US weighs in authorizing Pfizer Covid vaccine for young children

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Washington, (UrduPoint / Pakistan Point News – October 27, 2021): A high-level medical group of U.S. government advisers met on Tuesday to decide whether or not to authorize the Pfizer Covid-19 vaccine for ages 5 to 11 , probably paving the way for young children to get vaccinated in a matter of weeks.

If, as expected, independent experts convened by the Food and Drug Administration (FDA) vote in favor, it will trigger actions that allow an additional 28 million Americans to become eligible for vaccination.

Opening the meeting, senior FDA scientist Peter Marks said young children were “far from spared from Covid-19,” adding that in that group there had been 1.9 million infections and 8,300 hospitalizations, about a third of which required intensive care. .

There have also been around 100 deaths, making it one of the top 10 causes of death, he added.

The question put to the experts: Based on the available scientific evidence, do the benefits of the two-dose vaccine, given three weeks apart, outweigh the known risks.

Pfizer analysis released by the FDA ahead of the meeting showed that the vaccine – given at 10 micrograms instead of 30 micrograms as in the older groups – was 90.7% effective in preventing symptoms of Covid-19, and there were no serious security issues.

The FDA also performed a detailed risk-benefit analysis, which indicated that the agency’s scientists believe the benefits outweigh the most worrisome potential side effect for this age group: myocarditis or inflammation. cardiac.

FDA scientist Hong Yang presented a model that showed that at current infection rates, the vaccine would prevent many more hospitalizations from Covid than it could cause from myocarditis.

If community transmission were reduced to very low levels, that might change – but even then the vaccination might be worth it because of the long-term risks of out-of-hospital cases, she added.

These include pediatric multisystem inflammatory syndrome (MIS-C), a rare but very serious post-viral complication that has affected more than 5,000 children of all ages and killed 46.

William Gruber of Pfizer added that there were broader societal benefits as well.

For example, children probably play an important role in transmission, and childhood immunization can help achieve herd immunity.

“The vaccination will help ensure the in-person learning which is essential for childhood development by limiting the spread in the community and epidemics at school,” he added.

– Risk of myocarditis – In its clinical trial, Pfizer evaluated the safety data for a total of 3,000 vaccinated participants, with the most common side effects of mild or moderate, including pain at the injection site, fatigue, headache, muscle pain and chills.

There were no cases of myocarditis or pericarditis (inflammation around the heart), but there were not enough volunteers for the study to be able to detect very rare side effects.

Matthew Oster, a researcher at the Centers for Disease Control and Prevention (CDC), gave a presentation on what is known so far about side effects among groups already eligible for vaccines.

Of 877 cases of vaccine-related myocarditis in children under 29, 829 were hospitalized, according to official data. The vast majority have been discharged but five remain in intensive care.

The rate of the side effect will likely be lower in the 5 to 11 age group than in adolescent males, as it is believed to be related to testosterone.

The panel will have to weigh this theoretical risk against the prevention of Covid, which could cause more frequent and severe myocarditis.

The meeting comes as the United States comes out of its latest wave carried by the Delta variant.

But infections remain high in northern states such as Alaska, Montana, Wyoming and Idaho, which are experiencing colder weather and have lagging vaccination rates.

Overall, 57 percent of the total population is now fully immunized.

Confidence in vaccines has increased in recent months, but the United States lags behind all other G7 countries as a percentage of the fully vaccinated population.

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