Health

CDC director DEFENDS her decision to overrule her agency’s advisory committe

The director of the Centers for Disease Control and Prevention (CDC) has defended her decision to overrule her own agency’s advisory panel and recommend that people at risk of COVID-19 because of their jobs receive vaccine boosters.

On Thursday afternoon, the Advisory Committee on Immunization Practices (ACIP) said third doses should only be for Americans aged 65 and older and those with underlying conditions after six months.

But members said there wasn’t enough data suggesting those who live in institutional settings that increase their risk of exposure, such as prisons or homeless shelters, as well as healthcare workers, teachers and grocery store employees, are at heightened risk.

But Dr Rochelle Walensky disagreed and broke with the committee, but said she listened to their concerns before making her decision.

 ‘I did not overrule an advisory committee…This was a scientific close call,’ she said during a press briefing of the White House coronavirus task force on Friday. 

‘In that situation it was my call to make. If I had been in the room, I would have voted “yes.”‘ 

CDC Director Dr Rochelle Walensky on Friday (above) defended her decision to overrule her own agency’s advisory panel and recommend boosters for those at high-risk due their jobs and said that because it was a close vote it was her ‘decision to make’

Bosters doses were also approved for those aged 65 and older and all Americans with underlying conditions. Pictured: Shana Alesi administers a COVID-19 booster to Marine Corps veteran Bill Fatz at the Edward Hines Jr VA Hospital in Hines, Illinois, September 24

Bosters doses were also approved for those aged 65 and older and all Americans with underlying conditions. Pictured: Shana Alesi administers a COVID-19 booster to Marine Corps veteran Bill Fatz at the Edward Hines Jr VA Hospital in Hines, Illinois, September 24

On Thursday afternoon, ACIP voted unanimously to give the shot to people aged 65 and older and long-term care facility residents and 13-2 for Americans between ages 50 and 64 with underlying medical conditions.

Boosters were also recommended for those aged 18 to 49 with pre-existing conditions, but the vote was much closer with the recommendation passing 9-6. 

However, the committee voted against recommended use for those are at risk due to an ‘occupational or institutional settings,’ claiming there wasn’t enough data to make such a recommendation.  

Until the FDA announced its decision, ACIP was unable to recommend third doses, a necessary step before pharmacists or clinicians can immunize patients.  

Although the CDC is not bound to follow the advisory group’s recommendations, the agency usually does not go against guidance of ACIP. 

So it was a surprising move late Thursday night when Walesnky overruled her own agency’s advisory panel in a rare move late Thursday night and added a recommendation for COVID-19 vaccine boosters for people at risk because of their jobs.  

She  that giving boosters to healthcare workers and others would ‘best serve the nation’s public health needs.’ 

‘In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,’ Walensky said in a statement.    

Last month, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.

At least 2.37 million people in the U.S. have received booster doses as of Friday, according to data from the CDC.

The White House also announced last month booster shots would become available for all Americans starting on September 20 – a date that has come and gone – due to data suggesting waning efficacy of the initial shots.  

At the time, Pfizer said its early data suggested people who received booster doses between six and 12 months after their final dose had high levels of protection.  

Pfizer said data suggested efficacy of two doses declines from 96.2% to 83.7% after six months but that a third dose boosts antibody levels (above)

Pfizer said data suggested efficacy of two doses declines from 96.2% to 83.7% after six months but that a third dose boosts antibody levels (above)

The company filed for emergency use authorization for booster doses in late August and submitted data to the FDA, which was made public last week.  

The documents suggest that protection from two doses of the Pfizer vaccine declines from 96.2 percent at seven days after dose 2 to 90.1 percent two months later to 83.7 percent up to six months later. 

What’s more, they cited data from Israel showing people fully vaccinated in January 2021 had a 2.26-fold increased risk for breakthrough infections compared to those fully vaccinated in April 2021.

