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New York’s Compulsory Flu Vaccination Initiative for Health Care Workers
The following transcript is from the Saturday, November 7, 2009, interview of New York State Health Commissioner Richard Daines, M.D., by Alan Chartock, Ph.D., for The Capitol Connection program (transcribed November 11, 2009 by M. O’Leary). The audio for the program is available elsewhere. (1) This is the first time since the suspension of the New York State health care worker compulsory vaccination regulation by New York State Justice McNamara on October 22, 2009, that Health Commissioner Daines has spoken on the record to the media about the state H1N1 vaccination mandate and its suspension, to the best of this writer’s knowledge. A summary of his points is available at the end of this report.
On August 13, 2009, New York State Health Department Commissioner Richard Daines took the unprecedented step of ordering all health care workers in the state of New York to receive the H1N1 (swine flu) vaccination by November 30, 2009, unless they could prove a medical contraindication. (2)
Specifically, the new regulation applied to “all personnel [who] are affiliated with hospitals, licensed diagnostic and treatment centers, licensed home care services agencies (including certified home health agencies), long term home health programs including AIDS home care programs, and certified hospices programs and who have direct contact with patients (within a 6-foot space of a patient) or who perform duties that could, if they were ill, could infect patients or staff with direct patient contact (e.g., clerical, dietary, housekeeping, maintenance and volunteers). (2) The number of health care workers affected by the new regulation is in the range of a couple hundred thousand. New York State is the only governmental entity in the United States that adopted the mandatory H1N1 vaccination requirement. Neither the World Health Organization (WHO) nor the Centers for Disease Control and Prevention (CDC) has mandated vaccination of health care providers against either seasonal flu or H1N1 flu. Rather, they have recommended voluntary vaccination against seasonal flu, and now H1N1 flu. (3)
In response to some New York health workers who resisted the new flu vaccine rule (4), Commissioner Daines on September 24, 2009, released an open letter to health care workers, reprinted below (see note #3), stating, “Mandatory flu vaccine is in the best interest of patients.” (4) Some health care organizations around the country that are mandating flu vaccination for their employees threaten to discipline or even terminate employees who refuse the swine flu vaccination. (5) In response to criticism, including litigation, of the August 2009 regulation by a number of prominent organizations (e.g., the New York Civil Liberties Union [3] and the Service Employees International Union [6]) and a number of nurses (7), New York State Court Justice Thomas J. McNamara in Albany halted enforcement of Dr. Daine’s new rule on October 22, 2009. (7) The same day, October 22, 2009, New York Governor David Paterson suspended the flu vaccination mandate for health care workers in New York, as noted in his statement available below (see note #8).
The next day, October 23, 2009, Commissioner Daines sent a “Dear Administrator Letter” to health administrators around the state and available below (see note #9). He said in his letter that even though he had suspended state compulsory vaccination of health care workers for flu vaccine for the 2009 season, the Department of Health was “advancing a permanent regulation requiring health care personnel in these settings to be vaccinated.” (9)
Dr. Daines became commissioner of the New York State Department of Health in March 2007. (10) His department administers the state’s public health insurance programs, regulates hospitals and other health care organizations, conducts research in a biomedical laboratory (Wadsworth Center) (11), and supports public health prevention initiatives. Dr. Daines received his bachelor’s degree in history from Utah State University in 1974 and served as a missionary for the Church of Jesus Christ of Latter-day Saints in Bolivia from 1970 to 1972, according to his bio. He received his medical degree from Cornell University Medical College in 1978, and completed a residency in internal medicine at New York Hospital. He served as senior vice president for professional affairs and medical director at St. Barnabas Hospital in the Bronx before joining St. Luke’s-Roosevelt Hospital Center in 2000 as medical director. In January 2002, he became president and chief executive officer of St. Luke’s-Roosevelt, a capacity in which he served for five years (2002-2007) before accepting the appointment as health commissioner. *All bolding below is by MRO. Introducer: Welcome to The Capitol Connection, a weekly program questioning New York State leaders on a variety of issues. (1) Your host is Dr. Alan Chartock, political scientist and professor emeritus at the University at Albany [New York]. Distribution of The Capitol Connection is made possible by New York State United Teachers, representing professionals in education and health care, online at nysut.org and Nyscasa, the New York Coalition Against Sexual Assault, working to support men in their decision to end sexual violence with “My Strength is not for Hurting” campaign, online at nyscasa.org.
