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Regulators ask for more time to investigate data on booster shots only weeks ahead of their roll out

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The White House is being advised by some regulators to scale back plans to roll out COVID-19 booster shots this month.

Leadership of the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), told White House officials they would need more time to review data before making a decision, the report said. Washington Post.

The White House has announced plans to make boosters available starting Sept. 20 — less than three weeks from now — last month.

However, the announcement was made pending regulatory approval, and this could be a speed bump for the Biden administration’s plans.

dr.  FDA Commissioner Janet Woodcock (pictured) attended a meeting where regulators told officials they needed more time to review booster shot data

dr. Rochelle Walensky (left) and Dr. Janet Woodcook (right) told While House officials at a meeting Thursday they may not be willing to give a full green light to vaccine boosters by Sept. 20.

dr. Janet Woodcock, FDA Commissioner, and Dr. Rochelle Walensky, director of the CDC, met Thursday with White House pandemic coordinator Jeffrey Zients.

They told Ziens that they would not be able to make an informed decision in time to meet the target rollout date.

With the information they had, Woodcock and Walensky said they could only make a partial recommendation for the Pfizer-BioNTech vaccine, and not yet a recommendation for the Moderna shot.

Moderna only submitted data on the booster shots to regulators on Wednesday, just 19 days before the third shot was set to become available.

Pfizer and BioNTech were slightly ahead of their peers, submitting data on Aug. 16.

“We’ve always said we’d follow the science, and this is all part of a process that’s now underway,” a White House spokesperson told the Post on Friday.

Last month, the White House, along with the FDA and CDC, announced it would make booster shots available to Americans who received the Pfizer or Moderna vaccine.

Jeffrey Zients (pictured) said all available data regarding booster shots is being reviewed

Jeffrey Zients (pictured) said all available data regarding booster shots is being reviewed

People would be eligible for the third injection eight months after their second injection.

Officials cited the declining immunity offered by the current crop of COVID-19 vaccines, coupled with the Delta variant’s ability to cause breakthrough cases among vaccinated people as the reason boosters are needed.

However, the decision was awaiting regulatory approval.

Making the announcement before approval was given angered some regulators, and two FDA officials even resigned in protest at the Biden administration’s decision.

Ziens responded on Wednesday to the dismissal and the controversy surrounding the boosters.

“As our medical experts have pointed out, after reviewing all the available data, in their clinical judgment it is time to prepare Americans for a booster injection,” Ziens said at a news conference.

“We announced our approach to staying ahead of the virus, giving states and pharmacies time to plan and being transparent with the American people about the latest data and expert clinical assessments from the team so they have time to take their time to develop their skills.” own schedule.

“We’ve also been very clear all along that this is pending conducting an independent FDA review and issuing a recommendation from the CDC’s panel of outside experts for a booster dose.”

Booster shots for the Pfizer-BioNTech and Moderna vaccines will start rolling out September 20.  Any American is eligible for the third injection eight months after they receive their second.  (File photo)

Booster shots for the Pfizer-BioNTech and Moderna vaccines will start rolling out September 20. Any American is eligible for the third injection eight months after they receive their second. (File photo)

Other groups have criticized the decision to roll out boosters and announce the plans before regulators had a chance to investigate.

Some scientists have argued that the data does not support the need for booster shots, as hospitalizations and deaths among fully vaccinated people remain low, although breakthrough infections are increasingly common.

WHO director-general Tedros Adhanom Ghebreyesus also called for a pause in the rollout of booster shots, and instead for high-income countries to donate doses to low-income countries to help develop new ones. to avoid variants.

“Vaccine law and vaccine nationalism” increase the risk of more infectious variants emerging, Tedros said during a speech in Budapest, Hungary last month.

“The virus gets the chance to circulate in countries with low vaccination coverage, and the delta variant can evolve to become more virulent, and at the same time, more potent variants can emerge,” he added.

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