ICAN’s most recently filed Citizen Petition to the FDA is, perhaps, the most important one filed to-date. Approaching what appears to be the imminent licensure of Pfizer’s COVID-19 vaccine, ICAN’s legal team submitted a Citizen Petition demanding essential and specific data be required by the FDA before it licenses a vaccine for COVID-19. These requested data are vital to ensuring both safety and efficacy of the vaccine before any approval by the FDA.
Despite valid safety and efficacy concerns, COVID-19 vaccines have been and likely will continue to be mandated indiscriminately for groups that, for different reasons, have essentially zero or close to zero risk of serious complications from COVID-19.
Because of the compelling need to ensure the safety and efficacy of any COVID-19 vaccine approved by the FDA, including whether or not the risks do not outweigh the benefits, particularly in certain age categories, and in the face of such indiscriminate mandates, ICAN has requested that the FDA require that the following data be submitted to the FDA for review before approving any vaccine for COVID-19:
- Documentation of adverse events and reactions for at least twenty-four months for adults, thirty-six months for children and sixty months for infants and toddlers, or such longer duration as appropriate, and in no event ending prior to the subject reaching eight years of age;
- Data demonstrating that safety risks do not outweigh potential benefits for any age for which the vaccine is approved;
- Data reflecting that the vaccine does not cause DNA integration and germline transmission;
- Data on the safety and efficacy of the vaccine in individuals who currently have or have had a SARS-CoV-2 infection;
- Results of reproductive testing including proper immunological studies looking at potential reactivity of the vaccinated against the Syncytin 1 and 2 proteins;
- PCR tests used to qualify an event of COVID-19 for a trials’ endpoint use a maximum of 28 amplification cycles; and
- Accurate data reflecting actual risk reduction and number needed to vaccinate to prevent one case of COVID-19.
ICAN requests you write in support of this petition here. Please visit the FDA docket and click on the blue “Comment” button to submit supportive data or statements.
Please add your voice to the growing chorus demanding that the FDA do its job and put the safety of the people ahead of any other interests.