What follows after an emergency use authorization?
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(CNN) ––
Advisers from the US Centers for Disease Control and Prevention (CDC) called an emergency meeting for this Tuesday regarding the possible vaccine against covid- 19.
The objective will be to vote on which people recommend to be the first to receive it when it is authorized.
CDC's Advisory Committee on Immunization Practices (ACIP) wants to advise the public before any decision by the Food and Drug Administration (FDA) on the emergency authorization of an vaccine, committee chair Dr. José Romero told CNN.
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"We are meeting because the FDA, Operation Warp Speed, has asked states and other jurisdictions to present their plans by Friday of next week," Romero said.
'We anticipate an imminent authorization if this vaccine is shown to be effective and safe in the near future.
And we want to be at the point where we provide adequate guidelines to states and jurisdictions for the use of these vaccines, "said Romero.
In addition to chairing the ACIP, Romero is Secretary of Health for the Arkansas Department of Health.
This is not rushed.
We have already discussed the groups within the first level.
We are just going through the data one more time and having a vote mostly in group 1a of the first level.
That is, healthcare providers and people in long-term collective facilities, ”he said.
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The ACIP met last Monday to discuss priority groups for receiving any vaccine that gets FDA emergency use authorization.
The CDC has already recommended that the first group - designated 1a - should include frontline healthcare providers and support staff.
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"It's important because these are the people who are really on the front line providing care," said Romero.
Group 1a should likely also include residents of nursing homes and other long-term care facilities, which have been severely affected by the pandemic, according to the CDC.
“Residents and staff of long-term care facilities accounted for 6% of cases and 39% of deaths in the US This despite the fact that residents of long-term care facilities account for fewer 1% of the US population, ”CDC's Dr. Kathleen Dooling told ACIP on Monday.
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Getting them vaccinated could make a big difference, Romero said.
At first, there will not be enough vaccines for everyone, so decisions have to be made.
The CDC estimates that there are 21 million people in the health care sector, 87 million essential workers, 100 million adults with high-risk medical conditions, and 53 million people 65 and older.
The federal government has said that 40 million doses of coronavirus vaccines could be available by the end of December.
Dr. Larry Corey of the University of Washington who leads clinical trials of the coronavirus vaccine in the US has said that if both Pfizer and Moderna get their vaccines licensed, they could deliver 50 million more doses. in January and 60 million more in February and March.
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Advances are also being made in other vaccines.
Those vaccines require two doses given three to four weeks apart to be effective.
So that would mean roughly enough vaccinations to cover 75 million people by the end of March.
ACIP priorities will help decide who has access to these rare vaccines first.
“The plan is to apply doses of vaccines over the next few weeks or months to cover groups 1a, 1b and 1c.
There will not be enough vaccines for everyone in the first assignment, "said Romero.
"It is important that the public understand that we are dealing with select groups of people, not the general public," he insisted.
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Pfizer applied to the FDA for emergency use authorization for its vaccine.
Also, the biotechnology company Moderna confirmed on Monday that it did.
The FDA has scheduled a meeting of its own vaccine advisers for December 10.
Sources told CNN that there is another meeting planned for December 17.
Romero said it was important for people to know that ACIP will hold a public meeting and a public vote.
All meetings of this committee are public and broadcast live.
Members of the ACIP will also discuss clinical considerations.
One concern is whether the side effects of the vaccine could affect faith in the safety of immunizations.
There is also the concern whether vaccinating frail nursing home residents, who are likely to suffer a series of health events regardless of vaccination, could have the same effect on perceived safety.
"I think we can deal with that," Romero said.
The advisors will also discuss how to monitor safety after vaccine assignment, according to the meeting document.
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The whole process takes place in a faster chronology than usual.
Vaccine manufacturers accelerated development and manufacturing.
Also, they have been producing the vaccines at the same time they are testing them.
A situation that does not usually occur.
Although the safety and efficacy tests themselves are not being reduced, the FDA is considering the Pfizer vaccine and will likely evaluate any other under emergency use authorization rather than full approval.
Precisely because the first is a faster process in the face of the pandemic.
Vaccines will also need to undergo full approval later.
Usually, the ACIP only meets three times a year to consider the immunization schedule.
But, the committee added meetings to consider coronavirus vaccines.
CDCcovid-19FDAPandemicCoronavirus vaccine
