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Moderna Files with FDA for Full Covid Shot Approval

27.08.2021 - US biotech Moderna announced on Aug. 26 that it had completed its filing with the US Food and Drug Administration (FDA) for full marketing approval of its mRNA-based Covid-19 vaccine for people age 18 and older. The company said it has requested a priority review as was granted the Pfizer-BioNTech shot, also mRNA based.

Moderna began submitting data to the FDA for its Biologics License Application (BLA) in June. CEO Stéphane Bancel called the completion “an important milestone in our battle against Covid-19 and for Moderna itself as this is the first BLA submission in our company's history." The Massachusetts-based biotech was the second vaccine maker after Pfizer/BioNTech to receive an Emergency Use Authorization (EUA) for its shot in the US.  Moderna has also filed to the FDA for emergency use of its vaccine for young people aged 12 to 18.

The Pfizer/BioNTech vaccine already has won an EUA for that age group, both in the US and the EU. This week the FDA granted full approval for the American-German partnership’s shot to be administered to those 16 and older. This means it can now be officially distributed in the US under the name Comirnaty. In Europe, Moderna has now named its vaccine Spikevax, but cannot use the name in the US until full approval is granted to both the shot and the name.

Even with a priority review, the approval process can still take several months, experts point out. For Pfizer/BioNTech, it mobilized all resources to speed up the process that foresees having an FDA independent panel help parse the efficacy and safety data before recommending approval. Many believe it will do the same for Moderna.

Not only is Moderna an American company that received federal aid to develop its product;  the administration of US president Joe Biden is keen to get as many vaccines as possible fully approved to take the wind out of the sails of vaccine resisters who say the shots are “experimental.”

Tentative plans to produce Covid shot in Canada

Outside the US, Moderna is now planning to build up a manufacturing presence in Canada for its mRNA Covid vaccine. The company recently signed a Memorandum of Understanding with the Canadian government to build a manufacturing facility at an as yet undisclosed location. No further details nor a timeline for the project have been announced.

Moderna said it eventually wants to use the Canadian site to supply the US northern neighbor with “direct access to rapid pandemic response capabilities," including its Covid vaccine.  The biotech is also eyeing plans to produce a portfolio of vaccines against other respiratory diseases in Canada, including seasonal influenza and respiratory syncytial virus, pending regulatory approval. It is also in discussions with other governments about potential collaborations.

Contamination fears over Moderna vaccine lots in Japan

All was not good news for Moderna this week. On Aug. 25, the company said it was investigating reports that some of its vaccine doses shipped to Japan may have been contaminated, after receiving "several reports of particulate matter" in the vials. Its  Japanese marketing partner, Takeda, subsequently suspended the distribution of one product lot containing 1.63 million doses as well as two adjacent lots out of safety concerns.

Japan’s health ministry said the possible contamination was reported from multiple vaccination sites. While some doses already may have been administered, no adverse health effects have been reported, the ministry said. Moderna said the issue may involve a production line at Spanish CDMO Rovi.

Under an agreement with the US biotech, Rovi said in April it was doubling capacity at its plant in Grenada, Spain, to produce bulk drug substance and perform fill & finish duties for Moderna. The company said it is working together with Moderna, Takeda and Japanese authorities to find the source of the contamination.

Previously, all active ingredients for Moderna vaccines used in Europe were made by Lonza in Switzerland. This past spring, the Swiss CDMO was said to have faced supply constraints due to a shortage of qualified personnel.

Author: Dede Williams, Freelance Journalist

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