Dissemination of the coronavirus vaccine “could begin shortly after the Food and Drug Administration board meets on Dec. 10 to review Pfizer’s application for an Emergency Use Permit (EUA), Health and Human Resources Secretary Alex Azar said Tuesday.
Azar told reporters to update Operation Warp Speed, the federal government’s vaccine task force.
Azar also said that Admiral Erica Schwartz, Admiral Admiral Erica, had contacted President-elect Joe Biden’s transitional group and informed them of the working group’s plans, given Decision of the General Service Administration on Monday to start the formal transition process.
The FDA Vaccination Advisory Committee gives advice on whether to allow vaccination for emergency use, but the final decision is made by the commissioner. In a statement announcing the meeting last week, the agency said it would “thoroughly evaluate the data and information provided in the EUA’s application” before December 10 and will prepare for a “robust” discussion during the public meeting.
“The FDA has been preparing for the EUA review of COVID-19 vaccines for several months and is ready to do so as soon as the EUA application is submitted,” Commissioner Stephen M. Hahn said in a statement. “While we can’t predict how long the FDA review will take, the FDA will review the application as soon as possible, while doing so in a thorough and scientifically sound manner to help provide a vaccine that the American people deserve as soon as possible. . “
Pfizer and its German partner, BioNTech, announced that its vaccination appears to be 95% effective in preventing mild to severe COVID-19 on November 18th. Days later, the company formally filed an EUA application with the FDA. The move set the stage in a process that could eventually signal the beginning of the end of the pandemic, after a long, hard winter.
“It’s over nearby and we have a much happier holiday in our future,” Azar said Tuesday.
General Gustave Perna, chief operating officer of Warp Speed, said the first shipments will amount to 6.4 million servings and the goal is to distribute 40 million servings by the end of the year.
Distributing any vaccine possible proves to be a complex logistical challenge, in contrast to recent memories. Azar said Operation Warp Speed began test shipments to its network this week in order to ensure a “smooth logistics operation” after the vaccine is approved.
The task force has not officially announced who will be the first to receive the vaccine, but Azar says “basic groups” such as health workers and those living in nursing homes will be given priority. He said the administration expects the population to be able to vaccinate “by the second quarter of next year”, but added that supply chains are “constantly moving”.
He described the role of the federal government as the “air traffic controller” for the distribution of vaccines, and said that governors would ultimately determine how the vaccine would be distributed in each state. If individual governors feel the need for more customized distribution – based on hotspots spread by the in-state community – they are “fully in the leadership seat,” Azar said.
However, the health secretary noted that the current nationwide prevalence and susceptibility to the disease made per capita distribution the most attractive approach of the task force. “We thought it best to keep it simple,” he said.
The coronavirus is from coast to coast and kills more than 1,500 Americans every day. The flooding of the morgue in El Paso, Texas, required his state call the National Guard for help. In Ohio, more than 4,300 people have been hospitalized with COVID-19 symptoms since Monday, A 59% increase over just two weeks ago. Hospital care has also increased in New York, increased by 128% in three weeks – from 1253 to 2856 at the beginning of the month.
Due to the low temperature required to store vaccines, Azar said the current plan is to distribute initial orders directly from the manufacturer, 975 doses each, followed by a second dose 21 to 28 days later. Pfizer can be stored at -80 degrees Celsius for 20 days, while Moderna can be stored at -20 ° C for 30 days.
The secretary said vaccine developments offer hope, but the news does not mean Americans should let the guards down – especially during the festive period.
“We want to make sure everyone is here for next year’s Thanksgiving,” he said.
