Methods and compositions to inhibit adverse effects associated with vaccinations
Inventors
Iversen, Jacqueline M. • Dahl, Thomas A.
Assignees
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Publication Number
US-11793800-B2
Publication Date
2023-10-24
Expiration Date
Abstract
The invention relates to methods of inhibiting side effects associated with vaccination in a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject before the subject is vaccinated, wherein the pharmaceutical composition comprises: a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine and cetirizine and combinations thereof.
Core Innovation
The disclosure describes methods of inhibiting side effects associated with vaccination in a human subject in need thereof. The methods include administering an effective amount of a pharmaceutical composition before vaccination so that vaccination-associated side effects are inhibited in the human subject. The pharmaceutical composition consists essentially of a non-steroidal anti-inflammatory drug (NSAID) and a co-agent selected from fexofenadine, ketotifen, desloratadine, and cetirizine and combinations thereof.
The disclosure further addresses vaccination-associated side effects that may be inhibited, including injection site pain or soreness, congestion and coughing, fever, and muscle/joint pain or flu-like symptoms. Example compositions and embodiments include selection of particular NSAID/co-agent combinations, including naproxen sodium with fexofenadine, and use with vaccination regimens that may include an influenza vaccine. The disclosure states that the NSAID plus the antihistamine co-agent combination provides a synergistic effect.
The disclosure also includes an embodiment in which the pharmaceutical composition is administered within about 48 hours after vaccination, while the composition is still defined as consisting essentially of an NSAID and the co-agent selected from fexofenadine, ketotifen, desloratadine, and cetirizine and combinations thereof. The disclosure states that concerns that NSAIDs may reduce vaccine efficacy are addressed by the timing of administration, and reports reduced flu-like symptoms and reduced injection site pain in an example unit dose embodiment (JMI-001).
Claims Coverage
Two independent claims are directed to methods for inhibiting vaccination-associated side effects by administering an effective amount of a pharmaceutical composition that consists essentially of an NSAID plus a selected co-agent, with differing timing relative to vaccination. Across the independent claims, the inventive features focus on the specific composition definition and the timing of administration before versus within about 48 hours after vaccination.
Inhibiting vaccination-associated side effects by pre-vaccination administration of an NSAID plus selected antihistamine co-agent
Administering an effective amount of a pharmaceutical composition before the subject is vaccinated, wherein the pharmaceutical composition consists essentially of a non-steroidal anti-inflammatory drug (NSAID) and a co-agent selected from fexofenadine, ketotifen, desloratadine and cetirizine and combinations thereof, and wherein the vaccination-associated side effects are inhibited in the human subject.
Inhibiting vaccination-associated side effects by within-48-hours post-vaccination administration of an NSAID plus selected antihistamine co-agent
Administering an effective amount of a pharmaceutical composition within about 48 hours after the subject is vaccinated, wherein the pharmaceutical composition consists essentially of a non-steroidal anti-inflammatory drug (NSAID) and a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine and combinations thereof, and wherein the vaccination-associated side effects are inhibited in the human subject.
The independent claims cover inhibition of vaccination-associated side effects using a pharmaceutical composition consisting essentially of an NSAID plus a selected co-agent from fexofenadine, ketotifen, desloratadine, and cetirizine (or combinations), with the primary distinction being administration before vaccination versus administration within about 48 hours after vaccination.
Stated Advantages
Inhibits side effects associated with vaccination in the human subject.
States a synergistic effect with the NSAID plus the co-agent combination.
Reports reduced flu-like symptoms and reduced injection site pain in an example embodiment.
Addresses concerns that NSAIDs may reduce vaccine efficacy by using timing of administration.
Documented Applications
Inhibiting vaccination-associated side effects in a human subject, including use with an influenza vaccine.
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