Republican Texas Rep. Chip Roy pressed the director of the Center for Biologics Evaluation and Research Peter Marks, who works within the Food and Drug Administration (FDA), demanding answers over the possible approval of the COVID-19 vaccine for the 0-4 age group.
The Daily Caller first obtained the letter, where Roy presses Marks over recent comments about the need to vaccinate infants and toddlers with the COVID-19 vaccine and the potential approval of a COVID-19 vaccine for children under 5 years of age. Roy also calls for answers to multiple questions relating to communication with Pfizer, correspondence or documentation that shows any adverse effects of a COVID-19 vaccine for the 0-4 age group and more.
Roy mentions a Jan. 3 media call with Acting Commissioner Woodcock, where Marks responded to a reporters’ question on approving a COVID-19 vaccine for infants and toddlers, saying: “As for the zero- to five-year age range, although we can’t talk about our actions, we can say that we certainly understand that there is a pressing need [to vaccinate] in that age range, that we understand the hospitalizations that may be occurring in that age range, and we will move with appropriate speed with the appropriate data in hand.” (RELATED: EXCLUSIVE: House Republicans Demand FDA Withdraw Race-Based Criteria For Monoclonal Antibodies)
Here Are The Questions Roy Is Asking The FDA:
- What communication, if any, have you received from Pfizer personnel regarding the potential approval of a COVID-19 vaccine for the 0-4 age group or trials for this age group? For the approval of booster vaccine doses for other age groups under 18? Please provide copies of that correspondence.
- To date, have you received any correspondence or documentation that shows any adverse effects of a COVID-19 vaccine for the 0-4 age group? Please provide copies of that correspondence.
- Is the 0-4 age group at risk of cardiac adverse events (CAE), such as myocarditis, from a COVID19 vaccine? How does this risk compare to other age groups?
- What communication, if any, have you received from any member of the Vaccine and Related Biological Products Advisory Committee regarding a COVID-19 vaccine for the 0-4 age group? For the approval of a booster vaccine for the 12-15 age group? Please provide copies of that correspondence.
READ THE LETTER HERE:
“The long-term risks of COVID-19 vaccines for children are unknown. What we do know is that COVID-19 poses an extremely low risk of death or hospitalization to children. Dr. Marks’ comments are yet another hint at the FDA’s intentions. Congress has a duty to hold these federal health care ‘experts’ accountable, especially as the executive branch triples down on failing policies like mandates for a vaccine that does not prevent the spread of the virus,” an office spokesman told the Daily Caller before sending the letter. (RELATED: EXCLUSIVE: House Republicans Introduce Bill That Would Prohibit Agencies That Received COVID Funds From Issuing Vaccine Mandates)
Roy called for full and separate responses to each question he asked in the letter as well as the documents he requested by Feb. 26.