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October 8, 2021

Pfizer and BioNTech seek US FDA approval for Covid-19 vaccine in children

The FDA scheduled a meeting this month for discussions on the vaccine for children aged 5 to 11 years.

Pfizer and its partner BioNTech have reportedly submitted a formal request to the US Food and Drug Administration (FDA) for the emergency use authorization (EUA) of their Covid-19 vaccine for children aged 5 to 11 years.

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Last month, the company released the data obtained from a Phase II/III clinical trial, which was conducted on 2,268 subjects in this age group.

The trial was conducted using a two-dose regimen of 10µg administered 21 days apart, which is a smaller dose compared with the 30µg dose given to subjects aged 12 years and above.

This demonstrated that the vaccine was safe and indicated robust neutralising antibody responses.

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee last week to discuss the vaccine for children aged 5 to 11 years on 26 October, as reported on Cable News Network.

FDA acting commissioner Janet Woodcock said: “We know from our vast experience with other pediatric vaccines that children are not small adults and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger paediatric population, which may need a different dosage or formulation from that used in an older paediatric population or adults.”

Developed by BioNTech and Pfizer, the Covid-19 vaccine is based on the former’s messenger RNA (mRNA) technology.

In August, the vaccine was fully approved by the US FDA for individuals aged 16 and above.

However, it is still available under emergency use authorization for children aged 12 to 15 years.

Recently, Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the EU approval for its Covid-19 vaccine booster dose for individuals aged 18 years and above.

Related Companies

Free Whitepaper
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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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