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| Credit Taiwan FDA |
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Although flu season hasn't hit full stride in Hong Kong or Taiwan, South Korea raised their influenza epidemic alert 11 days ago, and both Taiwan and Hong Kong are well into their seasonal vaccination push.
Yesterday Taiwan's FDA announced the discovery of `impurities' - black and white flecks of unidentified materials - in batches of Sanofi's quadrivalent flu vaccine.This follows a similar incident with Sanofi flu vaccines a month ago involving a discolored vial of vaccine, as reported by Taiwan's CDC on October 26th, which was subsequently blamed on a defect in the vial's rubber stopper.
This latest report, however, involves multiple vials, and has led to the suspension and withdrawal of two batches in Taiwan, and one batch in Hong Kong.
First from Taiwan's CDC:
Food and Drug Inspection Agency found two batches of flu vaccine abnormal appearance, not sealed release, please rest assured that the people [Date: 2018-11-26] Company: Food and Drug Administration study examined group (Tifsan)
Food and Drug Administration (hereinafter referred to as the Food and Drug Agency) in response to recently publicly funded influenza vaccine appearance of abnormal events, has been in accordance with risk mechanism immediately for time this year follow-flu vaccine test sealed application, improve the inspection ratio of the appearance of the vaccine, then check to Sanofi Co., company Pasteur Pasteur influenza vaccine and quadrivalent influenza vaccine each batch of abnormal appearance, determine the failure, not sealed release, inviting the public to rest assured.
Food and Drug Department in October this year were accepted Sanofi Pasteur influenza vaccine batch Ltd. 1 (lot number R3J711V, R3J71, 438,190 agents, August manufacture, import early October) and a batch of flu vaccine Pasteur tetravalent (lot R3J721V, R3J72, 80,215 agents, August manufacture, import late October) sealed test applications, perform 10 tests are qualified according to the Chinese Pharmacopoeia, but to strengthen the visual inspection, we found lot R3J711V, R3J71 Pasteur 4 have vaccine influenza vaccine contents black suspension was batch R3J721V, R3J72 P. tetravalent vaccine influenza vaccines nine contents white suspension (Annex shown), and the manufacturer does not meet the Chinese Pharmacopoeia specifications product testing , determine the failure, not sealed the release of the second installment of the vaccine according to the Pharmaceutical Affairs law Enforcement Rules of the provisions of Article 36, the deadline shall be returned or destroyed.
All the manufacture or import of influenza vaccine are required, pursuant to section 74, "Pharmaceutical Affairs Law" law and "bio-pharmaceutical inspection practices of sealed" requirements by the Food and Drug Agency sent to check the temperature of storage and transportation, those who pass the test or reserve samples required for extraction of the amount of drugs, the test individual who pass on the packaging affixed drug test certificate before sale. People to use public expense and at their own expense influenza vaccine Jieyi Chinese Pharmacopoeia, the implementation of the appearance, identification, pH, formaldehyde, protein content, sterility, bacterial endotoxin, abnormal toxicity, egg protein, and inactivated viral titer, a total of 11 quality safety tests using the vaccines are inspected for people, make people feel at ease vaccination.Meanwhile, the Hong Kong Hospital Authority (HA) has announced the suspension of all flu vaccinations until at least December 1st, as affected vaccines are removed and replenished with new stock.
The following is issued on behalf of the Hospital Authority:Ninety minutes later Hong Kong's CHP issued the following statement:
Following the announcement by the Department of Health (DH) today (November 27) on the immediate suspension of the use of a batch of quadrivalent seasonal influenza vaccines (box label: R3J721V; syringe label: R3J72), the Hospital Authority (HA) spokesperson said today that the HA has informed all public hospitals and out-patient clinics to suspend using influenza vaccines of the affected batches immediately.
The HA has immediately suspended the vaccination service in all public hospitals and out-patient clinics. Meanwhile, the HA has requested the pharmaceutical company concerned to replenish the stock with other unaffected batches of influenza vaccines. The seasonal influenza vaccination service is expected to resume gradually from Saturday (December 1).
As of today, there has been no adverse reaction report related to vaccinations of the affected batches of influenza vaccines. Members of the public feeling unwell after vaccination should seek medical advice. The HA will continue to liaise closely with the Department of Health for an update on the latest situation.
Ends/Tuesday, November 27, 2018Issued at HKT 19:20
The Department of Health (DH) today (November 27) was informed by a licensed drug wholesaler, Sanofi-Aventis Hong Kong Limited (Sanofi), that it has decided to take a precautionary measure to suspend the market supply of a batch of quadrivalent seasonal influenza vaccines (SIVs) (box label: R3J721V; syringe label: R3J72) and arrange to dispatch a new batch of quadrivalent SIVs to local private healthcare facilities as soon as possible.
According to the information provided by Sanofi, around 175 000 doses of the affected batch of SIVs have been imported to Hong Kong and part of the batch has been distributed to the DH, the Hospital Authority and healthcare facilities. Based on the DH’s preliminary statistics, there are around 100 000 doses of unused vaccines in Hong Kong. Sanofi has committed to contact relevant organisations and arrange to dispatch a new batch of vaccines as soon as possible.
"The DH has immediately suspended the use of the affected vaccines. The DH's services, including the Elderly Health Centres, will suspend seasonal influenza vaccination service until the supplier dispatched a new batch of SIVs. On the other hand, the School Outreach Vaccination Pilot Programme under the DH is not affected by the incident as SIVs used under the pilot programme are supplied by another company," a spokesman for the DH said.
The DH also reminded residential care home operators and visiting doctors to pay attention on whether they have procured the affected quadrivalent SIVs. If they have, they should suspend the use of such vaccines and contact Sanofi for relevant arrangements.
"The DH will be in touch with the Hospital Authority and relevant healthcare facilities. We will also closely monitor the relevant arrangements and keep in close contact with Sanofi. So far, the DH has not received any adverse reports in connection with the affected batch of SIVs. Members of the public are advised to consult healthcare professionals if they feel unwell after receiving seasonal influenza vaccination," the spokesman said.
According to the record of Sanofi, more than 20 million doses of quadrivalent SIVs have been supplied around the world in the current influenza season. So far, it has not received any report about the safety of vaccines being affected.
According to Sanofi, samples of the concerned batch of quadrivalent SIVs were found to contain white particles by Taiwan authority. The company said that it has not received any report regarding the presence of white particles in the same batch of SIVs currently supplied to Hong Kong, and that there is so far no evidence showing that the quality, safety or efficacy of the SIVs supplied to Hong Kong have been affected, or that safety risk is imposed to those receiving the vaccines.
The DH has requested Sanofi to submit a full investigation report regarding the presence of white particles in the affected batch of SIVs. The DH has also asked Sanofi and another supplier providing quadrivalent SIVs to Hong Kong to import additional quantities of vaccines to meet the local demand.
Ends/Tuesday, November 27, 2018Issued at HKT 20:57
Early reports suggest none of these tainted vaccines were distributed in Taiwan, and Hong Kong has not reported any adverse vaccine reactions. Hopefully we'll get an explanation from Sanofi of what went wrong in the next few weeks.
Sadly, despite the benefits and excellent safety record of flu vaccines, incidents like these provide aid and comfort to the strident, and well organized, anti-vax brigade.And ultimately, that may produce the biggest negative impact to the public's health to come out of this event.
