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recall of Sanofi-Pasteur vaccines (not a safety issue)
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Anonymous
| So I wonder if they tested all of the lots that were shipped out? This whole thing definitely feels like they are figuring it all out as they go along.... |
Anonymous
| Great, I spent two Saturday's getting the shot for my 18 month old and she may not be fully protected. |
Anonymous
| Both of DD's shots were the Sanofi-Pasteur shots. In both cases, the nurses carefully documented the shot before they gave it to her. Do you think the clinics will try to contact those who received these recalled doses? Or is it worth a call to the clinics? We received the first dose at Farragut travel and the 2nd through Montgomery County. I wonder what the effectiveness is with two shots? |
Anonymous
|
According to the CDC, the kids receiving this shot are fully protected. This is DIRECT from the CDC (an update I received this morning from work). I will quote directly from it: "CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason, there is no need to revaccinate persons who have received vaccine from these lots."
Non-Safety Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes Summary As part of its quality assurance program, Sanofi Pasteur, Inc., performs additional routine, ongoing testing of influenza vaccines after the vaccine has been distributed to health care providers to ensure that vaccines continue to meet required specifications. In recent testing of the amount of antigen in its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels. The manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine. Background After performing these tests, Sanofi Pasteur notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) that the antigen content in one lot of pediatric syringes that had been distributed to providers was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that had fallen below pre-specified limits. This means that doses from these four vaccine lots no longer meet the specifications for antigen content. Recommendations While the antigen content of these lots is now below the specification limit for the product, CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason, there is no need to revaccinate persons who have received vaccine from these lots. Providers are being asked to return any vaccine to the manufacturer in the following lots that remains unused to the manufacturer: • 0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA UT028DA UT028CB • 0.25 mL pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70): UT030CA These lots were shipped in November and are intended for children 6 months through 35 months of age. Sanofi Pasteur will send directions for returning unused vaccine from these lots to providers. All vaccines are thoroughly tested prior to release and shipping to determine that they meet all manufacturer and FDA standards for purity, potency and safety. The affected vaccine met all specifications at the time of release. CDC and FDA have determined that there are no safety concerns for children who have received this vaccine. Sanofi Pasteur has discontinued distribution of the 0.25 mL syringes of H1N1 pediatric vaccines. The drop in antigen content below the required specification that is described here is specific to Sanofi Pasteur’s pediatric H1N1 monovalent vaccine in 0.25 mL pre-filled syringes. The same vaccine packaged in other forms, such as 0.5 mL pre-filled syringes for older children and adults and multi-dose vials, continue to meet specifications. The antigen content in the affected lots of vaccine is only slightly below the specification limit. The slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response. There is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. So, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine. For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials is safe and effective vaccine for children. One difference between vaccine in pre-filled syringes and the multidose vials is that the multidose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation for administration to infants 6-35 months old is the same as for the pre-filled syringes, 0.25 mL. For healthy children at least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is also an option. The nasal spray vaccine is produced in single units that do not contain thimerosal. For More Information: • For Questions and Answers related to the withdrawn vaccine see http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm • Call CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, which is available 24 hours a day, every day. |
Anonymous
|
If they are fully protected, then why bother with the recall?
Oh well, I guess time will tell. At least it wasn't anything dangerous. |
Anonymous
It's a logistical thing. There are regulations etc. and they said X was in the shot and even if it isn't a big deal, they have to do follow the rules. |
Anonymous
It's the opposite of that. They are doing systematic testing of product already in the field to make sure it continues to meet the specifications throughout the season. They are noting and publicly reporting a small change in the antigen content post-production. So what you are really seeing is an abundance of vigilance. You can bet that the average medication is not getting this level of monitoring. |
Anonymous
| and you know this how? |
Anonymous
| If your kids got these, how do you feel about it? I don't know if my DD did or not and well, i'm not sure what to think. I guess I would like to know 1) why this happened (i.e., the potency drop), and 2) how MUCH. They say slight, but I wonder how slight. |
Anonymous
I'm disappointed, but something's better than nothing. If he gets swine flu, he gets it. I just don't want him to die from it. This antigen-sticking-to-the-vial thing has apparently happened in other vaccines, not just the H1N1. I wonder if that means, however, they'll add another ingredient in order to prevent that from happening, and I am generally a fan of the fewer ingredients, the better. So that's a bit of a concern for future vaccines. |
Anonymous
I didn't know that. You'd think they'd realize this by now? WHere'd you hear this? |
Anonymous
| For the PP that asked about the amount of drop, I think I read somewhere that the drop in potency was 12%. Try googling sanofi recall twelve percent. To the PP who got the shot at Montgomery County, you should have gotten a pink slip of paper from them with the lot number on it. You might be able to call the travel clinic, too, and ask them for the lot number. (I called our ped and got the lot number; even though we got the single-dose shot from Sanofi, it was not one of the four recalled lots.) |
Anonymous
Well, I know the issue was minor because I read the CDC statement that says the potency is on the borderline of acceptable. I know that it is routine because this class of medication is always subject to stability testing, which is the term used to describe the tests to determine how a medication performs/degrades over its shelf life. And as for what I said about most medications, I know that the guidelines for stability testing of OTC drugs just came out in the summer of this year, so most medicine you take has been unregulated for stability until that point. It would be nice if you attempted to contribute in a post instead of just shooting off snarky one-liners. |
Anonymous
It was on WTOP. Experts have a theory that the problem is specific to the children's pre-filled syringes. For some reason, the antigen _ the key vaccine ingredient _ may be sticking to the walls of those syringes, said Dr. Jesse Goodman, the FDA's deputy commissioner for science and public health. Another manufacturer, Novartis, in February recalled five lots of seasonal flu vaccine packed in pre-filled syringes under similar circumstances. http://www.wtop.com/?nid=106&sid=1770336 |