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Vaccines and Related Biological Products Advisory Committee

Pfizer-BioNTech Ask FDA to Authorize COVID-19 Vaccine for Children 5 to 11

Kimberly Redmond | Equities.com |

Pfizer Inc (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced Thursday they have asked the US Food and Drug Administration (FDA) to expand their COVID-19 vaccine’s emergency use authorization to cover children ages five to 11.

If authorized, this would be the first coronavirus vaccine authorized for younger children. Currently, the Pfizer-BioNTech shots are only approved in the US for people ages 16 and up and in the EU for people ages 12 to 15.


FDA Advisory Panel Overwhelmingly Endorses Moderna's COVID-19 Vaccine for Emergency Use Authorization

Reuters | Equities.com |

The U.S. Food and Drug Administration (FDA) will “rapidly” work towards granting emergency approval of Moderna Inc’s COVID-19 vaccine candidate, FDA Commissioner Stephen Hahn said on Thursday.

A panel of outside advisers to the FDA — the Vaccines and Related Biological Products Advisory Committee — overwhelmingly endorsed the emergency use of Moderna’s coronavirus vaccine on Thursday, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.

The committee voted 20-0 with one abstention that the benefits of the vaccine outweighed its risks in people aged 18 and older.


Moderna on Doorstep of FDA Authorization for Its COVID-19 Vaccine

Reuters | Equities.com |

Moderna Inc’s COVID-19 vaccine appeared set for regulatory authorization this week after U.S. Food and Drug Administration staff endorsed it as safe and effective in documents released Tuesday.

The coronavirus pandemic has killed more than 300,000 people in the U.S. and the government is counting on the Moderna shot to help fulfill its promise to inoculate 20 million this month.

An FDA decision on whether to issue a so-called emergency use authorization for the Moderna vaccine will be made after a panel of outside advisers meets Thursday. The FDA typically follows the advice of the panel, but is not required to do so.


FDA Advisory Panel Endorses Widespread Use of Pfizer-BioNTech COVID-19 Vaccine

AP News | Equities.com |


By LAURAN NEERGAARD and MATTHEW PERRONE
today

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Documents created by Pfizer for the meeting with the Food and Drug Administration advisory panel, as Pfizer seeks approval for emergency use of their COVID-19 vaccine, are seen on Thursday, Dec. 10, 2020. The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in U.S. history. Depending on h...


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