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FDA adviser brings COVID-19 shots closer for children under 5 – Chicago Tribune

On Wednesday, the COVID-19 shot for infants, toddlers and preschoolers in the United States is one step closer.

The Food and Drug Administration’s external vaccine advisor thumbs up two shots of Moderna for the youngest children. The panel will vote later Wednesday on whether to recommend Pfizer’s three-shot series to these young people as well.

External experts unanimously voted that the benefits of Moderna’s shots outweigh the risks of children under the age of five (about 18 million young people).

They were the last group to be vaccinated in the United States and many parents have longed to protect their small children. Shots should be available next week if all regulatory procedures are cleared.

“This is the long-awaited vaccine,” said Dr. Jay Portnoy, a panel member at a children’s hospital in Kansas City, Missouri. “There are many parents who are eager to get this vaccine. I think it’s because of them that they give them the option to get the vaccine if they want.”

FDA Vaccine Officer Dr. Peter Markes held a meeting with data showing a “quite annoying surge” in infant hospitalization during the Omicron wave, killing 442 children under the age of four during a pandemic. Said. It is far less than an adult death, but he said it should not be rejected given the need to vaccinate the youngest children.

“The lost children basically break their families,” Marks said.

FDA reviewers said both brands appear to be safe and effective for 6-month-old children. Posted analysis Prior to the all-day meeting. Side effects such as fever and malaise were both generally minor and less common than those seen in adults.

The two vaccines use the same technique, but there are differences. In a phone call with a reporter earlier this week, vaccine experts pointed out that the shots haven’t been tested against each other, so there’s no way to tell parents if either is better.

“That’s a really important point,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. “Vaccines cannot be compared directly.”

If the FDA agrees with the advisor and approves the shot, there is another step. The Centers for Disease Control and Prevention will make formal recommendations after its own advisors meet on Saturday. If approved by the CDC, shots may be available at doctors’ clinics, hospitals and pharmacies on Monday or Tuesday.

Pfizer’s vaccine is intended for children between the ages of 6 months and 4 years. The Moderna vaccine is 6 months to 5 years.

Moderna shots are a quarter dose of the company’s adult shots. The two doses appeared to be powerful enough to prevent serious illness, but were only about 40% to 50% effective in preventing mild infections. Moderna hopes to add boosters to its research and eventually provide boosters.

Pfizer shots are only one-tenth the dose for adults. Pfizer and its partner BioNTech discovered that the two shots did not provide sufficient protection in the test, so a third shot was added during the Omicron wave.

Data submitted by Pfizer showed no safety concerns, suggesting that three injections are 80% effective in preventing symptomatic coronavirus infections. However, it was based on only 10 COVID-19 cases. Calculations can change as more cases occur in the company’s ongoing investigation.

The same FDA panel on Tuesday supported Moderna’s half-size shots from 6 to 11 years old and full-size teenage doses. If approved by the FDA, it will be the second option for those age groups. Currently, the Pfizer vaccine is the only option.

The national vaccination campaign began in December 2020, with adult vaccines launched by Pfizer and Moderna, with healthcare professionals and nursing home residents first lined up. Last year, teens and school-aged children were added.

Moderna said in April that it was seeking regulatory approval outside the United States for the shot of the little child. According to the World Health Organization, 12 other countries have already vaccinated children under the age of 5 with other brands.

In the United States, the number of parents who want the youngest vaccination remains unknown. COVID-19 is generally less dangerous to young children than older children and adults, but there are serious cases and some deaths. Many parents trying to keep their unvaccinated luggage safe have postponed family trips or enrolled their children in day care or preschool.

Still, some estimates suggest that three-quarters of all children are already infected. Since the start of Pfizer vaccination in November last year, only about 29% of children aged 5 to 11 have been vaccinated. This is a much lower percentage than the public health authorities consider ideal.

Dr. Nimila Jagopal, a family doctor at Cook County Health in Chicago, said she had been preparing her parents for months.

“Some of us hesitate, others rarely go,” she said.

FDA adviser brings COVID-19 shots closer for children under 5 – Chicago Tribune

Source link FDA adviser brings COVID-19 shots closer for children under 5 – Chicago Tribune

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