What’s Nuvaxovid and what’s it used for?
Nuvaxovid is a vaccine for stopping coronavirus illness 2019 (COVID-19) in individuals aged 18 years and older.
Nuvaxovid accommodates a model of a protein discovered on the floor of SARS-CoV-2 (the spike protein), which has been produced within the laboratory.
Detailed details about this vaccine is obtainable within the product info, which incorporates the bundle leaflet.
How is Nuvaxovid used?
Nuvaxovid is given as two injections, often into the muscle of the higher arm, 3 weeks aside.
Preparations for the provision of the vaccine would be the duty of nationwide authorities. For extra details about utilizing Nuvaxovid, see the bundle leaflet or seek the advice of a healthcare skilled.
How does Nuvaxovid work?
Nuvaxovid works by getting ready the physique to defend itself in opposition to COVID-19. It accommodates a model of the spike protein that has been produced within the laboratory. It additionally accommodates an ‘adjuvant’, a substance to assist strengthen the immune responses to the vaccine.
When an individual is given the vaccine, their immune system will determine the protein within the vaccine as international and produce pure defences — antibodies and T cells — in opposition to it.
If, afterward, the vaccinated particular person comes into contact with SARS-CoV-2 virus, the immune system will recognise the spike protein on the virus and be ready to assault it. The antibodies and immune cells can shield in opposition to COVID-19 by working collectively to kill the virus, forestall its entry into the physique’s cells and destroy contaminated cells.
What advantages of Nuvaxovid have been proven in research?
Outcomes from two most important medical trials discovered that Nuvaxovid was efficient at stopping COVID-19 in individuals from 18 years of age. The research concerned over 45,000 individuals in whole. Within the first research, round two thirds of contributors obtained the vaccine and the others got placebo (a dummy injection); within the different research, contributors have been equally break up between Nuvaxovid and placebo. Folks didn’t know if that they had been given Nuvaxovid or placebo.
The primary research, carried out in Mexico and the US, discovered a 90.4% discount within the variety of symptomatic COVID-19 circumstances from 7 days after the second dose in individuals who obtained Nuvaxovid (14 circumstances out of 17,312 individuals) in contrast with individuals given placebo (63 out of 8,140 individuals). Because of this the vaccine had a 90.4% efficacy on this research.
The second research carried out in the UK additionally confirmed an analogous discount within the variety of symptomatic COVID-19 circumstances in individuals who obtained Nuvaxovid (10 circumstances out of seven,020 individuals) in contrast with individuals given placebo (96 out of seven,019 individuals); on this research, the vaccine efficacy was 89.7%.
Taken collectively, the outcomes of the 2 research present a vaccine efficacy for Nuvaxovid of round 90%. The unique pressure of SARS-CoV-2 and a few variants of concern resembling Alpha and Beta have been the commonest viral strains circulating when the research have been ongoing. There’s at present restricted knowledge on the efficacy of Nuvaxovid in opposition to different variants of concern, together with Omicron.
Can individuals who have already had COVID-19 be vaccinated with Nuvaxovid?
There have been no extra negative effects within the individuals who obtained Nuvaxovid within the medical trials and had beforehand had COVID-19.
There weren’t sufficient knowledge from the trial to conclude on how effectively Nuvaxovid works for individuals who have already had COVID-19.
Can Nuvaxovid scale back transmission of the virus from one particular person to a different?
The influence of vaccination with Nuvaxovid on the unfold of the SARS-CoV-2 virus in the neighborhood shouldn’t be but recognized. It isn’t but recognized how a lot vaccinated individuals should have the ability to carry and unfold the virus.
How lengthy does safety from Nuvaxovid final?
It isn’t at present recognized how lengthy safety given by Nuvaxovid lasts. The individuals vaccinated within the medical trials will proceed to be adopted for as much as 2 years to collect extra info on the period of safety.
Can kids be vaccinated with Nuvaxovid?
Nuvaxovid shouldn’t be at present advisable for individuals beneath 18 years of age. EMA has agreed with the corporate on a plan to trial the vaccine in kids at a later stage.
Can immunocompromised individuals be vaccinated with Nuvaxovid?
There are restricted knowledge on immunocompromised individuals (individuals with weakened immune methods). Though immunocompromised individuals might not reply as effectively to the vaccine, there aren’t any explicit security considerations. Immunocompromised individuals can nonetheless be vaccinated as they could be at increased danger from COVID-19.