Alan Chartock: Welcome to The Capitol Connection. I’m Alan Chartock. Joining us today is New York Health Commissioner, Richard Daines. Dr. Daines, as always, thanks for being here. We always appreciate the fact that you can come and tell us what’s up! with health in New York state. So, let’s talk flu vaccine. You know, it seems to me, by the time it [the vaccine] gets here, maybe it’s a little cynical, but by the time we can get it, it’ll be too late. Dr. Richard Daines: Well, we’re not going to say too late, because there will still be reasons to get vaccine even if it appears that the wave has passed over us. But we are running behind in vaccine availability, we certainly are at this point. Alan Chartock: How come? Where is the stuff? Dr. Daines: Well, where we are is, actually, in July and August [2009], when we were looking forward to this, we had a projection from the federal authorities we would have nationally 200 million doses by the end of November [2009], which calculates to New York State about 12 million doses. It looks like we can rely on around 3 million doses is all for New York State by the end of November. Alan Chartock: So let’s cross that for a second. Three million doses and the last time I looked, we had something like 16 million people, something like that. Dr. Daines: Well, we have about 18 plus million people. When we had that projection the at risk populations, the prioritized populations in New York State are about 10 million. And because children 9 and under need two doses, if everyone in a priority group was going to get it, we would need about 12 million doses. And again, just 3 million by the end of November doesn’t even come close to satisfying that. Not everyone is choosing to take the vaccine. Uptake rates look, I’m going to say, around 50%, which is high for flu vaccine. That would mean we need 6 million doses for the people that want it and it looks like by the end of November we will have distributed only about 3 million or a little more than that in doses. Alan Chartock: OK. I’m not familiar with the words “uptake doses.” Dr. Daines: In other words, we recommend that all young people, aged six months to 24 years of age take this vaccine. Not all will decide to take it. Alan Chartock: Oh, so uptake is the ones who decide to take it. Dr. Daines: The typical flu season, about a third of eligible—recommended—people take the vaccine. This year, it is running in the 50% or higher rate, both for our regular seasonal vaccine and for the H1N1 vaccine. So the uptake rates are higher and if you take that uptake rate across our vulnerable population, we won’t have enough vaccine in the state until probably well into December [2009], or later. Alan Chartock: So, is that too late? Dr. Daines: No, it’s not too late for a couple of reasons. One, there will still be plenty of people vulnerable to flu in those months. In other words, not everyone who can get will have had it. Some people will have had flu-like illness over the course of these months and not be certain whether it is H1N1 or not. We don’t recommend diagnostic testing in everyone. Some flu seasons historically have had an odd pattern of coming back in a third time, so that famous Spanish flu came in a spring version, a fall version, and then came in another in the winter in the early months of the following year. So we’ll still be recommending that people catch up on these flu vaccines well into December and into January [2010]. Alan Chartock: Now, Commissioner Daines, a little birdie told me that you may have had the H1N1 flu. Is that true? Dr. Daines: Well, I may be similar to a lot of people. I had a somewhat flu-like illness and even I stayed home, just like my advice was, and I called my staff and said I’m halfway embarrassed, I’m really not sure if I have it or not. I waited until I didn’t have a fever for 24 hours and came back to work and I’m just not completely sure whether I had it or not. That’s probably what we’re hearing from a lot of people. Alan Chartock: So how do we know whether we have the H1N1 or the regular flu and I want to append a question while my mind is still working and that is, do we see the regular flu is with us this year or not? Dr. Daines: OK. In terms of symptoms, we probably can’t tell [the difference between regular and H1N1 flu]. The symptoms are so similar and there is such a gray zone between influenza and colds, allergies, “bad days,” that you can’t tell. Right now, the diagnostic testing we’re doing in our Wadsworth Laboratories [2], as is being reported all over the country, if you have influenza, it’s almost for sure H1N1. Alan Chartock: Interesting! Dr. Daines: The seasonal varieties that we expect to come later are not around right now. Alan Chartock: I got a regular flu shot. Did I do that in vain? Dr. Daines: No, because, if we’ve learned anything this year, it is that you cannot predict the behavior of flu. We have to be concerned that our regular seasonal flu is going to come around in January, February, March, and like you, I got my regular flu vaccine a few weeks ago and we should be protected if that comes around. Now, maybe it won’t, maybe there will be a crowding out phenomenon where this bad H1N1 outbreak, maybe there is no room left for seasonal flu, no one knows. Alan Chartock: How bad is it? Do we know if there are a lot of people dying? Is it worse than we thought it was going to be? Is it better than we thought it was going to be? Dr. Daines: I would say that the mortality and morbidity is about what we expected. Not counting the spring outbreak, this one [since September] we’ve had 12 deaths statewide [New York State] as