Independent FDA Committee says Pfizer vaccine is ready for the US

Pfizer vaccine, COVID
© LakshmiPrasad Lucky

The independent experts of the US Food and Drug Administration (FDA) say that the Pfizer vaccine is good to go – which means rollout in roughly a week

Currently there are 15.7 million cases of COVID-19 in the US. The loss of some jobs support without a new stimulus bill in place by 31 December looms on the horizon. Christmas is approaching quickly and without mercy.

The Pfizer and BioNTech vaccine rollout is hotly expected, as the country’s case numbers continue to rise. Now that there is formal approval from their analytic wing, the FDA is expected to take a few days to go ahead and approve Emergency Use Authorisation.

Notes released from the 10 December meeting said: “It is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2.”

The stats behind Pfizer’s success

The clinical study done by BioNTech and Pfizer has 43,538 people, with a success rate of over 90%. Crucially, 42% of the participants were of diverse racial backgrounds, meaning that the vaccine will function to protect those who have been shown to be most vulnerable to contracting and dying from the virus.

On 20 November, this vaccine was sent to the FDA to begin the examination process that would lead to regulatory approval or rejection. Over the last three days, the independent expert team at the FDA have been dissecting the available data on Pfizer and BioNTech’s mRNA vaccine.

The disparity in timeframe between the UK and the rest of the world on Pfizer approval has been highlighted by the media, but both the US and UK are using their emergency approval mechanisms. The UK celebrated their first vaccination, a 90 year old former jewellery shop assistant, on Tuesday.

In contrast, the EU is using a more traditional route for medicine approval – which would lay any liability with the vaccine-makers, not the Government. In the UK, the Government will be theoretically held responsible if anything goes wrong.

Which Americans could get the Pfizer vaccine first?

The NYTimes estimates that around 17 million to 20 million healthcare workers live in the US, with 1 million in nursing homes. This is the priority demographic for first use of the vaccine, which Pfizer officials said would produce roughly enough to immunise 20 million Americans before January. Other countries are still waiting to see what their regulatory authorities will decide, but it is likely that they will follow the same blueprint – nursing homes and healthcare workers first. The further rollout of vaccinations is expected for after 2020 ends.

Who funded the Pfizer vaccine?

While Vice President Mike Pence claimed that this over 90% effective vaccine was a result of the current administrations’ efforts via Operation Warp Speed, Pfizer actually self-funded this vaccine. Warp Speed was intended to produce and deliver 300 million doses of vaccine to the US population, with the initial doses to be available by January 2021. There’s no current confirmation if this timeline will go ahead.

“We were never part of the Warp Speed,” Kathrin Jansen, a senior vice-president and the head of vaccine research and development at Pfizer, said in an interview. “We have never taken any money from the US government, or from anyone.”


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