Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution


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Source: CNBC

By Meg Tirrell


  • Moderna is said to have asked the FDA to allow it to put additional doses in its vaccine vials.
  • The move is aimed at alleviating a bottleneck in Covid-19 vaccine manufacturing.
  • The change would add up to five doses to the 10-dose vials.

Moderna has asked the U.S. Food and Drug Administration for permission to fill its Covid-19 vaccine vials with up to five additional doses to ease a bottleneck in manufacturing, according to a person familiar with the matter.

The change would allow Moderna to put 15 doses in the same size vials now cleared to hold 10, alleviating pressure on the part of the manufacturing process known as fill/finish, said the person, who declined to be named because the application isn’t yet public.

The availability of Covid-19 vaccines has been a source of frustration since their clearance in the U.S. in mid-December. While the pace of administration has picked up to more than 1 million a day on average, constrained supply has hindered states’ ability to operate mass vaccination sites. As of Friday, the U.S. had distributed 49.2 million doses, and 27.9 million had been administered, according to the Centers for Disease Control and Prevention.

“We are having trouble producing these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and a physician at the Children’s Hospital of Philadelphia. “We’re up to about 1.2 million doses a day when we need to be at 3 million doses a day.”

The FDA declined to comment, deferring questions to the company. Moderna didn’t immediately respond to a request for comment.

The move from Moderna comes after Pfizer sought and obtained a change from the FDA in its emergency use authorization to specify its Covid-19 vaccine vials contain six doses, rather than five, after pharmacists observed a bonus dose could be extracted with the right syringes. Pfizer then said it would deliver fewer vials to the U.S., but the same number of doses specified in its contracts.

Moderna’s vials were also found to contain a bonus dose, but it’s seeking a regulatory change to add more volume to the vials.

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Categories: Vaccine

2 replies

  1. There have been “no red flags” seen in the more than 10,000 pregnant women who have received Covid-19 vaccine shots so far, White House health advisor Dr. Anthony Fauci said Wednesday.

    Pregnant women and young children were excluded from the original U.S. clinical trials of the vaccines, as is typical in experimental vaccine research. That’s led to some concerns that there’s not enough data to be sure that the vaccines are safe among pregnant women, but Fauci said the Food and Drug Administration has not seen reason to worry yet.

    “The FDA, as part of the typical follow up you have following the initial issuing of any [emergency use authorization] have found, thus far, and we’ve got to be careful, but thus far, no red flags about that, about pregnant women,” Fauci said Wednesday in an interview with The Journal of the American Medical Association’s Dr. Howard Bauchner.

    Since the authorization of the Moderna and Pfizer-BioNTech vaccines in December, over 10,000 pregnant women, many of whom were health-care workers, have gotten the shots, Fauci said. He noted that there is evidence that a coronavirus infection can lead to heightened risk of an adverse outcome in pregnancy, which might be why many pregnant health-care workers decided to get the vaccine.

  2. PARIS: A French lab will start producing Moderna’s COVID-19 vaccine in March, while another will begin making the vaccine from Pfizer and BioNTech in April, Industry Minister Agnes Pannier-Runacher said Wednesday.
    President Emmanuel Macron pledged Tuesday that four sites on French soil would begin making coronavirus vaccines soon, as the government draws sharp criticism over an innoculation drive that has started off slowly.
    French pride has also taken a hit after its pharma giant Sanofi said its Covid vaccine would not be ready until later this year.
    The health crisis has prompted governments to push for more widespread production of vaccines already available, overriding the industry’s fierce resistance to sharing intellectual property secrets.
    “Production at the first site will begin in March for the Moderna vaccine,” at a lab operated by Recipharm, Pannier-Runacher told RTL radio.
    “We’ll then have a production site running in April for the Pfizer-BioNTech vaccine,” she said.
    “And in May, we should (also) be producing the CureVac vaccine, for which we are waiting for approval,” she said, referring to the German biotech firm that could start French production at a lab owned by Fareva.
    A French Sanofi lab will start making the Pfizer-BioNTech vaccine in the second quarter, even as it pursues research on its own jab, as will the French firm Delpharm.
    Separately, Foreign Minister Jean-Yves Le Drian said Russia’s Sputnik V vaccine could be used in France as long as it meets “scientific norms” and European “standards.”

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