United States: Moderna authorized to significantly increase the distribution capacity of its COVID-19 vaccine

ARCHIVE.  Boxes with Moderna's vaccine against COVID-19 are prepared at a plant in Olive Branch, Mississippi, United States.  Paul Sancya / Pool via REUTERS / File Photo
ARCHIVE. Boxes with Moderna’s vaccine against COVID-19 are prepared at a plant in Olive Branch, Mississippi, United States. Paul Sancya / Pool via REUTERS / File Photo

The United States Federal Food and Drug Administration (FDA) made a minor change, but it may have a great impact on the authorization that Moderna laboratory has to distribute its vaccine against COVID 19.

So far Moderna has distributed its vaccine in lines that contain 10 doses each. The new FDA decision indicates that the laboratory can put 15 doses each way. In other words, with the same distribution capacity in the country, a 50 percent more dose, thus accelerating the distribution of this vaccine throughout the country.

Anthony Fauci, top adviser to the White House for the COVID-19 pandemic.  Patrick Semansky / Pool via REUTERS / File Photo
Anthony Fauci, top adviser to the White House for the COVID-19 pandemic. Patrick Semansky / Pool via REUTERS / File Photo

This change will begin to be seen in weeks ahead, as new tracks are packaged starting today. But even before that, another change will be seen. With the existing material on each of the tracks so far, the FDA authorized 11 doses per route instead of 10. From the beginning, hospitals and pharmacies warned that there was excess material for the vaccine on the Moderna roads. The problem was always finding the relevant needles to be able to extract it. Today the FDA authorized them to do so with the doses that are already in the vaccination centers.

“These two revisions made to Moderna’s authorization will have a positive impact on the distribution of doses. There will be more vaccines available in our communities, which will allow more doses to reach the arms of our people more quickly, “said in a press release the regulator of vaccines for the FDA, Peter Marks. “As a last resort, the more vaccines reach the population quickly, the faster we will reach the end of the pandemic ”.

This postponement does not affect the doses currently being used in the US, as they have been produced in the Netherlands, where the production lines are approved by US regulatory authorities.  EFE / EPA / ETIENNE LAURENT / Archive
This postponement does not affect the doses currently being used in the US, as they have been produced in the Netherlands, where the production lines are approved by US regulatory authorities. EFE / EPA / ETIENNE LAURENT / Archive

The other big change authorized today by the FDA for Moderna, is that the vaccine can be kept in good condition at room temperature for 24 hours, and not just 12 hours as indicated until now. And once the road is opened, it can be kept in good condition for 12 hours and not 6 hours, as was the norm until today.

The vaccine is transported at very low temperatures, but once the tracks reach the vaccination center, now they have a whole day to be laid. The idea is to avoid having doses that are not used.

Since February the laboratory has been in talks to make these changes to their authorization, but the FDA had to complete a period of investigation and testing before approval.

Laboratorio Moderna Inc in the United States develops a vaccine against the coronavirus (Moderna Inc)
Laboratorio Moderna Inc in the United States develops a vaccine against the coronavirus (Moderna Inc)

“We are committed to constantly learn and improve to facilitate an easier administration of our vaccine against COVID 19, which simplifies the work of medical staff and accelerates immunization programs ”, stated in a statement Stéphane Bancel, President of Moderna.

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