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0106 Data Byte
BioCentury & Infogram

Product Development

Marketing authorizations starting to stack up for COVID-19 vaccines: Data Byte

Jan 7, 2021 | 2:08 AM GMT

The European Commission’s conditional approval Wednesday of Moderna’s vaccine marks the second for a COVID-19 vaccine in Europe, and brings the number of countries the vaccine is authorized in to 30. It was already authorized in Canada, Israel and the U.S.

The conditional marketing approval for Moderna COVID-19 Vaccine (mRNA-1273) from Moderna Inc. (NASDAQ:MRNA) came mere hours after EMA’s CHMP recommended the vaccine to prevent COVID-19 in people age 18 and older.

The EU has secured 160 million doses of mRNA-1273, and Moderna said it will start deliveries to European countries next week.

Comirnaty (BNT162b2) from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) is the other COVID-19 vaccine with conditional approval in Europe. The EC has procured up to 300 million doses of Comirnaty.

Immunogenicity data from mRNA-1273 hint that prime-boost vaccination with half the authorized dose may provide the same level of protection as the full dose, and have prompted some, including Operation Warp Speed Chief Scientific Adviser Moncef Slaoui, to raise the prospect of adopting the lower dose to help stretch limited supplies.

Earlier this week, however, FDA advised against changing the dosing schedules of COVID vaccines.

By contrast, the U.K.’s emergency authorization of the COVID-19 vaccine from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and the University of Oxford prioritizes widespread vaccination with a flexible dosing schedule that’s supported by recent data showing up to 70% efficacy for a single dose. 

Like FDA, the EC based its decision on Moderna’s pivotal study testing two 100 µg doses. Whether it would be open to using two 50 µg doses, without another trial, to vaccinate twice as many people remains to be seen.

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