RHONDA RANDALL: Hi everyone, I'm Rhonda Randall and I proudly serve as UnitedHealthcare, Employer and Individuals Chief Medical Officer. Really appreciate the opportunity to address you again today. I'm going to cover a couple updates on the variants that we're seeing with the COVID-19 SARS-CoV-2 virus, important updates on the vaccine, some updates on treatment, and then finally, some of the things that we're looking at with return to care.
But let's start first with the changes that we're seeing to the virus. Coronaviruses as a family are slow mutators. So it's not unique to see slow mutations in these viruses as we are seeing now a year out with the SARS-CoV-2 virus. It's important to note that the risk of mutation of this virus as with any other increases with increased spread. So when we see that spread is rampant, it puts us at greater risk for seeing mutations in the virus, and when that spread slows down, it decreases the risk of future mutation.
So we currently see three variants of this virus. And one of the concerning things is all three of them seem to have the ability to increase their spread and the mutations have caused them to have an increase in the transmissibility. The three variants that we have seen so far and identified, we use a numerical system to label them. The first one, B.1.1.7. This one was first identified in the UK. It's the most widespread of the three variants that we've seen right now. It has a 50% increase in transmission rate, as well as a slightly increased risk of death associated with it. The second variant is B.1.351. That was first identified in South Africa. And the last of the three is P.1. That was first identified in Brazil. Of note with this variant, it has 17 different mutations, three of which are within the spike protein. So that leads to questions about future immunity, both for individuals who have natural immunity from recovering from the virus, as well as those who have received vaccinations. So one in particular to watch.
Let's move next to talk a little bit about a deep dive on vaccines. 12 vaccines have been approved globally. That includes four in China, three in Russia, one each in the UK, India and the Netherlands. There are an additional 57 vaccines in different stages of clinical trials around the globe that are being tracked. As of today three COVID-19 vaccines have received emergency use authorization by the US FDA. Let's talk about them in a little bit more detail. The first one to be approved on December 11th of 2020 was Pfizer and BioNTech. This is a messenger RNA technology that is approved in individuals 16 years of age and older. It requires two doses 21 days apart. Initially, we thought it required ultra-low freezing temperatures, and more recently, data has shown it can be stored in regular freezers and that is still effective. The Pfizer vaccine is 95% effective several weeks after receiving the second dose. The second one to be approved was Moderna’s also. A messenger RNA vaccine that was approved a week later on December the 18th.
This vaccine has emergency use authorization for individuals over the age of 18. It is also a two-dose vaccine. Those are to be taken 28 days apart, and it still does require that ultra-low temperature. It is 90% effective several weeks after the second dose is administered. The third one, the most recent one to receive approval just four days ago is J&J’s Janssen. It’s a [PH 00:04:12] killed adenovirus and it was approved on February 27th for individuals over the age of 18. It only requires typical refrigeration like that found in your doctor's office. Internationally, it's been found to be 66% effective overall at preventing disease and 72% effective overall at preventing disease in the United States.
What's more important, however, it was found to be 100% effective in preventing hospitalizations and death, the most important primary endpoints. J&J is anticipating producing three to four million doses this week, 20 million doses by the end of March and 100 million doses by the end of June. The other thing that makes this vaccine unique is that it is a one-dose regimen.
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Merck announced this week that it will be partnering with J&J on the manufacturing of the vaccine to increase production. It's important to note for those that were gone through the emergency use authorization and the FDA approval process, that all of the speed that you saw was really cutting the timeline of the logistics of regulatory approval, of manufacturing ,of supply chain, it did not cut the scientific rigor included in how we study these vaccines.
A couple vaccines to watch; the other one I'm watching is Novavax. It has trials right now going on in the UK. Like the J&J vaccine, it requires regular refrigeration that's available in your doctor's office. I expect to see them apply for FDA review in the May 2021 time frame. Another one to pay attention to is Oxford-AstraZeneca. This is approved for use in the EU today. They have not sought FDA review in the United States and that one has some conflicting information in some of the trial data, and that may be the reason why.
