Pfizer and BioNTech to ask FDA to authorize COVID-19 booster for kids as young as 5

Pfizer and BioNTech plan to ask the Food and Drug Administration to clear a 3rd dose of their COVID-19 vaccine for youngsters as young as 5, the businesses introduced Wednesday, citing trial outcomes exhibiting a “robust response” of antibodies on this age group after the booster shot. 

In the trial, 140 youngsters ages 5 to 11 years previous got a 3rd dose of the Pfizer-BioNTech COVID-19 vaccine six months after receiving their second shot. Blood drawn from the youngsters confirmed a six-fold enhance in antibodies in contrast to the quantity seen one month after the second dose, indicating “a strong immune response in this age group,” the businesses mentioned.

A subset of antibodies from the youngsters within the trial had been additionally examined in opposition to the Omicron variant. Those 30 samples had a powerful sufficient antibody response to neutralize the variant, with a “robust response” no matter whether or not the youngsters had beforehand survived a case of COVID-19, the businesses mentioned.

“Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose for children ages 5 through 11 in the U.S. in the coming days,” the businesses mentioned in a launch. 

While vaccine effectiveness in opposition to hospitalization remained comparatively excessive through the Omicron wave, the danger of breakthrough infections amongst Americans who had obtained solely two doses of a COVID-19 vaccine soared amongst all age teams — together with youngsters. 

According to information introduced last week by a Centers for Disease Control and Prevention official, two doses had been as little as 24% efficient at curbing an infection in youngsters 5 to 11 years previous through the Omicron wave.

If Pfizer and BioNTech’s request is greenlighted by the FDA and accredited by the CDC, solely a small handful of kids would seemingly initially be eligible for the booster. According to the CDC, simply 28% of Americans ages 5 to 11 have been totally vaccinated because the company formally really useful the photographs for that age group in early November

Federal officers have overtly expressed frustration with the lagging tempo of vaccinations. The CDC found in March that round 4 in10 mother and father of kids ages 5 to 11 in all probability wouldn’t have their kids vaccinated.

However, the announcement additionally comes as considerations are mounting amongst some well being consultants and officers of a brand new wave of circumstances within the coming months pushed by the BA.2 subvariant of Omicron. The nationwide tempo of COVID-19 circumstances and hospitalizations has begun to speed up in latest weeks, with the biggest upticks within the Northeast areas, the place the subvariant first grew to become dominant. 

“All that stuff you hear about, don’t worry about kids, let them get infected, is a bunch of nonsense. There have been about 12 million cases in kids, there have been over 120,000 hospitalizations,” Dr. Anthony Fauci mentioned Monday, in a lecture at Uniformed Services University.

“We really need to put that myth to sleep that we don’t need to protect the children now,” Fauci added. 

No information for youngsters underneath 5 

The launch doesn’t embody widely-anticipated information on the immune response in youngsters underneath 5. The FDA in February postponed plans to weigh authorizing two doses for kids in that age group, pledging to return to the difficulty after the businesses submitted information on the topic. 

“We at FDA really understand the urgency that people feel about wanting to get the youngest children vaccinated. We also understand that this is the age range when people are most concerned about potential side effects and the potential safety of vaccines,” Dr. Peter Marks, the FDA’s high vaccines official, instructed reporters last month

Data on three doses in youngsters underneath 5 is predicted within the “coming weeks,” in accordance to a Pfizer spokesperson.

“FDA has a lot of familiarity with these data sets and so they could act quickly on them. Assuming the data comes out in April, as is expected, I think the agency could potentially act in May,” former FDA Commissioner Dr. Scott Gottlieb, who sits on Pfizer’s board of administrators, instructed “Face the Nation” on Sunday

Moderna has additionally launched “positive interim data” from trials of simply two doses of its vaccine in youngsters as young as 6 months, with plans to search the FDA’s authorization within the coming weeks. 

“My hunch is it will slip a little bit because that sense of urgency will have dissipated because infection levels will be relatively low as we get into the spring,” added Gottlieb. 

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