President Donald Trump on Friday morning announced Moderna’s CCP virus vaccine is ready for distribution in the United States and would soon be sent to Europe to help countries hardest hit by the CCP (Chinese Communist Party) virus.
He also wrote: “Europe and other parts of the World is hit hard by the China Virus – Germany, France, Spain and Italy, in particular. The vaccines are on their way!!!”
The president’s comments come after a panel of advisers to the Food and Drug Administration (FDA) voted Thursday 20-0 with one abstention, to endorse for emergency use a COVID-19 vaccine from Moderna and the National Institutes of Health.
They were in agreement that the benefits of the vaccine outweighed its risks in people aged 18 and older.
Following the panel’s endorsement of the vaccine, FDA Director Dr. Stephen M. Hahn, and Director of Center for Biologics Evaluation and Research (CBER) Dr. Peter Marks issued a joint statement Thursday.
“Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” they wrote, adding, “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed (OWS), so they can execute their plans for timely vaccine distribution.”
On Monday, Army Gen. Gus F. Perna, chief operating officer of OWS, briefed the media on the COVID-19 vaccine distribution in Washington. He was joined by Heath and Human Services (HHS) Secretary Alex Azar and Dr. Moncef Slaoui, OWS chief adviser.
Azar thanked Trump for his work bringing all of America including “HHS, the military, the private sector, and the states to make this happen.”
Perna emphasized the role that the private sector is playing in the timely distribution of the vaccines. The plan to distribute the Moderna vaccine will rely on giant drug wholesaler McKesson Corp.
“Clearly, the next vaccine that we’re looking forward to EUA [emergency use authorization] this week is the Moderna vaccine. And in that light, we know that we’re going to ship just a little bit short of 6 million doses out to the American people,” Perna told reporters. “And we’re shipping it to 3,285 locations across the country. It’ll be a very similar cadence to that was executed this week with Pfizer.”
“I cannot tell you enough what role commercial industry is playing in this. Pfizer, eventually Moderna, and the work that they’re doing to get the vaccine prepared for final distribution, McKesson in the distribution of all the ancillary kits for the Pfizer vaccine, which included syringes, needles, alcohol wipes, and diluent, and then they will also be responsible for kitting the vaccine for Moderna.” He also noted the contribution of UPS and FedEx.
Meanwhile, Reuters reported that Europe’s medicines regulator on Thursday set up an exceptional meeting for Jan. 6 to assess a marketing authorization application for Moderna’s CCP virus vaccine.
The European Medicines Agency (EMA) had earlier planned to meet on Jan. 12 to review the application.
“Today, ahead of schedule, (Moderna) has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market,” the EMA said.
The regulator had said on Tuesday that an expert panel would convene on Dec. 21 to evaluate the vaccine made by Pfizer and German partner BioNTech. It had previously said the meeting could be as late as Dec 29.
Mimi Nguyen Ly and Reuters contributed to this report.