FDA weighs ‘black box’ warning for Covid-19 vaccines amid safety debate – Firstpost

The US FDA is preparing to add a “black box” warning — its strongest safety alert —to Covid-19 vaccines, according to a CNN report, citing people familiar with the plan.

A boxed warning — the FDA’s strongest alert placed at the top of a drug’s prescribing information — highlights the most serious risks, including life-threatening or disabling reactions that must be weighed against a treatment’s benefits. It can also signal risks that may be reduced by limiting use to specific groups.

Boxed warnings already appear on drugs like opioids, which note risks of abuse, addiction, overdose, and death; Accutane, for birth defects during pregnancy; and ACAM2000, for heart inflammation and encephalitis.

According to a CNN report, the FDA, led by Dr. Vinay Prasad, is planning similar warnings for Covid-19 vaccines, though the plan is not final and may change.

It’s unclear whether the warning would cover only mRNA vaccines or all Covid-19 shots, or which age groups would be affected, added the report.

Of the three FDA-approved Covid vaccines, two — Pfizer and Moderna — use mRNA technology.

“Unless the FDA announces it, any claim about what it will do is pure speculation,” CNN quoted Andrew Nixon, US Department of Health and Human Services spokesperson, as saying on Thursday.

Moderna, Pfizer reacts

In response to CNN inquiry about the FDA’s plans, Moderna cited its September statement emphasising the safety of its Covid-19 vaccine, SpikeVax, noting it is “rigorously monitored” by regulators worldwide and that over a billion doses distributed have not revealed new safety concerns in children or pregnant women.

Pfizer also reaffirmed the safety and efficacy of its Covid-19 vaccine in a September statement, amid reports that federal health officials might link the shots to risks in pregnant women and children. Pfizer declined further comment Thursday.

Studies suggest Covid-19 vaccines averted nearly 20 million deaths in their first year globally.

A CDC report Thursday found that children vaccinated in the 2024-25 season had a significantly lower risk of emergency visits, with effectiveness of about 76% for ages 9 months–4 years and 56% for ages 5–17.

The vaccines’ rapid development under Operation Warp Speed was a hallmark achievement of President Trump’s first term, praised by some Republicans for potential Nobel recognition, despite controversies surrounding HHS Secretary Robert F. Kennedy Jr., a vaccine skeptic criticised for opposing mainstream science.

Administration targets Covid-19 vaccines

Kennedy and allies have long questioned Covid-19 vaccine safety, despite placebo-controlled trials in 75,000 people and millions of doses given globally.

Dr. Prasad, FDA’s CBER director, has been a controversial figure, previously critiquing pandemic and vaccine policy.

He briefly resigned in July under pressure but returned weeks later. In late November, he sent a memo claiming staff had “found that at least 10 children have died after and because of receiving Covid-19 vaccination,” promising “swift action.”

“The FDA takes very seriously any death that is attributed to a regulated medical product,” CNN quoted HHS’s Nixon as saying.

Prasad highlighted myocarditis, a rare heart inflammation seen mostly in boys and young men after mRNA vaccines. A June CDC presentation noted most adolescents recovered and there were “no known deaths or heart transplants.” Adjusted dosing intervals have reduced risk in recent years.

The FDA requires Pfizer and Moderna labels to warn that myocarditis risk is “highest in males 12 years through 24 years of age.”

On Tuesday, Children’s Health Defense, led by Kennedy, petitioned to revoke vaccine licenses, claiming mRNA vaccines were misbranded under emergency use standards.

HHS said the FDA is investigating whether deaths “across multiple age groups” may be linked to the vaccines.

Prasad’s memo, proposing broader FDA vaccine oversight, alarmed public health experts.

A dozen former FDA commissioners cautioned in the New England Journal of Medicine against “sweeping new FDA assertions about vaccine safety.”

With inputs from agencies