Medical News Today further explains: “The FDA assigns boxed warnings to products that carry risks of death or serious injury. Different drugs can cause these outcomes in various ways.
“Because of this, a person taking a medication that has a boxed warning should talk with a doctor about any side effects they experience.”
According to the sources, the plans are expected to be unveiled at the end of the year; however, this could still change.
It’s also not clear if the warning would apply to all Covid vaccines, or just the mRNA jabs, such as Moderna and Pfizer, and whether it would span across all age groups.
US Department of Health and Human Services spokesperson Andrew Nixon said this week: “Unless the FDA announces it, any claim about what it will do is pure speculation.”
Earlier this year, the FDA approved updates to the Prescribing Information for the Pfizer and Moderna vaccines to include new information on the potential risks of myocarditis and pericarditis, which is inflammation of the heart and its lining, following a study that discovered a possible link.
Meanwhile, Moderna issued a statement about its safety earlier this year, writing: “The safety of Spikevax is rigorously monitored by Moderna, the U.S. FDA, and regulators in more than 90 countries.
“Multiple, overlapping safety monitoring systems are in place that work to detect and evaluate any new or evolving safety considerations.
“With more than one billion doses distributed globally, these systems – including in national health systems across Europe, the United Kingdom, Canada, Australia, and the U.S. – have not reported any new or undisclosed safety concerns in children or in pregnant women.
“Moderna is not aware of any deaths in the last year or pertinent new information from prior years. Published, peer-reviewed research by multiple governments, independent investigators and by Moderna has demonstrated the safety profile of Spikevax.”
Pfizer also shared a lengthy statement, including studies and references, adding: “Pfizer Inc. (NYSE: PFE) today reaffirmed the safety and efficacy of the COVID-19 vaccine and posted resources supporting its impact on global health.
“These sources reflect the company’s commitment to transparency and ensure the accessibility of the data. The evidence has previously been shared with regulatory authorities and presented in scientific forums, as well as published in peer-reviewed publications.”
Around 7,102,614 people worldwide are understood to have died from Covid.
The vaccine rollout was widely successful, with an estimated 67 per cent of the world’s population having received a Covid vaccine by December 2023, according to the WHO.
However, misinformation fueled growing mistrust of the vaccine, while reports of rare side effects associated with the drug also raised concerns.
Despite this, the vaccine was found to be highly effective in reducing the Covid mortality rate.
Published in the journal JAMA Network Open, researchers compared vaccinated and unvaccinated adults in France between the ages of 18 and 59. They found a 25 per cent lower risk of all-cause mortality among participants who’d been vaccinated.
A total of 22.7 million vaccinated individuals and 5.9 million unvaccinated people – around 40 per cent of France’s total population – took part in the study.
The study also revealed that vaccinated adults had a 74 per cent lower risk of dying in hospital from Covid complications.
LADbible has reached out to the US Department of Health and Human Services, as well as Pfizer and Moderna, for comment.