European medicines watchdog clears new COVID-19 vaccine

New COVID-19 vaccine seen available from Q1 2022

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.

EMA has so far given CMA for the use of the COVID-19 vaccines of Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson.

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.

The European Commission will now fast-track the decision-making process to grant a decision on the CMA for Nuvaxovid, allowing this vaccine to be included in vaccination programmes rolled out across the EU.

According to a press report in the morning, Novavax could hit the European market as early as the first quarter of 2022.

Two clinical trials show efficacy around 90%

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% reduction in the number of symptomatic COVID-19 cases

from 7 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 8,140 people). This means that the vaccine had a 90.4% efficacy in this study.

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 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%.

Taken together, the results of the two studies show a vaccineefficacyfor Nuvaxovid of around 90%.

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 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.

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