AstraZeneca expects FDA to be good for its COVID release in April and will ship 30 million

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

As soon as it gets the green light from the Food and Drug Administration (FDA), AstraZeneca will have 30 million doses of 62% effective shot ready to ship to the U.S., the company’s chairman of the company’s biopharmaceutical group said Tuesday. Dr. Ruud Dobber.

He told members of the House Energy and Commerce Committee 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 the vaccine designed by Oxford University.

It has already been authorized by more than 50 countries and the World Health Organization, but a mistrust was generated between the pharmaceutical giant and U.S. regulators, who placed their major U.S. trial on hold for a while. almost seven weeks.

Meanwhile, AstraZeneca’s easily storable $ 4 shot has helped countries like the UK advance to the U.S. in the vaccination race, and data from Scotland this week suggested the shot reduces hospital admissions at 94 percent.

The effective firing of 62% of AstraZeneca has been approved in more than 50 countries and could be authorized by the United States in April, according to the firm’s president, Dr. Ruud Dobber, to the legislators

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

AstraZeneca could ship to the US 30 million doses

AstraZeneca could ship 30 million doses to the U.S. “immediately” once it obtains FDA approval, which is expected in April, the firm’s president said. It would be a big boost for the launch, which has so far delivered 64 million doses

PIERS MORGAN: Why has the United States not yet approved the Oxford AstraZeneca vaccine used by Britain to kick the butt of the world?

The big question for Biden is not how well it does, but why a manufacturing technology superpower like America lags far behind these other nations, especially considering that the two vaccines it has so far approved are being manufactured. fully (Modern) or partially (Pfizer) within the US?

The answer lies in a British vaccine.

On February 15, the World Health Organization gave an emergency use list to the AstraZeneca vaccine developed in Oxford, England, and declared it safe to use.

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 it to be used in the United States and there is no sign of approval soon, which defies any rational logic.

It is true that there was an early clinical trial that provoked some initial concerns, but that soon faded with other results.

And it’s also true that it may be a little less effective against some of the new variants of COVID that are currently circulating, including the one in South Africa.

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

No one who has had the AstraZeneca vaccine has died so far from COVID.

And it is much easier to store than the other two, as it does not need to be stored in the very cold conditions they need.

Therefore, the United States should face off perfectly to add the AstraZeneca puncture to its vaccine cabinet, but it is still making its way through totally unnecessary FDA-led trials.

On the other hand, there have been reports of people in Germany and other parts of the EU rejecting the shooting, saying they would have one of the vaccines that showed greater effectiveness in the trials.

And the company also falls short in Europe.

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

However, the immediate availability of 30 million doses of the vaccine would be a great advantage for vaccine implantation in the United States.

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

AstraZeneca could offer almost as many doses on the day the vaccine is approved as any of the American companies has in more than 60 days.

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

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

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

Based in part on these findings, the UK allows the British to wait up to 12 weeks between doses and focused on getting a first dose to as many people as possible instead of making sure people at higher risk receive it. two. WE.

The FDA and experts like Dr. Anthony Fauci has 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 U.S. is testing a four-week gap between doses and the company is likely to have data from those tests “in the coming weeks,” Dr. Dobber said.

He noted that a delayed second dose could be more effective and that the company is studying it both in trials and through “real-world data” in the UK.

AstraZeneca is headquartered in Maryland and Dr. Dobber said the U.S. supply is being manufactured entirely in America.

He said the facilities are already “operating at or near full capacity,” but “there are no restrictions on material or equipment.”

After FDA approval, “we will launch 30 million doses instantly and at the end of the month 50 million. Then, the production of 15 to 20 million doses per month will set us on track to deliver 300 million doses.” , Dr. Dobber said.

“It will take some time … as we are working to increase our production, this will take a while, but we feel very confident that we will fulfill it.”

He added that the AstraZeneca trait “shows promise against the UK variant” and that the firm “is actively studying the vaccine and various variants, including the South African variant”.

In a small trial in South Africa where the variant, known as B1351, is now dominant, none of the participants who received the vaccine developed serious illness or had to be hospitalized, but only reduced mild to moderate cases in less than 25 percent.

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

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