of a couple of days ago and 2 of those were pediatric [NY population 18 plus million]. In one sense, that is not a large number, but it is not a number that we should tolerate at all. I’m particularly concerned about children and pregnant women. There, if you look at children under age 5, they are having about double the incidence of having flu at all as are older children. And if they get it, they have five times the rate of being hospitalized and about that rate of dying from it. Same kind of thing with pregnant women. They are more prone to get the flu and the worse thing, if they get it, they have 6-9 times the rate of being hospitalized and dying from the flu. We are just not a society willing to tolerate any avoidable mortalities among children and pregnant women. Alan Chartock: Wow! We’ve been reading lately that those of us who are of a certain age are less likely to get the flu because we were probably exposed to it earlier. Is that an old wives’ tale or is it true? Dr. Daines: No, no, there’s some truth to that. It looks like the 1957 pandemic was similar enough to this H1N1 pandemic that there is some residual protection literally a half of century later. It tells you how wonderful the immune system is and how wonderful vaccination is. If you get vaccinated for the right thing once, you’ve got a lifetime of immunity. [?] Alan Chartock: That’s fascinating, just fascinating. Dr. Daines: Yeah, yeah. Alan Chartock: Are we in a predicament now in terms of trying to figure out whether this is coming on a regular basis or is it likely that you get hit one year and then it metamorphisizes. Dr. Daines: How can you answer that? We go back to 1957 and 1918 to find some useful historical parallels, and so maybe you’d say, ok, every half a century you have to worry about something like this, but biology surprises us. I think we’ll come out of this saying we have to be prepared for unpredictable events, certainly with influenza. Fortunately, we’ve done a lot of preparation around avian influenza but in terms of being able to produce more vaccine more quickly and distribute it widely and properly we’ll all have to reexamine those systems and probably have them geared up better just in case next time. Alan Chartock: Now, Commissioner Daines, we had H1N1 is the name we’re calling it now, but it started out being called “swine flu.” Was that on purpose that we’ve changed the name? Dr. Daines: It was a useful name change because swine flu didn’t even describe the virus very well. It has components that come from swine, birds, and human, and they scramble together, and to ascribe it to one species or a country where we had a case or two doesn’t make sense. So, H1N1 just says flu. It took us awhile to arrive at that but it’s better than calling it swine flu. Alan Chartock: I want to give you a chance to explain something that many of us in the press perhaps got wrong. Our assumption was that you had first called for health care workers to get the vaccine, which made a lot of sense to me. I’d like to have the vaccine if I could. If I were treating people with symptoms, I’d darn well want to have that vaccine. However, you changed your mind, and a lot of us thought it was the politicians telling you to change your mind because there were a lot of vocal people who said “Cut it out, we don’t want to have to take this vaccine.” Can you tell us the genesis of all of that?
Dr. Daines: Well, it really comes out of those numbers I told you. We adopted this mandatory vaccine policy for health care workers in August [2009]—that’s when we had a projection of 12 million doses available for New York at the end of November. We needed about 12 million doses to cover all the risk groups in the state, including health care workers, so we could have the mandate be effective. We built into that, however, if vaccine supplies are not adequate, we’ll suspend it for that year for that flu season. So, as we got very close to November I’m looking at numbers that say we’ll have around 3 million doses in November, I need 12 million, even if there is only a 50% uptake, we’d have demand for 6 million and a supply of 3 million, and then I didn’t want to be caught on my own words, and we had from the beginning said that the principle here is that the interests of patients come first. It’s one thing when you have enough vaccine for everyone, then you say, OK, the interests of patients is that health care workers get vaccinated. Now when you’re in short supply and you have to say does this health care worker, every health care worker in the hospital get vaccinated ahead of children, pregnant women, people with high-risk conditions, if you’re putting patients’ interests first there, you back off on the health care workers. I used as an example, up until I took this job with the government [2007], every fall, typically in October, I was the attending physician on one of the services at Roosevelt Hospital. Alan Chartock: Even though you were the head? Dr. Daines: Even though I was the head. I took the month off from the administrative stuff and I saw patients, mostly older patients. Alan Chartock: Really? Why did you do that? Dr. Daines: Well, you know what? Like most doctors, the pleasures of practicing medicine are enormous. If we didn’t have to make a living, we’d all practice medicine as a hobby. It’s the making a living at it that’s tough. So, I enjoyed doing it. It was useful to see how the hospital worked, I loved teaching young residents. If my mandate [compulsory swine flu vaccine for health care workers] had been in effect when I was working there, Dr. Daines, 58 years old, around in 1957, treating