The European Medicines Agency (EMA) yesterday approved the vaccine of the American company Novavax against Covid-19, also known as NVX-CoV2373 Nuvaxovid, referred to the Commission for final formal approval.
This is the fifth vaccine, after those of Pfizer-BioNTech, Moderna, Oxford / AstraZeneca and Johnson & Johnson, to be used to fight the coronavirus in the European Economic Area (27 of the EU plus Norway, Iceland, Liechtenstein).
Novavax vaccine dose deliveries are expected to begin in the European Union in January 2022.
What is the Nuvaxovid vaccine and why is it used?
Nuvaxovid is a vaccine for the prevention of coronavirus disease 2019 (COVID-19) in people aged 18 and over.
Nuvaxovid contains a laboratory-produced version of a protein found on the surface of the SARS-CoV-2 virus (spike protein).
Detailed information about this vaccine is available in the product information, which is included in the package leaflet.
How is the Nuvaxovid vaccine used?
Nuvaxovid is given as two injections, usually in the upper arm muscle, 3 weeks apart.
Arrangements for the supply of the vaccine will be the responsibility of the national regulatory authorities.
How does the Nuvaxovid vaccine work?
Nuvaxovid vaccine works by preparing the body to defend itself against infection COVID-19. Contains a laboratory-produced version of the spike protein. It also contains an "adjuvant", a substance that helps boost the immune response to the vaccine.
When a person receives the vaccine, their immune system will recognize the protein in the vaccine as foreign and will produce natural defenses - antibodies and T cells - against it.
If, later, the vaccinated person comes in contact with the SARS-CoV-2 virus, the immune system will recognize the spike protein in the virus and will be ready to attack. Antibodies and immune cells can protect against disease COVID-19 working together to kill the virus, prevent it from entering the body's cells and destroy the infected cells.
What benefits have the Nuvaxovid vaccine shown in studies?
The results of two main clinical trials showed that Nuvaxovid was effective in preventing the disease COVID-19 in people aged 18 and over.
A total of more than 45,000 people participated in the studies. In the first study, about two-thirds of the participants received the vaccine and the rest received placebo (a sham injection).
In the second study, participants were divided equally between the group of participants receiving the Nuvaxovid vaccine and the group of participants receiving the placebo.
Participants did not know if they had been given the Nuvaxovid vaccine or placebo.
The first study, conducted in Mexico and the United States, showed a 90.4% reduction in the incidence of symptomatic disease. COVID-19 in people who received the Nuvaxovid vaccine (14 cases 17,312 people) 7 days after the second dose, compared with people who received the placebo (63 of 8,140 people).
This means that in this study the vaccine had an efficacy of 90,4%.
A second study in the United Kingdom also showed a similar reduction in the number of cases of developing symptomatic disease. COVID-19 in people who received the Nuvaxovid vaccine (10 cases out of 7,020 people) compared with people who received the placebo (96 out of 7,019 people).
In this study, the vaccine efficacy was 89.7%.
Overall, the results of both studies show that the effectiveness of the Nuvaxovid vaccine is approximately 90%.
The original strain of SARS-CoV-2 and some variants of concern such as the alpha variant and the beta variant were the most common viral strains circulating when the studies were ongoing. There are currently limited data on the efficacy of Nuvaxovid against other variants of concern, including the Omicron variant.
Can people who are already sick with COVID-19 to be vaccinated with the Nuvaxovid vaccine?
There were no additional side effects in people who received Nuvaxovid in clinical trials and had previously had COVID-19.
There were insufficient data from clinical trials to conclude how well the Nuvaxovid vaccine works for people who have already had COVID-19.
Can the Nuvaxovid vaccine reduce the transmission of the virus from one person to another?
The effect of the Nuvaxovid vaccine on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known whether vaccinated individuals may still be able to transmit and spread the virus.
How long does protection against the Nuvaxovid vaccine last?
The duration of protection provided by the Nuvaxovid vaccine is currently unknown. Individuals vaccinated in clinical trials will be monitored for up to 2 years to gather more information about the duration of protection.
