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The European Medicines Agency (EMA) announced today, Thursday, that it will publish the outcome of its deliberations on Novavax’s vaccine on Monday.
This means the vaccine could be approved before Christmas. Many who are not now vaccinated have been waiting months for Novavax’s inactivated vaccine. The main difference between it and the mRNA vaccines, which some have questioned, is that inactivated spike proteins are injected. In contrast, with mRNA vaccines, the spike protein is first formed by the body’s own cells – according to the blueprint that is injected.
The Novavax vaccine is usually referred to as a dead vaccine. More accurately, it is called a “protein-based vaccine.” Tiny particles of the pathogen are presented to the body. In the case of Novavax, this is done by means of relatively new technology: the virus particles contained in the vaccine are not obtained from the viruses, but in cell cultures.
Clinical pharmacologist Markus Zeitlinger stressed on Thursday’s “Mittagsjournal” on Ö1 that Novavax offers no advantage over mRNA vaccines in protecting against infection or serious illness and death. But he is positive about the very likely approval. “There’s nothing wrong with the vaccine, but in my opinion, there’s not the big upside either. Possibly people who are skeptical of mRNA vaccines will be convinced to get vaccinated with this one. It’s also easier to store and much more stable.”
He expects the vaccine could be available in Austria before the end of the year.
Novavax can be stored at refrigerator temperatures of two to eight degrees Celsius. The vaccine is considered well tolerated.
What is lacking so far is data showing its efficacy against delta and omicron. “With other vaccines, we are already generating data. With Novavax, so far it only exists in vitro (in the test tube, note),” Zeitlinger said. Novavax did well in a study that crossed vaccines.
After basic immunization with Biontech/Pfizer or Moderna, a booster with Novavax boosted the immune response. However, this was no stronger than after a homologous vaccination series, i.e. a booster with Biontech/Pfizer or Moderna.
Florian Krammer, an Austrian vaccine expert at the Icahn School of Medicine at Mount Sinai Hospital in New York, also emphasized on Ö1 that it is not yet possible to assess how well Novavax works against the new variant Omikron. Studies to date show only a very good effect against the wild type and the alpha variant.
The inactivated vaccine will not be approved for children for the time being. For now, the application was for ages 18 and older. However, some are waiting for Novavax’s vaccine specifically for children. Krammer advises them to follow the National Immunization Panel’s (NIG) recommendations that mRNA vaccines can currently be used in children.
“I don’t think it’s a good idea to vaccinate children off-label with Novavax. You need safety data to do that, which doesn’t currently exist. That may change, but right now those data are not available,” Krammer said.
- source: kurier.at/picture: Image by Alexandra_Koch from Pixabay
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