The vaccine was tested with a 10 microgram dose, while older age groups received 30 micrograms (File)
Washington:
Pfizer’s Covid-19 vaccine is more than 90 percent effective in preventing symptomatic disease in children aged 5 to 11, the company said in a document released on Friday, which put forward its case for authorization.
The new data was published on the website of the Food and Drug Administration, which has called an advisory panel of independent experts to meet on Tuesday to vote on whether to give the shot the green light.
The analysis was based on approximately 2,250 trial participants who were randomized to receive either the vaccine or the placebo, with data received as of October 8. Most of the positive cases were reported when the delta variant was dominant in the US and globally.
The document states, “VE (vaccine efficacy) against laboratory-confirmed symptomatic Covid-19 at least 7 days post-dose 2 in evaluable participants without evidence of prior SARS-CoV-2 infection was 90.7 %,” the document said.
The vaccine was tested with a 10 microgram dose, while the older age groups got 30 micrograms. The doses were administered three weeks apart.
There were no cases of severe covid and no case of multisystem inflammatory syndrome in children (MIS-C), a rare but serious post viral condition.
Since the start of the pandemic, 158 children between the ages of 5 and 11 have died of covid in the United States, according to official figures.
Pfizer argued that “although the death rate for Covid-19 in children is significantly lower than in adults, Covid-19 is among the top 10 leading causes of death for children aged 5 to 14 between January and May 2021.” there was one. .”
Safety data were examined among a total of 3,000 vaccination participants, with a low incidence of serious events.
There were no cases of myocarditis or pericarditis — inflammation or swelling around the heart — but there weren’t enough study volunteers to be able to detect the extremely rare side effects.
In any case, male teenagers and young men are considered a higher risk group for these conditions.
This is the first time that Pfizer has released an efficacy estimate for its Covid vaccine in young children with a detailed dataset.
Its earlier press statements only said that the vaccine produced a strong immune response and was safe.
During the pandemic, pharmaceutical companies are making big announcements via press releases with little data, a situation that has disappointed some experts.
A document containing the FDA’s own analysis should be released soon, and will indicate the agency’s own view of whether the benefits of the vaccine outweigh the risks to this group.
President Joe Biden’s administration has said it is ready to roll out the shot to the nation’s 28 million 5 to 11-year-olds as soon as the vaccine is authorized by science agencies.
The FDA panel meeting will be followed by a panel convened by the Centers for Disease Control and Prevention (CDC) on November 2-3. If both committees vote in favour, the authorization could come into force within a few days or weeks.
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)
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