Health - BCG vaccine against TB

No babies in Ireland have had the BCG* vaccination since April 2015. Stock of the vaccine, which provides protection against tuberculoses (TB), ran out then and there still isn’t a supply over three years later.

Coincidental to a supply becoming unavailable (and it was coincidental, the HSE says) an expert medical group in Ireland called the National Immunization Advisory Committee (NIAC) – along with the Health Information and Quality Authority (HIQA) – was recommending that the BCG vaccine does not need to be given routinely to all babies in Ireland.

Instead of universal vaccination (every child getting it), it is recommending a move to selective vaccination where only high-risk babies receive the vaccine.

The current stance is that the Department of Health has received the NIAC and HIQA recommendations (over three years ago now) and that a decision is awaited on what future policy will be when BCG vaccine is back in stock. That’s expected to be into 2019.

High-risk

About 100,000 babies have been born since 2015. Eight thousand of those are deemed to be in the high-risk group as their parents are from countries where TB is prevalent. TB is most prevalent nowadays in Asia and Africa, but the more challenging multi-drug-resistant types of TB mostly occur in the Baltic states – Estonia, Latvia and Lithuania.

TB was, of course, a very common illness in Ireland in the past, with as many as 7,000 cases a year diagnosed here in the early 1950s.

Dr Noel Browne and his free TB screening programme and building of sanatoria led to the virtual eradication of the disease in humans in Ireland. Vaccination later became the norm. Most of us born since still have the tell-tale white spot/s on our upper left arms. While TB does occur in Ireland occasionally, TB rates are now very low here – that’s why a switch from universal to selective vaccination is being recommended.

There were 328 cases of TB in Ireland in 2017 – that’s 7.1 per 100,000. This was the lowest notification rate recorded since surveillance began in 1998 apparently.

A Health Protection Surveillance Centre (HPSC) report in 2017 stated that 40% of those 328 people were foreign born. TB was stated as the cause of three deaths.

But what is the experience of contracting TB like? How difficult is it to recover from? Science graduate and dairy farmer’s daughter, Saranna Kavanagh from Avoca, Co Wicklow, had her BCG vaccination as a new-born, but was diagnosed with TB when she was 14.

She was in New York on a Gaelic football trip when she first fell ill.

“I actually fainted when we were at the top of the Empire State building,” she says. “Everyone thought it was just a bug, travelling on aeroplanes and so on, but about two weeks later, back in school, I got worse. I had bad fevers and a really bad pain in my upper back when I coughed, or laughed, or sneezed and I was very tired.”

A two-week stay in hospital and an operation to drain fluid from her lung followed – and a wait for a definite diagnosis.

“They had to send cultures away to get tested to see what antibiotics would work. They had discovered that there was a pocket of fluid between my lung and chest wall, so the operation was to insert a chest drain to clear that out.”

While Saranna was isolated during her stay in hospital, it was just a precaution, she says.

“Because the bacteria was in my pleural cavity, there wasn’t a fear that I was breathing the bacteria in and out, so I couldn’t pass it on to anyone.

“Doctors didn’t know where I got it,” she says. “They were able to tell me it wasn’t a bovine form of TB quite quickly. Obviously living on a dairy farm that was a concern, but they said it was a human form and with the amount of fluid that had developed in my pleural cavity that it would have been about a year previous that I was exposed.

“We speculate, but I might have picked it up on a trip a year earlier to Canada.”

Treatment involved a cocktail of four antibiotics that she had to take for 18 months.

“It involved taking nine tablets and two oral medicines a day. Initially it was supposed to be for six months, but unfortunately my lung didn’t stay clear so it went on longer. At the end there was a solid mass – a shell – left in my lung that wasn’t clearing, so surgery was suggested as this was affecting my lung capacity.”

This decortication surgery took place before Christmas 2010.

“It was quite invasive and had risks, but thankfully it worked.”

Overall, Saranna missed five months of school because of TB – from November 2008 until April 2009. She excelled in her Junior Cert the next year, however, and had the decortication surgery while in TY.

Since then Saranna has been well and busy, doing a PhD in chemistry at UCD.

Saranna's mother's perspective

Marian still has vivid memories of her daughter being ill.

“It’s one slice of my life that I’d love to just cut off and let down the river,” she says, “but saying that, Saranna was so well looked after all through her illness. We couldn’t have asked for better care. It went on for quite a while, that was the only problem. Saranna’s TB, we were told, was presenting unusually in that she had an enclosed sac in her lung in which the TB bacteria was kept.”

Seeing Saranna in intensive care was upsetting.

“She had always been such an active, sporty girl – I couldn’t believe she was knocked out like that.”

Marian says they were very anxious to find out where the TB came from.

“As Saranna says, we don’t know. Doctors did say, however, that some people are more susceptible to picking up the illness than others. Testing of family and friends by the HSE did take place, of course, but thankfully everybody was clear.”

She remembers all the trips to the Central Drugs Unit to collect medication for Saranna.

“We had to get big containers each time. It was an incredible day for us all when she finished taking medication,” she says.

Incidence in Ireland

We asked Dr Breda Corcoran from the National Immunization Office some questions about the BCG vaccination and the delay in sourcing it.

Why is it so difficult to source a new supply of the vaccine?

There aren’t very many countries in the western Europe part of the EU using a universal BCG vaccine now. Only Ireland and Portugal are vaccinating every newborn. As a consequence of this there are very few providers of the BCG vaccine licensed by the European Medicines Agency. The product we used in Ireland was manufactured in Denmark. That company (Statens Serum Institut) was sold and the manufacturing processes of the company that bought it have to be rigorously tested to meet the licensing requirements for the BCG vaccine. That has taken an inordinately long period of time. That’s why we have not been able to find another source that will meet our licensing requirements.

BCG is unlike other vaccines. It generally isn’t licensed as a job lot by the EMA – the European Medicines Agency. It is instead licensed by individual countries because it is not a vaccine that is used universally across the EU. Vaccines take a long time to grow and be licensed. You can’t just get a year’s supply today.

How come the swine flu vaccine was available so quickly?

Swine flu was different – it was a global issue, everyone was trying to manufacture a product and they already had plants and licenses.

Are there fears that TB incidence will increase because babies haven’t been vaccinated since 2015?

The first thing to note is the BCG is not a very effective vaccine. The measles vaccination is 95-99% effective, but if you are given the BCG as a baby the only main protection is from the serious forms of TB, including TB meningitis of the lining of the brain. Getting the vaccine doesn’t mean that you will never, ever get TB. It’s not that good a vaccine. All over the world they are trying to develop more effective vaccines. The UK changed to selective vaccination because the rates had dropped. It stopped the universal BCG because 1) it’s not 100% effective and 2) it also has side effects. If you vaccinate babies with BCG a small number of them will get a very sore arm, some even with an abscess, because it is a different type of injection than normal ones – it is given under the skin, not into the muscle. Many parents wouldn’t want their child to be left with a very unsightly scar.

Where do we stand now?

Coincidental to all this, the licensed supplier that we’d been getting our supply from changed hands almost simultaneously to this information coming from the expert group and from HIQA. We await the Department of Health’s decision on policy.

But have TB cases increased since 2015?

No. The numbers are extraordinarily small in children.

Will selective vaccination not be an administrative minefield?

It will be a change so there will have to be a lot of information for the health professionals and the parents of the newborn babies.

*BCG stands for Bacillus Calmette-Guerin