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Wednesday, December 8, 2021

COVID: Not everyone will need boosters, say experts

Originally Published: 15 October 21 02:22 ET

Updated: 15 OCT 21 15:46 ET

By Travis Caldwell, CNN

(CNN) – US Food and Drug Administration advisers voted unanimously to recommend emergency authorization of a booster dose of Moderna’s Covid-19 vaccine, and a day later to do so again for a booster dose of Johnson & Johnson’s vaccine did.

The group voted Friday to authorize a booster shot of Johnson & Johnson’s vaccine for Americans age 18 and older at least two months after receiving their first shot. Johnson & Johnson said studies have shown that increases in two or six months can bring effectiveness up to 94%.

If the FDA follows its advisors’ recommendations, more than 90% of people vaccinated with the Johnson & Johnson shot — about 14 million people — would be eligible for a booster immediately.

Meanwhile, Moderna’s EUA request mirrored that of groups authorized to receive booster doses of Pfizer’s mRNA vaccine. The third dose of Moderna and Pfizer Covid-19 vaccines is already authorized for some immunocompromised people.

Yet some experts are noting that while antibodies may dwindle over time, the initial two-dose regimen for both Pfizer and Moderna vaccines still protects against serious Covid-19 infections.

Dr. Paul Offit, member of the FDA Vaccines and Related Biological Products Advisory Committee voted, told CNN’s Wolf Blitzer on Thursday that reasonable expectations need to be set about what vaccines should do and how effective they remain.

“We have to define what the goal of this vaccine is. If the goal of this vaccine is to prevent serious illness, which means the kind of illness that requires you to seek medical attention or go to a hospital or ICU, So current vaccines, two-dose vaccines, are doing exactly that,” he said. “So, you don’t really need a booster dose, at least as far as those figures are concerned.”

The committee’s recommendation for Moderna’s booster is the same as last month for the Pfizer/BioEntech third dose: it’s authorized for people over 65, and people 18 years and older at risk of serious illness have or who live or work in a condition that puts them at higher risk for complications or serious illness.

Offit said that although he voted to recommend half-dose booster shots for some people six months after the first two doses of Moderna’s vaccine, he doesn’t think everyone needs one.

“I worry about 18- to 29-year-olds because that’s the group that has a higher risk of myocarditis — that’s an inflammation of the heart muscle,” he said. “So, without any clear advantage that a third dose is necessary, I think we have created this kind of ‘third dose fever’ in this country because of the way it played out.”

Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences at the National Institutes of Health, agreed.

“I don’t see the need for a let-it-rip campaign for boosters,” Kurilla said.

According to the latest figures from the Centers for Disease Control and Prevention, more than 9 million people have received a booster dose of the coronavirus vaccine, which is about 5% of those who were already fully vaccinated.

According to CDC data, the number of people receiving a booster dose currently exceeds the number of people receiving the first dose of the vaccine. More than a million doses were given on Wednesday, but an average of about 230,000 people are beginning the vaccination process every day.

President Joe Biden highlighted progress since July when nearly 100 million eligible Americans remained unaffiliated, but said the nation is in a “very critical period” and urged more to do.

“We are down to 66 million, with still an unacceptably high number of non-vaccinated people,” he said on Thursday. “Now is not the time to give up.”

Read Also:  Experts Encourage COVID Growth in Europe

The FDA will consider the committee’s recommendations, and if an EUA is approved, the CDC will specify which groups will be eligible.

Vaccine mandates go ahead

As discussions on boosters continue, experts continue to point to a greater need to vaccinate those who have not been vaccinated to get ahead of the pandemic. And while many Covid-19 vaccine mandate campaigns from the public and private sectors have been a success, some agencies are receiving pushback from a vocal subgroup.

In Chicago, the president of the police union said more than half of the city’s officers could be placed on unpaid leave starting Friday because of the failure of individuals to report vaccination status as required by the city. The police department said this week that it would be fully staffed over the weekend.

Many state workers in Washington are four days away from the deadline for a full vaccination against Covid-19, and officials will not push that deadline.

“If people choose to leave public service, we will replace them,” Gov. Jay Inslee said Thursday.

More than 90% of state workers have provided proof of vaccination, Inslee said, and about two percent more have been given special accommodations that would allow them to live without vaccinations because of medical conditions or religious beliefs.

In Nevada, rural hospital intensive care units stretched to their limits may face staffing shortages as a vaccine mandates for health care workers on Nov.

“We know there are staff members who will refuse vaccinations,” Joan Hall, president of Nevada Rural Hospital Partners, said at a briefing Thursday. Hall said vaccination rates for staff at his hospitals range from 60% to 90%.

But experts have consistently pointed out that areas with high rates of vaccination are doing better with fewer Covid-19 hospitalizations.

Many businesses in New York City have an indoor vaccine mandate, and Mayor Bill de Blasio said Thursday that 85% of adult residents have received at least one dose of the Covid-19 vaccine.

According to Dr. Michelle Katz, CEO of NYC Health + Hospitals, the rate of Covid-19 hospitalizations in the city’s public health system has hit its lowest point since the start of the pandemic.

Antiviral pill application will be reviewed

Vaccines have proven to be the most effective means of Covid-19 protection, yet are still a preventive measure. An antiviral pill that may help newly infected people is now up for review next month.

The agency announced Thursday that the FDA’s antimicrobial drug advisory committee will meet on November 30 to discuss Merck and Ridgeback’s emergency use authorization application for their experimental Covid-19 antiviral drug mollupiravir.

If authorization is eventually granted, the drug – which comes in capsule form – will 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 of Covid-19, while 14.1% of 377 patients received a placebo, Merck reported this month. Said in the beginning.

“During the 29 days, no deaths occurred in patients receiving mollupiravir, compared to 8 deaths in patients receiving placebo,” the statement said.

The FDA notes that it does not always convene an advisory committee meeting to discuss a potential EUA, but it may if the committee’s discussion will help 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 a clear understanding of the scientific data and information that the FDA makes in its decision about authorizing 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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