FDA approves Pfizer vaccine for emergency use
The Pfizer/BioNTech vaccination has been granted emergency use authorisation by the FDA, but when will Operation Warp Speed begin distributing shots to at-risk Americans?
Following a hearing held on Thursday, a US government advisory panel was approved the use of Pfizer’s covid-19 vaccine in people aged 16 and older. The Food and Drug Administration (FDA) have granted emergency use authorisation for the vaccination which is hoped to help turn the tide on the pandemic which has cost over 295,000 Americans their lives.
This is the first FDA-approved coronavirus vaccine but the Agency is one of two regulatory bodies that have to authorise Pfizer’s shot before it can be administered to Americans. The Centers for Disease Control and Prevention (CDC) is still yet to vote on the vaccine, with the CDC’s Advisory Committee for Immunization Practices expected to make a decision on Saturday or Sunday.
FDA Commissioner Stephen Hahn says review process for authorizing COVID-19 vaccine was made "as transparent as possible," adding the Pfizer vaccine's benefits "outweighs its risks." https://t.co/5a2mfR6PdE pic.twitter.com/ZzhkzfL54X— ABC News Politics (@ABCPolitics) December 12, 2020
What does the Pfizer vaccine approval mean for the pandemic?
This positive news comes during one of the darkest periods of the pandemic as the US draws close to 300,000 coronavirus deaths. Earlier this week over 3,000 Americans died of covid-19 in a single day, the most since the pandemic began. Despite warnings from health experts and government officials there is likely to be an increase in travel and social gatherings over the Christmas period which will increase the infection rate further.
Yesterday marked another tragic, preventable milestone in our fight against COVID-19, but this news is a bright light. I’m grateful for every scientist, researcher, and public health expert who made it possible. https://t.co/ooDP8SZFrk— Joe Biden (@JoeBiden) December 11, 2020
However the FDA approval of Pfizer’s vaccine does mean that some of the most vulnerable Americans can start receiving their shots in the coming days, with the elderly and healthcare workers expected to be the first priority. The winter months are expected to be the most dangerous and the FDA called the authorisation a "significant milestone" in the fight against covid-19.
It is not yet clear what guidance will be issued in the US after two allergy sufferers in the UK, where the vaccine is already being distributed, reported a negative reaction to the vaccine. Two healthcare workers who suffer from food allergies reported anaphylactic symptoms after receiving their shots, provoking the British medical regulators to advise that anyone with severe allergies does not receive the vaccination.
When will the Pfizer vaccine be available in the US?
The CDC advisory group has previously recommended that front line healthcare workers and care home residents should be the first to receive the vaccine, regarding them as the most at-risk groups. This prioritisation will be key in the first months of vaccine availability as nations around the world scrabble to get a limited number of doses distributed quickly. The US is currently planning to vaccinate 2.9 million people in the first wave, which will consist of two doses of the Pfizer shot administered three weeks apart.
First COVID-19 Vaccine May Be Distributed Next Week#USArmy Gen. Gustave Perna, C.O.O. for #OperationWarpSpeed, said within 24 hrs of an emergency use authorization by the FDA, the vaccine will be shipped out & available to Americans who need it most.https://t.co/qMO1Xs0Q1c pic.twitter.com/iim5yCAIht— U.S. Army (@USArmy) December 10, 2020
General Gustave Perna, head of President Trump’s Operation Warp Speed task force, has previously suggested that the US would be able to start this process within a day of receiving the emergency use authorisation. In late November, he told ABC News: “We're going to be ready to distribute vaccines within 24 hours".
Around 7.5 million doses are available to ensure that these high-risk groups are vaccinated as quickly as possible, but there are plans already in motion to see the shots rolled out more widely. The US government expects to receive a total of 25 million doses of the vaccine before the end of 2020, with Pfizer supplying another 75 million by March 2021.
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