The Novavax vaccine against COVID-19: What you need to know – World Health Organization

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 Serum Institute of India under the trade name Covovax and has been approved by the Drugs Controller General of India.

TheWHO Strategic Advisory Group of Experts on Immunization (SAGE) has issuedinterim policy recommendationsfor 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 availablehere.

Where COVID-19 vaccine supplies are limited, priority should go to health workers at high risk of exposure and older people.

Countries can refer to theWHO Prioritization Roadmap and theWHO Values Frameworkfor guidance.

The vaccine is not recommended for people younger than 18 years of age. Safety and immunogenicity data for under-18s are currently being generated but until such data are sufficiently available and can be further reviewed, vaccination of individuals in this age group is not recommended.

Data regarding the safety and efficacy of the use of Novavax (NVX-CoV2373)vaccine in pregnant women is not yet available. However, based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to non-pregnant women of a similar age.

WHO recommends the use of the COVID-19 vaccine in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination.

Vaccination is recommended for people living with conditions that have been identified as increasing the risk of severe COVID-19, including cardiovascular disease, respiratory disease, diabetes, liver disease, obesity and neurodevelopmental and neurodegenerative conditions.

The vaccine can be offered to people who have had COVID-19 in the past. Available data shows that symptomatic reinfection from the same variant is unlikely for up to 6 months after infection. Those with documented infection may therefore choose to delay vaccination to nearer the end of this period, especially when vaccine supply is limited, to allow others priority for vaccination.

WHO recommends the same use of Novavax (NVX-CoV2373) vaccine in breastfeeding and non-breastfeeding women. Data are not available on the potential benefits or possible risks of the Novavax (NVX-CoV2373)vaccine to breastfed children. However, as Novavax (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.

Persons living with human immunodeficiency virus (HIV) or who are immunocompromised are at higher risk of severe COVID-19 disease. There are not enough data at present to allow assessment of the efficacy or safety of this vaccine for people living with HIV. It is possible that the immune response to the vaccine may be reduced, which could lower its clinical effectiveness. In the interim, however, given that the vaccine is nonreplicating, people living with HIV that is well controlled may be vaccinated with the standard primary series of 2 doses, when part of a group prioritized for vaccination.

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 38.5C should postpone vaccination until they no longer have a fever.

Most children and adolescents are at very low risk of severe COVID-19. Safety and immunogenicity data are currently being generated for those aged under 18 years. Until this data are available, vaccination of persons under the age of 18 is not recommended.

SAGE recommends the use of the Novavax (NVX-CoV2373)vaccine as 2 doses (0.5 ml) given intramuscularly. The two doses should be administered with an interval of 3-4 weeks.

SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary vaccination series and are at higher risk of severe COVID-19 disease.

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.

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 and hospitalization due to COVID-19.

SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 18 and above. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy.

Safety data is currently limited for persons above 65 years of age (due to the small number of participants of this age group in clinical trials). However, the trial data indicate that the vaccine has an acceptable safety profile for this age group and WHO recommends the vaccine for use in persons aged 65 years and over.

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%.

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 is compromised, these recommendations will be updated accordingly. There are insufficient data still for Omicron.

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.

See the original post:

The Novavax vaccine against COVID-19: What you need to know - World Health Organization