‘Don’t Make Promises Until You Have The Data’: FDA Gamble On Speeding Up COVID Vax In Kids Flops

FDA praised for pulling back on plans to host 15 February advisory committee review of Pfizer’s COVID-19 vaccine in children but faulted, along with other parts of US government, for raising expectations this month that the vaccine might be available for this population imminently.

roulette wheel, gambling scene
FDA’s failed bet on Pfizer’s two-dose data for COVID-19 vaccines in children under five raises public confusion • Source: Alamy

The US Food and Drug Administration did a rapid about face on 11 February, canceling Pfizer Inc. and BioNTech SE’s 15 February advisory panel review of the sponsors' COVID-19 vaccine in children 6 months through 4 years of age saying the agency needed to review data on the impact of a third dose of the vaccine before making an authorization decision.

The sudden shift raised questions about why FDA so publicly hyped up the possibility of a faster-than-anticipated authorization in this...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Vaccines

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

More from Pink Sheet

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.