San Antonio Express-News (Sunday)
DIFFICULTIES OF DELIVERY
Getting shots in arms is easier said than done
Vaccines are considered the best weapon against a disease that has killed more than 400,000 Americans. But a little more than a month into the distribution of shots, vaccine demand has far outstripped the existing supply.
That's meant that thousands of San Antonians who are eligible for vaccinations are dealing with busy phone lines, online appointments that fill up in minutes and frustrations when trying to secure shots.
On the first morning the city began taking appointments for its mass vaccination center at the Alamodome, for example, it received 187,000 calls for 9,000 available appointments.
We interviewed Dr. Joanne Turner, a scientist who serves as Texas Biomedical Research Institute's vice president for research, to learn more about how vaccines are developed and why communities are struggling to secure supplies. Turner usually studies bacterial infections and how they affect older adults, but amid the pandemic, her focus has shifted to COVID-19.
This interview has been edited for length and clarity.
The push to protect Americans against COVID-19 is the largest mass vaccination effort since the campaign to combat polio that started in the mid-1950s. How do mass vaccination efforts of the past help shed light on what’s happening with the vaccine rollout now?
Let me back up way back in history – because when you're talking about the past, a lot of those vaccines that were given to people existed before U.S. Food and Drug Administration regulations and review. They were tested rigorously in animal models, and then they were tested in small cohorts of individuals, but they didn't necessary have those oversight committees that really made sure they were absolutely safe to use.
We now have those safety procedures in place because there were adverse effects from some of those vaccines and therapies. If you develop a vaccine now, you have to follow very specific procedures. Usually, it starts with fundamental research. We often work on government grants to develop a vaccine.
Once we think it's working, which means we've tested it in an animal model, it has to then get rolled out in clinical trials. The animal studies have to be very supportive of putting it into people; those have to be reviewed very carefully. And then we have that long process of clinical trials that we've all been hearing about — phase 1, phase 2 and so on — that really looks at how individuals respond to a vaccine. Is it safe? That's followed by rolling it out to a bigger population to gather data from a large number of people and understand the statistical likelihood of something going wrong.
All of that documentation is filed with the FDA in the U.S. — other countries have their own regulatory agencies — and they look at all that data and they have an independent agency evaluate it to make sure it's safe. Normally, that takes years to do.
Why were scientists able to develop a vaccine so fast?
We've sped it up because of the urgency. A lot of people would ask, why we've been able to do this so quickly? Have we cut corners? The answer is “no.” There's no interest in putting something into a person that hasn't been validated. We just did it quicker because there was an emergency during the pandemic.
Funding was given to scientists to develop things faster, and money drives everything. Research is a very expensive endeavor, so the more money that comes into your lab, the more you can do.
What they've also done in parallel to that is to start working on the manufacturing process, which in itself is very well regulated to make sure you can only put the thing that you want to in the vial — that it's controlled in every process. They've got the vials, the rubber stoppers, the labels all in place to package everything safely. All of that was ramping up at the same time, so when we had the “yes” from the FDA, it was already in production so it could rolled out to people sooner.
We keep hearing that medical providers would want to administer more vaccines — but we don’t have the supply. How complicated is the supply chain?
I think what we're seeing is No. 1, it takes time to make the vaccine. We have a processing delay. They're
ramping up as fast as they can; every company that can make the vaccine is probably making the vaccine to the detriment of making other things that we need as a society.
But then it's getting it out to the people who need the vaccines. It's a communication issue. They're working at a state level for the most part, and every state is trying to get vaccines for themselves, instead of it being a national initiative. Once it gets to states and cities, you've got to have people trained to give vaccines. And, you have to have people documenting who's got it, who's coming back in three or four weeks for a vaccine and then get the word out to those individuals.
This is the first time our country has dealt with a pandemic in the online era. Instead of going door to door or setting up vaccination hubs in community centers, residents are having to make appointments online and rely on technology to find out about availability. Is that making it harder to get the vaccines to some of the people who need them?
