Shortage of Flu Vaccine Persists, But No Flu Cases Confirmed Yet

RAY SUAREZ:

Since a shortage was first announced in early October, government officials have been scrambling to make sure flu vaccines are delivered to the highest priority groups.

Two weeks ago, the Centers for Disease Control announced recommendations to ration and better distribute the remaining vaccine. All told, about 50 million doses have been shipped around the country.

So, how are states doing as flu season approaches, and what choices have they already had to make? For that, we turn to two people directly dealing with those questions.

Dr. Richard Raymond is president of the Association of State and Territorial Health Officials. He is the chief medical officer for the state of Nebraska. And Dr. Calvin Johnson is the secretary of health for the state of Pennsylvania.

Well, Dr. Raymond, looking at the nation as a whole, how are we coping with this severe shortage of doses?

DR. RICHARD RAYMOND:

I think, as a whole, we've done a great job of getting the vaccine wherever it was most needed.

The Advisory Committee for Immunization Practices was called into action on Oct. 5 when the announcement was made that Chiron would not be distributing their 50 million doses.

And they came up with revised recommendations for eight high priority groups that should receive the vaccine.

And the stories I'm hearing is the states have been able to fill that need, perhaps not universally, but to the most part that need has been met and is being met this month.

RAY SUAREZ:

And Dr. Johnson, inside the borders of one state, have you had some places with sufficient vaccine or more than they expected while others got less and you've had to work within your borders to smooth out some of those supply problems?

DR. CALVIN JOHNSON:

Well, mostly in Pennsylvania the majority of vaccine is ordered by the private sector, and so it's been a situation where one hospital could have gotten their order filled completely, where a hospital a few miles away may not have gotten it.

So it's been that kind of inequity.

RAY SUAREZ:

Dr. Raymond, have people had to be turned away? Is that a frequent experience, people who think they may be in the vulnerable groups but are judged not to be?

DR. RICHARD RAYMOND:

Well, I think early on when the shortage was announced there were probably people scrambling earlier to get their vaccine than they normally might have done, and at that point in time when the vaccine was still only partially shipped, I think there were people turned away.

But I think they were also given reassurances to continue to persist to try to find a vaccine because as the vaccine was manufactured and rolled off the assembly line, it did continue to flow into the states and continued to be available in incremental doses.

RAY SUAREZ:

Well, are new supplies still shaking loose, a couple hundred thousand here or there, as new suppliers are located?

DR. RICHARD RAYMOND:

Well, the Aventis-Pasteur plant can produce about three million doses a week, so each week those doses have been produced were being shipped out to previous contracts and also to public health entities that had ordered from Chiron to try to make sure those needs were met.

What has recently been announced is, after all the governmental contracts and groups like the Minnesota multi-state purchasing contract had been met for the health departments and some government agencies, the Centers for Disease Control and Aventis-Pasteur have now allocated a certain amount of the remaining vaccine to be produced to the states based on need and the most fair method they could determine.

And that vaccine still has not all been shipped because it's still in the manufacturing stage. The last date for shipment will be Dec. 18.

RAY SUAREZ:

And Dr. Johnson, is that system working? Are there enough doses in a state like Pennsylvania so that if elderly, the chronically ill, people with compromised immune systems, very young children, all came into your health facilities to get dosed, they could get some?

DR. CALVIN JOHNSON:

Well, one of things we're experiencing this year, and I think this is the case across the nation, is that people who may not have ever considered getting a flu shot before are getting it this year because we've heard that there's a vaccine shortage.

And so we're experiencing an unprecedented demand, which is good from a public health perspective. The word is out.

We estimate looking at the number of people in Pennsylvania who fit into the categories of high risk. We estimate we have about three million people.

To date, and including the most recent allocation that's been identified to come to Pennsylvania, though it's not here yet, we have a little more than two million doses.

So we still see that there is about a one million gap in terms of the high risk population.

RAY SUAREZ:

Is there reliable sharing of information so that you can find out when you're short where some is available?

