The European Union has recently authorized the use of the COVID-19 vaccine of Novavax in individuals aged 18 years old and above, providing a boost to the American biotech after long delays and giving way to a firth shot in the European Union as there is a rapid spread of the Omicron variant of the virus.
An Al Jazeera report specified that the European Medicines Agency had cleared the way for a fifth authorized COVID-19 jab that authorizes its use in adult individuals 18 years old and above.
According to the EMA, data from two large studies presented that the vaccine had a 90-percent efficacy rate against some variants of concern, which include the new Omicron variant.
Following a comprehensive investigation, the human medicines committee or CHMP of EMA finished by a compromise that the vaccine data provided were strong and met the criteria of the EU in terms of efficacy, quality, and safety.
Novavax to Supply Up to 200 Million Doses in January
Essentially, the EU Commission followed shortly after the decision of the EMA to grant the final official go signal.
Novavax said it would begin to ship its vaccines to the 27 member states of the EU next month as part of its deal to provide a maximum of 200 million doses.
Reports said member states have ordered approximately 27 million doses for the first quarter of 2022, adequate enough to vaccinate roughly 13.5 million people, explained the Commission.
The Novavax Vaccine
The authorization for a two-dose jab, with Nuvaxovid as a brand, as described in the Precision Vaccinations site, comes way ahead of a possible sanction in the United States, where Novavax has needed to deal with problems when it comes to manufacturing. More so, it is expecting to apply for authorization of its first-ever COVID-19 jab by the end of 2021.
In the EU, the regulatory process has taken longer than expected. The said regulatory began its actual rolling examination of the data in early 2021.
In December last year, Novavax and the EU reached an initial deal to supply the said vaccine, although because of regulatory and production problems, the final contract was only signed in August 2021.
The shot was granted its first authorization from the regulatory in Indonesia in November. In connection to this, it is waiting for authorization in Japan, the country where it would be manufactured and distributed through the Takeda Pharmaceutical firm.
Vaccine for Low- and Middle-Income
On Friday, the World Health Organization issued an emergency use listing to the vaccine made by Novavax made by the Serum Institute of India or SII, the biggest vaccine manufacturer in the world, giving way for its use in low and middle-income nations where rollout has been much slower compared to Europe. However, faced with surging contagions, the EMA has been fast-tracking reviews of other jabs and treatments.
The protein-based vaccine of Novavax is using substitute technology to the other four shots, making it more interesting to the EU as it has sought to diversify its vaccine portfolio.
To date, nearly 70 percent of EU citizens have received their two shots of COVID-19 vaccine, and many countries are now scrambling to inoculate third booster doses of the vaccine in an initiative to reinforce defenses against the Omicron variant.
Approval of Novavax as the 5th vaccine is shown on DW News's YouTube video below:
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