Outraged Americans are demanding to know why the Pfizer COVID-19 vaccine has been approved in the UK but not in the US, where it was developed and funded.
On Wednesday, British health authorities said they had approved the vaccine and that it will start being rolled out to the most needy patients imminently.
In the US, the FDA says it won’t meet to even discuss emergency authorization for either Pfizer’s vaccine or the one that has been developed by Moderna until December 10.
Even then, it will take another five days for the first doses to start being rolled out, according to a document obtained by
Stephen Hahn, the head of the FDA, has said that they are taking longer because they look at the raw data and determine themselves whether or not it is safe, rather than relying on the drug company’s findings.
But with COVID-19 deaths and hospitalizations at an all-time high and with millions of people desperate to get back to work, the urgency to approve it is unprecedented.
Dr Stephen Hahn, the commissioner of the FDA, was summoned to the White House on Tuesday to explain why it was taking so long for vaccines to be approved
Many Americans have complained that another country has approved a US-produced drug before them
Scientists from Operation Warp Speed, the Trump administration’s COVID task force to get a vaccine out, have assured the American people that the science stands up.
Pfizer says its vaccine is 95% percent and Moderna says its is 94% effective which scientists say is a higher standard than most vaccines, especially given the size of the test groups they were used in.
AstraZeneca, another brand, says its vaccine is 70% effective.
President Trump has put pressure on the FDA to act swiftly to get a vaccine out. Sources say he and other White House officials are angry that it has been approved overseas before on US soil.
‘It’s crazy to imagine the European Union or U.K. may approve a vaccine developed in the United States before us though, right?’ one source said.
Dr Hahn was summoned to the White House on Tuesday to explain why it was taking so long for vaccines to be approved but so far, there has been no public explanation for it.
The administration did not immediately respond to inquiries on Wednesday morning.
While the wait for approval drags on, the committee that decides who gets it first has begun having their own talks.
Across the board, healthcare workers and nursing home residents seem to be the first in line to receive the vaccine, both in the US and the UK.
HOW DO THE MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
How it works:
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
How well does it work?
94.1% effective (90 positive in placebo group, 5 positive in vaccine group)
90% effective (estimated 86 positive in placebo group, 9 positive in vaccine group)
How much does it cost?
US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose; $30.50 (£23.14) per person.
US will pay $1.95bn (£1.48bn) for the first 100m doses, suggesting a cost of $19.50 (£14.80) per dose; $39 (£29.61) per person.
Can we get hold of it?
Moderna will produce 20m doses this year, expected to stay in the US.
First vaccinations expected in December.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.