WHO approves Novavax vaccine against COVID-19

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The World Health Organization (WHO) included the COVID-19 vaccine in the list of emergency use Nuvavoxid (NVX-CoV2373), developed by the American manufacturer Novavax.

The homologation came after the WHO included Covovax, another version of the same immunization manufactured in India, on the list on December 17. The European Medicines Agency also authorized the use of Nuvavoxid today.

Both vaccines are made with the same protein subunit technology, which has previously been used against diseases such as whooping cough, human papillomavirus and hepatitis B. In addition, they have the advantage that they do not require freezing at very low temperatures like other immunizations.

It is the tenth vaccine to enter the list for emergency use after those of Pfizer, AstraZeneca (which the WHO counts as two, one of them manufactured in India), Janssen, Moderna, Sinopharm, Sinovac, Covaxin and Covovax Produced by the Serum Institute of India under license from the American Novovax.

Novavax

Trial volunteer receives Novavax COVID-19 vaccine

Recommendations for use

WHO has also published the Nuvavoxid recommendations developed by the Strategic Advisory Group of Experts (SAGE). The vaccine should be administered in two doses three to four weeks apart.

Kids

The vaccine has no age limit for older people, but should not be used in children and adolescents under 18 years of age until safety and immunogenicity data are available

Pregnant

The WHO explains that the trials of this vaccine did not include a sufficient number of pregnant women to be able to draw conclusions about the safety of the adjuvant. No post-marketing data is yet available, nor are there any on neonatal outcomes.

However, “based on previous experience with the use of other protein-based vaccines during pregnancy, the efficacy of Nuvavoxid in pregnant women is expected to be comparable to that seen in non-pregnant women of a similar age,” he explains.

Since pregnant women are considered a high-risk group if they contract COVID-19, the WHO recommends the use of Nuvavoxid “if the benefits of vaccination for the pregnant woman outweigh the potential risks“For example, if there is high transmission in the community and there is no other vaccine” with a more established safety record in pregnancy “available locally.

Lactating women

WHO recommends the same use of Nuvavoxid vaccine in lactating women and not lactating. “As the NVX-CoV2373 vaccine is not a live virus vaccine, it is unlikely, from a biological and clinical point of view, that it poses a risk to the nursing child,” he points out, noting that “WHO does not recommend interrupting breastfeeding maternal due to vaccination ”.

Moderately and severely immunocompromised people

People who are moderately and severely immunocompromised (PIC) are at increased risk for severe COVID-19, regardless of age.

Building on other vaccine platforms and extrapolating knowledge from vaccine immunology, Nuvavoxid is expected to elicit a lower immune response in this group than in non-immunosuppressed people.

ThereforeFor immunocompromised people, the WHO recommends an additional (third) dose. For the purposes of vaccination, the WHO considers people with active cancer or immunodeficiency, transplant recipients and those receiving active treatment with immunosuppressants to be part of this group. It also includes people living with HIV.

The additional dose can also be Nuvavoxid or a different dose can be used “taking into account the vaccine supply.”

The available evidence suggests that the additional (third) dose should be given between one and three months after the second dose in order to increase protection as quickly as possible.

Combination of different vaccines

Novavax / Elliott O’Donovan

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WHO considers as “standard practice” to use the same type of vaccine in the initial and booster doses, as reflected in the recommendations recently issued by the Strategic Advisory Group of Experts.

However, it “supports a flexible approach” and considers that two heterologous (different) doses of any vaccine included in the emergency list constitutes a complete regimen.

“Heterologous vaccination should only be applied with the current vaccine supply and access considerations in mind, along with the potential benefits and risks of the specific products used,” the experts add.

  • Countries that use inactivated vaccines (Sinopharm) for initial doses may consider using vectorized (AstraZeneca) or mRNA (Pfizer and Moderna) vaccines for subsequent doses.
  • Countries that apply the vectorized vaccines (AstraZeneca) for the initial doses may consider using the mRNA vaccines (Pfizer and Moderna) for the subsequent doses.
  • Countries using the WHO mRNA vaccines (Pfizer and Moderna) for initial doses may consider using the vectoring vaccines (AstraZeneca) for subsequent doses.
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