Contraindication guidelines to flu vaccine cut down in KOR

Contraindications apply to patients with severe hypersensitivity reaction…patients with chronic disease are removed from the list of contraindications

The Ministry of Food and Drug Safety (MFDS) plans to significantly reduce the list of contraindications for influenza (flu) vaccines.

 

The MFDS has decided to create a new set of recommended guidelines because the previous contraindications were deemed inconsistent with current clinical practice and international standards.

 

The MFDS collected public opinion on the recommended guidelines for contraindications and precautions for inactivated influenza vaccines until September 19.

 

Most flu vaccines are inactivated vaccines (made from killed viruses).

 

The new recommendations reduced the number of contraindications to two: ▲Individuals with a severe hypersensitivity reaction to any of the vaccine's components (active ingredients and excipients) or to egg ingredients (ovalbumin, egg protein), formaldehyde, or polysorbate ▲Individuals who have previously had a severe hypersensitivity reaction (e.g., anaphylaxis) to an influenza vaccine.

 

In addition to contraindications, a new category for cautious administration group was also established.

 

This category includes three key points: ▲Caution should be exercised when administering intramuscular injections to individuals with thrombocytopenia or coagulation disorders, as bleeding may occur ▲For individuals who have a history of developing Guillain-Barre syndrome or other neurological disorders within six weeks of a previous influenza vaccination, the benefits and risks of vaccination should be carefully considered ▲Vaccination should be postponed for individuals with a severe febrile illness or acute illness.

 

According to the current vaccination approval, the listed contraindications are over 10, where items may vary.

 

For example, ▲Individuals with fever or severe malnutrition ▲Patients with cardiovascular diseases, kidney disease or liver disease whose disease states are in aggressive state, middle state, or active state ▲Patients with acute respiratory disease or active infectious disease.

 

However, in clinical practice, these patient groups, particularly those with chronic diseases, are strongly encouraged to get vaccinated.

 

The MFDS official explained, "The influenza vaccines were approved a long time ago, so they don't align with today's reality or international standards.

 

This is why we have prepared these new recommendations." The new recommendations were established at the request of pharmaceutical companies.

 

Meanwhile, approximately 28 million doses of flu vaccine are scheduled to be supplied in the second half of this year.

 

Seven domestically manufactured products, including those from companies such as Green Cross and SK Bioscience, as well as seven imported products from companies like GSK and Sanofi, will be available.

 

Sanofi announced that it has been supplying its trivalent flu vaccine, 'Vaxigrip,' nationwide since September 3.