mostly older patients in the hospital, I would have lined up and got a vaccine possibly ahead of a pregnant woman or a child. I said to my staff, to my legal people, I think we need to wave it this year. I said, you know what? I’d probably engage in civil disobedience against my own mandate in that case because I want to put my patients’ interests first. [What?] That’s what we did with this. Patients come first. The political process often kind of goes on in parallel with the decisions we make on an evidence-basis in public health. And we made decisions in public health on an evidence basis. If you look at the arithmetic, you can see why we did it [withdraw the mandate for state compulsory vaccination for health care workers]. Alan Chartock: So you didn’t hear from the second floor, otherwise known as the governor’s office, who said, “Hey, Daines, cut it out. We’re getting too much flak on this. We don’t want to hold the health care workers to make this mandatory.” Dr. Daines: No. I came in on a Monday after--we actually have a Friday national call with all the state health directors and the CDC [Centers for Disease Control and Prevention] and I looked at the projections of vaccine availability, and we all pondered and discussed over the weekend, whatever week that was, and we said we just can’t assert this mandate this year because we’re going to withhold vaccine from people who really ought to get it. One of the things about it is once you shift an assigned vaccine to a certain locale under federal standards, you can’t just then pull it out of that institution and send it off to an OB [obstetrics] practice somewhere. So, even if the floodgates opened in late November [2009], we can’t be sure that would happen, right now they saw it won’t happen, so you can’t go backwards and say we wish we had prioritized only pregnant women this month because we didn’t get the vaccine or we stockpiled it in the hospitals for the mandate and then we couldn’t shift it to other areas. So we needed the flexibility of not a mandate, but the intelligence and the ethics of health care workers and the anecdotal reports we’re getting is 50, 60, 50% uptake rates, when it’s available. Health care workers are doing the right thing, coming and saying they want the vaccine. Alan Chartock: Well, I sure would. So to summarize, the captain of the Titanic was supposed to have yelled out from the top of his deck, “Women and children first!” Is that what you are saying? Dr. Daines: (Laughter) Alan Chartock: I mean, “Pregnant women and children first!” Dr. Daines: Well, yeah. Pregnant women and children really need to get it. One of the problems, Alan, is that we were talking about doses. There are actually different forms of it [swine flu vaccine]. The most abundant supplies have been of the nasal spray [FluMist] that we call an attenuated live virus. That can only go to healthy people 2-49 years and not to pregnant women. So, even though you may have quite a bit of that [FluMist], we can’t give it to the pregnant women. One of the things for people who are listening, if you’re in one of those high risk groups, try to get the vaccine. As of yesterday [Friday, November 6, 2009], we have had requests for about 6 million doses across the state outside of New York City and we’ve had about a million doses that we could ship. Only one in six orders is getting filled for a vaccine dose. So what can you do besides continue to try to get vaccine? Alan Chartock: Yeah! Dr. Daines: One is please don’t take your frustration out on your provider, your doctor or your hospital. They are trying to do their absolute best as we are at the state and federal level. But when you can only fill one in six orders for demand it’s very easy to find the five other demands for it and say somebody’s messing up. Nobody is messing up. It is being distributed fairly and just as quickly as we can do it. But if you’re in a high-risk group, one, if you can reasonably keep away from people that you might be exposed to, it’s time to do that. Alan Chartock: For example, here at WAMC, if somebody comes down with what we think is the flu, we say get out and stay out for a couple of days. Dr. Daines: That’s right. Shut the door in their face and wave to them as they go home and stay home until they are better for 24 hours. That’s one thing to do. If you’re in a high-risk group, asthma, diabetes, pregnant, little kids, call your doctor right away. If you have to visit a hospital or an ER [emergency room], do it, because you may be in a group that ought to be on either prophylaxis with a drug like Tamiflu, or, at the first sign of symptoms, on treatment with Tamiflu. Alan Chartock: Let’s go back and ask the question, for people who are listening who haven’t heard of Tamiflu, this is what you take after you get the flu, right? Dr. Daines: After you get the flu, but also if you are exposed to the flu and you are in one of those groups that cannot afford to get it. You can actually take it to prevent coming down with the flu. Alan Chartock: Will Tamiflu work on H1N1? Dr. Daines: Yes. H1N1 almost without exception has been sensitive to Tamiflu. It is an antiviral in the same sense that we have penicillin and other antibiotics for bacteria, this is an antiviral for viruses. And Tamiflu is available, it’s effective for both prevention and treatment. Alan Chartock: Why don’t we just give everyone Tamiflu if we don’t have enough H1N1 vaccine? Dr. Daines: Well, you’d try to give it to 18 plus million New Yorkers for the duration of the season. We don’t know how long it [the season] will be and we would run out of it if we tried to do that. We have [antiviral] treatment courses for about 25% of New Yorkers. We’re not anywhere near that kind of demand. But, you’d hate to burn it up by treating everyone in the state for a few weeks and not have it. But one of the things we have to remind people is to be effective in treatment, it has to be taken in the first 24-48 hours of symptoms. Alan Chartock: The Tamiflu needs to be taken. Dr. Daines: Yes. So at the first symptoms, the first signs, if you’re in one of those high risk groups, talk to your physician about being on Tamiflu. Don’t wait 48 hours to see if you get better. You need to start right away. Alan Chartock: So what are the symptoms of H1N1? We gave out something here that we got from the web that may or may not be right. Some of them were surprising in terms of, yes, cough is very important, yes, chills are very important for H1N1, but not necessarily sneezing. Dr. Daines: Yes, not necessarily sneezing, but muscle aches and pains and being just very, very tired and worn out, some people have GI [gastrointestinal] symptoms, nausea and vomiting, but again the symptoms [of pandemic flu] are just like regular influenza and just like the others--colds and that, that many of us get several times a year. Probably more important to people listening is how do you know if you have one of the cases that needs to seek medical attention. I’ve talked about high risk groups—pregnant, little children, asthma, diabetes, extreme overweight--but also a perfectly healthy person who gets influenza typically starts to get better in three or four days. If I had it, I’m not sure I did, and I have an excellent internist who I didn’t call. I just stayed home and got better. How would you know if you weren’t getting better like you should be. It’s the worst case you’ve ever had, you can’t get out of bed, you can’t keep anything down, rapid breathing, in particular in children, if they’re breathing rapidly and they’re fussing and you can’t hold them and you can’t put them down, when they start to turn bluish or their fingers or toes are cold their lips are blue, that’s when you get them in to medical attention right away. We sort of have a process here. We need ordinary healthy people, even if they think they have flu, to stay home to see if they get better. If you’re in a high-risk group, seek medical attention right away. But if you’re in that ordinary healthy group staying home, and then you think you’re getting better and then you get worse, or those worrisome symptoms about rapid breathing, shortness of breath, chest pain, start to come on, that’s when you seek medical attention. Alan Chartock: Let me talk to you about that, because when you go to the hospital, I’ve known of at least one hospital that used to have a sign on it that said, if you are suffering from respiratory infection, I don’t know what the exact words were, but the import of it was, don’t come in here. Dr. Daines: (Laughter) Alan Chartock: So if you go into a hospital, isn’t that likely to infect the people who are in that hospital? Dr. Daines: That’s why we say, if you’re healthy and it seems like a regular case of the flu, we prefer you don’t go into hospital and crowd into an emergency department if the symptoms progress or you are in a high-risk group, see a provider. Again, if you have access to a primary physician, that’s a lot better, because they’ll know you in advance and they may even be able to handle some things over the phone, tell you to not worry about it or by golly you are someone who ought to be on Tamiflu. It will take you a long time in an ER to establish that and so we prefer that you see a private practitioner. But the ERs are ready to handle this. Alan Chartock: Here on public radio in our public forums, we will hear from people from time to time, never to take an injection of any kind. They’re made with mercury, they’ll kill you, they’ll do this, they’ll do that. Do you want to talk about that for a minute? Dr. Daines: Well, “injection of any type” is very broad. Vaccines… Alan Chartock: …Yeah, yeah, vaccines. Dr. Daines: Vaccines are probably the most effective tool we have in public health. The vast improvements in survival rate in children, one of the real correlates [note, he didn’t say causes] has been vaccines. Every study of vaccine safety says they are safe and they are effective. This story about mercury and autism and thimerosal has been completely disproven as we’re capable to do with the scientific method. So if you want to apply science to policy, it says vaccines are safe and thimerosal does not make them unsafe. In fact, last week I waived another regulation. We had legislation that said that children under 3 and pregnant women should be given thimerosal-free vaccine. Again, we, the legislature, built into that, that a shortage year we could waive that requirement and I waived that last week, so that pregnant women and children with consent can receive vaccines that contain thimerosal. I’ve had several personal queries from people I know on what I think about that. I have said that if you can get H1N1 vaccine with thimerosal for you, if you are pregnant, or for your children, you should go ahead and get it. Alan Chartock: So, H1N1 vaccine is made with and without thimerosal? Dr. Daines: Yes, it is made in a single dose vial without thimerosal and that is the form that has the biggest shortage. There is a both a shortage in production and then as you can imagine the packaging supply line is more difficult for single dose vials. Extreme shortages of that across the state and the country. What we have a lot of is the nasal spray and we have more of the multi-dose vial