Safety monitoring to detect and quickly investigate any unexpected, rare or serious adverse events with the H1N1 vaccine has earned a “very encouraging” assessment from Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M.D.

The FDA, the Centers for Disease Control and Prevention (CDC), and other agencies across the Department of Health and Human Services, and other parts of the federal government, including the Department of Defense and the Department of Veterans Affairs, have enhanced and expanded their vaccine safety monitoring systems and provided a detailed description of vaccine safety efforts, which can be found online at

The monitoring efforts involve two different surveillance systems, the Vaccine Adverse Event Reporting System (VAERS) and the CDC’s Vaccine Safety Datalink (VSD). The FDA and CDC are assessing the H1N1 vaccine safety data on a continuing basis and have published a detailed report  on the safety profile of the 11.3 million doses of live, attenuated monovalent vaccine (LAMV) for intranasal administration and 34.9 million doses of monovalent, inactivated, split-virus or subunit vaccines for injection (MIV) that were distributed.

As of November 24, 2009, the FDA and CDC evaluated 3,783 reports of adverse events reported to VAERS and found no increase in any of the pre-selected adverse events under surveillance, such as Guillain-Barre syndrome.

Monitoring of activities as of December 30, 2009, during which a total number of vaccines distributed was 99.3 million, the vast majority (94 percent) of adverse events reported to VAERS were classified as “non-serious” with symptoms such as soreness at the vaccine injection site.

“To date, our experience with the H1N1 influenza vaccination program has met high safety expectations, based on the track record of the licensed seasonal vaccines, including live attenuated and inactivated vaccines. We are also collaborating with other agencies around the world to share our vaccine safety information and experiences. Should any safety concerns arise, we will evaluate them thoroughly and bring them to the public’s attention quickly,” Dr. Hamburg said in her update.

While H1N1 influenza disease transmission appears to be waning, Dr. Hamburg says that there is a significant possibility that the disease will return. Twelve states – California, Georgia, Hawaii, Indiana, Maine, Nevada, New Hampshire, New Jersey, New Mexico, New York, Tennessee, and Virginia – continue to report regional influenza activity. As a result, everyone, especially those in high-risk groups, are encouraged to get the H1N1 vaccine as soon as it becomes available to them in their communities.

“While antiviral resistance remains at low levels, future potential development of resistance is still a concern, so immunization is the best protection,” Dr. Hamburg urged. 

We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Beasley Allen attorney Danielle Mason warns of...

Could your medication be harming you? New drugs are approved by the FDA before they go to market, to...

Blood pressure medication linked to fetal injury, death

Women who are pregnant should avoid drugs used to treat hypertension, or high blood pressure, because...

Topamax linked to birth defects

Women of childbearing age who take the prescription medication Topamax should be aware that new studies...

Buyers Beware: Generic drug makers not required to...

A Supreme Court ruling on June 23 reversed separate U.S. appeals court rulings that would have held...

Popular diabetes drug linked to cancer

The FDA is evaluating Actos for a possible link to bladder cancer. Preliminary results from a long-term...

SSRI antidepressants increase risk of birth defects

A new study has verified that antidepressants known as selective serotonin reuptake inhibitors (SSRIs)...

A positive manner

Several years ago my brother and sister -in-law were in a terrible car accident. My sister in-law was paralyzed from her neck down. Beasley Allen handled the case for my brother to see to it that my sister-in-law received the proper and necessary care she needed. I appreciate the attorneys and staff of Beasley Allen in handling this matter quickly and in a positive manner. Good job Beasley Allen!!