The United States aims to share up to 60 million doses of AstraZeneca vaccine with other countries after FDA review

Authorities confirmed Monday that the Biden administration plans to share up to 60 million doses of AstraZeneca’s COVID-19 vaccine with other countries. This decision is made after the White House is faced with growing calls for sharing shots that may not be used in the United States.

White House spokesman Jen Psaki said about 10 million doses manufactured in the United States could be shipped to other countries within the “next few weeks.” However, Saki said Shot must first clear a safety review by federal regulators.

“Given the strong portfolio of vaccines that are already licensed by the United States and are available in large quantities, including two double-dose vaccines and one single-dose vaccine, AstraZeneca is not licensed for use in the United States. So you don’t have to use AstraZeneca in the fight against COVID in the coming months, “Psaki told reporters.

Authorities are still “considering what the process will look like,” Saki said, sharing the dose. The Biden administration is facing criticism of its previous plans to lend AstraZeneca doses directly to Canada and Mexico. MarchInstead of sharing them with the international COVAX efforts to vaccinate poor countries facing the serious challenge of expanding production.

Federal health authorities also provided little detail on what the current safety review entails. AstraZeneca doses have been manufactured in the same factory operated by Emergency Biosolutions, and contaminated concerns have forced the disposal of approximately 15 million doses of Johnson & Johnson’s COVID-19 vaccine. I did.

AstraZeneca spokesman later stated that the dose passed “strict requirements” and was subject to “safety testing and quality control measures” before being used in Mexico and Canada.

Emergent Biosolutions has since announced that it plans to reduce production of AstraZeneca and quarantine the administration of all vaccines produced at its Baltimore plant. This is due to efforts to resolve many issues reported by FDA inspectors.

The move begins with the Biden administration announcing a number of actions to address the deadly surge in COVID-19 that has devastated India’s healthcare system.The White House said it would divert “pending orders for vaccine filters” from its U.S. factory over the weekend. To India To support national efforts to produce doses of AstraZeneca vaccine.

India has set a world record for coronavirus infections. 5 consecutive days On Monday, we reported 352,991 new cases and 2,812 deaths.

When asked if the White House plans to prioritize India for AstraZeneca’s vaccine dose, Pusaki said the country’s current priorities are the availability of oxygen and PPE, ready for the United States to provide. He pointed out that there is no dose of AstraZeneca yet. When doses become available, the White House will work to “evaluate different demands and needs around the world,” Pusaki said.

In March, AstraZeneca said it would seek an emergency use authorization for shots in the United States “within the next few weeks,” but has not yet announced its submission to the Food and Drug Administration. This process can take an additional month to clear the scrutiny. Of the regulator.

During the COVID-19 vaccination by Pfizer, Modana, Johnson & Johnson, the Byden administration has sufficient supply to vaccinate all adults by the end of May and may vaccinate children in the summer. We expect a million doses to increase.

However, thanks in part to the deal closed by the Trump administration’s Operation Warp Speed, the U.S. is working on vaccine development from pharmaceutical companies AstraZeneca, Novabax and Sanofi, and plans to produce another 500 million doses of vaccine. ..

All six vaccines ordered by the US government are accelerated by the Defense Production Act. This allows companies to prioritize US orders for major vaccine equipment and consumables.

However, a report from the Government Accountability Office warned earlier this month that exercising priority orders could have started to overcrowd other important medicines, leading to an unnecessary stockpile of major supplies. .. Vaccine makers abroad, including India, have complained that the Biden administration’s use of the Defense Production Act is equivalent to an export ban. This is a claim that the White House has repeatedly rejected.

Bio, a trade lobbying group that spans US biotechnology companies such as Pfizer, Moderna, and Johnson & Johnson, recently told the Biden administration that it was “in good faith, but at this stage it went a little wrong. Called to reduce the use of power.

“We need to put these raw materials into the limited production capacity that exists around the world, and it’s time to tackle this,” Bio’s president Michel McMurray Heath said in a recent press conference.

The United States aims to share up to 60 million doses of AstraZeneca vaccine with other countries after FDA review

Source link The United States aims to share up to 60 million doses of AstraZeneca vaccine with other countries after FDA review

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