So how many Americans have received their vaccine? Well, as of 8:00 PM last night, according to the CDC, the three manufacturers: Pfizer, Moderna and Johnson & Johnson have distributed 102.4 million doses nationally in the United States, and of those, 78.6 million doses have been put in someone's arm and been administered. 51.8 million, which is 15% of the United States population have received at least one dose and 26.2 million, about half as many. 8% of the United States population have received both doses of either the J&J or Pfizer vaccine.
In long-term care, I call out this in particular because of the COVID deaths in the United States. About 40% of them are attributed to people who live in long-term care congregate settings like nursing facilities and assisted living. In that setting, 4.7 million residents and staff have received at least one dose, and 2.4 million residents and staff have received two doses. 55% of the vaccines in the United States that have been administered so far have been distributed to people over the age of 65, and 45% under the age of 65, the most- the highest population being healthcare workers, followed by those under the age of 65 who have chronic diseases. Last Friday, the United States administered almost 2.5 million doses in a single day.
So let's talk a little bit more about what's coming next. Children. So Pfizer’s vaccine is approved aged 16 and above, the other two, age 18 and above. Clinical trials are underway with each of the three looking at children 12 and above, and then they intend the next stage after that to look at children under the age of 12. But I expect that by fall we'll have the possibility of more vaccines being available for children.
One of the other things I want to draw your attention to is UHC has a vaccine locator that is incredibly user friendly and it's on our public domain. You don't need to be a UHC member to get access to it. It's on UHC.com, you can enter your zip code and it will show you the places that are administering vaccines so you can call them directly and don't have to hunt around through your state's health department website and make several different phone calls.
We know that there's some vaccine hesitancy around vaccines in general. In fact, if you look at the flu shot, we want to see 70% of people every year get their flu shot. Last year was the highest ever, we saw about 40% of Americans get their flu shot. We've done several- The United States has conducted several polls around COVID-19 vaccine hesitancy and acceptance rate and those results have varied, sometimes over 40% of people saying I'm not sure I would be comfortable getting it. The most recent poll that I took a look at said vaccine hesitancy was about 30%, about 30%of the population not willing to get the vaccine just yet.
Probably the one that concerns me the most is some long-term care workforce has refused to get the vaccine, and that's really important because of the vulnerability of that population. So my advice is, if you have a loved one who long-term care placement is necessary at this point where they can no longer be cared for safely in their home, that would be an important question that I would ask to that facility, what percentage of your staff that work here on a full-time or part-time basis have received the vaccine?
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A couple of things to mention about side effects of the vaccine, very similar to the side effect profiles of other vaccines. Pain and swelling at the injection site are the most common. And the next is fatigue, muscle pain. Also, the more common side effects, particularly with the two-dose shots after the second shot is administered seems to be when those symptoms of fatigue and muscle pain are most prominent. In fact, many people would advise you the day that you get that second shot, you might want to decrease your schedule or even take the day off, and generally, by the subsequent day, everyone's feeling back to normal. Headaches and nausea are also sometimes reported as side effects with these vaccines as well as others. Some rare allergic reactions have been reported, particularly in individuals who have a prior history of anaphylaxis. So people who carry an EpiPen because they're allergic to something else, that was more common with the messenger RNA vaccines and it's recommended that those individuals still do get vaccinated but get vaccinated under the supervision of a healthcare facility, like in a hospital, for example, where they could administer an EpiPen if it was necessary.
One of the other questions I often get is, is it okay for me to get the first dose from one manufacturer and the second dose from another manufacturer. That is not recommended. It has not been studied. There is no evidence to suggest that that would be effective and there's no evidence to suggest that it wouldn't carry additional risk. However, expert opinion currently is if you receive your first dose of one of the two messenger RNA vaccines, either Pfizer or Moderna, and for some reason several weeks out, the only vaccine available to you is the other one, maybe you’re a snowbird and you've moved to a different location. But what we're seeing now is with supply really ramping up, this is becoming more and more rare, and I'm expecting that I'm not going to get asked that question as much in the future as I have historically.
