FDA Move Will Block COVID Vaccines for Millions
Act Now to Protect Access to Vaccines Before It’s Too Late
This week, FDA officials announced a policy that would severely limit who can get updated Covid-19 vaccines—shutting out healthy adults under 65 and most children. Unless we act now, this will roll back decades of progress to protect lives with vaccines. Submit your public comment by Friday, May 23 at 11:59PM EDT to urge the FDA to reverse course.
This week, two appointed FDA officials announced via publication and town hall meeting that Covid-19 vaccines will only be approved for those 65 and over or with at least one chronic health condition. To get approval to offer updated vaccines to younger adults and children without a chronic health condition, the updated vaccines must undergo a new clinical trial with an inert, placebo control and at least 6 months of data.
This decision limits the availability of vaccines shown to be safe and effective from those who want them. It prevents people from being able to make informed decisions, by removing their ability to make a decision at all. This is possibly the first of many limitations on vaccine access under RFK Jr.’s HHS.
Use the talking points below and your own to submit a comment to the FDA by Friday, May 23 at 11:59PM EDT asking them to go through the regular vaccine approval process for updated vaccines and NOT to restrict access to safe and effective vaccines.
Talking points:
This decision will limit access to Covid-19 vaccines for anyone under age 65 who does not have a chronic health condition.
According to the American Academy of Pediatrics, 41% of children aged six months to 17 years who were hospitalized with Covid did NOT have a chronic or underlying condition. The vaccine is proven to reduce the risk of hospitalization.
This decision will prevent younger healthy people who care for or are in frequent close contact with immunocompromised people from choosing to be vaccinated to lower their risk of passing on covid.
Note: vaccines do not work as well in immunocompromised individuals, which is why some healthy people who are not at risk of serious infection decide to get vaccinated - this choice has now been taken away.
This decision will put people at risk of long covid, which can occur even with mild infection. Vaccination has been shown to significantly reduce the risk of long covid.
This decision could impact insurance coverage of covid vaccines, and have an outsized impact on those who cannot afford to pay out of pocket for the vaccines.
Requiring a placebo-controlled trial for an updated vaccine would mean withholding a known safe and effective preventive treatment to those in the trial, which is unethical and makes it less likely that enough people will sign up for the trial. Requiring six months of data, means approvals would not happen quickly enough to have the vaccine ready to combat new variants.
This decision bypassed ethical standards used for making evidence-based health policy decisions. It was made by two appointed officials at the FDA, rather than going through the normal scientific process built to answer these questions and the public forum under which health policy decisions are typically made. The typical process would have included:
New data presented
A vote by the FDA’s Vaccines and Related Biological Products Advisory Committee
A meeting of the CDC’s Advisory Committee on Immunization Practices
Transparency and time for public comment and discussion