USA: Recommend third booster dose of Moderna 3:41
(CNN) -
After advisers to the US Food and Drug Administration (FDA) unanimously voted to recommend emergency authorization of a booster dose of the covid vaccine -19 from Moderna, another tool in the fight against the pandemic could soon be available to millions of Americans.
Moderna's emergency clearance request is similar to that of groups authorized to receive a booster dose of Pfizer's mRNA vaccine.
The third doses of Moderna and Pfizer's covid-19 vaccines are already licensed for some immunosuppressed people.
However, some experts note that although antibodies may decline over time, the initial two-dose regimen of both vaccines is still valid against severe COVID-19 infection.
Dr. Paul Offit, a member of the FDA's Vaccines and Related Biologics Advisory Committee who held the vote, told CNN's Wolf Blitzer on Thursday that proper expectations need to be set about what vaccines are supposed to do and how they follow. being effective.
Watch Dr. Gupta argue with a vaccine skeptic 5:44
"We have to define what the objective of this vaccine is. If the objective of this vaccine is protection against serious diseases, that is, the type of disease that causes medical attention to be sought or to go to the hospital or ICU, the vaccines Today, with two doses, they are doing exactly that, "he said.
"So you don't really need a booster dose, at least as far as that data is concerned."
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The committee's recommendation is the same as that given last month for the third dose of Pfizer / BioNTech: it is licensed for people 65 years of age and older, and for people 18 years of age and older who are at risk for serious illness. or who live or work in a situation that puts them at higher risk for complications or serious illness.
Offit said that while he voted to recommend half booster doses for some people six months after their first two doses of Moderna's vaccine, he doesn't think everyone needs one.
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An expert thinks
"I am concerned about people between 18 and 29 years old because they are the group that has a greater risk of myocarditis, that is, of inflammation of the heart muscle," he said.
"So without some kind of clear benefit that that third dose is necessary, I think we've created this kind of 'third dose fever' in this country because of the way it's developed."
Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for the Advancement of Translation Sciences at the National Institutes of Health, agreed.
"I don't see the need for a 'let it run' campaign for reinforcements," Kurilla said.
More booster shots than first doses
More than 9 million people have received a booster dose of the coronavirus vaccine, according to the latest data from the US Centers for Disease Control and Prevention (CDC). which represents almost 5% of the people who were already fully vaccinated.
According to CDC data, the number of people receiving booster doses is outpacing the number of people receiving the first dose of the vaccine.
This Wednesday it was reported the administration of more than a million doses, but only an average of about 230,000 people are starting the vaccination process each day.
President Joe Biden highlighted the progress made since nearly 100 million Americans with the right to get vaccinated in July still failed to do so, but said the country is in a "very critical period" and called for more to be done.
"We have dropped to 66 million, a still unacceptably high number of unvaccinated people," he said Thursday.
"Now is not the time to loosen up."
The FDA will review the commission's recommendations and, if an emergency clearance is approved, the CDC will decide which groups are eligible for it.
This Friday the Johnson & Johnson vaccine will be studied, as well as a presentation on the combination of vaccines.
Covid-19 vaccine mandates advance
As the booster debate continues, experts consistently point to the increased need to inoculate the unvaccinated to stay ahead of the pandemic.
And while many of the public and private sector covid-19 vaccination campaigns have been successful, some agencies are encountering rejection from a subset of people.
In Chicago, the president of the police union said that up to half of the city's officers could be on leave without pay as of Friday, because individuals did not report their vaccination status as required by the city.
The police department said this week that it will be fully staffed for the weekend.
Many state employees in Washington are four days from the deadline to be fully vaccinated against COVID-19, and officials will not extend that deadline any further.
"If the people make the decision to leave public service, we will replace them," Gov. Jay Inslee said Thursday.
More than 90% of state employees have provided proof of vaccination, Inslee said, and about 2% more have received special accommodations that will allow them to remain unvaccinated due to medical conditions or religious convictions.
CDC Predicts Continued Drops in Covid-19 Hospitalizations and Deaths Over the Next 4 Weeks
In Nevada, the critical care units of rural hospitals, which are at the limit of their capacity, could experience a staff shortage when the mandate to vaccinate health workers takes effect on November 1.
"We know there are staff members who will refuse to get vaccinated," Joan Hall, president of Nevada Rural Hospital Partners, said at a briefing Thursday.
Vaccination rates for its hospital employees range from 60% to 90%, Hall said.
But experts have consistently pointed out that areas with higher vaccination rates do better with COVID-19 hospitalizations.
CDC: Covid-19 booster doses are well tolerated 1:44
New York City has a vaccination mandate within many businesses, and Mayor Bill de Blasio said Thursday that 85% of adult residents have received at least one dose of the COVID-19 vaccine.
The covid-19 hospitalization rate in the city's public health system has reached its lowest point since the start of the pandemic, according to Dr. Mitchell Katz, CEO of NYC Health + Hospitals.
The application of the antiviral pill will be reviewed
Vaccines have been shown to be the most effective means of protection against the covid-19 virus, but it is a preventive measure.
An antiviral pill that can help the newly infected is now scheduled to be reviewed next month.
The FDA's Antimicrobial Drug Advisory Committee will meet Nov. 30 to discuss Merck and Ridgeback's application for emergency use authorization for their experimental covid-19 antiviral drug, molnupiravir, the agency announced Thursday.
If authorization is finally granted, the drug - which is presented in capsule form - would be the first oral antiviral treatment against COVID-19.
Preliminary results showed that 7.3% of the 385 patients who received the antiviral were hospitalized or died from COVID-19, compared with 14.1% of the 377 patients who received a placebo, Merck said earlier. of this month.
"As of day 29, no deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients receiving placebo," the statement said.
The FDA noted that it does not always call an advisory committee meeting to discuss a possible emergency authorization, but may do so when the committee's discussion helps inform agency decision-making.
"We believe that, in this case, a public discussion of these data with the agency's advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating to make a decision on the authorization of this treatment for emergency use, "said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, in a statement.
CNN's Virginia Langmaid, Jen Christensen, Maggie Fox, Lauren Mascarenhas, Andy Rose, Peter Nickeas, Laura Ly, and Casey Riddle contributed to this report.
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