This webpage was updated on 28 September 2022 to ensure consistency of formatting.
The Technical Advisory Group for Emergency Use Listing listed Nuvaxovid (NVX-CoV2373) vaccine against COVID-19 and Covovax (NVX-CoV2373) vaccine against COVID-19 for emergency use on 20 December 2021 and 17 December 2021 respectively.
The Novavax vaccine will be manufactured in two different facilities. In Europe, the vaccine will be manufactured under the trade name Nuvaxovid and has been approved by the European Medicines Agency, and in India, the vaccine will be manufactured by\r\n Serum Institute of India under the trade name Covovax and has been approved by the Drugs Controller General of India.
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim policy recommendations for the use of the Novavax (NVX-CoV2373) vaccine. This article provides a summary of those interim recommendations.
For the purposes of this article, the vaccine will be referred to as Novavax (NVX-CoV2373).
The background documents are also available here.
Who can take this vaccine?
The vaccine is safe and effective for all individuals aged 12 and above. In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritised. Adolescents with moderate to severe immunocompromising conditions belong to the highest priority-use group.
The Novavax vaccine can be offered to people who have had COVID-19 in the past. But individuals may choose to delay vaccination for 3 months following the infection.
Should pregnant and breastfeeding women be vaccinated?
Emerging post-introduction pharmacovigilance data relating to the use of NVX-CoV2373 in pregnant women have not identified any pregnancy-related safety concerns and based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to\r\n non-pregnant women of a similar age.
WHO has identified pregnant persons as a high priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. WHO recommends the use of the Novavax (NVX-CoV2373) vaccine in pregnant persons when the benefits of vaccination to the pregnant persons outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks\r\n of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant persons. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend\r\n delaying pregnancy or terminating pregnancy because of vaccination.
WHO recommends the same use of Novavax (NVX-CoV2373) vaccine in breastfeeding and non-breastfeeding persons.Vaccine effectiveness is expected to be similar in breastfeeding persons as in other adults. As Novavax\r\n (NVX-CoV2373) vaccine is not a live virus vaccine, it is biologically and clinically unlikely to pose a risk to the breastfeeding child. WHO does not recommend discontinuing breastfeeding because of vaccination.
Who is the vaccine not recommended for?
The vaccine is not recommended for people younger than 12 years of age.
Individuals with a history of anaphylaxis to any component of the vaccine should not take it.
Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met.
Anyone with a body temperature over 38.5°C should postpone vaccination until they no longer have a fever.
Is it safe?
SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 12 and above. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy.
Very rare serious adverse events of myocarditis and pericarditis have been observed though cases typically occurred within a few days after vaccination, and were generally mild.
How efficacious is the vaccine?
The efficacy of Novavax (NVX-CoV2373) has been assessed in three Phase 2 and Phase 3 trials. Of the two Phase 3 trials, both found that the efficacy of the vaccine against mild, moderate, and severe disease is 90%.
The efficacy of Novavax(NVX-CoV2373) in adolescents 12 to 17 years of age was evaluated in an interim analysis of the paediatric expansion portion of the ongoing phase 3 study in United States. The vaccine effectiveness reached 80% for this population.
What is the recommended dosage?
SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. An 8-week interval is recommended between primary series doses of NVX-CoV2373.
A first booster dose is recommended 4-6 months after the completion of the primary series. In accordance with the WHO Prioritization Roadmap, the highest priority-use groups (e.g. older adults, persons with moderate to severe immunocompromising conditions, and health workers) should be offered it first.
To further reduce the risk of severe disease, deaths and disruptions of health services, WHO recommends countries should consider a second booster dose 4-6 months after the first booster dose for all older persons, all persons with moderate and severe immunocompromising conditions, regardless of age, adults with comorbidities, pregnant persons and health workers.
For adolescents 12-18 years of age, there is currently insufficient evidence for recommending a booster dose, except for those with immunocompromising conditions.
Can this vaccine be ‘mixed and matched’ with other vaccines?
SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. However, there is limited evidence available on the use of Novavax (NVX-CoV2373) in a heterologous schedule.
Does it prevent infection and transmission?
As there is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission, public health and social measures must continue, including use of face masks, physical distancing, handwashing, appropriate ventilation, and other measures as appropriate in particular settings, depending on the COVID-19 epidemiology and potential risks of emerging variants. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed.
Does it work against new variants of SARS-CoV-2 virus?
In a Phase 3 study conducted in the USA and Mexico during a period in which multiple variants (Alpha, Beta and Delta) were in circulation, vaccine efficacy against mild, moderate, or severe COVID-19 was 90%.
In view of these findings, WHO recommends the use of Novavax (NVX-CoV2373) vaccine according to the WHO Prioritization Roadmap, even if currently recognized Variants of Concern (VOC) are present in the country. If new VOCs emerge for which vaccine performance\r\n is compromised, these recommendations will be updated accordingly. There are insufficient data still for Omicron.
How does this vaccine compare to other COVID-19 vaccines already in use?
It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease\r\n and hospitalization due to COVID-19.
This webpage was updated on 28 September 2022 to reflect updated interim recommendations.
There will be no further updates to this page. For more information on Covid-19 vaccines.
