FDA Approves New Influenza Vaccine For Adults Over 65

Recently, the U.S. Food and Drug Administration has approved a new influenza vaccine called Fluzone® High-Dose Quadrivalent. It is a more advanced form of the previous Fluzone vaccine specified for adults aged 65 and over.

Currently, the only vaccine given for the prevention of influenza is the trivalent formula that received approval by the FDA in 2009. It contained one influenza B strain and two influenzas A strains. On the other hand, High-Dose Quadrivalent has an additional B strain in its formula for better protection.

David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur states that such developments are mandatory for improvement of public health. He also adds that the vaccine has also filed for approval outside the US and may receive one from the European Union in the spring of the coming year.

The biological license provided by the U.S. Food and Drug Administration was the final step of the company’s procedure of switching entirely to quadrivalent influenza vaccines. The new vaccines will be available in the flu season of 2020-21. In the season of 2019-20, Sanofi Pasteur will continue the usage and delivery of the previous trivalent vaccines.

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Influenza is a serious threat to public health, especially in the older adult population. The senior Vice President, Global Research and Development, Sanofi Pasteur, John Shiver comments that the Fluzone High-dose quadrivalent vaccines are a big step in improving the performance of the vaccines. Fluzone High-Dose has helped millions of people worldwide and will continue doing so in their journey.

The quadrivalent vaccines gave similar systematic and local results to those of the trivalent formula in its study trials. During the immunization process, the common reactions after having the vaccines were myalgia in 22.7 percent people, pain at the injection site in 41.3 percent of the people, the malaise in 13.2 percent, and headache in 14.4 percent of the people.

These reactions usually appeared in the first three days of receiving the quadrivalent vaccine. However, all symptoms were also resolved after a time period of two to three days. The results of the study appeared in the journal Vaccine in September of 2019.

Furthermore, the trial also showed that Fluzone High Dose is the only vaccine that has better and improved effects in comparison with Fluzone in adults aged 65 and older. In the study, around 32,000 adults were observed for two influenza seasons in Canada and the United States.

After the evaluation of the results, the results showed that the new vaccine successfully prevents 24 percent more cases of influenza caused by any of the known strains as well as 51 percent more cases caused by strains also present in the vaccine.

While Fluzone High Dose has more systematic and injection site reactions in comparison with the previous vaccine, it also shows better and more effective results. There are, however, some important safety precautions regarding the new vaccine.

Fluzone High-Dose Quadrivalent is not suitable for people who have had any allergic reactions to the components of its formula such as egg products or after having any influenza vaccine before.

It is important to consult a healthcare provider in case of any severe reaction including allergies, breathing problems, or muscle weakness as soon as possible.

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