Another Israeli study discussed in the documents showed that effectiveness against  infection was 39 percent and against symptomatic disease was 40 percent from June 20, 2021 to July 17, 2021, when the Delta variant was the dominant strain.

Comparatively, between January and April, these rates were at 95 percent or higher. 

The team also released data from a clinical trial involving 23 participants who participated in Pfizer’s early-stage trials last year.

Each had received two doses of the vaccine and were given a booster dose at least six months later.

Of the participants, 11 were in the younger adults group of those aged 18 to 55 and 12 were aged 65 to 85. 

After the third dose, neutralizing antibodies against the original strain of the virus rose five-fold in the 18-to-55 age group and seven-fold in the 65-to-85 group.

Against the Delta variant, antibody levels after a booster shot rose five-fold in the younger adult group and 12-fold in the older adult group. 

But many scientists, including senior officials at the FDA, disagreed with booster shots and argued that the vaccines are still highly effective at preventing severe illness and death. 

FDA officials also expressed concern over a lack of data on the potential side effects of a third dose, especially for younger adults who may be at risk for heart inflammation. 

In a separate briefing document also published last week, FDA scientists wrote with a skeptical tone about the need for booster shots.

‘Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,’ the scientists wrote.

They added that studies on booster doses have presented conflicting findings and that ‘known and unknown biases that can affect their reliability.’

WHO IS ELIGIBLE FOR COVID-19 BOOSTER SHOTS AND WHEN SHOULD THEY GET THEM?

By Mary Kekatos, Acting U.S. Health Editor for DailyMail.com 

What are COVID-19 vaccine boosters? 

A booster shot is given at least six months after people have been fully vaccinated against COVID-19. 

It is meant to prolong immunity and give a ‘boost’ to the immune system to create higher levels of antibodies against the virus.

Is vaccine protection waning? 

Not necessarily, although this topic is hotly debated.

Some people have weakened immune systems, either due to medical conditions or to age, that have left them unable to mount a full immune response to the first doses.

Some studies have found that vaccine protection does decrease after more than four months, which is common with several other immunizations.

However, health officials insist that vaccines are still highly effective against the most severe outcomes from COVID-19, including hospitalization and death.   

Who is currently eligible? 

Last month, boosters were authorized for Americans with compromised immune systems.

This week, the U.S. Food and Drug Administration (FDA) expanded that authorization to specific at-risk groups.

These include people aged 65 and older, long-term care facility residents and people aged 18 to 64 at high risk of severe COVID-19 due to underlying medical conditions.

Although the Centers for Disease Control and Prevention’s (CDC) advisory committee recommended that boosters not be for people at high risk due to their jobs or other factors, CDC director Dr Rochelle Walensky overruled this decision and sided with the FDA.

This means people who are at high-risk of severe illness due to their occupations – such as healthcare workers, teachers and grocery store employees – and those who live in institutional settings that increase their risk of exposure, such as prisons or homeless shelters, are also eligible.

Which COVID-19 vaccine booster can I get?

Right now, only recommended groups who received two doses of the Pfizer-BioNTech vaccine, and were given their final shot at least six months ago, can get booster shots. 

Pfizer’s booster shot is exactly the same – both ingredients-wise and dosage (30 micrograms) – as the first two doses. 

What if I received the Moderna or Johnson & Johnson vaccine?

Moderna has submitted an application to the FDA asking that its booster shot be authorized while Johnson & Johnson is expected to do so soon.

Because of this, recipients of either of these two vaccines are not eligible to receive boosters yet.

President Joe Biden said on Thursday that scientists are still examining data for boosters shots from the two companies.

‘Our doctors and scientists are working day and night to analyze the data from those two organizations on whether and when you need a booster shot, and we’ll provide updates for you as the process moves ahead,’ he said.

Can I mix and match?

Currently, federal health officials do not recommend getting a booster shot made by a different vaccine manufacturer than that of your initial doses.

This means that Moderna and Johnson & Johnson recipients are not recommended to get a booster dose from Pfizer and vice-versa.  


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