Safety of pandemic (H1N1) 2009 vaccines
Are pandemic vaccines safe?
Outcomes of studies completed to date suggest that pandemic vaccines are as safe as seasonal influenza vaccines. Side effects seen so far are similar to those observed with seasonal influenza vaccines.
What about safety for pregnant women?
To date, studies do not show harmful effects from the pandemic influenza vaccine with respect to pregnancy, fertility, or a developing embryo or fetus, birthing or post-natal development. In view of the elevated risk for severe illness for pregnant women infected by the new influenza, in clinical studies, pregnant women are a group that should be vaccinated against infection, as supplies allow.
Recent studies show that infected pregnant women have a 10 times higher chance to require hospitalization in intensive care units than infected persons in the general population, and 7% to 10% of hospitalized cases are women in their second or third trimester of pregnancy. The benefits of vaccination far outweigh the risks.
Additional studies on pregnant women following immunization are continuing.
What about my child’s safety from a reaction?
The most frequent vaccine reactions in children following influenza immunization are similar to those seen after other childhood immunizations (such as soreness at the injection site, or fever). A child’s health care provider or vaccinator can advise on the most appropriate methods for relief of the symptoms. If there are concerns about a child’s safety from a reaction, consult a health care provider as soon as possible. Please note that a child may suffer from a condition not related to immunization, which coincidentally developed after vaccination.
Testing and approval
What kind of testing is being done to ensure safety?
Because the pandemic virus is new, both non-clinical and clinical testing is being done to gain essential information on immune response and safety. The results of studies reported to date suggest the vaccines are as safe as seasonal influenza vaccines. However, even very large clinical studies will not be able to identify possible rare events that can become evident when pandemic vaccines are administered to many millions of people.
WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and report serious adverse events.
Who approves pandemic vaccines for use?
National authorities for medicines approve (or license) pandemic influenza vaccines for use. These authorities carefully examine the known and suspected risks and benefits of any vaccine prior to its licensing. Expedited regulatory processes in some countries have helped to license the new vaccine in a timely manner. However, the testing and manufacturing processes for the new vaccines are similar to seasonal influenza vaccines to ensure quality and safety.
Conversamos?!... 
