CBER Response to Lyn Redwood 06-08-18

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From: CBER OCOD Consumer Account <cberocod@fda.hhs.gov>

Date: June 8, 2018 at 3:34:13 PM EDT

To: Lyn Redwood <tlredwood@mindspring.com>

Subject: 18135 RE: Information Request

Dear Ms. Redwood:

Thank you for your follow-up inquiry about vaccine safety. I apologize for the delayed response.

FDA imposes a high standard of safety for vaccines, as the vast majority of the over one billion doses of vaccines manufactured worldwide each year are given to healthy babies, children and adults. FDA ensures that vaccines undergo a rigorous and extensive development program to determine safety, purity and potency. The development programs for vaccines include studies conducted by the manufacturers to evaluate safety and effectiveness in the target population(s). Clinical trials are conducted according to plans that reflect FDA input and review to ensure the highest scientific standards. The results of the clinical trials are evaluated by FDA to assess the safety and effectiveness of each vaccine. Manufacturing data, as well as data from animal studies and human clinical trials, are evaluated by highly trained FDA scientists and clinicians before vaccines are approved for use in the United States. The clinical trials and all other data must show that a vaccine’s benefits outweigh the potential risks for people who will receive the vaccine. Only if a vaccine’s benefits are found to outweigh its potential risks does the FDA approve a vaccine, allowing it to be used by the public.

FDA continues to monitor the safety of approved vaccines through the Vaccine Adverse Event Reporting System (VAERS), a nationwide joint CDC‐FDA post‐marketing passive surveillance program that collects information about adverse events that are reported to occur after vaccines are administered.

In addition to VAERS, The Sentinel Initiative is FDA’s national electronic surveillance system for the post‐market safety monitoring of medical products. The Sentinel System was implemented as an Active Post‐Market Risk Identification and Analysis program in response to section 905 of the Food and Drug Administration Amendments Act of 2007. The Post‐Licensure Rapid Immunization Safety Monitoring (PRISM) System, the vaccine safety portion of the Sentinel system, was initiated in 2009 as one of several national vaccine safety surveillance systems deployed during the H1N1 influenza pandemic. The PRISM database covers more than 171 million individuals in a number of data partner organizations. PRISM, which has capabilities for broad‐based signal detection as well as for evaluating safety signals that may be identified, is used by FDA to evaluate vaccine safety in the post-licensure setting.

FDA evaluates safety signals as they arise, and takes appropriate steps as needed, such as communicating vaccine safety information to the public and healthcare providers and requiring manufacturers to change the prescribing information. FDA also routinely reviews peer‐reviewed scientific medical literature as part of its post‐marketing safety monitoring for vaccines.

The term adverse event refers to any untoward medical event associated with the use of a drug (including vaccines) in humans, whether or not the event is considered drug-related. For purposes of prescription drug labeling, an adverse reaction is an undesirable effect, reasonably associated with the use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event. The labeling of each approved vaccine must describe the overall adverse reaction profile based on all available safety information. An adverse event will be listed if there is a basis to believe that it was caused by the vaccine. FDA has issued a Guidance for Industry on this subject that you may find helpful: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075057.pdf.

In addition, FDA works with our international counterparts to share data on vaccine safety signal detection and evaluation and improving methodologies.

I hope this information is helpful.

Sincerely,

Amy Temple

Consumer Safety Officer

Center for Biologics Evaluation and Research
Office of Communications, Outreach and Development
U.S. Food and Drug Administration

Tel: 800-835-4709

OCOD@fda.hhs.gov

This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.

—–Original Message—–

From: Lyn Redwood [mailto:tlredwood@mindspring.com]

Sent: Tuesday, May 29, 2018 9:10 PM

To: CBER OCOD Consumer Account <cberocod@fda.hhs.gov>

Subject: Information Request

Dear Amy,

I was inquiring about the process for adding an adverse event to a vaccine package insert.  Can you please provide details regarding how such decisions are made?

Sincerely,

Lyn Redwood