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“We are meeting because the FDA, Operation Warp Speed, has asked states and other jurisdictions to please submit their plans on Friday of next week,” Romero said.
“We anticipate imminent authorization if this vaccine proves to be effective and safe in the near future and we want to be at the point where we provide appropriate advice to states and jurisdictions for the use of these vaccines,” said Romero, who is Arkansas Department of Health Secretary of Health.
“It’s not something that is rushed. We have already discussed groups within the first level. We just re-examine the data and vote primarily on the first level of group 1a – healthcare providers and people in the long-term collective facilities. “
ACIP met on Monday to discuss priority groups for receiving any vaccine that may obtain emergency use clearance from the FDA. The CDC has already recommended that the first group – referred to as 1a – include primary care providers and support staff.
“It’s important because these are the people who are really on the front lines providing care,” Romero said.
Group 1a is also expected to include residents of nursing homes and other long-term care facilities, who have been hit hard by the pandemic, the CDC said. “Residents and staff of long-term care facilities accounted for 6% of cases and 39% of deaths in the United States, despite the fact that residents of long-term care facilities represent less than 1% of the US population Says Dr. Kathleen Dooling of the CDC. told ACIP on Monday.
Vaccinating them could make a big difference, Romero said.
There won’t be enough vaccines for everyone at the start, so choices have to be made.
The CDC estimates that there are 21 million healthcare workers, 87 million essential workers, 100 million adults with high-risk medical conditions, and 53 million others 65 and over. The federal government has said 40 million doses of the coronavirus vaccine could be available by the end of December.
Dr Larry Corey of the University of Washington, who heads the coronavirus vaccine clinical trials in the United States, said if Pfizer and Moderna get licensed vaccines they could deliver an additional 50 million doses in January and 60 millions more in February and March. .
These vaccines require two doses spaced three to four weeks apart to be effective, which would mean roughly enough vaccines to cover 75 million people by the end of March.
ACIP’s priorities will help decide who gets access to these rare vaccines first.
“The plan is to roll out vaccine doses over the next few weeks or months to cover groups 1a, 1b and 1c. There won’t be enough vaccine for everyone in the first batch,” a Romero said.
“It is important for the public to understand that we are dealing with particular groups of individuals – not the general public.”
Pfizer has asked the FDA for an EUA application for its vaccine and biotech company Moderna to do so soon. The FDA has scheduled a meeting of its own vaccine advisers for December 10. Sources told CNN that another meeting was scheduled for December 17.
Committee members will also discuss clinical considerations. One of the concerns is the side effects of the vaccine and whether the vaccination of frail residents of nursing homes, who are at risk of suffering from a number of health events independent of vaccination, could adversely affect the confidence in the safety of vaccinations.
“I think we can deal with it,” Romero said.
The advisers will also discuss how to monitor safety after vaccine allocation, according to the meeting document.
The whole process is happening on a faster schedule than usual. Vaccine makers have accelerated the development and manufacture of vaccines and made them at the same time they were tested – which is usually not done.
While the safety and efficacy testing itself is not being halted, the FDA is considering the Pfizer vaccine and will likely consider any other vaccine with emergency use authorization rather than full approval – a faster process. due to the pandemic. Vaccines will also need to be approved later.
And while ACIP typically only meets three times a year to review the vaccine schedule, the committee has added meetings to review the coronavirus vaccines.
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