Wyeth is the only stockist of Prevenar (pneumococcal vaccine) in Australia. There is a supply shortage until June 2004.
Questions & Answers
Wyeth, the manufacturer of Prevenar Vaccine (for childhood pneumococcal disease) has supplied the following question and answer information due to the current shortage of Prevenar vaccine for the commercial market.
There is no shortage of Prevenar vaccine for the funded schedule for children with medical risk problems and Aboriginal and Torres Strait Islander children according to Victorian requirements.
Q. Why is there a shortage of stock available in Australia for Prevenar?
A. Due to a temporary shutdown of the Prevenar filling line in the US manufacturing facility to make modification and upgrades, the company will experience some supply constraints of Prevenar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) until June.
Q. What are the modifications causing this delay?
A. Wyeth voluntarily extended the shutdown of one of the operations within our manufacturing facility. The operation was shut down to complete preventive maintenance activities, equipment repair and upgrades, and operator training on these changes. We are working to restart operations as quickly as possible to ensure consistent delivery of Prevenar.
Q. How much downtime are you expecting?
A. We are working to implement the planned manufacturing enhancements as quickly as possible and hope to resume supply of Prevenar in June.
Q. Is this product safety related?
A. No. The temporary shut down of the Prevenar filling line in the US manufacturing facility is to undertake preventative maintenance activities, equipment upgrades and operator training on the changes.
Q. Who will get the limited supply of Prevenar in Australia?
A. During the limited period of restricted supply, Wyeth will work in partnership with health authorities to distribute available stocks of Prevenar in the most appropriate manner. Priority has been given to the following groups of infants:
Those infants that identified as being at highest risk and part of the National Childhood Pneumococcal Vaccination Program.
Those infants who less than 12 months of age have already commenced vaccination Prevenar will be set aside for second and third doses.
Q. Can I use another vaccine instead of Prevenar for healthy infants?
A. No, there are no alternatives vaccines for children under two years. Two different types of pneumococcal vaccines are available - Prevenar (conjugate) and Pneumovax 23 (polysaccharide).
The other pneumococcal vaccine available is a polysaccharide type vaccine, Pneumovax 23 from Merck, Sharp & Dohme. This vaccine is effective in older children and adults but does not work well in children younger than two years of age as their immature immune system cannot respond to the vaccine. As such, Pneumovax 23 is not indicated for routine use in children under two years of age.
Prevenar is the only pneumococcal vaccine approved for use in children under two years and is the only one recommended on the Australian Standard Vaccination Schedule for use in all children under 2 years. This is because Prevenar is a conjugate vaccine and young children's immature immune systems are able to generate a good immune response.
Q. How long can I wait for my next Prevenar dose if my child has already commenced vaccination with Prevenar?
A. Doses of Prevenar are usually given at 2, 4 and 6 months on the Australian Standard Vaccination Schedule. There is a minimum interval between doses of 4 weeks however there is no maximum interval between doses of Prevenar, e.g. child who has received one dose of Prevenar at 2 months may be given subsequent doses at 6 and 10 months to complete the primary series. Full protection will not occur until all doses are given.
Q. What do I do if my child has started on Prevenar? ie How do I get the next doses?
A. Children who are less than 12 months of age who have already commenced vaccination need to take their script for their remaining doses (2nd and 3rd doses) to their local pharmacy. Pharmacies will need to call Wyeth customer service directly on 1800 700 802 to place an order. Wyeth will ship Prevenar directly to the pharmacy with the patient's initials. Only 2 doses per patient will be supplied. All wholesalers will be notified of the supply situation in the last week of December. Pharmacists and doctors will be notified in the first week of January. For those doctors with direct accounts with Wyeth, we will continue to supply for children who have commenced vaccination. No new accounts will be opened.
Children who have started their vaccines with the council do not need a script. Please see top of page for children who have started their doses
Q. Will the restricted supply mean higher prices?
A. No. Wyeth will not be changing the wholesale price and would therefore not expect to see any retail price increases.
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