What is the Nuvaxovid vaccine Nuvaxovid and why is it used?
Nuvaxovid is a vaccine to prevent coronavirus 2019 (COVID-19) in people aged 18 years and older.
Nuvaxovid contains a version of a protein found on the surface of the SARS-CoV-2 virus (spike protein), which has been produced in the laboratory.
Detailed information about this vaccine is available in product information, which includes the package leaflet.
How is the Nuvaxovid vaccine used?
Nuvaxovid is administered as two injections, usually into the upper arm muscle, with a 3-week interval.
Arrangements for the supply of the vaccine will be the responsibility of national regulatory authorities. For more information on the use of Nuvaxovid, see the package leaflet or consult a healthcare professional.
How does the Nuvaxovid vaccine
Nuvaxovid vaccine works by preparing the body to defend itself against COVID-19 infection. It contains a version of the spike protein that has been produced in the laboratory. It also contains an "immune booster," a substance that helps boost immune responses to the vaccine.
When a person receives the vaccine, their immune system will recognize the protein in the vaccine as foreign and produce natural defenses - antibodies and T cells - against it.
If, later, the vaccinated person comes into contact with the SARS-CoV-2 virus, the immune system will recognize the spike protein in the virus and be ready to attack. Antibodies and immune cells can protect against COVID-19 disease by working together to kill the virus, prevent it from entering the body's cells and destroy infected cells.
What benefits of the Nuvaxovid vaccine have been demonstrated in studies?
Results from two main clinical trials showed that Nuvaxovid was effective in preventing COVID-19 disease in people aged 18 years and older. The studies involved a total of more than 45,000 participants. In the first study, about two-thirds of the participants received the vaccine and the rest received a placebo (placebo injection). In the second study, participants were equally divided between the group of participants who received the Nuvaxovid vaccine and the group of participants who received placebo. Participants did not know whether they had been given the Nuvaxovid vaccine or placebo.
The first study, conducted in Mexico and the United States, showed a rate of 90.4% reduction in the number of cases of COVID-19 symptomatic disease in people who received the Nuvaxovid vaccine (14 of 17,312 cases) 7 days after the second dose, compared to people who received placebo (63 of 8,140 cases). This means that in this study the vaccine had an efficacy of 90.4%.
The second study conducted in the UK also showed a similar reduction in the number of cases of COVID-19 symptomatic disease in people who received the Nuvaxovid vaccine (10 cases out of 7,020 people) compared to people who received placebo (96 out of 7,019 people). In this study, the efficacy of the vaccine was 89.7%.
Overall, the results of the two studies show that the efficacy of the Nuvaxovid vaccine is approximately 90%. The original SARS-CoV-2 strain and some variants of concern such as the Alpha variant and Beta variant were the most common viral strains circulating when the studies were ongoing. At this stage there are 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 be vaccinated with the Nuvaxovid vaccine?
There were no additional adverse events in people who received Nuvaxovid in clinical trials and were previously sick with COVID-19.
There were not enough data from the clinical trials to draw a conclusion regarding how well the Nuvaxovid vaccine works for people who have previously been sick with COVID-19.
Can the Nuvaxovid vaccine reduce the transmission of the virus from one person to another?
The effect of vaccination with the Nuvaxovid vaccine on the spread of SARS-CoV-2 in the community is not yet known. It is not yet known whether vaccinated individuals may still be able to carry and spread the virus.
How long does protection from the Nuvaxovid vaccine last?
The duration of protection provided by the Nuvaxovid vaccine is not currently known. People vaccinated in clinical trials will be followed for up to 2 years to gather more information on 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 immunocompromised patients (people with compromised immune systems). Although immunocompromised patients may not respond as well to the vaccine, there are no particular safety concerns. Immunosuppressed patients may be vaccinated as they may be at greater risk of COVID-19 disease.
Can pregnant or lactating women be vaccinated with Nuvaxovid vaccine?
Animal studies show no harmful effects in pregnancy, but data on the use of Nuvaxovid vaccine during pregnancy are limited. Although there are no studies on breastfeeding, no risk is expected during breastfeeding.
The decision on the use of the vaccine in pregnant women should be made in close consultation with a healthcare professional after taking into account the benefits and risks.
Can people with allergies be vaccinated with Nuvaxovid vaccine?
People who already know that they are allergic to one of the vaccine components listed in paragraph 6 of the package leaflet should not receive the vaccine.
Cases of anaphylaxis (severe allergic reaction) have occurred in people receiving COVID-19 vaccines. Therefore, as with all vaccines, Nuvaxovid vaccine should be administered under close medical supervision, with appropriate medical treatment available. People who have had a severe allergic reaction to the first dose of Nuvaxovid vaccine should not receive the second dose.
How well does Nuvaxovid vaccine work for people of different ethnicities and genders?
The main trials included people of different ethnicities and genders. Efficacy was maintained across gender and ethnic groups.
What are the risks associated with the Nuvaxovid vaccine?
The most common adverse reactions with Nuvaxovid in the 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, fatigue, and feeling unwell. 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 pruritic rash were uncommon adverse reactions (affecting fewer than 1 in 100 people).
Why did the EMA recommend licensing the Nuvaxovid vaccine?
The Nuvaxovid vaccine offers a high level of protection against COVID-19, which is a critical need in the current pandemic. The main trials have shown that the vaccine has about 90% efficacy. Most adverse reactions are mild to moderate in severity and have resolved within a few days.
Therefore, the Agency decided that the benefits of the Nuvaxovid vaccine outweigh its risks and that its licensing in the EU is recommended.
The EMA recommended that the Nuvaxovid vaccine be granted a conditional marketing authorisation. This means that more data on the vaccine are expected (see below), which the company is required to provide The Agency will review any new information when it becomes available and this review will be appropriately updated.
What information is still expected for the Nuvaxovid vaccine
As the Nuvaxovid vaccine is recommended for conditional marketing authorisation, the company marketing the Nuvaxovid vaccine will carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine.
In addition, independent studies of COVID-19 vaccines coordinated by the EU authorities will also provide more information on the long-term safety and benefit of the vaccine in the general population.
What measures are taken to ensure the safe and effective use of Nuvaxovid vaccine?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuvaxovid vaccine have been included in the summary of product characteristics and the package leaflet.
A risk management plan (RMP) is also in place for Nuvaxovid which contains important information on the safety of the vaccine, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.
Safety measures for Nuvaxovid will be implemented in accordance with the EU Safety Monitoring Plan for COVID-19 vaccines to ensure that new safety information is collected and analysed rapidly. The company marketing the Nuvaxovid vaccine will provide monthly safety reports.
Like all medicines, data on the use of the Nuvaxovid vaccine are continuously monitored. Suspected adverse reactions reported with Nuvaxovid vaccine are carefully evaluated and appropriate measures are taken to protect patients.
Other information about Nuvaxovid
The Committee for Medicinal Products for Human Use (CHMP) of the EMA on 20 December 2021 recommended granting a conditional marketing authorisation for Nuvaxovid, valid throughout the EU. The European Commission will soon adopt a decision.
Detailed recommendations for the use of this product are described in the product information, which will be available in all official languages of the European Union following the decision on marketing authorisation by the European Commission.
(AF)
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