Pfizer clinical data brings US closer to Covid-19 vaccine for youngsters – .

Pfizer clinical data brings US closer to Covid-19 vaccine for youngsters – .

A Food and Drug Administration review this week determined that Pfizer-BioNTech’s Covid-19 vaccine is safe and effective for children ages 5 to 11, paving the way for a vaccine to be approved for this group. of age from the beginning of November.

Pfizer also announced on Friday that the vaccine is over 90% effective in protecting school-aged children from serious illness or hospitalization from Covid-19, similar to the level of protection it offers adults.

The FDA analysis looked at data from Pfizer’s clinical trials in four different scenarios and concluded that all of the risks – in particular, vaccine-related pediatric myocarditis that typically lasts a few days – were negligible compared to the benefits to the patient. age group.

Previous data from Pfizer has shown that young children are able to tolerate the vaccine well and produce a strong immune response, and the results of Friday’s FDA review confirm its effectiveness.

The 2,268 children aged 5 to 11 in Pfizer’s clinical trials received doses one-third the size of an adult vaccine dose, spaced 21 days apart.

Now that the initial review is complete, there are only a few steps left before Pfizer’s coronavirus vaccine can be licensed for the estimated 28 million American children aged 5 to 11.

Next week, the FDA’s independent expert panel will review the research and make specific recommendations to the FDA on administering the Pfizer vaccine to this age group.

As with the booster injection recommendations, the advisory committee is able to offer precise and granular advice on the safety and need for the vaccine. For example, in September of this year, after the Biden administration planned a widespread rollout of vaccine boosters, the FDA panel recommended that only certain populations receive an additional injection.

However, as Vox’s Dylan Scott points out, “The groups already approved by the FDA and the Centers for Disease Control and Prevention for booster injections are quite large and cover a large portion of the adult population.”

The FDA panel will meet on Tuesday and offer its assessment to FDA officials. The FDA generally follows the advice of its expert panel, but its advice is not binding.

If the advisory committee’s opinion is consistent with the agency’s initial review of the data, the FDA will likely clear the vaccine soon after.

After that, Pfizer must then present its data to the CDC’s Advisory Committee on Immunization Practices or ACIP. This is a body similar to the FDA advisory committee – a rotating, independent group of scientists and other experts who can make specific recommendations to the CDC on the administration of the vaccine. This panel is scheduled to meet Nov. 2-3 to discuss pediatric vaccines, according to CNN.

Then, ultimately, it’s up to CDC director Dr Rochelle Walensky to guide the CDC’s decision on pediatric vaccines against Covid-19. As with the FDA advisory body, ACIP’s recommendations are not binding, but the CDC generally follows them.

Both agencies must authorize the vaccine; the FDA is first and foremost concerned with the safety of anything that is subject to emergency use authorization or full regulatory approval. This means not only asking if the drug itself is safe, but also inspecting the facilities and manufacturing practices while the drug in question is licensed. Meanwhile, the CDC’s concerns are more focused on how the drug should be administered and to whom, in addition to its safety and effectiveness.

As the White House awaits clearance, President Joe Biden earlier this week announced a plan to distribute pediatric vaccines to 25,000 pediatric and primary care practices, as well as children’s hospitals and school clinics. and community. The administration has already purchased enough doses to immunize all children in this age group; shots come in reconfigured packaging, with smaller needles for smaller arms.

“Children have different needs than adults and our operational planning is designed to meet these specific needs, including delivering immunizations in environments that parents and children know and trust,” told the reporters. reporters Jeff Zients, White House Covid-19 response coordinator. Wednesday.

The plan aims to avoid the chaotic and chaotic rollout that adults faced earlier this year, as well as build trust with families who may be reluctant to vaccinate their children. relying heavily on trusted sites like the pediatricians offices, and messaging across schools.

Children are not as vulnerable to Covid-19 as adults, but they are still positive

The likely authorization of Pfizer’s Covid-19 vaccine for children aged 5 to 11 is expected to make schools a much safer place as Covid-19 continues to spread in the United States.

While children don’t often show symptoms of Covid-19, as Vox’s German Lopez explained earlier this month, the combination of the delta variant and a return to class last month resulted in a sharp increase in pediatric cases of Covid-19 compared to the start of the pandemic.

According to the American Academy of Pediatrics, nearly 6.2 million children have tested positive for Covid-19 since the start of the pandemic. In the six weeks leading up to October 14, 1.1 million children tested positive.

About 280 children under the age of 18 died from Covid-19 between January and September this year, according to Lopez.

“In this latest wave of Covid-19, especially in the south, thousands of children have been hospitalized. And, frankly, it’s embarrassing in a developed country to have even 100 children, as we have had, die from an infectious disease that is preventable, ”said Dr Peter Marks, director of the Center for Biologics Evaluation. and Research of the FDA, at a press conference. town hall at the beginning of the month.

Ever since American school districts implemented a patchwork of vaccine and mask recommendations – some states like Texas and Florida ignoring scientific evidence for the effectiveness of masking and banning mask warrants and vaccines in school systems – students and teachers are vulnerable to the disease.

And despite the eagerness of many kids, teachers, and parents to get students back to class, high infection rates in the United States have meant there have been shutdowns and starts, quarantine of exposed students. the closure of entire campuses after an outbreak. Vaccinating schoolchildren would help reduce the spread of the virus – not to mention reduce the number of disruptions in the school year.

Despite the benefits, however, some parents say they are still wary of vaccinating their children, or will choose not to. According to a September study by the Kaiser Family Foundation, only about a third of parents surveyed – 34% – said they would vaccinate their children aged 5 to 11 as soon as this age group became eligible. Thirty-two percent said they would wait to see the vaccine’s effectiveness before having their child immunized, and 24 percent said they would not immunize their children at all.

More vaccines for more children should arrive soon

Authorization of a Covid-19 vaccine for children aged 5 to 11 would mean almost everyone in the United States is eligible for a vaccine, and pharmaceutical companies are already making progress on injections for even younger children .

Pfizer, which, along with BioNTech, makes the only vaccine licensed for use in children under 18, is also conducting clinical trials on children aged 2 to 5 and separate trials for children as young as six months .

Data from those trials is expected before the end of the year, according to Pfizer.

Moderna, which makes the other mRNA vaccine licensed for U.S. adults, is also recruiting for its pediatric clinical trials in children aged 6 months to 11 years. The company submitted its clinical trial data on the effectiveness of the vaccine in adolescents aged 12 to 18 in June, but the FDA has paused to authorize it due to a high risk of myocarditis in adolescents. young men. Swedish and Danish health authorities have stopped giving Moderna vaccines to people under the age of 18 in those countries due to this possible high risk.

With more approvals on the horizon, many parents will likely be relieved to add Covid-19 vaccines to their children’s immunization schedules: As Friday’s FDA review confirmed, vaccine is safe and effective for young children, and the Biden administration plans to make it widely available as soon as it is authorized. And if Covid-19 is something we will have to live with as a society, as experts increasingly believe, then taking one step closer to the Covid-19 vaccine routine for young children is indeed a very good news.


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