After advisers from the US Food and Drug Administration voted unanimously to recommend emergency authorization of a booster dose of Moderna’s Covid-19 vaccine, another tool in the fight against the pandemic may soon become available for millions of Americans.
Moderna’s EUA request mirrored the groups authorized to receive a booster dose of Pfizer’s mRNA vaccine. Third doses of the Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.
Yet some experts are noting that while antibodies may wane over time, the initial two-dose regiment for both vaccines is still holding up against severe Covid-19 infection.
Dr. Paul Offit, a member of the FDA Vaccines and Related Biological Products Advisory Committee that 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 remain effective.
“We have to define what’s the goal of this vaccine. If the goal of this vaccine is protection against serious illness, meaning the kind of illness that causes you to seek medical attention or go to the hospital or the ICU, the current vaccines, as two-dose vaccines, are doing exactly that,” he said. “So, you don’t really need a booster dose at least as far as those data are concerned.”
The committee recommendation is the same as what was granted last month for the Pfizer/BioNTech third dose: it’s authorized for people older than 65, and people 18 and older who are at risk of severe disease or who live or work in a situation that puts them at a higher risk for complications or severe disease.
Offit said that although he voted to recommend half-dose booster shots for some people six months after their first two doses of Moderna’s vaccine, he doesn’t think everyone needs one.
“I do worry about the sort of 18- to 29-year-old because that’s the group that has a higher risk of myocarditis — that’s inflammation of the heart muscle,” he said. “So, without sort 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 this has played out.”
Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translation Sciences at the National Institutes of Health, agreed.
“I don’t see the need for a let-it-rip campaign for boosters,” Kurilla said.
More than 9 million people have received a booster dose of coronavirus vaccine, according to the latest data from the US Centers for Disease Control and Prevention, which is nearly 5% of those who were already fully vaccinated.
The number of people getting booster doses is currently outpacing the number of people getting their first doses of vaccine, according to CDC data. More than a million doses were reported administered Wednesday, but just an average of around 230,000 people are starting the vaccination process each day.
President Joe Biden highlighted progress from when nearly 100 million eligible Americans remained unvaccinated in July, but said the nation is in a “very critical period” and urged more to be done.
“We’re down to 66 million, still unacceptably high number of unvaccinated people,” he said Thursday. “Now’s not the time to let up.”
The FDA will consider the committee’s recommendations, and if an EUA is approved then the CDC will confer on which groups would be eligible.
Boosters of the Johnson & Johnson vaccine will be considered Friday, as well as a presentation on mix-and-match vaccines.
Vaccine mandates move forward
As the discussion on boosters continues, experts consistently point to the greater need to inoculate those unvaccinated to get ahead of the pandemic. And while many Covid-19 vaccine mandate campaigns from the public and private sectors have been met with success, some agencies are finding pushback from a vocal subset.
In Chicago, the police union president said up to half of the city’s officers could be placed on unpaid leave starting Friday, because of individuals’ failure to report their vaccination status as required by the city. The police department said this week that it will be fully staffed going into the weekend.
Many state employees in Washington are four days away from a deadline for being fully vaccinated against Covid-19, and officials will not extend that deadline further.
“If people do make the choice to leave public service, we will replace them,” Gov. Jay Inslee said Thursday.
More than 90% of state employees have given proof of vaccination, Inslee said, and about two percent more have been given special accommodations that will allow them to remain unvaccinated due to medical conditions or religious convictions.
In Nevada, rural hospital intensive care units stretched to their limits may face a staffing shortage as a health care worker vaccinate mandate kicks in on November 1.
“We know that there are staff members that will refuse to be vaccinated,” Joan Hall, president of Nevada Rural Hospital Partners, said in a briefing Thursday. Vaccination rates for employees at their hospitals range from 60% to 90%, Hall said.
But experts have consistently pointed out that areas with higher rates of vaccination are faring better with Covid-19 hospitalizations.
New York City has an indoor vaccine mandate for many businesses, and Mayor Bill de Blasio said Thursday that 85% of adult residents have received at least one dose of Covid-19 vaccine.
The Covid-19 hospitalization rate in the city’s public health system has reached its lowest point since the beginning of the pandemic, according to Dr. Mitchell Katz, CEO of NYC Health + Hospitals.
Antiviral pill application will be reviewed
Vaccines have been proven to be the most effective means of Covid-19 protection, yet the measure is a preventative one. An antiviral pill that may help those newly infected is now slated for review next month.
The FDA’s Antimicrobial Drugs Advisory Committee will meet November 30 to discuss Merck and Ridgeback’s emergency use authorization application for its experimental Covid-19 antiviral drug molnupiravir, the agency announced Thursday.
If authorization is eventually granted, the drug — which comes in capsule form — would be the first oral antiviral treatment to fight Covid-19.
Preliminary results showed that 7.3% of 385 patients who received the antiviral were either hospitalized or died from Covid-19, compared with 14.1% of the 377 patients who received a placebo, Merck said earlier this month.
“Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo,” the statement said.
The FDA noted it doesn’t always convene an advisory committee meeting to discuss a potential EUA, but it can when the committee discussion would help inform the agency’s decision making.
“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
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