that does have thimerosal. One of the complaints we have had across the state is individual providers don’t understand why they’ll hear—well, one provider in my community has vaccine but I can’t get any. When you dig into that, you will frequently find that the provider that doesn’t have any vaccine said when they called in to place the order, said yes, I can handle the FluMist, the nasal spray, I can take mine as multidose vials with thimerosal. The one that didn’t get it maybe said, “I can only take the single dose without thimerosal.” So we’re going back to people and saying can you switch your order. The real problem is shortage, overall shortage for everyone right now. Alan Chartock: We only have a minute and a half, but what does cause autism? Dr. Daines: No one knows. That’s probably the most troublesome thing is that we have to tell parents that we don’t know. One thing we do know is that it is not caused by vaccines or preservatives. We know that with great certainty. Alan Chartock: I am interested in Vitamin D and learned there is an inverse correlation between Vitamin D and autism. Did you hear anything about that? Dr. Daines: In my reading, I have learned that in general Vitamin D has been ignored… Alan Chartock: Is there anything you want to leave us with? Dr. Daines: Well, again, everyone across the state is doing a great job with this H1N1. There’s a lot of uncertainty. It’s not confusion, it’s uncertainty. We don’t necessarily know what is going to happen, so we prepare two or three different contingencies and then events force us down one pathway or another. In particular, our physicians, our nurses, our schools, our hospitals and health service providers are doing a wonderful job, which gives us a lot of confidence that whatever happens, we have a great system to take care of it. Alan Chartock: Thank you for being here and giving us all this great information. Dr. Daines: It’s a pleasure to be here. A summary of the points made in the interview between Alan Chartock and Richard Daines follows: Notes:
ALBANY, N.Y. (Sept. 24, 2009) - State Health Commissioner Richard F. Daines, M.D., today released this open letter to health care workers in New York State: As health care workers, we share one of the proudest traditions of all professions: we put our patients' interests ahead of our own. As a physician who spent more than 20 years working in hospitals, I had the honor of working side by side with other physicians, nurses, food service workers, technicians and transporters in the early and uncertain months of what would become the HIV epidemic, in those first confused days of the anthrax attacks, and when any new international traveler with a fever might have been carrying SARS. Never once, no matter what our private fears might have been, did we shirk from our duties or put personal anxieties ahead of the interests of our patients. We took the recommended precautions, worked carefully and cautiously, and gave our patients the compassionate and selfless care for which our professions and institutions are rightly given a special place in our society. In furtherance of that tradition, on August 13th the New York State Hospital Review and Planning Council adopted a regulation recommended by the New York State Health Department making approved annual influenza vaccinations mandatory, unless medically contraindicated, for health care workers in hospitals, outpatient clinics and home care services. Legislation applying the same standards to nursing home workers has also been proposed. The new regulation will apply first to the routine annual seasonal influenza vaccine now available. With the recent FDA approval of the vaccine for novel H1N1 flu ("swine flu"), the regulation will also apply to that vaccine, just in time for the second wave of novel H1N1 influenza already returning this fall. Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50% rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed. Throughout this fall and winter, more patients than ever may enter our hospitals and clinics without effective influenza immunity. Some will be too young or have other contraindications to vaccination or will have failed to receive vaccinations for a variety of reasons. Others will be too frail for vaccination to be effective. Large numbers of people quite clearly would like to take the new H1N1 vaccine as soon as it is available but will be denied that opportunity because they do not fall into one of the first prioritized groups. For all of these individuals, safety lies in being treated in institutions and by health care personnel with the nearly 100% effective immunity rates seen with other long-mandated vaccinations for health care workers, such as measles and rubella. In recognition of health care's noble tradition of putting patients' interests first and understanding the need to keep our health care system functioning optimally during this challenge, federal authorities made a remarkable decision regarding the first groups to be given access to the new H1N1 vaccine. In addition to giving highest priority for the new vaccine to those who would receive the direct or personal benefit -- pregnant women, caregivers to infants, children and the chronically ill -- authorities declared that health care workers would also be given earliest access to the vaccine, ahead of millions of other individuals who have roughly equal or even higher risks of contracting H1N1 influenza with all the discomfort or worse that could mean for them as individuals. Knowing that our privileged access to the new vaccine is earned not by our personal risk factors but by the special