“We’re meeting because the FDA, Operation Warp Speed, has asked states and other jurisdictions to submit their plans next Friday,” Romero said.
“If the vaccine proves to be effective and safe in the near future, we anticipate authorization and want to be at the point where we give proper guidance to states and jurisdictions on the use of these vaccines,” Romero said. Secretary of Health of the Arkansas Department of Health.
“We’re not in a hurry. We’ve already discussed the groups in the first tier. We’ll simply review the data and vote primarily on the first group 1a – healthcare providers and people. It will gather the facilities in the long run.”
The ACIP met on Monday to discuss priority groups for vaccines that could be approved for emergency use by the FDA. The CDC has already suggested that the first group, called 1a, should include frontal health care providers and support staff.
“It’s important because these are the people who are really at the forefront of providing care,” Romero said.
Group 1a is likely to include residents of nursing homes and other long-term care facilities severely affected by the pandemic, the CDC said. “Residents and staff in long-term care facilities in the United States accounted for 6% of cases and 39% of deaths, despite the fact that residents of long-term care facilities make up less than 1% of the U.S. population.” said Dr. Kathleen Dooling to the CDC, ACIP said on Monday.
Their vaccination can make a big difference, ”Romero said.
At first, there will not be enough vaccinations for everyone, so you have to choose.
The CDC estimates that there are 21 million health workers, 87 million essential workers, 100 million adults with high-risk illnesses and 53 million more people aged 65 and over. According to the federal government, 40 million doses of coronavirus vaccine could be available by the end of December.
Dr. Larry Corey of the University of Washington, who conducts coronavirus vaccine clinical trials in the United States, said that if both Pfizer and Moderna allow the vaccines, they could give 50 million more doses in January and 60 million more in February and March. be. .
These vaccines need two doses taken three to four weeks apart to be effective, which would mean roughly enough to detect 75 million people by the end of March.
ACIP’s priorities will help you decide who can get your scarce vaccines first.
“The plan is to introduce vaccine doses in the coming weeks or months to cover groups 1a, 1b and 1c. There will not be enough vaccinations for everyone in the first allocation,” Romero said.
“It’s important for the public to understand that we’re dealing with selected groups of individuals – not the general public.”
Pfizer has turned to the FDA for an EUA vaccine, and the biotechnology company Moderna is expected to do so soon. The FDA has set its own vaccination advisory meeting for Dec. 10. Sources told CNN that another meeting is scheduled for Dec. 17.
Committee members also discuss clinical aspects. One concern is the side effects of the vaccine, and whether vaccinating residents of homes for the elderly, who are likely to suffer a number of health events regardless of vaccination, could undermine faith in the safety of immunization.
“I think we can deal with it,” Romero said.
The consultants will also discuss how to check safety after the vaccine is distributed, according to the meeting document.
The whole process is moving on a faster schedule than usual. Vaccine manufacturers have accelerated the development and production of vaccines and, at the same time, produced those that have been tested – which is not usually the case.
While the safety and efficacy test itself will not be shortened, the FDA is considering the Pfizer vaccine and will likely subject others to emergency approval rather than full approval – a faster process due to the pandemic. Vaccinations must also be fully approved at a later date.
And although ACIP usually only meets three times a year to consider a vaccination schedule, the committee has added meetings to look at vaccinations against coronavirus.