Demand Action

Call On Congress

Representative Outreach

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Suggested Email Script

Dear XXXX,

To date, more than 400 children under the age of five have died from COVID. During the omicron wave, children under 5 have been hospitalized at the same rates as adults aged 18-49. Thousands more are suffering from serious issues such as MIS-C, increased risk of diabetes, and other complications.The imminent end to public health precautions, such as universal masking at schools, dramatically increases risk to our youngest children as it greatly increases the risk that their big siblings will bring infection home from school with them. This puts families in impossible situations of deciding between in-person school or protecting their young children. The situation could not be more dire. Moreover, we are now learning that Omicron hits babies and young children harder than previous variants, causing croup and bronchiolitis. It may be months or years before we can fully appreciate the toll of pediatric long COVID.

The FDA’s decision to postpone the February 15th meeting to review the Pfizer trial data for children under 5 and instead review the data behind closed doors comes as a blow for transparency and institutional credibility. Regardless of what the data might have shown, regulators had an obligation to proceed with their plans for public discussion. The FDA’s expand-and-delay approach to pediatric trials is unconscionable during a surge that has disproportionately affected babies and toddlers.

Our leaders acted with great urgency to make vaccines available to adults. We must now act urgently to protect our children under 5 years old. Many face daily, high-risk exposure in childcare. The only tool available to protect children in this age group is complete isolation, a “luxury” few families can afford. Babies and toddlers under the age of 2 cannot mask, and children between the ages of 2 and 4 must remove their masks to eat and nap. 

We implore you to help make life saving vaccines accessible to our youngest children.  I respectfully ask for your support in the following:

  1. Call on FDA Commissioner Califf to consider Moderna’s submission for an EUA for their under-6 vaccine independent of the myocarditis issues present for teenages and young adults. Myocarditis is linked to puberty’s release of testosterone, which is not a concern for young children.  We understand a waiver might need to be issued by the FDA for this EUA to comply with the Pediatric Research Equity Act; if Moderna’s data indicate its vaccine is safe and effective, then the FDA should issue such a waiver. 

  2. Urge the FDA to be transparent and publicly share trial data and evaluation process for the Covid-19 trials . Trust is already eroding in our health agencies, and withholding data only harms public health.  Parents and physicians deserve to know why there are delays and why the FDA made decisions that have impacted vaccine access for children under 5.

  3. Call on the CDC director to enable joint decision-making between willing parents and pediatricians to vaccinate off-label. In Germany, over 40,000 children under 5 have already been protected in this way. Off-label prescribing is a fundamental right for pediatric physicians with strong precedent. The explicit prohibition of off-label use in the provider agreement for covid vaccines is highly unusual and unjustified.

I would appreciate a meeting to discuss this issue in more detail.  I would also request that you ask your colleague Sen. Murray, who chairs the HELP Committee, to organize joint letters on behalf of senators and make these requests to the FDA and CDC.


Thank you,

XXX

Senate Outreach

Please note that the following representatives sent a joint letter last August to the FDA demanding the status on emergency use authorization for Covid vaccines for children under 11.  There are two versions of this script based on whether the rep signed the letter or not.  

Reps who signed the letter:

Adams, Aguilar, Allred, Auchincloss, Axne, Barragán, Bass, Bera, Bonamici, Bourdeaux, Bowman, Boyle, Bush, Butterfield, Cárdenas, Carson, Case, Castor, Cicilline, Clarke, Watson Coleman, Connolly, Cooper, Correa, Craig, Crow, Cuellar, Davis (Danny K.), Dean, DeLauro, Demings, Espaillat, Evans, Fitzpatrick, Fletcher, Gallego, Garamendi, Gomez, Gottheimer, Hayes, Higgins, Houlahan, Jacobs, Jayapal, Johnson (Eddie Bernice), Jones, Kelly, Khanna, Kildee, Kilmer, Langevin, Larsen, Lawson, Lee (Susie), Levin (Andy), Lofgren, Lowenthal, Mace, McBath, McCollum, Meeks, Meng, Morelle, Nadler, Napolitano, Neguse, Newman, Holmes Norton, Panetta, Phillips, Pocan, Porter, Pressley, Quigley, Blunt Rochester, Ross, Roybal-Allard, Ruppersberger, Rush, Scanlon, Schakowsky, Schiff, Schrier, Wasserman Schultz, Sherrill, Slotkin, Smith, Spanberger, Speier, Stanton, Stevens, Suozzi, Swalwell, Takano, Thompson, Tlaib, Tonko, Torres (Ritchie), Trahan, Underwood, Vela, Velázquez, Waters, Welch, Wild, Williams, Wilson (Frederica), Yarmuth.

