FDA and CDC Letter for Boosters and BA4/5 Vaccine Access

Please sign this letter urging the FDA and CDC to update guidance on second boosters to include all adults immediately, and to commit to ensuring our kids are not left behind when the new vaccine formula rolls out in the fall.

Robert Califf, MD, Commissioner
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993

Rochelle Walensky, MD, MPH
Director Centers for Disease Control and Prevention
1600 Clifton Road, Atlanta, Georgia 30333

Dear Dr. Califf and Dr. Walensky,

We respectfully ask for your leadership and attention to offering Covid vaccine boosters to populations that will be left vulnerable without guidance and approval from your agencies.

As you know, we are currently in a continuous surge of variants from the Omicron line, and we understand that full vaccine effectiveness wanes after several months of administration.  This is why booster shots are critical in our nation’s pandemic management strategy.  We have two specific requests regarding upcoming boosters that will help prevent unnecessary deaths and long-term Covid complications.

1: Please revise your current guidance to allow second boosters for all adults, not only those who are over 50 or immunocompromised.  Many adults under 50 are caregivers to the elderly and parents to young children, and we need to ensure that entire families remain healthy.  Furthermore, expanding eligibility for second boosters may help blunt the impact of severe business continuity repercussions due to Covid staffing shortages in the workforce.

  • Many adults under 50 who received their initial booster are now likely well past 6 months out from their last shot.  At the recent VRBPAC meeting on June 28, 2022, an alarming slide indicated reduced effectiveness of only 54% against hospitalization for ages 18-49 more than 4 months after the third dose of an MRNA vaccine. Yet, no action was recommended in response to that concerning statistic. According to another slide presented at the same VRBPAC meeting, double boosted people over 50 years old were found to be 4 times less likely to die of COVID this spring than those who were single boosted. There is no logical reason to think that this effect wouldn’t to some extent hold up for adults under 50, especially those over 35, whose first booster was administered over half a year ago. 

2: Please ensure the next formulation of Covid vaccines and boosters are available to the entire population, including children of all ages.

  • The FDA has indicated that there will be a campaign pushing for boosters in the fall for a reformulated vaccine, which will include protection designed for the Omicron BA4/5 variants.  Furthermore, the FDA has announced that it will not require human clinical trials to roll out the new formula given the highly safe nature of the mRNA vaccines.  In the fight against Covid, time is of the essence, and it will be critical to allow protection from this virus to the entire population.  This includes children, many of whom were left behind in the original vaccine roll out.  Parents deserve the option to offer every layer of protection available, and we must ensure that all children have the same access to a vaccine that has been proven to be safe.  

We would appreciate your urgent attention to these requests.  Too many lives have already been impacted by Covid, and offering vaccine access to a broader group will be critical to keeping our communities healthy and safe.

Respectfully,
Melissa Braveman, MD, FAAP
Carrie Castonguay, MS, CGC
Wendy Orr -Mom
Jacquelyn Heney
Catharine Diehl, PhD
Joris Hernandez
Kate Schenk
Mindi Ashworth
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MSW, LCSW
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Tara Lish
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Sharon Paige, MD, PhD, FAAP
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