The FDA could add a strict safety warning to Covid vaccinations
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The Food and Drug Administration could add its toughest safety warning on Covid vaccinations – marking another big shift in vaccine oversight.
It could also expand a series of actions by the Trump administration’s health officials that some health experts say could weaken confidence in the vaccinations that have saved millions of lives worldwide since their rollout. uptake of these vaccines Already crashing: The National Foundation for Infectious Diseases said last week, citing IQVIA data, that there has been a 27% decline in Covid vaccinations from retail pharmacies since 2024.
Here’s what we know so far.
The FDA is preparing to add a so-called “black box” warning on Covid vaccines by the end of the year, CNN first reported Friday.
This plan, which is not yet finalized, is being led by Dr. Vinay Prasad, the FDA’s chief medical and scientific official and director of the agency’s Center for Biologics Evaluation and Research, CNN reported.
This type of label is not used lightly. It appears at the beginning of a medicine’s prescribing information and is intended to warn of risks, such as death or serious injury, which should be weighed against a product’s benefits.
For example, warnings about opioids warn about the risks of addiction, overdose and death.
But here too there are still many open questions.
Firstly, the Department of Health and Human Services has not confirmed any of the plans today.
In a statement to CNBC, HHS spokesman Andrew Nixon said: “Until the FDA announces this, any claim about what it will do is pure speculation.”
We also don’t know if this warning applies to all three Covid vaccines.
HHS Secretary Robert F. Kennedy Jr. — a known vaccine skeptic — and some of his appointees have previously targeted mRNA Covid shots from Pfizer and Moderna.
But Novavax also offers a protein-based Covid vaccine.
It is also unclear whether this warning only applies to certain age groups and what problem the label is intended to indicate.
Prasad attempted to link 10 child deaths to Covid vaccines in an internal FDA memo last month without providing any evidence. He also highlighted myocarditis, an extremely rare side effect after receiving mRNA shots from Pfizer and Moderna. Cases of this side effect were identified during early use of the vaccine, when it was recommended that the first and second doses be taken at least three weeks apart. The side effect also occurred predominantly in boys and men.
But health authorities around the world, including the Centers for Disease Control and Prevention, have stressed that the benefits of vaccination in preventing severe Covid-19 illness and even myocarditis from the infection itself far outweigh the small risk of the vaccination’s side effects. Myocarditis cases have also declined dramatically in recent years.
How are the vaccine manufacturers responding to this today?
Pfizer pointed to previous statements supporting the safety and effectiveness of its Covid vaccine.
The vaccination has “consistently provided strong protection against symptomatic and severe COVID-19 disease across multiple variants and subvariants, resulting in over 14 million lives saved worldwide in the first year of approval – and many more since then,” Pfizer said.
Moderna pointed to a September statement that said the safety of its Covid vaccine was being “strictly monitored” by the company, the FDA and regulators in more than 90 countries. With more than a billion doses being distributed worldwide, these systems “have reported no new or undisclosed safety concerns in children or pregnant women,” the statement said.
We’ll be watching closely to see if the FDA adds these warnings to the vaccinations, so stay tuned for our coverage.
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