trust society places in us, then how can we as health care workers maintain that our cooperation in protecting the most vulnerable members of society is nevertheless optional? Without mandated vaccinations, many ethically troubling situations may occur. A health care worker unconcerned about "ordinary flu" might refuse the routine seasonal vaccine, but then expect to be in the front of the line for the "good stuff" – the new and strictly rationed swine flu vaccine. Institutions may find themselves short staffed and less than fully capable if their workers fail to get the seasonal influenza vaccine but then proceed to consume hundreds of doses of the new vaccine, therefore denying those doses to other groups. This scenario will certainly not achieve the staff-wide immunity levels needed to assure patient safety and optimal staffing -- the very reasons for which health care workers received their priority in the first place. Influenza vaccination has saved thousands upon thousands of lives over the last three decades, and thousands more could have been saved if the vaccinations had been more widely used. This year, through effective use of vaccination, we have perhaps the best opportunity to save lives and keep our society and institutions running more smoothly than we have had in 50 years or more. This is not the time for uninformed or self-interested parties to attempt to pump air into long-deflated arguments about vaccine safety in general or to use a single 33-year-old episode to deny decades of safety and saved lives achieved by influenza vaccines prepared in the same way as this year's formulations. The seasonal influenza vaccine has completed, and before its approval the new H1N1 vaccine also underwent, the most careful development, production and testing processes leading scientists, clinicians and public health authorities can devise. Approval of the H1N1 vaccine was based on the application of the same scientific standards and methods that we believe should govern all our health care practices. We, as health care workers, owe it to our patients and to society in general to demonstrate our confidence in those scientific standards. Even more importantly, we should reconfirm our noble commitment to the tradition of putting patients' interests first by supporting the mandatory influenza vaccination requirement. Richard F. Daines, M.D. New York State Commissioner of Health Available at http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm; accessed November 11, 2009. Governor David A. Paterson today announced that State Health Commissioner Richard F. Daines, M.D., has suspended the mandatory influenza immunization requirement for New York health care workers so that the limited vaccine supplies can be used for populations most at risk of serious illness and death – especially pregnant women and children and young people between the ages of 6 months and 24 years. “Over the last week, the Centers for Disease Control and Prevention (CDC) acknowledged that New York would only receive approximately 23 percent of its anticipated vaccine supply by the end of the month,” Governor Paterson said. “As a result, we need to be as resourceful as we can with the limited supplies of vaccine currently coming into the State and make sure that those who are at the highest risk for complications from the H1N1 flu receive the first vaccine being distributed right now in New York State.” In July and August [2009], the federal government gave states vaccination planning scenarios projecting that 120 million doses of H1N1 vaccine would be available nationwide by the end of October. This week the CDC acknowledged that only about 27.7 million doses of vaccine would be available by the end of the month – just 23 percent of the original projection. Similarly, the CDC originally projected 200 million doses of H1N1 vaccine would be available by the end of November; the CDC’s now projects 65.9 million doses will be available nationwide by the end of that month. New York State receives 6 percent to 7 percent of the national vaccine supply, based on population. “We had told hospitals that if they had to choose between vaccinating patients or employees to vaccinate patients first,” Commissioner Daines said. “This week, the CDC confirmed that most of the national supply of seasonal flu vaccine has been distributed, and that H1N1 vaccine distribution is far behind projections. New evidence is showing that H1N1 can be especially virulent to pregnant women and young people – so they should get vaccinated first.” Demand for the H1N1 influenza vaccine by New York’s health care providers has far exceeded supply. The State Health Department opened a call-in center this week for doctors to place orders of H1N1 vaccine for their patients. So far this week, the CDC has allowed the State to enter actual orders for 146,300 doses of vaccine – while New York’s providers have requested more than 1,482,822 doses. The CDC also recently reported that, due to increased demand this year for seasonal flu vaccine, many providers do not currently have enough of that vaccine to immunize their patients. “We are pleased that so many people are seeking to be vaccinated against seasonal and H1N1 flu,” Governor Paterson said. “Although the H1N1 vaccine supply is coming in far more slowly than expected, we urge people most at risk of serious complications from the flu to keep in touch with their health care provider so that they can get vaccinated as soon as vaccine is available.” “The vaccination of health care workers continues to be an important patient safety measure, and I urge hospitals and other health care