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Moderna seeks FDA approval to increase vaccine doses

Moderna seeks FDA approval to increase vaccine doses

 


A bottle with the words “Vaccine Covid-19” next to the Moderna biotechnology company logo, taken on November 18, 2020. [Photo/Agencies]

Moderna wants to allow US regulators to add coronavirus vaccine to each vial to increase the number of vaccinations that can be given to Americans.

A biotechnology company, one of the two fedly licensed manufacturers of coronavirus vaccines, wants to allow the Food and Drug Administration (FDA) to add up to 50% of the vaccine (5 additional doses) to each vial on Monday. Said. CNBC reported that Moderna filed a request with the FDA on February 5.

If evidence indicates that it is effective and the request is approved, it can significantly increase the number of doses generally available in a few weeks.

“The company is proposing to fill the vials with up to 15 additional doses of the vaccine for the current 10 doses,” Moderna president Stephen Hoge told Reuters. “Moderna needs further discussion with the Food and Drug Administration (FDA) to ensure the authority’s comfort to this approach before implementing it.”

Moderna was the second pharmaceutical company in the United States to receive an FDA emergency use authorization for a coronavirus vaccine, following Pfizer BioNTech. Both the Pfizer and Moderna vaccines need to be given twice.

The company said it quickly noticed that filling a small vial with a small amount of vaccine slowed it down. However, tests have shown that too much dose in one vial can break it. The maximum vaccine for Moderna is 15 per vial.

Pharmaceutical companies aim to provide the US government with 100 million doses by the end of March and another 100 million doses by the end of June.

On January 27, Modana said it would take another 100 million doses in consultation with the US government, for a total of 300 million doses.

President Joe Biden has made speeding up national coronavirus vaccination an important pledge of his administration. Last week, the pace of vaccination accelerated.

According to CNN, the average number of shots last week was about 1.3 million per day.

As of Monday morning, the US Centers for Disease Control and Prevention (CDC) had been receiving 42.4 million doses of coronavirus vaccine.

Secretary of Defense Lloyd Austin announced last week that 1,110 active military personnel would support five Federal Emergency Management Agency vaccination centers.

According to Pentagon officials, each team includes service members from the Army, Navy, Air Force, and Marine Corps.

On Monday, President and Vice President Kamala Harris took a virtual tour of the vaccine site at State Farm Stadium in Glendale, Arizona, and thanked the staff for their efforts. So far, 160,000 doses have been administered.

Biden told the staff: “I hope we can maintain our commitment to get 100 million shots in the first 100 days. I think it’s well beyond that, but now I’m out and personally vaccinated. You can talk to the vendor … Thank you for what you are doing. “

“We want to go ahead, not behind this virus. We want 300 million shots before the summer. That’s our hope.”

The White House recently announced plans to get local pharmacies to help distribute the coronavirus vaccine. The federal government plans to send one million doses of vaccine to 6,500 pharmacies on February 11.

This is because 27,057,411 coronaviruses have been identified in the United States, killing 464,372 people.

Johnson & Johnson will soon seek FDA approval for the vaccine. However, the vaccine may only contribute to 7 million doses by April.

The deployment of the coronavirus vaccine occurs amid concerns about the spread of two coronavirus variants from the United Kingdom and South Africa to the United States.

A contagious British strain known as B.1.1.7 doubled its prevalence in US cases every 9 days.

In South Africa, the Oxford-AstraZeneca vaccine deployment was discontinued on Monday after studies showed that it provided “minimal protection” for mild and moderate cases of the new variant. New variants account for 90 percent of new cases in South Africa.

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