European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid.
European Medicines Agency (EMA) „has recommended granting a conditional marketing authorisation (CMA) for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age,” it said in its announcement published last week.
Vaccine approved by the Commission
The same afternoon European Commission President Ursula von der Leyen informed that the EU executive has granted conditional marketing authorisation to the Novavax vaccine.
„With 5 approved vaccines, the EU has a varied portfolio, based both on novel technologies, such as mRNA, and classic ones, like Novavax, which is protein-based,” von der Leyen tweeted on December 20. „Vaccination, and boosters, are our best protection against COVID-19,” she added.
EMA’s recommended conditional approval for the use of Nuvaxovid vaccine on people from 18 years of age. The results of clinical trials show a vaccine efficacy for Nuvaxovid of around 90 per cent.
Nuvaxovid is the fifth vaccine approved in the EU for prevention against 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 stated.
It said that 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.
90 per cent efficacy
EMA conducted two main clinical trials aimed at evaluating the efficacy of the vaccine. The first study was conducted in Mexico and the United States, and the second – in the UK.
The two 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 second trial, participants were equally split between Nuvaxovid and placebo. The participants did not know if they had been given Nuvaxovid or placebo.
The first study found a 90.4 per cent efficacy of the vaccine. The second one, conducted in the UK, showed a slightly worse result – 89.7 per cent.
Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90 per cent.
Nuvaxovid: Too little data on the efficacy against the Omicron variant
European Medicines Agency stressed, however, that the most common SARS-CoV-2 viral strains circulating when the studies were ongoing were Alpha and Beta. The obtained data on the efficacy of Nuvaxovid against other variants of concern, including Omicron, are so far very limited. Neither can be told with full confidence whether Nuvaxovid shows similar results against the newer SARS-CoV-2 variants.
EMA also named the possible side effects after inoculation with Nuvaxovid. 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. The effects classified as „mild or moderate” and cleared within a couple of days after vaccination.
„The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities,” EMA announced.
How does the new vaccine work?
Nuvaxovid works by preparing the body to defend itself against COVID-19. The vaccine contains a version of a protein found on the virus’s surface, which has been produced in the laboratory, and an excipient strengthening the immune response.
When a person is given the vaccine, their immune system identifies the protein as foreign and builds natural defences against it.
Once the vaccinated person comes into contact with SARS-CoV-2, the immune system recognises the spike „S” protein in the virus and is prepared to defend the organism.
Antibodies and immune cells can prevent organism against the COVID-19, cooperating with each other to kill the virus, making it unable to reach the organism’s cells and kill the infected ones.
Nuvaxovid vaccine is provided in two injections, similarly to the other vaccines approved in the EU, in the arm, with an interval of three weeks.