"Nuvaxovid" is the name of the new corona vaccine from Novavax. As an alternative to the previous corona vaccinations, the Novavax vaccine could be of particular interest to previously unvaccinated people who have reservations about the mRNA and vector vaccines, even if, according to the Robert Koch Institute, they are effective and the safest way to build up protection are before Covid-19.
How effective is the new corona vaccine?
In two studies with a total of over 45,000 test persons, he is said to have reduced the number of symptomatic Covid 19 cases by around 90 percent after two doses of the vaccine. However, the alpha and beta variants of the coronavirus in particular circulated during the course of the study.
According to Novavax, the vaccine should also work against other variants. Especially with a booster vaccination, six months after the second dose, the immune response to the delta and omicron variants is comparable to the results of the two earlier studies. The Paul Ehrlich Institute notes that there is currently limited data on efficacy against Omicron and other variants of concern.
When will it be available?
According to the Federal Ministry of Health, a first partial delivery of 1.4 million Nuvaxovid vaccine doses is expected in the week of February 21, 2022. In total, Germany is said to have ordered up to 34 million vaccine doses from Novavax for 2022.
For comparison: According to the German Bundestag, around 287.3 million vaccine doses were ordered by December 2021 from BioNTech/Pfizer, around 120.3 million from Moderna, around 56.3 million from AstraZeneca and around 55 million doses from Johnson&Johnson.
The Standing Committee on Vaccination (STIKO) currently recommends the Novavax vaccine for people aged 18 and over. For a basic immunization, two vaccinations should be given at least three weeks apart. Pregnant and breastfeeding women are excluded from the recommendation.
Who should be prioritized when awarding?
According to a decision by the Conference of Health Ministers on January 20, 2022, the vaccine should be given as a priority to employees who have not yet been vaccinated, for whom the facility-related vaccination obligation will apply from mid-March. The challenge – as at the beginning of the vaccination campaign in December 2020 – is that initially only very limited quantities of the Novavax vaccine will be available, says NRW Health Minister Karl-Josef Laumann (CDU).
Does the vaccine also work in children and adolescents?
According to a statement from Novavax, the effect of the vaccine was comparable to that in adults in a study with adolescents aged 12 to 17 years. The vaccine was 82 percent effective against the Delta variant. The immune reaction in adolescents against all variants examined was about two to three times higher than in adults. In addition, the vaccine was well tolerated.
With further data, Novavax plans to apply for global approval of the corona vaccine for 12 to 17 year olds by the end of March.
How does it compare to mRNA and vector vaccines?
The vaccine with the trade name "Nuvaxovid" is a recombinant protein vaccine. "Recombinant" means that the contained proteins were produced in genetically modified cell cultures. In this case it is the spike protein from SARS-CoV-2, which the virus uses to get into the cells.
As with the previously available corona vaccinations, the body's immune response should also react to the spike protein with the Novavax vaccine. Unlike mRNA and vector vaccines, however, the protein vaccine does not contain a blueprint for the body to produce the spike protein itself, but the finished protein in the form of nanoparticles.
For a strong and long-lasting immune response, the Novavax vaccine needs an potentiator, also called an adjuvant. In the Novavax vaccination, the potentiator is based on saponins, which are obtained together with lipids from the Chilean soap bark tree. Saponins are bitter substances that cause foam to form on beer or when using shampoos, for example.
Is "Nuvaxovid" an inactivated vaccine?
Although the Novavax protein vaccine is an inactivated vaccine, this designation is very imprecise. In general, this means that a vaccine does not contain any pathogens capable of replication, but rather dead pathogens or only parts of them. Depending on the definition, synthesized vaccines such as mRNA and vector vaccines that do not contain any living pathogens are also included. In addition to the protein vaccine from Novavax, the Robert Koch Institute describes all previously available corona vaccines as dead vaccines.
How well does the Novavax vaccine protect against omicron?
In Germany, Omicron has almost completely replaced other virus variants, such as the Delta variant. The Robert Koch Institute describes the omicron variant as the clearly dominant virus variant since the beginning of 2022.
According to Novavax, as with the other virus variants tested, a strong immune reaction against the omicron variant was also shown. After two doses of vaccine, however, the reaction is still comparatively small. After a third vaccination six months apart, protection against omicron increased significantly. According to Novavax, an omicron-specific vaccine is already in development. The clinical studies are scheduled to start by the end of March 2022.
What is known about side effects so far?
In two clinical investigations, adverse events following vaccination with the Novavax vaccine were predominantly mild to moderate and transient, generally more frequently after the second dose. Local tenderness and pain at the injection site were commonly reported. Headaches and muscle pain, a general feeling of illness and tiredness also occurred more frequently.
Safety concerns regarding severe adverse effects were not identified in the approval studies according to STIKO. The data on "Nuvaxovid" is still limited, as STIKO notes.