- Pfizer - BioNTech’s COVID-19 vaccine has obtained the Emergency Use Authorization (EUA) in the US for adolescents.
- The two companies also notified they had submitted data to the European Medicines Agency (EMA) and other worldwide regulators.
- The pandemic continues to create havoc with the World Health Organization (WHO) reclassifying the triple mutant COVID-19 variant, emerging in India, as a variant of concern.
COVID-19 vaccine developed by Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) has been granted emergency approval from the Food and Drug Administration (FDA) for the children in the age group 12-15 in the US.
Earlier, the Centers for Disease Control and Prevention (CDC) highlighted that vaccination of children is crucial to achieving herd immunity and protecting the world against the virus. With the increasing spread of the highly contagious strain of novel coronavirus, having a vaccine for adolescents is considered a critical step to reduce the massive chaos caused by the COVID-19.
Meanwhile, the World Health Organization (WHO) revealed that the agency is reclassifying the highly infectious triple mutant COVID-19 strain spreading in India as a variant of concern for the globe.
Pfizer’s COVID-19 vaccine gains emergency approval for Adolescents
Pfizer and BioNTech have announced that the US FDA has given the EUA (Emergency Use Authorization) to their vaccine for administration in adolescents. This is the first COVID-19 vaccine authorized in the country for individuals in the 12 - 15 years age bracket.
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The FDA has concluded that the vaccine developed by Pfizer-BioNTech has met the statutory benchmarks to amend the EUA.
The partners have also submitted data to the EMA (European Medicines Agency) and other regulators worldwide. Further approvals are anticipated in the upcoming weeks.
Albert Bourla, Chairman and CEO of Pfizer, commented-
Furthermore, the pediatric clinical trial is evaluating the safety and efficacy of the vaccine in younger children aged six months to 11 years.
The FDA also stated that from 1 March 2020 through 30 April 2021, ~1.5 million COVID-19 cases were reported to the CDC in individuals aged 11 to 17 years.
The WHO reclassifies triple mutant COVID variant
The WHO disclosed that it is reclassifying the triple mutant variant of the novel coronavirus that is creating havoc in India as a variant of concern. The technical lead of WHO for COVID-19, Maria Van Kerkhove, stated that in primary studies B.1.617 variant had been discovered to circulate more rapidly than the original coronavirus. Besides, there is some evidence that the new variant might evade the protections provided by the available COVID-19 vaccines.
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As per the WHO, a variant can be categorized as a variant of concern if proven to be more deadly, more transmissible, or more resistant to the available COVID-19 vaccines and treatments.