75,000 doses of Sanofi Pasteur flu vaccine from batch containing impurities have been used in HK

29-Nov-2018 Intellasia | South China Morning Post | 6:00 AM Print This Post

About 75,000 doses of imported flu vaccine belonging to a batch containing impurities have been administered in Hong Kong, the city’s health authorities disclosed on Tuesday.

The Department of Health said 175,000 doses from a batch containing “white particles” had been delivered to the city’s public health care providers from French manufacturer Sanofi Pasteur.

All flu vaccination services had therefore been suspended at hospitals and outpatient clinics, but were expected to resume gradually from Saturday, the Hospital Authority said.

“There has been no adverse reaction reported related to vaccinations with the affected batch,” the authority added. “Members of the public feeling unwell after vaccination should seek medical advice.

“The authority will continue to liaise closely with the Department of Health for an update on the latest situation.”

The revelation comes after Taiwan’s Food and Drug Administration on Monday said two batches by Sanofi Pasteur had been found to contain impurities. The problematic doses were discovered during routine inspections.

The Department of Health said the batch concerned in Hong Kong carried the box label R3J721V and syringe label R3J72.

Sanofi Pasteur said in a statement that the vaccines had been made in France and there was no evidence that quality, safety or efficacy had been compromised.

The company said it had obtained from Taiwanese authorities the samples with impurities and sent them to the manufacturer’s headquarters in France for analysis.

The firm said it had supplied more than 20 million quadrivalent doses globally during the flu season this year, and had not received any report about safety concerns.

Medical facilities stocking the affected batch would be contacted and the doses replaced, Sanofi said.

William Chui Chun-ming, president of Hong Kong’s Society of Hospital Pharmacists, said contamination during the manufacturing process or storage temperatures could be to blame. Crystallisation could take place in refrigerators with a temperature lower than 2 degrees Celsius, he said.

Chui was also concerned about the effects of a possible shortage.

“If the public are eager to get vaccinated at government facilities in the coming months, there could be a shortage if the drugmaker cannot refill in time,” he said.

But anyone who had received jabs from the batch in question should stay calm, because the vaccine was administered into muscles, meaning the possibility of the white particles entering blood vessels was low, he added.

Paediatrician Dr Tse Hung-hing said it was difficult to discern at this stage if the safety of the vaccine had been compromised, but he agreed with the suspension of services.

Public immunity during the peak flu season around Lunar New Year could be hit if the manufacturer was unable to deliver fresh stock in time, he said.

Sanofi and GlaxoSmithKline are Hong Kong’s two major suppliers of quadrivalent flu vaccines, which protect against four different viruses. The majority of private clinics had stocks from these firms, Tse said.



Category: Hong Kong

Print This Post

Comments are closed.