does not state a preference for a particular COVID-19 vaccine; rather, they recommend that individuals can get any of the ACIP-recommended COVID-19 vaccines, and they encourage individuals to receive the earliest vaccine available to them.
The Janssen vaccine is a much-needed addition to our toolbox and increases the number of vaccine doses available, and makes it possible for people to get — for more people to get vaccinated and protected from COVID-19.
It also offers several unique benefits. It’s a single-dose vaccine that provides COVID-19 protection with just one shot. That can help fully vaccinate people who may have difficulty, or who are not interested, in returning for a second dose. For those administering the vaccine, this vaccine is also easier to store and transport since it does not need to be kept in a freezer. This will make it easier to provide vaccine in community settings and mobile sites as supplies scale up.
Having multiple types of vaccine available, especially ones with different dosing regimens and different storing and handling, offers more flexibility. For example, clinics and mass vaccination sites that do not have freezer capacity may be able to use the Janssen vaccine, increasing access to more communities.
I know that many Americans look forward to rolling up their sleeves with confidence as soon as a COVID-19 vaccine is available to them. We are working hard to get and distribute these vaccines to your communities. I also know that some people may not be there today and may still have questions about these vaccines, including wanting more information about the process for developing and authorizing them. That’s natural. And I know that some people have had experiences that may have diminished their confidence in the health system. That’s also understandable.
I want to emphasize several important facts about these vaccines. We have conducted the largest-scale clinical trials of any vaccine, and what made that possible so quickly was the high amount of disease in the community and the fact that so many people were interested in participating. All of the available data show that these vaccines are safe and are highly effective.
Over 100,000 people participated in clinical trials to evaluate the safety and effectiveness of these vaccines, and they have all met rigorous FDA scientific standards. Equally importantly, as of today, nearly 50 million people in the United States have received at least one dose of a COVID-19 vaccine. We have put in place the most intensive vaccine safety monitoring systems in U.S. history, and we are actively monitoring for any new safety signals.
CDC’s new V-safe smartphone-based health checker has now enrolled approximately 4.5 million people to capture patient-reported side effects in real time. These results are all reassuring. Some people have no side effects after vaccination. Many people have reported mild side effects like pain, swelling at the injection site, and headache and chills or fever. These are common with all vaccines and should go away after a day or so. Serious, generally reversible reactions remain exceptionally rare.