Dear XXX,

[For letters directed at reps who DID sign the letter, add the opening paragraph]: We thank you from the bottom of our hearts for the letter that you, along with many of your colleagues, sent to the FDA on August 17, 2021 regarding COVID-19 vaccine authorization for children. Since then we have thankfully seen approval for children ages 5-11, but the vaccine approvals for our youngest children have continued to suffer, even while we have endured the Omicron surge - the most infectious variant to date. We are asking for your help to once again call on the FDA to ensure timely and transparent review of vaccine trial data for children under 5. 

To date, more than 400 children under the age of five have died from COVID. During the omicron wave, children under 5 have been hospitalized at the same rates as adults aged 18-49. Thousands more are suffering from serious issues such as MIS-C, increased risk of diabetes, and other complications. .The imminent end to public health precautions, such as universal masking at schools, dramatically increases risk to our youngest children as it greatly increases the risk that their big siblings will bring infection home from school with them. This puts families in impossible situations of deciding between in-person school or protecting their young children.  The situation could not be more dire. Moreover, we are now learning that Omicron hits babies and young children harder tract than previous variants, causing croup and bronchiolitis. It may be months or years before we can fully appreciate the toll of pediatric long COVID.

The FDA’s decision to postpone the February 15th meeting to review the Pfizer trial data for children under 5 and instead review the data behind closed doors comes as a blow for transparency and institutional credibility. Regardless of what the data might have shown, regulators had an obligation to proceed with their plans for public discussion. The FDA’s expand-and-delay approach to pediatric trials is unconscionable during a surge that has disproportionately affected babies and toddlers.

Our leaders acted with great urgency to make vaccines available to adults. We must now act urgently to protect our children under 5 years old. Many face daily, high-risk exposure in childcare. The only tool available to protect children in this age group is complete isolation, a “luxury” few families can afford. Babies and toddlers under the age of 2 cannot mask, and children between the ages of 2 and 4 must remove their masks to eat and nap.

We implore you to help make life saving vaccines accessible to our youngest children.  I respectfully ask for your support in the following:

  1. Call on FDA Commissioner Califf to consider Moderna’s submission for an EUA for their under 6 vaccine independent of the myocarditis issues present for teenages and young adults. Myocarditis is linked to puberty’s release of testosterone, which is not a concern for children under five years of age.  We understand a waiver might need to be issued by the FDA for this EUA to comply with the Pediatric Research Equity Act; if Moderna’s data indicate its vaccine is safe and effective, then the FDA should issue such a waiver. 

  2. Urge the FDA to be transparent and publicly share trial data and evaluation process for the Covid-19 trials . Trust is already eroding in our health agencies, and withholding data only harms public health.  Parents and physicians deserve to know why there are delays and why the FDA made decisions that have impacted vaccine access for children under 5.

  3. Call on the CDC director to enable joint decision-making between willing parents and pediatricians to vaccinate off-label. In Germany, over 40,000 children under 5 have already been protected in this way. Off-label prescribing is a fundamental right for pediatric physicians with strong precedent. The explicit prohibition of off-label use in the provider agreement for covid vaccines is highly unusual and unjustified.

[FOR Reps who did NOT sign Porter/Khanna letter]: I also wanted to see if you could work with your colleagues to make the above request through bipartisan support, similar to this letter.  I would be grateful for a meeting to discuss this critical issue further.

[For Reps who DID sign on Porter/Khanna letter]: I wanted to see if you could once again send a joint bipartisan letter similar to the one sent last August to the FDA demanding the status on emergency use authorization for Covid vaccines for children under 11.  Your voice and support were meaningful and made a difference.  We need your help once again to protect our youngest children.  I would be grateful for a meeting to discuss this critical issue further.


Thank you,

XXX