AstraZeneca awaits FDA approval for its COVID injection in April and will ship 30 million doses

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

As soon as it receives the green light from the Food and Drug Administration (FDA), AstraZeneca will have 30 million doses of the 62 percent effective injection ready to ship to the U.S., the president of the US said Tuesday. the company’s biopharmaceutical division, Dr. Ruud Dobber.

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

The Trump Administration signed an agreement with AstraZeneca for 300 million doses of its vaccine designed by the University of Oxford.

It has already been licensed by more than 50 countries and the World Health Organization, but mistrust has been generated between the pharmaceutical giant and US regulators, who put their large late-stage American trial on a nearly seven-week suspension. .

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

AstraZeneca’s 62% effective vaccine has been approved in more than 50 countries and could be licensed by the United States in April, the firm’s president, Dr. Ruud Dobber, told lawmakers.

AstraZeneca could ship all 30 million US doses

AstraZeneca could ship the 30 million US doses “immediately” once it gets clearance from the FDA, which is expected in April, the firm’s president said. It would be a huge boost for the launch which has seen 64 million doses administered so far.

PIERS MORGAN: Why hasn’t America STILL endorsed the Oxford AstraZeneca vaccine that Britain is using to kick the world’s butt?

The big question for Biden is not how well he’s doing, but why is a manufacturing tech superpower like the United States lagging so far behind these other nations, especially given that the two vaccines he’s approved so far are made on his own. totally (Modern) or partially (Pfizer). within the United States?

The answer is in a British vaccine.

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

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

But there is no approval for use in the US yet, and there are no signs of approval anytime soon, which defies any rational logic.

True, there was a failed initial clinical trial that raised some initial concerns, but they were soon dispelled with more results.

And it is also true that it may be slightly less effective against some of the newer COVID variants currently circulating, including that of South Africa.

But one crucial thing is clear: 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 is not necessary to keep it in the very cold conditions that they need.

So the US should be eager to add the AstraZeneca jab to its vaccine arsenal, but is still working its way through totally unnecessary additional trials led by the FDA.

On the other hand, reports have emerged of people in Germany and other parts of the EU rejecting the vaccine, saying they had one of the vaccines that showed the highest efficacy in trials.

And the company is falling short in Europe too.

An EU revealed to Reuters that AstraZeneca will not deliver the 180 million doses it promised to the bloc for the second quarter, but will deliver about half that amount.

Still, the immediate availability of 30 million doses of the vaccine would go a long way toward launching the vaccine in the United States.

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

AstraZeneca could offer almost the same number of doses on the day your vaccine is approved as any of the US companies in more than 60 days.

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

During the first week, one dose reduces the risk of being hospitalized for COVID-19 by about 70 percent. In one month, it is about 90 percent effective in reducing the risks of hospitalization.

By comparison, Pfizer has only shown that its vaccine reduces the risks of hospitalization by about 40 percent in the first week or two, increasing to a reduction of just over 80 percent in the risks of hospitalization one 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 at higher risk get two doses – the approach adopted by the US.

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

AstraZeneca’s ongoing trial in the US is testing a four-week gap between doses, and the company will likely have data from those trials “in the next few weeks,” Dr. Dobber said.

He noted that a 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 is headquartered in North America in Maryland, and Dr. Dobber said the American supply is being made entirely in the United States.

He said the facilities are already “operating at or near full capacity”, but “are not limited by material or equipment.” ‘

With FDA clearance, ‘we will instantly release 30 million doses and at the end of the month 50 million. Thereafter, producing 15-20 million doses per month will put us on track to deliver 300 million doses, ”said Dr. Dobber.

“It will take some time … as we are working to expand our production, that will take some time, but we are very confident that we will succeed.”

He added that the AstraZeneca injection “shows promise against the UK variant” and that the company 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 participant who received the vaccine 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 stop the use of the AstraZeneca vaccine, offering its doses to Australia.


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