CDC backs FDA in reducing time between main dose and booster dose of Pfizer vaccine – CBS Pittsburgh

By Deidre McPhillips, CNN

(CNN) – The U.S. Food and Drug Administration on Monday extended emergency use authorization for Pfizer’s COVID-19 vaccine booster to children ages 12 to 15.

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The agency also shortened the time needed before receiving a booster shot from at least six months after completing the first series to at least five months, for everyone 12 years of age and older.

FDA Acting Commissioner, Dr. Janet Woodcock said in a statement. “Given the current wave of omicron variant, it is important that we continue to take effective, life-saving precautions such as primary vaccinations and boosters, wearing masks and staying away. society to effectively combat COVID-19.”

The U.S. Centers for Disease Control and Prevention on Tuesday supported the FDA’s decision to shorten the time between an initial series of Pfizer vaccines and a booster shot, but plan to face the issue. their vaccine consultation on Wednesday to discuss expanding youth booster eligibility.

The FDA updated the emergency use authorization after reviewing factual data from Israel showing “no new safety concerns” in expanding the teen booster or shortening the timeframe. between the first series and the booster dose.

Specifically, the data showed no new cases of myocarditis or pericarditis in adolescents who received the booster injection, according to a statement from the FDA.

FDA leaders said in a call with reporters Monday, FDA leaders said the rapid increase in cases around the country demonstrates the benefits of expanding eligibility. The strengthening condition clearly outweighs the risk.

“We should move as quickly as possible,” said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research.

These new measures apply to the Pfizer / BioNTech vaccine. A booster shot is still recommended for all adults who received their original Moderna vaccine series at least six months ago or a Johnson & Johnson shot at least two months ago.

As additional data becomes available for other vaccines, the FDA “will take action on that data as quickly as possible,” Marks said.

The booster dose of Pfizer contains the same amount of vaccine as the original dose: 30 micrograms.

Adolescents aged 12 to 15 years are eligible to receive the initial Pfizer/BioNTech COVID-19 vaccine series in mid-May, expanding the immunization round to an additional 17 million people.

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Currently, about half of the population between the ages of 12 and 15 – about 8.7 million people – are fully immunized, according to data from the US Centers for Disease Control and Prevention. About 5 million of them have been fully immunized over five months and are now eligible for a booster shot.

Children in this age group make up about 5% of the total US population. They make up about 4% of the fully vaccinated population in the US and about 3% of those eligible for a booster shot, according to the latest CDC data.

In October, the CDC recommended that everyone 16 years of age and older who completed their initial series of Pfizer or Moderna vaccines at least six months ago should get a booster shot, along with people who had already had the shot. The original Johnson & Johnson at least two months ago.

The FDA on Monday also authorized a third dose as part of a major series of drugs for certain immunocompromised children ages 5 to 11, including those who have received organ transplants.

The CDC agreed with the FDA on this, consistent with their recommendations for adults with moderate or severe immunodeficiency.

“As we have done throughout the pandemic, we will continue to update our recommendations to ensure the best possible protection for the American people. Following FDA approval, today’s recommendations ensure everyone can increase their protection in the face of Omicron and the growing cases nationally, while ensuring that children The most vulnerable may receive an additional dose to optimize protection against COVID-19,” CDC Director Dr. Rochelle Walensky said in a statement Tuesday.

Children under 12 years of age are not yet eligible for a booster shot, and many have only been fully immunized with their initial series in recent weeks.

“We certainly understand that there is an urgent need in that age group. We understand the possible hospitalizations in that age range and we will move at the appropriate pace but with the appropriate data in hand,” Marks said Monday.

Overall, about 68.8 million people are fully vaccinated and boosted against COVID-19. That’s less than half of the nearly 180 million people eligible for the booster shot and about one-fifth of the total US population.

And at least 69 million people age 5 and older have not yet received their first dose of the COVID-19 vaccine, according to the latest CDC data.

“Hopefully this will not only be a call to people to get vaccinated, but give tens of millions of Americans who haven’t had a chance to consider the consequences of not being fully vaccinated, but another opportunity. Marks said.

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