Ministry denies link, launches an inquiry
Bangkok Post
01/29/2010
H1N1 flu vaccinations among pregnant women have been suspended after a woman who received a jab lost her baby to miscarriage a day later.
The Public Health Ministry yesterday denied any link between the vaccinations and the foetal death, but as a precaution suspended flu shots among pregnant women pending an investigation into the miscarriage in the southern province of Satun.
It said it would press ahead with a plan for an H1N1 vaccination campaign aimed at high risk groups despite concerns about possible side-effects.
“There’s no substantiated report of H1N1 vaccine having a harmful effect on pregnant women,” Public Health permanent secretary Paijit Warachit said yesterday. “The product is certified and safe for use.”
Over 6,000 pregnant women have received the vaccination, imported from the French company Sanofi Pasteur, under a national campaign to tackle the mortality rate caused by type-A (H1N1) influenza among high-risk groups including pregnant women.
The 39-year-old woman lost her baby during the 24th week of pregnancy in Satun’s Thung Wa district on Monday, only a day after she was given a flu shot.
An investigation into the miscarriage at Songkhlanagarind Hospital is under way and the results are expected within a week, Dr Paijit said.
A case of a 32-year-old woman delivering a baby during her 33rd week of pregnancy was not caused by vaccination or toxaemia in pregnancy.
Early delivery was essential in this case because the mother had taken a fall and suffered internal bleeding in the brain, he said.
Kamnuan Ungchusak, an epidemiological expert at the Disease Control Department, conceded the report might affect confidence in the vaccination scheme, particularly among pregnant women.
The antigen which is the active ingredient in the H1N1 vaccine could not pass from the mother to an unborn child.
However, the medical committee would discuss the case at its next meeting on Feb 9.
Thailand is conducting the first human trial of a locally made vaccine for type-A (H1N1) influenza.
A preliminary report had found the vaccine was safe and could provide immunity against the virus among volunteers.
The initial result of the first-phase trial was satisfying, said Vichai Chokewiwat, the Government Pharmaceutical Organisation board chairman.
Of 24 volunteers, only 13 had reported minor side-effects such as headaches, joint pain and a runny nose.
Researchers, however, would not rush to begin the vaccine trials with a larger group of 400 volunteers as more work was needed to improve the vaccine’s stability. The second-phase of the trial was scheduled for April.
The first batch of locally produced vaccine would be ready to combat any influenza outbreak during the monsoon season if the trial went as planned.