HealthHIV’s Brian Hujdich Delivers Comments to FDA’s Vaccines and Related Biological Products Advisory Committee

September 17, 2021 – Today, HealthHIV’s Executive Director delivered comments to the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee in support of recommending COVID-19 vaccine booster shots for people aged 16 and above. Read the full comments below.

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Brian Hujidich, FDA VRBPC meeting, September 17, 2021: 

Thank you for the opportunity for health advocates to provide direct feedback to the advisory committee. 

I'm Brian Hujdich, Executive Director of HealthHIV, a national non profit organization based in Washington, DC. We conduct health services research, provide education and capacity building, and advocate for communities impacted and affected by HIV. 

Today, I am speaking to you as a health services advocate in an effort to get us all one step ahead of breakthrough infections among fully vaccinated people. 

While data clearly show that COVID-19 vaccines are highly effective against current strains, preliminary data also indicate that protection against infection overall appears to be waning. And that concerns us, because it puts the populations we serve at even further risk for infection based on the point-in-time immunity of the general population. 

As we have learned, COVID-19 is a serious and potentially fatal and life-threatening virus—not just for those most at-risk, like the immunocompromised and immunosuppressed—but for everyday Americans, especially front-facing service sector minority communities and marginalized populations in geographies with the highest viral load concentration, often a result of vaccine hesitancy or opposition. 

Not surprisingly, breakthrough infections appear to be more common among those with weakened immune systems. And according to data presented at a CDC Advisory Committee on Immunization Practices meeting in July, it showed that immunocompromised patients represent 44 percent of hospitalized COVID-19 breakthrough cases—even though they only make up about 2.7 percent of the total population. 

As part of this data lookback, the FDA evaluated the science on the use of a third dose of the Pfizer or Moderna vaccines in people with compromised immune systems, and they rightly determined that a third vaccine dose may better protect them—and others around them. 

In fact, they interpreted the findings to state that targeted policies, like the “booster” shot being proposed today, need to evolve as both science and risk evolve. 

It confirms that people with underlying conditions, like advanced HIV, cancer, organ transplant, hemodialysis, and those on immunosuppressive therapies, are seen as a significant risk for poorer outcomes from COVID-19. 

In essence, it highlights the need for our populations to stay as healthy as possible, but it also depends on the health of those around us.

Fortunately, the vast majority of breakthrough infections are typically mild, but we are discussing the rationale for a “booster” shot in efforts to prevent the clock from winding backwards.

Based on the available data, HealthHIV encourages the advisory committee to recommend booster shots for people aged 16 and above, just as you did to protect people living with HIV. Thank you. 

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