Nearly 15 million more Americans could be fully vaccinated against COVID-19, getting back to work and seeing their families – but millions vials of AstraZeneca’s vaccine are sitting unused in a manufacturing plant.
That’s because the shot – which, along with its highly successful delayed dosing program – that has helped the UK speed ahead of most of the rest of the world in its vaccine rollout has not been authorized in the U.S.
In fact, AstraZeneca hasn’t even applied for authorization.
‘I hope it does so and does so quickly because…there is a lot sitting in the stockpile waiting to be used. Those vials of vaccine help nobody sitting in a warehouse,’ former Food and Drug Administration (FDA) official Peter Pitts told DailyMail.com.
AstraZeneca ‘has had problems of late, and that might be one explanation why they haven’t filed with the U.S. FDA,’ Pitts said.
But on Thursday, EU regulators declared AstraZeneca’s vaccine safe after several countries paused its use over fears it was causing blood clots.
Now, under pressure from the U.S.’s neighbor to the South, President Biden announced Thursday that four million out of about 30 million doses of AstraZeneca’s two-shot vaccine to Mexico and Canada, in part because the unapproved doses are currently useless to Americans.
So far, just 23 percent of Americans have had at least one dose of vaccine, and just over 12 percent are fully vaccinated. By comparison, nearly 39 percent of Britons have had one dose, with a large portion getting the cheap, easily stores AstraZeneca shot.
Pitts added that Biden could ‘encourage’ the firm to submit its application for emergency approval quickly and guarantee it speedy FDA review.
Officials have speculated that AstraZeneca’s highly-anticipated shot will be authorized in April, but the Biden administration has otherwise said nothing to indicate that it is ‘encouraging’ AstraZeneca and the FDA to make the shot available more quickly.
So just what is taking so long?
DailyMail.com breaks down the red tape and missteps standing between Americans and nearly 30 million doses of the AstraZeneca that’s been hailed a ‘game-changer.’
AstraZeneca’s vaccine has been approved in more than 50 countries – but not in the U.S. where it hasn’t applied for authorization, despite a stockpile of nearly 30 million doses sitting in an American facility (file)
With the help of the AstraZeneca jab and its delayed dosing schedule, new COVID-19 cases have plummeted by 90% (and by more than 80% per million people, pictured) since the January peak, while new infections have fallen by less than 80% in the US
Vaccine development and approval processes are notoriously protracted, but the pandemic has changed that for most developers in most countries, with the approval of AstraZeneca’s vaccine, designed by Oxford University, in the U.S.
‘People have been clamoring for it to be approved and everybody wants it to go faster,’ Dr Amesh Adalja, a senior researcher at Johns Hopkins Center for Health Security told Kaiser Health News last month.
Dr Adalja has advocated for the drug regulatory bodies in the U.S., UK and the EU – the FDA, the Medicines and Healthcare products Agency (MHRA) and European Medicines Agency (EMA), respectively – to sync up, so that an approval from one agency would equate to approval across all three.
‘The question would be from a policy standpoint, would the FDA be willing to say that what the EMA does is equivalent to them and they would have full confidence in the EMA decision?
The fact that AstraZeneca simply hasn’t yet asked the Food and Drug Administration for emergency use authorization (EUA) of its vaccine is the primary and most obvious reason it isn’t yet approved.
‘The FDA can’t take action on an application it hasn’t received,’ says Pitts.
‘Clearly the FDA didn’t delay in fielding US trials [of AstraZeneca’s vaccine] so why hasn’t AstraZeneca applied for an EUA at this point?’
The answer, so far, is no.
The FDA has been stalwart in its insistence that it won’t cut corners, including by accepting data from trials conducted elsewhere, even though that data was good enough for the World Health Organization (WHO) and many nations to accept.
In fairness, there’s no precedent for the FDA basing its decision on non-U.S. trials, and in the context of the pandemic and emerging variants, data – including from AstraZeneca’s trials – show that a shot formulation that is highly effective in one country may be less so in another.
But the bottom line is that the shot offers very good protection, there are millions of doses already made and ready to distribute in the U.S., and hundreds of millions of Americans with no protection whatsoever from COVID-19.
And while U.S. health officials like Dr Anthony Fauci continually repeat that the U.S. is in a race between vaccines and variants, the protocols of the oldest drug regulatory agency in the world are not keeping up.
Meanwhile, the some-protection-is-better-than-none approach has done wonders for the UK, which has relied heavily on its supply of the AstraZeneca vaccine (although it is currently facing supply shortages).
New COVID-19 cases there have declined by 90 percent since their January 9 peak (and by more than 80 percent per million people), according to tracking from Our World in Data.
In the US, new coronavirus infections have decreased by less than 80 percent since the January 11 peak.
‘Britain’s free-fall in cases is all the more impressive,’ Dr Robert Wachter, chair of the University of California, San Francisco’s Department of Medicine, told the New York Times newsletter.
‘Clearly their vaccination strategy has been highly effective.’
Daily deaths in the UK have also declined sharply in recent weeks – especially among those 65 and older, nearly all of whom have had one or more shot.
In total, 38.5 of the British population has had at least one dose, fueling the free-fall in cases and deaths despite the fact that less than three percent of its population has had both doses of shots made by AstraZeneca, Pfizer or Moderna.
The US, by contrast, has fully vaccinated more than 12 percent of its population, but only 22.7 percent of Americans – 115.7 million – have had a first dose, according to Bloomberg tracking.
However, Wachter noted that at this point in the rollout, introducing a delayed dosing schedule in the U.S. would likely result in more confusion and mistrust in a nation where a quarter of Americans still say they don’t want to be vaccinated against COVID-19.
Speculation swirled last year that President Trump was pressuring vaccine-makers and the FDA to move quickly, amid criticism from cautious public health experts that corner-cutting could result in unsafe shot.
Now the U.S. has three clearly safe shots, but is missing a cheap, easily stored fourth that’s ready to ship.
‘Back channels are useful,’ Pitts said of closed-door negotiations between leaders vaccine-makers.
‘But I think that calling out AstraZeneca publicly would actually be a bad thing because it would cast negative aspersions on a company that has worked very long and very hard.’