Novavax Inc has also filed an application for emergency use of its COVID-19 vaccine to the European Medicines Agency. The company said it has completed the submission of all data and modules to the EMA to support the final regulatory review.
The World Health Organization is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, chief executive Stanley Erck told Reuters on Monday. Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.
SII is authorized to make the Novavax vaccine and the U.S. company said it will apply for regulatory authorization for other facilities, such as its plant in the Czech republic, in the coming weeks.Article content
It's essential that we uncover the COVID-19 pandemic's origins. We must ensure that those responsible are held accountable and that such an outbreak can never happen again.
Great news! Novavax is a protein subunit vax. Tetanus, pertusis & hep B vaccines are made in this way. They've been in use for decades. Trial results show fewer side effects and efficacy against Delta variant. I know many are waiting for it!
Canadians won't even see it. It was already promised for donation ahead of time, even if it does get approved.