EMA recommends Nuvaxovid jab against Covid-19 for authorisation in EU

Written by on December 20, 2021 in Bulgaria - Comments Off on EMA recommends Nuvaxovid jab against Covid-19 for authorisation in EU

The European Medicines Agency (EMA) said on December 20 that it had recommended granting a conditional marketing authorisation for Novavax’s Covid-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent Covid-19 in people from 18 years of age.

Nuvaxovid is the fifth vaccine recommended in the EU for preventing Covid-19.

It is a protein-based vaccine and, together with the already authorised vaccines, will support vaccination campaigns in EU member states during a crucial phase of the pandemic, the EMA said.

After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.

Results from two main clinical trials found that Nuvaxovid was effective at preventing Covid-19 in people from 18 years of age. The studies involved over 45 000 people in total. In the first study, around two thirds of participants received the vaccine and the others were given a placebo (dummy) injection; in the other study, participants were equally split between Nuvaxovid and placebo. People did not know if they had been given Nuvaxovid or placebo.

The first study, conducted in Mexico and the United States, found a 90.4 per cent reduction in the number of symptomatic Covid-19 cases from seven days after the second dose in people who received Nuvaxovid (14 cases out of 17 312 people) compared with people given placebo (63 out of 8140 people). This means that the vaccine had a 90.4 per cent efficacy in this study, the EMA said.

The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic Covid-19 cases in people who received Nuvaxovid (10 cases out of 7020 people) compared with people given placebo (96 out of 7019 people); in this study, the vaccine efficacy was 89.7 per cent.

“Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90 per cent,” the EMA said.

“The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” the agency said.

The side effects observed with Nuvaxovid in the studies were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting.

Moderna, Inc. announced on December 20 preliminary neutralizing antibody data against the Omicron variant following the company’s booster candidates at 50 µg and 100 µg dose levels.

It said that the currently authorized 50 µg booster of mRNA-1273 increased neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels and a 100 µg dose of mRNA-1273 increased neutralizing antibody levels approximately 83-fold compared to pre-boost levels.

“The dramatic increase in Covid-19 cases from the Omicron variant is concerning to all. However, these data showing that the currently authorized Moderna Covid-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring,” Moderna CEO Stéphane Bancel said.

“To respond to this highly transmissible variant, Moderna will continue to rapidly advance an Omicron-specific booster candidate into clinical testing in case it becomes necessary in the future.

“We will also continue to generate and share data across our booster strategies with public health authorities to help them make evidence-based decisions on the best vaccination strategies against SARS-CoV-2,” Bancel said.

Bulgaria’s Education Ministry said on December 20 that as of January 24, a green certificate will be required for admission to all the ministry’s buildings.

A green certificate means a valid document for vaccination, disease, antibodies or a negative laboratory test. The rapid antigen test will be valid for up to 48 hours and the PCR test for up to 72 hours. The ministry will not have a laboratory on its territory.

A green certificate will not be required from children and members of the public who come to the ministry’s building’s reception only to submit applications.

People who cannot be immunised for health reasons will have to present a medical document certifying this.

Education Ministry employees who do not have a green certificate will work remotely if their tasks allow it, or will have to go on leave, the ministry said.

The December 20 update by the unified information portal showed that of Bulgaria’s 28 districts, 19 were Covid-19 red zones and nine were yellow zones.

The yellow zones, meaning a morbidity rate from 100 to 249.9 per 100 000 population on a 14-day basis, are Veliko Turnovo, Dobrich, Kurdzhali, Pazardzhik, Razgrad, Silistra, Sliven, Shoumen and Yambol.

The update said that Bulgaria’s national Covid-19 morbidity rate was 312.77 out of 100 000 population on a 14-day basis.

(Archive photo: Bulgaria’s Ministry of Health)

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