AstraZeneca expects the FDA OK for its COVID dose in April and will ship 30 million doses

AstraZeneca expects the FDA OK for its COVID dose in April and will ship 30 million doses

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AstraZeneca expects to obtain US emergency clearance for its COVID-19 vaccine in April, the company’s president told lawmakers on Tuesday.

Once AstraZeneca receives the green light from the Food and Drug Administration (FDA), it will have 30 million doses of the 62 percent effective injection ready to ship to the United States, said the president of the company’s biopharmaceutical arm, Dr. Ruud Dobber at Tuesday.

He told members of the Chamber of Deputies’ Energy and Commerce Committee that the company could deliver “up to 50 million” doses by the end of April.

The Trump administration struck a deal with AstraZeneca for 300 million doses of its vaccine designed by the University of Oxford.

It has already been authorized by more than 50 countries and the World Health Organization, but mistrust has grown between the pharmaceutical giant and US regulators, who have suspended their grand final testing stage in the United States for nearly seven weeks.

Meanwhile, the $ 4 injection of AstraZeneca, easily stored, helped countries like the UK to speed up the vaccination race, and data from Scotland suggested that the injection reduces hospital admissions by 94%.

AstraZeneca's 62% effective shot was approved in more than 50 countries and can be authorized by the United States until April, company president Dr. Ruud Dobber told lawmakers on Tuesday.

AstraZeneca’s 62% effective shot was approved in more than 50 countries and can be authorized by the United States until April, company president Dr. Ruud Dobber told lawmakers on Tuesday.

AstraZeneca could ship the US 30 million doses

AstraZeneca could ship the US 30 million doses “immediately” as soon as it obtained FDA authorization, which is expected in April, said the company president. It would be a big boost for the launch, which has seen 64 million doses administered so far

PIERS MORGAN: why hasn’t America STILL approved the Oxford AstraZeneca vaccine that Britain is using to kick the world’s ass?

The big question for Biden is not how well he is doing, but why a technological manufacturing superpower like America is lagging so far behind these other nations, especially considering that the two vaccines he has so far approved are made entirely (Modern) or partially (Pfizer) within the USA?

The answer lies in the British vaccine.

On February 15, the World Health Organization provided an Emergency Use List for the AstraZeneca vaccine developed in Oxford, England, and declared its use safe.

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

But there is still no approval for its use in the United States, and no sign that it will be approved any time soon, which defies any rational logic.

It is true that there was a failed initial clinical trial that raised some initial concerns, but these were soon dispelled by new results.

And it is also true that it may be a little less effective against some of the new variants of COVID currently in circulation, including that of South Africa.

But one crucial thing is certain: like the Pfizer and Moderna vaccines, it is incredibly effective in preventing serious illness or death.

No one who has received the AstraZeneca vaccine has so far died of COVID.

And it is much easier to store than the other two because it does not need to be stored in the cold that they do.

Therefore, the US should be striving to add the AstraZeneca jab to its vaccine arsenal, but is still working on other totally unnecessary tests led by the FDA.

On the other hand, there have been reports of people in Germany and elsewhere in the EU refusing the injection, saying they had one of the vaccines that showed the most effectiveness in the tests.

And the company is also failing in Europe.

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

Still, the immediate availability of 30 million doses of the vaccine would be a great benefit for the vaccine’s launch in the United States.

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

AstraZeneca could offer almost the same amount of doses on the day its vaccine is approved, which any of the American companies offered in more than 60 days.

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

In the first week, a dose reduces the risk of hospitalization because of COVID-19 by about 70 percent. In one month, it is about 90% effective in reducing the risk of hospitalization.

In comparison, Pfizer showed that its vaccine reduces hospitalization risks by about 40% in the first or two weeks, increasing to a little over 80% 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 focus on getting the first dose to as many people as possible, rather than ensuring that those most at risk receive two doses – the approach adopted by NOS.

The FDA and experts like Dr. Anthony Fauci have declared that US regulators consider it acceptable to receive a second dose of Pfizer or Moderna within six weeks of the first, but only if necessary. It is not recommended in the USA.

AstraZeneca’s ongoing test in the United States is testing a four-week interval between doses, and the company will likely have data from those tests “in the coming weeks,” said Dr. Dobber.

He noted that a second additional delayed dose may actually be more effective, and that the company is studying this in tests and using ‘real-world data’ in the UK.

AstraZeneca is headquartered in North America in Maryland, and Dr. Dobber said that the US supply is being made entirely in America.

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

Upon FDA authorization, ‘we will instantly launch 30 million doses and, by the end of the month, 50 million. After that, producing 15 to 20 million doses per month will put us on the right path to deliver 300 million doses, ‘said Dr. Dobber.

‘It will take some time … as we are working to increase our production, it will take some time, but we feel very confident that we will find it.’

He added that the AstraZeneca injection ‘shows promise against the UK variant’ and that the company is ‘actively studying the vaccine and several variants, including the South African variant’.

In a small trial in South Africa, where the variant, known as B1351 is now dominant, no participant who received the injection developed a serious illness or had to be hospitalized, but only reduced mild or moderate cases by less than 25 percent.

South Africa decided to suspend the use of the AstraZeneca vaccine, offering its doses to Australia.

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