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Maryland’s Novavax gets fast-track tag from FDA for COVID-19 vaccine

The Novavax labs in Gaithersburg, Maryland on March 20.ANDREW CABALLERO-REYNOLDS/Photographer: ANDREW CABALLERO-R

(Bloomberg) -- Novavax Inc. said Monday it expects to launch a large, late-stage study in the US before the end of the month.

Its experimental COVID-19 vaccine also received a fast-track designation from regulators Monday, which could help shuttle the candidate forward into a short-list of frontrunners in the race to bring a vaccine to market.

Shares in the Gaithersburg, Maryland-based company were up 4.1 percent in premarket trading in New York. Novavax is expected to report its third quarter results Monday afternoon.

Earlier, the shares had fallen after Pfizer Inc. and BioNTech SE reported preliminary results showing their vaccine candidate was 90 percent effective in a late-stage trial. The New York-based drug giant and its German partner could be the first to seek an emergency use authorization in the US.


Novavax has received $1.6 billion from the US government’s Operation Warp Speed program to speed development and manufacturing of coronavirus shots and therapies.

Novavax launched Phase 2 trials in the US and elsewhere in August and expects to begin its Phase 3 trials in the US and Mexico by the end of November.

The company already has its vaccine in a late-stage trial in the United Kingdom and said Monday it could have interim data from that trial in early 2021. Phase 2 trials enroll hundreds of people, whereas late-stage, or Phase 3, trials enroll many thousands of people.

Novavax’s vaccine, which consists of synthetic spike proteins grown in armyworm moth cells, lags behind those that launched large, late-stage trials at the outset of the summer.

Globe Correspondent Anissa Gardizy contributed to this report.

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