How effective is the vaccine on these different variants? Well, that's being tested right now. I mentioned earlier that there was concern with particularly the P.1 identified in Brazil, that there may be a less likelihood that the vaccines are effective on that particular variant. One of the other questions I often get are, what about employers and in the workplace, do you recommend that we mandate vaccines and that really is an employer by employer decision. Each of you work in a different industry, in a different location. I would advise you to get legal counsel if you're going to think about mandating vaccines, but also just think about the logistics. Right now, we don't have enough supply, but that will change over the next few months and so you may want to revisit that at some point in time.
What about somebody who's already had COVID, should they get vaccinated? Yes. So individuals who previously had COVID, we don't know how strong the natural immunity they have is. It often depends on their viral load that they receive, their immune system, for example. So it is very much recommended by clinicians that they get vaccinated. Some people might say, I'll wait my turn and let those of you who haven't had COVID yet go to the front of the line and I'll get in the back of the line, but I still intend to get vaccinated, and that would be a reasonable response as well.
One of the other questions I often get is what happens if I get the vaccine and I get COVID? Well, we know that the effectiveness of these vaccines as well as all others, increase over time. So you're getting your own body's immune system, which is a very complicated… your immune system is a very complicated inner working, and how long it takes, generally a couple weeks after you received the first dose of the J&J vaccine, a couple of weeks after you received the second dose of the two-dose vaccines, until you have enough immunity that you're not going to show symptoms of the disease or get seriously ill. So it is possible to get COVID, particularly shortly after, and we still don't know yet the effectiveness of the vaccine on transmissibility, that's something that we're still studying.
Really quick, a couple of other things that I wanted to cover are on treatment. So vaccine is all about preventing disease, particularly serious disease, requiring hospitalization or leading to death, treatment for somebody who's already been infected. So there are greater than 370 active clinical trials with therapeutics.
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The most notable, I think, are the monoclonal antibodies.
There are two manufacturers that are of note. Eli Lilly received emergency authorization for its two drug cocktail, and Regeneron also has emergency use authorization for its new drug cocktail. Both of them are approved for individuals greater than 12 years old. These are infusions and they're EUA for individuals who are at very high risk of getting seriously ill, which would require hospitalization and have the risk of leading to death. These are outpatient treatments and are not to be administered in an individual who is already seriously ill enough to require hospitalization. You may also have seen in the news UnitedHealthcare’s work, particularly with Eli Lilly, in making sure that individuals who have COVID symptoms get a test and their results very quickly. So particularly people over the age of 65 who are at highest risk for requiring hospitalization should they get infected, so that we can bring that treatment to them as fast as possible and avoid that serious illness and avoid the hospitalization.
The only new drug that has full FDA approval is remdesivir. It's under the brand name Veklury. That has approval for individuals who are hospitalized over the age of 12. Generally, these patients are very sick, often requiring ICU or ventilator support. A couple other things that have EUA… convalescent plasma and dexamethasone, a steroid that already had long standing EUA approval for a variety of other conditions. That has been shown to decrease mortality for people who are severely ill and require hospitalization, again, often people who are in the ICU or need to be on a ventilator.
So let me just close with this, we've talked many times over the past several months about getting back to care and closing those gaps on screening and immunizations. We're still seeing in UnitedHealthcare’s data and nationally some really concerning trends in children not getting their immunizations like measles, for example, which is a very highly transmissible and deadly disease in children. We're seeing that there are less cancer screenings, particularly colon cancer screenings and mammography, and that has started to catch up, but we haven't made up for the significant dent that we saw throughout the course of 2020.
One of the other things that I’m watching and particularly concerned around is some of the data that Craig shared with you earlier around behavioral health. I think that we're going to continue to see impacts for several years around that front and we see it very much in our telemedicine utilization. Telemedicine and telebehavioral health both increased significantly when the pandemic started. The telemedicine for primary care conditions and urgent care conditions has dropped off since then, but for behavioral health conditions, it has stayed at a very high rate. Really glad to see that people have the ability to access behavioral healthcare through these new modalities and telehealth, but it's concerning that we see those rates be sustained. I'm also very much following things like suicide rates and opioid overdoses.
So in our next call, we're going to spend a lot more time going deeper and talking about behavioral health probably in the month of April.