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Repair Windows errors before they cause bigger problemsFix Now →Scan for outdated or missing drivers - takes under a minuteDriver Scan →On October 24, 2006, USDA’s Animal and Plant Health Inspection Service (APHIS) approved Boehringer Ingelheim Vetmedica’s Ingelvac CircoFLEX for swine against diseases caused by porcine circovirus type 2 (PCV2). The announcement described a single-dose vaccine intended for young pigs before exposure. Current regulatory records show that Boehringer Ingelheim still holds licensed porcine circovirus products, while the current Ingelvac CircoFLEX leaflet sets the practical age, protection, storage and withdrawal details for its covered market.
What APHIS approved in 2006
The historical announcement, published October 24, 2006, concerned Ingelvac CircoFLEX, a vaccine for swine diseases associated with PCV2. Boehringer Ingelheim described it as a single-dose product that could immunize pigs as young as three weeks before PCV2 exposure. The company expected U.S. producer availability in the first quarter of 2007.
Klaas Okkinga, then a Boehringer Ingelheim Vetmedica marketing manager, said the vaccine was intended to protect pigs without “the systemic irritation and tissue reactions some vaccines can cause.” That statement is a launch-era company comment, not a current universal claim for every regional label.
Historical launch details versus a current label
| Item | October 2006 U.S. announcement | Current Ingelvac CircoFLEX leaflet details |
|---|---|---|
| Purpose | Protection of swine against diseases caused by PCV2 | Active immunisation against PCV2-associated disease |
| Age mentioned | As young as three weeks before exposure | From two weeks of age |
| Dosing | Single dose | One 1 ml intramuscular injection |
| Withdrawal | 21 days in the launch statement | Zero days on the current leaflet |
| Availability | Expected first quarter of 2007 | Depends on the country’s authorization and veterinary supply chain |
The differing withdrawal periods illustrate why the date and jurisdiction must accompany any product claim. A historical U.S. announcement should not be substituted for the instructions on the label currently supplied in a particular country.
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What Ingelvac CircoFLEX contains and how it is given
The current leaflet calls the product “Ingelvac CircoFLEX suspension for injection for pigs.” Each 1 ml dose contains the porcine circovirus type 2 ORF2 capsid protein with carbomer adjuvant. The product is administered as a single intramuscular injection.
APHIS’s product-summary record identifies a U.S. Boehringer Ingelheim product under code 19K5R9 as “Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector,” with trade name Ingelvac CircoFLEX AD and target species listed as swine. The record does not specify a distributor.
Which pigs can be vaccinated, and when does protection begin?
Minimum labeled age
The current leaflet permits vaccination from two weeks of age. This is a current leaflet instruction and should not be generalized to every CircoFLEX presentation or country.
Onset and duration
Onset of immunity is listed as two weeks after vaccination. Duration of immunity is listed as at least 17 weeks. These figures describe the labeled protection period; they do not replace a herd veterinarian’s timing plan for expected exposure, maternal antibodies, disease pressure or follow-up vaccination.
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Vaccinate healthy animals
The leaflet instructs users to vaccinate healthy animals only. A veterinarian should assess pigs that are febrile, clinically ill, severely stressed or otherwise unsuitable for routine vaccination.
What protection has been documented?
The current product information describes reductions in several PCV2-related outcomes:
- mortality;
- clinical signs, including weight loss;
- lymphoid-tissue lesions;
- PCV2 nasal shedding;
- viral load in blood and lymphoid tissues; and
- the duration of viraemia.
These are disease and infection measures listed in the product information, not a single percentage efficacy figure. The available material does not establish one universal effectiveness percentage for all herds, management systems or PCV2 exposure patterns.
Storage, withdrawal and prescription requirements
Cold-chain handling
- Store and transport refrigerated at 2–8°C.
- Do not freeze.
- Protect from light.
- Use immediately after first opening.
Breaks in refrigeration, freezing or prolonged exposure after opening can make a regulated biologic unsuitable for use. Follow the package leaflet and veterinary-supply procedures rather than trying to restore a compromised vial.
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Food-animal withdrawal
The current leaflet states a zero-day withdrawal period. That is separate from the 21-day withdrawal period reported in the October 2006 launch announcement; the applicable requirement is the one on the product authorized and supplied in the relevant jurisdiction.
Prescription status
The current leaflet classifies Ingelvac CircoFLEX as prescription-only. Pig owners should obtain it through a veterinarian or an authorized veterinary distributor and use it under the directions for the locally authorized product.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.How current APHIS records fit the story
APHIS publishes summaries of safety and efficacy studies used to license USDA-regulated veterinary biologics. Its search system can be queried by manufacturer, trade name, product number or microbial agent. The current APHIS record for product code 19K5R9 lists Ingelvac CircoFLEX AD for swine. APHIS also lists FLEXCircoPRRS, product code 19P9R1, a related combined porcine reproductive and respiratory syndrome–circovirus vaccine for swine.
A listing in the APHIS summary system confirms a regulatory product record; it does not mean that every presentation is sold in every country or that the instructions on one regional label apply elsewhere.
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Before ordering
- Confirm the exact trade name, presentation and country authorization.
- Check the minimum age, dose, route, onset and duration on that product’s current leaflet.
- Confirm prescription requirements and an authorized supply route.
Before administration
- Verify the cold chain remained between 2 and 8°C and that the vaccine was not frozen.
- Check the expiry date, appearance and package integrity.
- Vaccinate only healthy pigs and use the labeled intramuscular route.
After vaccination
- Record the product, batch, date, dose, route and animals treated.
- Monitor for unexpected reactions and contact the attending veterinarian if they occur.
- Do not infer that a zero-day withdrawal label eliminates the need to follow food-animal recordkeeping and local veterinary rules.
Bottom line for readers today
APHIS’s October 2006 approval introduced Ingelvac CircoFLEX as a single-dose PCV2 vaccine for swine. The current leaflet describes a 1 ml intramuscular dose from two weeks of age, immunity beginning after two weeks and lasting at least 17 weeks, zero withdrawal days, and refrigerated 2–8°C storage. Because approval, labeling and availability are jurisdiction-specific, use the current leaflet and veterinary direction for the product actually supplied to your herd.
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