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Highlights
- The Pfizer-BioNTech Covid-19 vaccine Comirnaty has been authorized for use on children aged 12 in the US and several other countries.
- On Sep 20, Pfizer Inc and BioNTech announced positive results from phase 2 and 3 trials of the vaccine on 2,268 children in the age group of 5-11.
- On Sep 20, Pfizer Inc and BioNTech announced positive results from phase 2 and 3 trials of the vaccine on 2,268 children in the age group of 5-11.
The Pfizer-BioNTech Covid-19 vaccine Comirnaty has been authorized for use on children aged 12 in the US and several other countries, the companies said.
Also, on Sep 20, Pfizer Inc and BioNTech announced the positive results from phase 2 and 3 trials of the vaccine on 2,268 children in the age group of 5-11.
The vaccine was administered in two doses in a gap of 21 days. Under this trial, the administered dose was one-third of what was used in 12-year-olds, they said.
The companies now plan to get quick approval from FDA, EMA, and other regulatory agencies after they submit the final data so that it could be used in children under 12 years.
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Pfizer-BioNTech vaccine development
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to FDA and other regulators with urgency,” Reuters quoted Pfizer Chief Executive Albert Bourla as saying.
Data from another trial conducted on children between six months and under five years of age is expected to come before the end of this year, he said. The Pfizer-BioNTech vaccine got FDA approval for use for 12 years old and full approval for 16 years old or more.
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Source – pixabay
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Threats from Delta Variant
Infections from the Delta variant have been fatal in several cases over the past few months. Children were also affected. Kids are more likely to transmit the Delta variant, say experts.
Referring to the Pfizer-BioNTech vaccine trials, FDA acting commissioner Janet Woodcock said the agency would investigate the clinical data to see how children responded to the drug before taking a decision, according to Reuters.
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The government is also expecting a booster dose for adults, old- and high-risk individuals this week. Other covid vaccine manufacturers like Moderna and Johnson and Johnson have not yet received full FDA approval for their drugs for any age group.
Pfizer, Inc. (NYSE:PFE) stock closed at US$43.92, down 0.63%, while BioNTech SE (NASDAQ:BNTX) stock was up 0.69% to US$341.35 on Tuesday.
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Bottomline
The healthcare companies are expected to see quick bottom-line growth after the approval from FDA for their vaccine for children aged 5-11 years. The healthcare sector has made significant strides this year, boosted by rapid vaccine developments and approval, mainly for covid drugs. However, investors should evaluate the stocks carefully before investing.
