Commercially manufactured Tamiflu for Oral Suspension (12 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules. However, preparation of an oral suspension from the 75 mg Tamiflu Capsules, as described in the FDA-approved labeling resulting in a concentration of 15 mg/ml, may be necessary when the commercial suspension, Tamiflu for Oral Suspension (12 mg/ml), is not readily available in a timely manner because of an actual shortage of the product.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced interim results that show that children nine years of age and younger have a significantly improved immune response when given a second 15-microgram dose of 2009 H1N1 influenza vaccine.

Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

Ensuring that vaccines are as safe as possible is a public health priority and national expectations for vaccine safety are high. A robust plan for monitoring adverse events following immunization (AEFI) during mass vaccination for 2009 H1N1 influenza is an important component to ensure the safety of this novel vaccine. At the federal level, within the United States Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), Health Resources and Services Administration (HRSA), and Indian Health Service (IHS) are involved in vaccine safety research, surveillance, or programmatic activities as well as Department of Veterans Affairs (VA), and the Department of Defense (DoD). The HHS National Vaccine Program Office (NVPO) is responsible for coordinating federal vaccine activities, including vaccine safety.

As of 25 October 2009, worldwide there have been more than 440,000 laboratory confirmed cases of pandemic influenza H1N1 2009 and over 5700 deaths reported to WHO.

The announcement was made at the conclusion of meetings with Chinese officials at the US-China Joint Commission on Commerce and Trade (JCCT).

Influenza viruses evade infection-fighting antibodies by constantly changing the shape of their major surface protein.

Through July 2009, a total of 43,677 laboratory-confirmed cases of 2009 H1N1 were reported in the United States, which is likely a substantial underestimate of the true number.

Waiver or Modification of Requirements under Section 1135 of the Social Security Act

Why do the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) recommend that pregnant women receive seasonal and influenza A (H1N1) 2009 Monovalent vaccines?

CMS Free Care Rule for 2009 H1N1 Influenza Vaccination (PDF - 55 KB)

Currently there is no intravenous formulation of antiviral product approved by the U.S. Food and Drug Administration (FDA) for the treatment of hospitalized patients with influenza.

For questions relating to this Emergency Use Authorization, contact: EUA.OCET@fda.hhs.gov

A printable chart which notes age, dose, manufacturer, number of doses, and route.

Section 1135 of the Social Security Act permits the Secretary of Health and Human Services to waive certain regulatory requirements for healthcare facilities in response to emergencies.

Pneumococcal disease is an infection caused by a type of bacteria called Streptococcus pneumoniae (pneumococcus).

Hospitalized Patients with 2009 H1N1 Influenza in the United States- April-June 2009: Questions and Answers, NEJM

WHO Updates International H1N1 Situation

The U.S. Food and Drug Administration announced today that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

This update provides new information about vaccination and treatment of HIV-infected adults affected by the 2009 H1N1 flu.