Can children be vaccinated with the Nuvaxovid vaccine?
Nuvaxovid is not currently recommended for people under 18 years of age. The EMA has agreed with the company on a plan to test the vaccine in children at a later stage.
Can immunocompromised people be vaccinated with the Nuvaxovid vaccine?
There are limited data in immunosuppressed patients (individuals with weakened immune systems). Although immunosuppressed patients may not respond equally well to the vaccine, there are no particular safety concerns. Immunosuppressed patients can be vaccinated, as they may be at higher risk of the disease COVID-19.
Can pregnant or breast-feeding women be vaccinated with the Nuvaxovid vaccine?
Animal studies do not show any adverse effects on pregnancy, however data on the use of the Nuvaxovid vaccine during pregnancy are limited. Although there are no studies on breastfeeding, no risk is expected during breastfeeding.
The decision to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.
Can people with allergies be vaccinated with the Nuvaxovid vaccine?
People who already know they are allergic to one of the components of the vaccine listed in section 6 of the package leaflet should not get the vaccine.
Cases of anaphylaxis (severe allergic reaction) have occurred in people receiving the vaccine against the disease COVID-19. Therefore, as with all vaccines, the Nuvaxovid vaccine should be administered under close medical supervision, with the appropriate medical treatment available. People who have had a severe allergic reaction to the first dose of Nuvaxovid should not take the second dose.
How well does the Nuvaxovid vaccine work for people of different nationalities and genders?
The main tests included people of different nationalities and genders. Effectiveness was maintained between the sexes and ethnic groups.
What are the risks associated with the Nuvaxovid vaccine?
The most common side effects with Nuvaxovid in trials were usually mild or moderate and improved within a few days after vaccination. These included headache, nausea (feeling sick) or vomiting, muscle and joint pain, tenderness and pain at the injection site, and fatigue and malaise. These affected more than 1 in 10 people.
Redness and swelling at the injection site, fever, chills, and pain in the extremities occurred in less than 1 in 10 people. Swollen lymph nodes, high blood pressure, rash, redness of the skin, itching at the injection site, and itchy rash were uncommon side effects (affecting less than 1 in 100 people).
Why did the EMA recommend the licensing of the Nuvaxovid vaccine?
The Nuvaxovid vaccine offers a high level of protection against the disease COVID-19, which is a critical need in the current pandemic. The main tests showed that the vaccine is about 90% effective. Most side effects are mild to moderate in severity and have subsided within a few days.
The Agency has therefore decided that the benefits of the Nuvaxovid vaccine outweigh its risks and that its EU authorization is recommended.
The EMA has recommended the conditional marketing authorization for the Nuvaxovid vaccine.
This means that more information is expected about the vaccine (see below), which the company is required to provide. The Agency will consider any new information when it becomes available and this review will be properly updated.
What information is still pending about the Nuvaxovid vaccine?
Because the Nuvaxovid vaccine is recommended for conditional marketing authorization, the company marketing the Nuvaxovid vaccine will conduct additional studies to provide additional assurance about the medicinal quality of the vaccine.
In addition, independent vaccine studies against the disease COVID-19 coordinated by EU authorities will also provide more information on the long-term safety and benefit of the vaccine to the general population.
What measures are taken for the safe and effective use of the Nuvaxovid vaccine?
Recommendations and precautions to be followed by health professionals and patients for the safe and effective use of Nuvaxovid vaccine are included in the product summary and in the package leaflet.
There is also a risk management plan (RMP) for Nuvaxovid which contains important information about the safety of the vaccine, how to gather further information and how to minimize any potential risks. A summary of the RMP is available.
Nuvaxovid safety measures to be implemented in line with EU vaccine safety monitoring plan COVID-19 to ensure that new security information is collected and analyzed quickly. The company that markets the Nuvaxovid vaccine will provide monthly safety reports.
Like all medicines, the data on the use of the Nuvaxovid vaccine are constantly monitored. Suspected adverse reactions reported with the Nuvaxovid vaccine should be carefully evaluated and the necessary measures taken to protect patients.
(KYPE / ELA / AHR)