health

AstraZeneca expects FDA O.K for its COVID shot in April and will ship 30M doses


AstraZeneca expects to get US emergency authorization for its COVID-19 vaccine in April, the firm’s president told lawmakers on Tuesday. 

As soon as it gets the Food and Drug Administration’s (FDA) greenlight, AstraZeneca will have 30 million doses of the 62 percent effective shot ready to ship to the US, said president of the biopharmaceuticals arm of the company, Dr Ruud Dobber on Tuesday. 

He told members of the House of Representatives’ Committee on Energy and Commerce that the company could deliver ‘up to 50 million’ doses by the end of April. 

The Trump Administration inked a deal with AstraZeneca for 300 million doses of its Oxford University-designed vaccine. 

It has already been authorized by more than 50 countries and the World Health Organization, but mistrust brewed between the pharma giant and US regulators, who placed its large late-stage US trial on a nearly seven-week hold. 

Meanwhile, AstraZeneca’s easily stored, $4 shot has helped countries like the UK speed ahead of the US in the vaccination race, and data from Scotland this week suggested the shot reduces hospital admissions by 94 percent. 

AstraZeneca's 62% effective shot has been approved in more than 50 countries, and could be authorized by the US by April, firm president Dr Ruud Dobber told lawmakers Tuesday

AstraZeneca’s 62% effective shot has been approved in more than 50 countries, and could be authorized by the US by April, firm president Dr Ruud Dobber told lawmakers Tuesday 

AstraZeneca could ship the US 30 million doses 'immediately' once it gets FDA authorization, which is expected in April, the firm's president said. It would be a major boost to the rollout which has seen 64 million doses administered so far

AstraZeneca could ship the US 30 million doses ‘immediately’ once it gets FDA authorization, which is expected in April, the firm’s president said. It would be a major boost to the rollout which has seen 64 million doses administered so far 

PIERS MORGAN: why has America STILL not approved the Oxford AstraZeneca vaccine Britain is using to kick the world’s butt? 

The big question for Biden is not how well it’s doing but why a manufacturing technological superpower like America is lagging so far behind these other nations, especially given that the two vaccines it has so far approved are made entirely (Moderna) or partially (Pfizer) inside the US?

The answer lies with a British vaccine.

On February 15, the World Health Organisation gave an Emergency Use Listing to the AstraZeneca vaccine developed in Oxford, England and declared it safe to use.

It had already been approved in the UK on December 30 last year, and in the European Union last month.

But there is still no approval for it to be used in the US, and no sign of being approved any time soon, which defies any rational logic.

It’s true there was a botched early clinical trial which raised some initial concerns but those were soon allayed by further results.

And it’s also true it may be slightly less effective against some of the new variants of COVID currently circulating including the one from South Africa.

But one crucial thing is in no doubt: like the Pfizer and Moderna vaccines, it is incredibly effective against preventing severe disease or death.

Nobody who’s had the AstraZeneca vaccine has so far died from COVID.

And it is far easier to store than the other two because it doesn’t need to be kept in the very cold conditions they need.

So, the US should be chomping at the bit to add the AstraZeneca jab to its vaccine armoury, but it’s still working its way through totally unnecessary further FDA-led trials.

On the other hand, reports have emerged of people in Germany and other parts of the EU turning down the shot, saying they’d one of the vaccines that showed greater efficacy in trials. 

And the company is coming up short in Europe as well. 

An EU revealed to Reuters that AstraZeneca will fail to deliver the 180 million doses it promised the bloc for the second quarter, instead delivering about half that amount.  

Still, the immediate availability of 30 million doses of the vaccine would be a major boon to the US vaccine rollout.  

In the two months since Pfizer’s and Moderna’s vaccines were given emergency use authorization by the FDA, they have distributed 40 million and 45 million doses of their vaccines, respectively. 

AstraZeneca could offer nearly as many doses on the day its vaccine is approved a either of the US firms have in over 60 days.  

It is designed to be a two-dose inoculation, but AstraZeneca’s shot has the added advantage of offering more protection after a single dose compared to Pfizer’s vaccine.  

Within the first week, one dose cuts the risk of being hospitalized for COVID-19 by about 70 percent. Within a month, it is about 90 percent effective at reducing hospitalization risks. 

By comparison, Pfizer has only shown its vaccine to reduce hospitalization risks by about 40 percent in the first week or two, rising to a just over 80 percent reduction in hospitalization risks a month later. 

Based in part on these findings, the UK allows Britons to wait up to 12 weeks between doses and focused on getting as many people as possible a first dose rather than ensuring that the most at-risk people got two doses – the approach taken by the US.  

The FDA and experts like Dr Anthony Fauci have stated that American regulators consider it acceptable to get a second Pfizer or Moderna dose up to six weeks after the first, but only if necessary. It is not recommended in the US. 

AstraZeneca’s ongoing US trial is testing a four-week gap between doses, and the firm will likely have data from those tests ‘in the coming weeks’ said Dr Dobber. 

He noted that a further delayed second dose might actually be more effective, and that the company is studying this both in trials and through ‘real world data’ in the UK.  

AstraZeneca has its North American headquarters in Maryland, and Dr Dobber said the US supply is being made entirely in America.  

He said the facilities are already ‘operating at or near full capacity’ but ‘are not encountering material or equipment constraints. ‘

Upon authorization from the FDA, ‘we will release instantly 30 million doses and by the end of the month 50 million. Thereafter, production of 15 to 20 million doses a month will put us on track to deliver 300 million doses’ said Dr Dobber. 

‘It will take some time…as we are working on scaling up our production, that will take some time, but we feel very confidant we will meet it.’ 

He added that the AstraZeneca shot ‘shows promise against the UK variant’ and that the firm is ‘actively studying the vaccine and multiple variants, including the South African variant.’ 

In a small trial in South Africa where the variant, known as B1351 is now dominant, no participants who got the shot developed severe disease or had to be hospitalized, but it only reduced mild or moderate cases by less than 25 percent. 

South Africa decided to halt the use of AstraZeneca’s vaccine, offering its doses to Australia.   



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