EMA Pushes For Approval Of Novavax Vaccine

EMA Pushes For Approval Of Novavax Vaccine
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The European Medicines Agency (EMA) recommended the authorization of Novaxovid, a new COVID-19 vaccine by American biotechnology company Novavax, Inc. (NASDAQ:NVAX) to be used in people aged +18 years. It is set to become the fifth vaccine to bolster the world’s arsenal against the pandemic.

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Lined Up For Approval

As reported by the Financial Times, the Novaxovid vaccine has received —by consensus and after a thorough evaluation— a positive recommendation by the Human Drugs Committee, as it meets the criteria of efficacy, safety, and quality.

The endorsement is grounded on the positive results obtained after two clinical trials in which the shot was effective at preventing infections among 45,000 people over 18 years.

The first study took place in Mexico and the U.S. and showed a reduction of 90.4% in symptomatic cases through two doses, after seven days. The second trial took place in the U.K. where the reduction in the number of symptomatic cases was 89.7%.

“Together, the results of these studies show a 90% efficacy of Nuvaxovid... [it is] the first approved vaccine that uses a different platform since it is based on recombinant proteins,” the EMA said.

Side effects seen with Nuvaxovid are generally "mild or moderate" and disappear within a few days after vaccination. The most common are arm tenderness and pain, tiredness, muscle pain, headache, malaise, joint pain, nausea, and vomit.

Emergency Use

Nuvaxovid dosing consists of two intramuscular shots about three weeks apart. Following EMA recommendations, the vaccine will most likely receive conditional marketing authorization from the European Commission, which will allow its inclusion in vaccination programs.

This type of authorization is considered a way of expediting the availability of medicines and vaccines in health emergencies. It is used when the benefits of having a drug that has not yet completed the usual authorization processes outweigh the risks of the lack of data.

In any case, the authorization guarantees that the efficacy, safety, or quality of the product has been rigorously verified, the EMA recalls. Based on this conditional authorization, Novavax must provide more data and studies to the European authorities for final authorization.

Novavax stock jumped 12% before markets opened “on the initial announcement recommending use of the inoculation as a two-shot vaccine for all adults in Europe, though was down 5% in early market trading,” the FT reports.

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