DR. CALVIN JOHNSON:

We've actually… from the very beginning, we entered into partnerships and have been communicating I think very effectively and very well with a number of groups across the state, from the nursing home associations to the hospital associations to representatives of private providers and others.

And from every indication we have, we have been finding out where the vaccines are, who's been using them and when there is some available or extra that we make sure that it's gotten to those who need it the most. And I think we've been very successful in that.

RAY SUAREZ:

Dr. Raymond, Illinois, New Mexico and the city of New York have announced plans or are in the process of trying to import their own supplies. How does that work?

DR. RICHARD RAYMOND:

Well, to import their own supplies would mean they'd be buying a vaccine that has not been approved by the FDA, therefore would be considered illegal.

The quality controls, the follow-up for side effects, et cetera, just won't be in place. I think the better route to go is to plan on the Centers for Disease Control being able to reallocate, redirect some of this vaccine that's being manufactured.

Some states have indicated they have already met the demands for those eight high priority groups. They're being encouraged to forego their last allotments and let other states in greater need have that vaccine.

RAY SUAREZ:

But if they are successful with their purchases, if they make landfall in the United States, how do those drugs get released? Do they have to be signed off by the FDA, or is there some mechanism so that if, for instance, the Illinois Gov. Rod Blagojevich goes ahead with his plan, somebody in Chicago might get one of those shots?

DR. RICHARD RAYMOND:

Well, there is a mechanism in place, but it's not part of the Illinois plan. There is a mechanism in place for the Centers for Disease Control, and HHS is working diligently to purchase vaccine from other countries, manufactured in other countries.

They are very close to having FDA approval for the first investigational new drug purchase, which would bring about 500,000 doses into America early to mid December, and there's two other companies that are also negotiating.

If those products were purchased, then they would be administered under certain protocols where they could be monitored for side effects, effectiveness and complications, and that would be the only legal route to go.

RAY SUAREZ:

Dr. Johnson, if you're a person who had been turned away or found long lines the first time you tried to get a shot and you think you're in a risk category, is it worth taking another crack at it? Is that something you'd recommend?

DR. CALVIN JOHNSON:

Oh, it absolutely is. As Dr. Raymond has indicated, that as vaccine has been reallocated and is going to continue to be distributed, there are opportunities still to get vaccine in Pennsylvania and in other states.

And so, if you have not gotten your shot yet and you are a member of one of the high risk groups, you certainly should try again.

RAY SUAREZ:

And there's been some talk that this might be a mild flu season. Is the calendar your friend at some point? When will you know whether you are indeed experiencing a milder than usual season?

DR. CALVIN JOHNSON:

Well, as you know– and you're indicating the flu season is really difficult to predict– we don't have any confirmed case of flu here in Pennsylvania to this point. It could happen at any time.

I think the later that that happens, you know, or the further we get into the season without getting a confirmed case, certainly that shortens… hopefully shortens the overall flu season.

I don't think we'll really know that answer until we're typically at the end of the flu season, which gets into late winter/early spring. I think then is when we can really give a sigh of relief and say for sure what the season was and was like.

RAY SUAREZ:

And Dr. Raymond, harsh season or not, are there things under way right now to make the United States a little less vulnerable next year to an experience like the one we're having now with Chiron, one major manufacturer, dropping off the scene?

DR. RICHARD RAYMOND:

Well, anything done to try to prevent this from happening again is going to have to occur at the federal level.

The vaccine manufacturing process itself needs to be streamlined, needs to be modernized. That's expensive. There's a very small profit margin in the industry itself.

Vaccine has to be discarded every year that's not purchased. There's no carryover. All those issues have to be addressed along with the number of companies that we do contract with to produce the vaccine.

And I think we've learned our lesson that to rely on only two companies– one of which is in the continental United States and one is not– is probably not going to happen again.

RAY SUAREZ:

Dr. Raymond, Dr. Johnson, gentlemen, thank you both.

DR. CALVIN JOHNSON:

Thank you.

DR. RICHARD RAYMOND:

Thank you.