Sept. 20, 2021 -- With grounds numbers of COVID-19 cases being reported successful kids, Pfizer and its spouse BioNTech have announced that their mRNA vaccine for COVID-19 is harmless and appears to make a protective immune effect successful children arsenic young arsenic 5.
The companies person been investigating a little dose of the vaccine -- conscionable 10 milligrams -- successful children betwixt the ages of 5 and 11. That’s one-third the dose fixed to adults.
In a objective proceedings that included much than 2,200 children, Pfizer says 2 doses of the vaccines fixed 3 weeks isolated generated a precocious level of neutralizing antibodies, comparable to the level seen successful older children who get a higher dose of the vaccine.
On the proposal of its vaccine advisory committee, the FDA asked vaccine makers to see much children successful these studies earlier this year.
Rather than investigating whether the vaccines are preventing COVID-19 unwellness successful children, arsenic they did successful adults, the pharmaceutical companies that marque the COVID-19 vaccines are looking astatine the antibody levels generated by the vaccines instead. The FDA has approved the attack successful hopes of speeding vaccines to children, who are present backmost successful schoolhouse afloat clip successful astir parts of the U.S.
With that successful mind, Evan Anderson, MD, a doc with Children’s Healthcare of Atlanta who is an researcher for the proceedings — and is truthful kept successful the acheronian astir its results — said it’s important to support successful caput that the institution didn’t stock immoderate efficacy information today.
“We don’t cognize whether determination were cases of COVID-19 among children that were enrolled successful the survey and however those compared successful those who received placebo versus those that received vaccine,” helium said.
The institution says broadside effects seen successful the proceedings are comparable to those seen successful older children. The institution said determination were nary cases of bosom inflammation called myocarditis observed. Pfizer says they program to nonstop their information to the FDA arsenic soon arsenic possible.
The institution says broadside effects seen successful the proceedings are comparable to those seen successful older children. Pfizer says they program to nonstop their information to the FDA arsenic soon arsenic possible.
“We are pleased to beryllium capable to taxable information to regulatory authorities for this radical of school-aged children earlier the commencement of the wintertime season,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said successful a quality release. “The information illustration and immunogenicity information successful children aged 5 to 11 years vaccinated astatine a little dose are accordant with those we person observed with our vaccine successful different older populations astatine a higher dose.”
When asked however soon the FDA mightiness enactment connected Pfizer’s application, Anderson said others had speculated astir timelines of 4 to 6 weeks, but helium besides noted that the FDA could inactive workout its authorization to inquire the institution for much information, which could dilatory the process down.
“As a genitor myself, I would emotion to spot that timeline occurring quickly. However, I bash privation the FDA to afloat reappraisal the information and inquire the indispensable questions,” helium said. “It’s a small speculative to get excessively definitive with timelines.”
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