December 4, 2021

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Independent panel recommends FDA approval for Pfizer’s Govt-19 vaccine for 5-11 year olds | Univision Health News

An important step towards the availability of the vaccine against Govt-19 in children between the ages of 5 and 11 is now in place: after rigorous analysis of the results of clinical trials The independent expert panel recommended food and drug administration (FDA) Grant emergency recognition to Pfizer.

The Vaccines and Biological Advisory Committee (VRBPAC) concluded that the benefits of vaccinating children outweigh the risks, a decision that millions of parents have been waiting for months.

Yes OK It is not yet bound because the FDA has the power to enforce or enforce itEverything points to the fact that historically it has been difficult to go against an independent panel of experts on a controversial issue such as the urgent approval of a vaccine.

In an analysis of Pfizer clinical trial data released by the FDA in the past, federal regulators injected two-dose Pfizer 91% effective in preventing symptomatic infections In this population group – even before the delta variation – that too They do not cause unexpected security problems.

“Children are not safe from the virus”

Further 1.9 million children between the ages of 5 and 11 have tested positive for Govit-19 and 8,300 of them have been hospitalized., One-third of whom had to enter the intensive care unit.

Vaccination may begin next week

If the FDA decides to give emergency approval to Pfizer’s Covid-19 vaccine for children between the ages of 5 and 11 – something that could happen in the next few hours – it will finally have to go two more steps to reach the hands of the little ones. One.

Consultants of The Disease Control and Prevention Committee on Immunization Procedures is scheduled to meet on November 2nd It will be decided after a few hours whether to review the performance and safety information and advise the agency director Rochelle Walenski to recommend its use, which will take place after a few hours.

That is what it means Vaccination of children 5 to 11 years of age against Govt-19 can begin on November 3 or 4.Well, at that point Pfizer would have sent the first batch to children’s offices and other vaccination sites.

“If Pfizer gets emergency approval on Tuesday, before the CDC vote on November 2-3, they will start sending it to the distribution chain,” said former Scott Field Commissioner Scott Godlip. CNN.

Effective and safe to a lesser extent

The FDA review confirmed Pfizer’s results Two-dose injections were almost 91% effective To prevent symptomatic disease in young children, even with delta variation.

The dose Pfizer used for this group was one-third higher than the dose already allowed for people over 12, but it exhibited an equally strong immune response.

However, FDA scientists noted that this study was not sufficient to diagnose very rare side effects, including myocarditis, an occasional type of heartburn that occurs after the second dose.

The agency used a statistical model to predict how many COVID-19s would be vaccinated against the number of hospital admissions and the number of potential cardiovascular side effects, and determined that the vaccine’s safety benefits outweigh its risks.