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EU’s drug regulator approved Novavax COVID-19 vaccine

EU’s drug regulator approved Novavax COVID-19 vaccine

The European Union’s drug regulator recommended approval for Novavax’s COVID-19 vaccine, which is 94.1% effective in Phase 3 trial, UPI has learned on Monday.

The European Medicines Agency (EMA) issued on Monday its official recommendation for the antiviral drug developed by the US-based Novavax and the Serum Institute of India. Moreover, the vaccine was developed for use in the European Union.

On Saturday, the World Health Organization (WHO) has already granted emergency authorization for the Novavax vaccine in low-income countries. Two days after, the EMA recommended the drug for adults over the age of 18, citing recent trials conducted in Mexico, the US and England.

The EMA noted Monday that needed two studies were done when only the COVID-19 variants like Alpha and Beta were dominant. The more transmissible Delta and Omicron variants are still needing more studies.

The Novavax drug is the 5th vaccine to approved by the EMA

The Novavax vaccine the ninth to be approved by the WHO and fifth – by the EMA. The recently approved drug is expected to make up a large chunk of the world’s vaccine supply because of its ability to be stored and shipped at normal refrigeration temperatures.

As Dr Mariangela Simao, WHO assistant director general for access to medicines, said, all vaccines aim to increase access particularly in lower-income nations, 41 of which have still not been able to vaccinate 10%of their populations, while 98 nations have not even reached 40% of immunization.