Getting vaccines to elderly people in nursing homes
is moderately easy because we know where they are — you can go to them with the vaccine. But when you're talking about individuals in the community who are 65 and older, they have to find a way now to get the vaccine for themselves. We're not always reaching out to them. We have the Alamodome — it's wonderful that they're doing that on such a large scale — but not everyone is savvy on the internet or has the time to get on the phone to call or go online to sign up for appointments.
We've really started to see that breakdown a little bit locally. Technology is supposed to make things easier, but it doesn't always, especially for certain subsets of the population. And, the challenge with these vaccines is they have to be kept very, very cold. It's really hard to go out and vaccinate people in the community because they don't have the ability to store the vaccine. Otherwise, you could go to a school, or a community center where everyone could come in and get vaccinated.
We also have challenges with the availability of trained personnel. Every state has had budget cuts. They don't always have the personnel there to administer all the vaccines and do all of that community outreach anymore.
Many public health experts had expected that the federal government would oversee a nationwide vaccine rollout in the event of a pandemic. What happened?
There's been a change in how the country has thought about science and health care over the last few years. The fact that we didn't have somebody to respond to a pandemic in the (Trump administration) slowed that down. They funded science less, and we're now seeing the repercussions of that. Had we had more money in science and health care, perhaps we could've done this a little better, and a little quicker.
Five or six years ago, we had people in the government who knew how to respond to a pandemic. This wasn't a surprise. We always knew it was inevitable … and we did have people in place who knew what they were doing.
What we've seen is decentralization to the states so every state is responsible for coming up with their own plan. There hasn't been a national mandate. I think that will change this year, and it will be more structured. But it really is a consequence of not having that national centralization and management of health care in that way.
We have a pandemic about every 100 years — we don't know if it's year 100, or if it's year 90, or 110. So you can imagine if you're really looking to think about how you're using your money, you might think about putting it into some other process. It just happened that the money got prioritized elsewhere.
What have been some of the biggest challenges to getting the vaccines into
Americans’ arms?
We're really looking at vaccines that people developed in an emergency, and they're not always going to be the most easy to deliver. The Pfizer and Moderna vaccines are out, and they're maybe not ideal because you need to keep them cold and give them twice.
It does make the logistics much more challenging. Just tracking people, making sure they're scheduled for the second appointment and making sure they come back for the appointment — all of those layer on complexity. In an ideal world, we'd have a vaccine that could be stored at room temperature, and it could just be carried out in the community and one dose only. But it's actually quite hard to get really good protection that way. We have vaccines that do it, but they've had a lot of research. We just need to wait for the research to catch up so we have ones that are easier to deliver.
President Joe Biden has pledged to ramp up production of vaccines and push a nationwide strategy to administer 100 million shots during his first 100 days in office. What do you think the next few months will hold?
We should expect to be optimistic, and we should also expect to see some control of the pandemic. We'll also probably see companies like Pfizer and Moderna modify their vaccines, because I'm sure they'd like to give a single dose. They'll be modifying those and testing them – maybe the time between the first vaccine and the second vaccine dose can be extended? We just don't know because they haven't tested it or have it reviewed.
We should also see four or more vaccines coming online this year. We should see manufacturing go up and better management of how we get vaccines out to individuals. The hope is in the next three to six months, that we'll see the majority of the population vaccinated — as long as they come out to get vaccinated. I think people are seeing why it's so important to do. They want to go back into normal life. Toward the end of the year, I think you'll see states start to loosen restrictions.
What about the new variant that’s been reported in Texas? Will the vaccines protect us?
The only way we'll know for sure is to test it experimentally, but I think there's optimism that the vaccines will work against them just based on what the mutations are. It's normal for viruses to mutate — I think that's key for people to know. The mutations we're seeing are making them more infectious — so more people will catch them, but they won't necessarily get sicker. It seems like the vaccines will work against these mutants, but the best thing we can do is to shut down spread in the community so that we don't have any.