Deadline Passes for Pfizer to Submit Results of Post-Vaccination Heart Inflammation Study to US Regulators

Contact Your Elected Officials
The Epoch Times Header

The deadline has passed for Pfizer to submit the results of a study exploring the frequency of heart inflammation following receipt of the company’s COVID-19 vaccine.

Pfizer was required by the U.S. and Food and Drug Administration (FDA) to conduct multiple studies on its vaccine after the FDA approved the shot in August 2021 because regulators determined that without the studies, there would not be sufficient data to assess the “known serious risks of myocarditis and pericarditis,” or heart inflammation and a related condition.

Regulators were also concerned about the potential risk of subclinical myocarditis, or heart inflammation without typical symptoms.

The FDA told Pfizer to carry out six studies, with various deadlines for completion and reporting final results to the agency. The first final deadline arrived on Dec. 31, 2022.

Pfizer was required to submit a report on the study, which was to assess the incidence of subclinical myocarditis following administration of a third dose of Pfizer’s vaccine, or a booster shot, in people aged 16 to 30.

It’s unclear whether Pfizer met the deadline. The company and the FDA did not respond to requests for comment, and neither have issued any information about the study or its results since the deadline passed.

According to the FDA, Pfizer had until June 30, 2022, to complete the study and then another six months to prepare and submit the final results.

In a Dec. 8, 2022, memorandum explaining why the FDA authorized Pfizer’s bivalent booster without any clinical data, FDA officials noted that Pfizer was “conducting additional safety-related post-authorization/post-marketing studies for the PfizerBioNTech COVID-19 Vaccine, including post-marketing requirements to assess known serious serious risks of myocarditis and pericarditis and an unexpected serious risk of subclinical myocarditis..”

‘Shouldn’t Have to Ask’

The results of the study should be shared promptly, according to Jessica Adams, a former regulatory officer at the FDA.

“We shouldn’t have to ask or demand this information. We should expect that it’d be promptly shared by default,” Adams wrote on Twitter.

By Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

A Few Fun Alternatives to the”Gory Stuff” at Halloween

Halloween has gone off the rails with gore through the decades.  But there are ways to enjoy the "scary stuff" without giving into darker, pagan alliances.  

Germany Stands To Lose & Poland To Gain From The EU’s Latest Energy Move

The US is geostrategically re-engineering Europe at Germany’s expense in order to facilitate Russia’s post-Ukraine containment.

EBT Serfs Threaten Violent Mass-Shoplifting Spree if Food Stamps Cut

The EBT serfs of the underclass may be in for a rough ride come November, when mommy government is slated to wean them off the teat of state.

The Real Reason Why the Left is Unhinged

Nine out of thirteen of the original states required you to be a Bible believing Christian to serve in government at the time of the founding.

The Sacrificial Lambs of the Riyadh Standup Scene

Which is the greater injustice: jailing political dissidents, or millions dead from pharma crimes with no accountability for those responsible?

ICE Tracker Planned by Democrats Could Endanger Agents, Bondi Says

AG Pam Bondi warned Democrats’ plan for an online platform tracking ICE in LA could put federal agents at risk of harassment or violence.

Trump Responds to Report He’s Seeking $230 Million From DOJ for Past Investigations

President Trump acknowledged the odd position he’s in given that the lawsuit was launched when he was a private citizen: ‘I’m suing myself.’

Food, Drink Companies Launch New Group in Bid for National Food Standards

PepsiCo and major food makers launched a coalition urging national standards for ingredient safety and labeling to replace inconsistent state regulations.

With CDC Reports on Hold Amid Shutdown, Private Groups to Launch Alternative

Private organizations are planning an alternative to the CDC’s weekly MMWR publication, sometimes known as the voice of the public health agency.

Trump Calls off Meeting With Putin, White House Says

White House says Secretary Rubio and Russia’s Lavrov had a productive call; no further meetings or Trump-Putin talks are planned soon.

President Signs Rare Earth Agreement With Australia’s PM

President Trump hosted Australian PM Albanese at the White House, where both leaders signed a new agreement on rare earth mineral cooperation.

Trump Says Insurrection Act Is ‘Strongest Power a President Has’

President Trump detailed plans to invoke the Insurrection Act to address rampant crime, calling it the “strongest power a president has.”

Army Corps of Engineers to Pause $11 Billion in Projects During Shutdown: Vought

Russ Vought, director of the White House’s OMB, has added to the growing pile of federal projects paused during the government shutdown.
spot_img

Related Articles

Popular Categories

MAGA Business Central