Can pregnant or breast-feeding ladies be vaccinated with Nuvaxovid?
Animal research don’t present any dangerous results in being pregnant, nevertheless knowledge on the usage of Nuvaxovid throughout being pregnant are restricted. Though there aren’t any research on breast-feeding, no danger for breast-feeding is predicted.
The choice on whether or not to make use of the vaccine in pregnant ladies must be made in shut session with a healthcare skilled after contemplating the advantages and dangers.
Can individuals with allergy symptoms be vaccinated with Nuvaxovid?
Individuals who already know they’ve an allergy to one of many parts of the vaccine listed in part 6 of the bundle leaflet mustn’t obtain the vaccine.
Instances of anaphylaxis (extreme allergic response) have occurred in individuals receiving COVID-19 vaccines. Subsequently, as for all vaccines, Nuvaxovid must be given beneath shut medical supervision, with the suitable medical remedy obtainable. Individuals who have a extreme allergic response when they’re given the primary dose of Nuvaxovid mustn’t obtain the second dose.
How effectively does Nuvaxovid work for individuals of various ethnicities and genders?
The primary trials included individuals of various ethnicities and genders. Efficacy was maintained throughout genders and ethnic teams.
What are the dangers related to Nuvaxovid?
The most typical negative effects with Nuvaxovid within the trials have been often gentle or reasonable and obtained higher inside a number of days after vaccination. These included headache, nausea (feeling sick) or vomiting, muscle and joint ache, tenderness and ache on the injection website, tiredness and feeling unwell. These affected greater than 1 in 10 individuals.
Redness and swelling on the injection website, fever, chills and ache within the limbs occurred in lower than 1 in 10 individuals. Enlarged lymph nodes, hypertension, rash, reddening of the pores and skin, itching on the injection website and itchy rash have been unusual negative effects (affecting lower than 1 in 100 individuals).
Why has EMA advisable the authorisation of Nuvaxovid?
Nuvaxovid affords a excessive stage of safety in opposition to COVID-19 which is a important want within the present pandemic. The primary trials confirmed that the vaccine has round 90% efficacy. Most negative effects are gentle to reasonable in severity and are gone inside a number of days.
The Company due to this fact determined that Nuvaxovid’s advantages are higher than its dangers and that it may be advisable for authorisation within the EU.
EMA has advisable a conditional advertising authorisation for Nuvaxovid. Because of this there’s extra proof to return concerning the vaccine (see beneath), which the corporate is required to offer. The Company will evaluate any new info that turns into obtainable and this overview might be up to date as crucial.
What info remains to be awaited for Nuvaxovid?
As Nuvaxovid is advisable for a conditional advertising authorisation, the corporate that markets Nuvaxovid will perform research to offer extra assurance on the pharmaceutical high quality of the vaccine.
As well as, impartial research of COVID-19 vaccines coordinated by EU authorities may even give extra info on the vaccine’s long-term security and profit within the common inhabitants.
What measures are being taken to make sure the protected and efficient use of Nuvaxovid?
Suggestions and precautions to be adopted by healthcare professionals and sufferers for the protected and efficient use of Nuvaxovid have been included within the abstract of product traits and the bundle leaflet.
A danger administration plan (RMP) for Nuvaxovid can also be in place and accommodates necessary details about the vaccine’s security, find out how to acquire additional info and find out how to minimise any potential dangers. A abstract of the RMP is obtainable.
Security measures might be applied for Nuvaxovid consistent with the EU security monitoring plan for COVID-19 vaccines to make sure that new security info is quickly collected and analysed. The corporate that markets Nuvaxovid will present month-to-month security stories.
As for all medicines, knowledge on the usage of Nuvaxovid are constantly monitored. Suspected negative effects reported with Nuvaxovid are fastidiously evaluated and any crucial motion taken to guard sufferers.
Different details about Nuvaxovid
Nuvaxovid was advisable by EMA’s human medicines committee (CHMP) on 20 December 2021 for a conditional advertising authorisation legitimate all through the EU. The European Fee will situation a choice shortly.
Detailed suggestions for the usage of this product are described within the product info, which might be obtainable in all official European Union languages after a choice on the advertising authorisation has been issued by the European Fee.