facilities to encourage employees to be vaccinated against the flu and to schedule flu clinics for that purpose when enough seasonal and H1N1 vaccine becomes available,” Commissioner Daines said. Citing the authority granted to the Commissioner by the regulation, Commissioner Daines noted that because vaccine supplies are inadequate, he is suspending the mandatory requirement for health care worker vaccination. With vaccine supplies coming in at lower amounts and at a slower pace of delivery than originally projected, not all workers would be able to get vaccinated before the November 30 deadline provided in the regulation. The Commissioner referred to the clause in the regulation that states: “If the commissioner determines the vaccine supplies are not adequate given the numbers of personnel to be vaccinated or vaccine(s) are not reasonably available, the commissioner may suspend the requirements(s) to vaccinate and/or change the annual deadline for such vaccinations(s)” The priority groups to receive the H1N1 flu vaccine, as established by the CDC, are: Dr. Daines noted that the CDC reported 43 pediatric deaths from the flu during September – an unusually high number. “I urge parents to get their children vaccinated and to take their children for treatment if they develop fever and breathing difficulties so that antiviral medication can be administered right away,” said Dr. Daines. Dear Administrator: In August 2009 the State Hospital Review and Planning Council (SHRPC) adopted on an emergency basis 10 NYCRR Subpart 66-3, requiring certain health care facility personnel to be vaccinated with influenza vaccines. I am writing to inform you of my determination pursuant to Section 66-3.2 of those regulations that supplies of seasonal and 2009 H1N1 influenza vaccines are not adequate and that such vaccines are not reasonably available. Therefore, I hereby suspend the requirement for the health care personnel to be vaccinated against both influenza viruses for the current influenza season (through April 1, 2010). On October 14, 2009, the Centers for Disease Control and Prevention (CDC) issued an update on the availability of the 2009 trivalent seasonal influenza vaccine. According to the CDC, 114 million doses of seasonal vaccine will be brought to market in the U.S. The CDC update stated that "Because the total number of doses that will be made this year is approximately the same as the number of doses that were actually administered last year, an increase in demand cannot be met this season." The Department of Health (DOH) has received numerous calls from hospitals, other regulated facilities, county health departments and members of the public about difficulty in obtaining seasonal influenza vaccine. The national vaccine ordering website indicates that the major influenza vaccine distributors have little or no vaccine available to order. According to the CDC, manufacturers are not able to produce additional 2009 seasonal influenza vaccine. Supplies of monovalent 2009 H1N1 influenza vaccine have become available from the federal government in the last three weeks. Federal planning scenarios for H1N1 vaccination programs at the time SHRPC adopted Subpart 66-3 showed that 120 million doses of vaccine would be available by the end of October and 200 million doses would be available by the end of November, almost twice the number of doses of seasonal vaccine usually administered. More concrete projections, made available by CDC just prior to the opening of the federal H1N1 vaccine ordering and distribution program, estimated a total of 52.5 million doses available by October 30 and 84.9 million doses available by November 27. However, as of this date, CDC is estimating only 27.7 million doses available by October 30 and 65.9 million doses by November 27, representing a 47% and 22% reduction respectively. These circumstances set up a dynamic where health care personnel covered under the regulation might compete for vaccine with persons with underlying risk factors for adverse outcome of influenza infection. In a situation where the choice to vaccinate is between health care personnel and persons at risk, I have always held that patients take precedence. Maintaining the health care personnel vaccination requirement would delay persons in need from being vaccinated. For these reasons, I have determined that there will not be sufficient supplies of either vaccine to meet the intent of the regulation in the 2009-2010 influenza season. The most important consideration driving the need for the regulation requiring health care personnel influenza vaccination is patient safety. Patients in hospitals and other health care settings have the right to expect that they will not be infected by their health care worker with a preventable disease which could be fatal. I believe that New York's experience with mandatory influenza vaccination for health care personnel in 2009 will have a positive impact on the health of New Yorkers this year. The current emergency regulation mandating influenza vaccinations for health care workers will expire on November 11, 2009, and a second emergency regulation would not have the desired effect during the current H1N1 influenza season or the expected seasonal outbreaks expected later this year and in early 2010. Therefore, no new emergency regulations will be promulgated. Instead, the DOH is advancing a permanent regulation requiring health care personnel in these settings to be vaccinated. Draft regulations will be published soon for a period of public comment. Sincerely, Richard F. Daines, M.D. |
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