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COVID-19: Moderna files for U.S. European emergency Vaccine approval

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Moderna – along with other U.S. pharmaceuticals – filed for U.S. and European emergency regulatory approval of its highly successful vaccine that they hope to make available on a large scale, according to reports. The push for approval comes as epidemiologists raise concerns that the virus will surge this winter as more and more people travel throughout the holiday season.

According to reports, the trial data of Moderna’s mRNA vaccine will be examined by regulators. In Moderna’s clinical studies – which was released several months ago – the vaccine is 94% effective at protecting people from Covid-19.

Pfizer also has a highly successful vaccine and has applied for the same emergency approval.

From the BBC:

Moderna says it hopes to gain UK approval soon, now that it has trial data from 30,000 volunteers – including high risk groups like the elderly – that suggests it works. In those studies, 15,000 people received the real vaccine while the other participants got placebo injections. No serious side effects were reported.During the studies, 185 people in the placebo group fell ill with Covid-19, and some severely so. 

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Food & Drug Administration clears first lab-grown meat product for human consumption

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Last week the U.S. Food and Drug Administration (FDA), for the first time ever, approved a unique “meat product”. Reported by Reuters, the FDA announced the product is “grown from animal cells for human consumption.”

In a release from the FDA, it announced UPSIDE Foods, a company that makes cell-cultured chicken by harvesting cells from live animals and using the cells to grow meat in stainless-steel tanks, will bring the new “meat” product to market once it has been inspected by the U.S. Department of Agriculture (USDA).

“The world is experiencing a food revolution and the (FDA) is committed to supporting innovation in the food supply,” said FDA Commissioner Robert M. Califf and Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition in a statement.

Documents released by the FDA stated it had reviewed data from the company and had no further questions about the company’s conclusion that its product is safe for humans to eat.

“We are thrilled at FDA’s announcement,” said David Kay, UPSIDE’s director of communications, in an email. “This historic step paves the way for our path to market.”

Reuters reports:

The review is not technically an approval and applies only to UPSIDE products, though the agency is ready to work with other firms developing cultured animal cell food, the FDA said in a release.

USDA and FDA together regulate cell-cultured meat under a 2019 agreement between the two agencies. USDA will oversee the processing and labeling of cell-cultured meat products.

Demand for alternatives to farmed meat has grown alongside awareness of the high greenhouse gas emissions of raising livestock. Cultivated chicken was served to attendees at this year’s COP27 climate conference in Egypt.

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