INFLUENZA VACCINE, FLUVIRIN, RECALL (from FDA/CBER)

[Giuseppe]

Hong Kong: DH closely monitors the recall of influenza virus vaccine (2/9/2009) [DH]

In response to media enquiries, a spokesman for the Department of Health (DH) said today (February 9) that DH was closely monitoring the recall of influenza virus vaccine manufactured by the British manufacturing plant of a drug company.


According to United States Food and Drug Administration, Novartis Vaccines and Diagnostics Inc has requested customers to immediately discontinue the use of and return any remaining doses from five lots of FLUVIRIN Influenza vaccine Luer-Lok pre-filled syringes, manufactured in Britain.

Routine stability testing of FLUVIRIN revealed a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine.

The lots affected bear the following lot numbers: 878771P, 878772P, 878773P, 878775P, 878776P.

The spokesman said that according to DH's records, FLUVIRIN has not been imported into Hong Kong.

"The Influenza virus vaccines manufactured by Novartis available in Hong Kong are manufactured in the company??s manufacturing plant in another country and are tested to be effective for the current strains of influenza virus recommended by the World Health Organization,'' he said.

"The DH will continue to closely monitor the recall and keep the public posted of the latest developments."
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[Giuseppe]

Re: INFLUENZA VACCINE, FLUVIRIN, RECALL (from Hong Kong Department of Health)

Re: INFLUENZA VACCINE, FLUVIRIN, RECALL (from Hong Kong Department of Health)

Novartis recalls Fluvirin VACCINE---U.S./U.K. total recall info

RECALL INFORMATION
Feb 4
---

Novartis recalls Fluvirin

VACCINE
---
U.S./U.K.Manufacturer: See Below
Product: Medical
Start Date: 2009-02-04
End Date: 2009-03-04
FLUVIRIN ? (Influenza Virus Vaccine) Luer-Lok pre-filled syringes

LOT NUMBER / EXPIRATION DATE:
Lot Number - Expiration Date - 878771P 05 / 2009 - 878772P 05 / 2009 - 878773P 05 / 2009 - 878775P 05 / 2009 - 878776P 05 / 2009

MANUFACTURER:Novartis Vaccines and Diagnostics Limited - Liverpool United Kingdom
REASON:Novartis Vaccines and Diagnostics Inc. has requested their customers to immediately discontinue use of and return any remaining doses they may have from five lots of FLUVIRIN? Influenza vaccine Luer-Lok pre-filled syringes.

Routine stability testing of FLUVIRIN in prefilled Luer-Lok syringes revealed a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine.

The vaccine met all required specifications at the time of release and has been monitored in monthly time intervals during its shelf life; it has consistently met specification until the most recent test point in early January 2009 that identified a minimal decrease in H1N1 antigen content.

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and Novartis Vaccines have agreed that no public health impact is expected because
1) all of the affected vaccine was shipped when the vaccine met potency requirements,
2) most influenza vaccine in the US is administered during October and November, months when the vaccine met potency requirements, and
3) the decrease in antigen content is small and would have a negligible if any effect on immune response to vaccination.
Revaccination of patients that have been vaccinated with the affected lots is not necessary
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​

<cite cite="http://www.totalrecallinfo.com/freerecalls.php?id=9394">Novartis recalls Fluvirin VACCINE---U.S./U.K. total recall info</cite>

 

[Giuseppe]

Re: INFLUENZA VACCINE, FLUVIRIN, RECALL (from Hong Kong Department of Health)

Re: INFLUENZA VACCINE, FLUVIRIN, RECALL (from Hong Kong Department of Health)

FDA/CBER - Important Notification: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes - Novartis Vaccines and Diagnostics Limited

Important Notification

FLUVIRIN ? (Influenza Virus Vaccine) Luer-Lok pre-filled syringes

DATE NOTIFICATION INITIATED:February 4, 2009

LOT NUMBER / EXPIRATION DATE:
Lot Number / Expiration Date: 878771P 05 / 2009 - 878772P 05 / 2009 - 878773P 05 / 2009 - 878775P 05 / 2009 - 878776P 05 / 2009

MANUFACTURER:
Novartis Vaccines and Diagnostics Limited - Liverpool United Kingdom

REASON:
Novartis Vaccines and Diagnostics Inc. has requested their customers to immediately discontinue use of and return any remaining doses they may have from five lots of FLUVIRIN? Influenza vaccine Luer-Lok pre-filled syringes.Routine stability testing of FLUVIRIN in prefilled Luer-Lok syringes revealed a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine. The vaccine met all required specifications at the time of release and has been monitored in monthly time intervals during its shelf life; it has consistently met specification until the most recent test point in early January 2009 that identified a minimal decrease in H1N1 antigen content.

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and Novartis Vaccines have agreed that no public health impact is expected because
1) all of the affected vaccine was shipped when the vaccine met potency requirements,
2) most influenza vaccine in the US is administered during October and November, months when the vaccine met potency requirements, and
3) the decrease in antigen content is small and would have a negligible if any effect on immune response to vaccination. Revaccination of patients that have been vaccinated with the affected lots is not necessary.
-
​

<cite cite="http://www.fda.gov/CBER/recalls/novflu020409.htm">FDA/CBER - Important Notification: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes - Novartis Vaccines and Diagnostics Limited</cite>

 

[HenryN]

Re: INFLUENZA VACCINE, FLUVIRIN, RECALL (from Hong Kong Department of Health)

Re: INFLUENZA VACCINE, FLUVIRIN, RECALL (from Hong Kong Department of Health)

FDA/CBER - Important Notification: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes - Novartis Vaccines and Diagnostics Limited

3) the decrease in antigen content is small and would have a negligible if any effect on immune response to vaccination. Revaccination of patients that have been vaccinated with the affected lots is not necessary.
-
​

<CITE cite=http://www.fda.gov/CBER/recalls/novflu020409.htm>FDA/CBER - Important Notification: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes - Novartis Vaccines and Diagnostics Limited</CITE>

The CDC disclaimer in its weekly reports (starting at week 2) suggest a more general vaccine failure.