Novavax’s vaccine is about to be approved in the EU. Many people are waiting for the vaccine: what consumers should know about it.
Update from Sunday, December 19, 2021, 9.45 a.m.: Some people are waiting for their corona immunization for vaccines that are based on other technologies such as the vaccines that are currently available. Nuvaxovid, one of these, is about to be approved in the EU. A commission of the drug agency EMA wants to deal with the application of the manufacturer Novavax on Monday.
Further alternatives to the four previously approved vaccines could follow in the coming year. This is also linked to the hope that some people will still be vaccinated – an overview of the Novavax vaccine.
Novavax vaccine: what you need to know about the new vaccine
- How does the Novavax vaccine work? According to the Paul Ehrlich Institute (PEI), Nuvaxovid consists of virus-like particles that contain the spike protein of the coronavirus. The body recognizes the proteins as foreign and the immune system is turned on – specific antibodies and T cells are formed. This means that you are better prepared for a real infection. mRNA preparations, for example, work differently. Here, body cells are stimulated with the help of snippets of genetic material to produce the spike protein themselves in order to trigger an immune response.
- How well does Novavax’s new vaccine work? In a pivotal study by Novavax, its effectiveness in terms of disease was 90 percent. This means that 90 percent fewer diseases occurred among the subjects in the vaccinated group than among the subjects in a control group. Two doses were given three weeks apart. However, the results mainly relate to the alpha variant, which has been almost completely displaced by Delta in Germany. According to experts, the new Omikron variant will soon have a strong influence on the infection process. “This vaccine will also have to be adapted to Omikron,” wrote Carsten Watzl, Secretary General of the German Society for Immunology, recently with a view to the Novavax agent on Twitter.
- Why do some people wait for certain vaccines? Some seem to have greater reliance on vaccines made by classical methods. For example, there is a distrust of the new mRNA technology on which the vaccines from Moderna and Biontech / Pfizer are based. There are concerns that these could cause previously unknown long-term damage. Football national player Joshua Kimmich (FC Bayern), for example, initially explained his vaccination with “a few concerns, especially about the lack of long-term studies”. After emotional debates and a corona infection, he recently announced that he would be vaccinated after all. Experts believe it is almost impossible that the approved vaccines will cause long-term effects that are still unknown.
When it comes to alternatives to the approved vaccines, the term dead vaccine is often used. What’s behind it?
According to the Federal Ministry of Research, inactivated vaccines contain pathogens that have been killed, i.e. no longer able to reproduce. They can also contain only components or individual molecules of these pathogens. Examples are vaccines against hepatitis A and influenza. The body cannot differentiate between the dead vaccine and the pathogen and activates a targeted immune system that protects against a real infection. For some people who have so far refused to be vaccinated, this approach sounds “more natural” than that of mRNA vaccines, for example. - Is the class of dead vaccines clearly defined? No. The term is not used consistently. If the definition is that the real virus or at least parts of it must be included in the vaccine, Novavax, for example, would not be a dead vaccine in the narrower sense. Because the crucial component that is supposed to trigger the immune response was not taken from a real virus, but is a genetically engineered virus protein. On the other hand, one could also say that all vaccines without living – i.e. reproductive – pathogens are dead vaccines. “The name is wrong,” says Watzl. “All Covid-19 vaccines approved so far are dead vaccines.” What many meant by dead vaccine are “vaccines that are based on principles that are also used in other vaccinations”.
- Which vaccines against Covid-19 could come soon? Several products are already being assessed in the EMA’s rolling review process, although not all parts of the approval application have yet been submitted. The vaccines from the manufacturers Sinovac and Valneva (France), for example, contain killed coronaviruses.
- Is it worth waiting for other vaccines? “If someone only wants to be vaccinated with such a vaccine, then that is still better than being completely unvaccinated,” says immunologist Watzl. But he thinks it is unwise to wait – Novavax will not come until next year, Valneva in the second quarter of 2022 at the earliest. “Anyone who waits for these vaccines will be unprotected for a long time. So it’s better to vaccinate now than to wait. ”Even the boss of the manufacturer Valneva doesn’t think much of hesitation. “I do not advise anyone to wait for our vaccine,” said Thomas Lingelbach, managing director of the French biotechnology company, the news magazine Spiegel. “That would be ethically unacceptable.” He is currently recommending vaccines from other manufacturers to relatives and friends and recently had himself boosted with the mRNA product from Biontech.
- Are there also live vaccines? Yes, for example against mumps, measles and rubella. They contain real pathogens that can still multiply, but whose disease-causing properties have been bred.
Novavax: EMA decides on vaccine approval
Update from Thursday, December 16, 2021, 3:15 p.m.: The European Medicines Agency (EMA) has announced that it will decide in the coming week on the approval of the corona vaccine from the US pharmaceutical company Novavax. The responsible drug committee will hold an extraordinary meeting on December 20, the EMA said on Thursday. It should be about the vaccine developed by Novavax under the name Nuvaxovid.
The US group had applied for marketing authorization for Nuvaxovid for the EU in mid-November. Novavax uses the so-called spike protein from Sars-CoV-2 for its vaccine and reproduces it en masse in insect cells. After vaccination, the human immune system uses it to generate antibodies against the protein and can thus fight off Covid 19 disease. Because the vaccine – unlike the Biontech Pfizer vaccine, for example – can be stored at refrigerator temperature, the product is also considered a beacon of hope for poorer countries.
Novavax vaccine – when will it be approved in the EU?
First report from Sunday, December 5th, 2021, 1 p.m .: Gaithersburg – Many are longingly waiting for the Covid vaccine from Novavax – because this differs from the previous vaccines and promises a high level of effectiveness. As early as 2020, Novavax managing director Stanley Erck announced that deliveries of up to two billion vaccine doses could be expected in 2021. So far, however, the approval is pending. Will that change anytime soon?
In contrast to the mRNA vaccines from Biontech and Moderna, which are currently considered the most popular, immunization with the vaccine from the Novavax company is carried out using protein particles. This means that the vaccine contains laboratory-produced particles of the Sars-CoV-2 protein, which trigger the production of antibodies in the body.
In contrast to mRNA vaccines, which contain parts of the genetic information of the virus, vaccination with protein-based vaccines has been tried and tested for a long time – an argument with which vaccination skeptics can still be convinced of a vaccination against corona. In addition, experts rate such a vaccine as particularly effective.
Novavax Corona Vaccine: CEO Announces Emergency Authorization Application
After the CEO of Novavax in the USA had already spread hope for an early approval in 2020, he again emphasized to CNN in November 2021 that he was planning to submit an application for emergency approval of the vaccine to the American drug regulatory authority FDA this year.
So far, Novavax’s corona vaccine is only approved in Indonesia and the Philippines. Several approval processes are currently underway, for example in Europe, Great Britain, Canada and Australia. In October there were media reports in the US that Novavax was having production problems. But Novavax boss Erck is confident that the problems have been overcome. In a Novavax announcement in response to US media reports in October, it said, “Our global supply chain is expected to reach 150 million cans per month by the end of the fourth quarter.”
Novavax: Corona vaccine – means is already being adapted against the Omikron variant
The US government has already funded the vaccine company with 1.6 billion dollars, and for some time Novavax has had a partnership with the Serum Institute of India, the world’s largest manufacturer of vaccines. Silvia Taylor, Vice President Of Global Corporate Affairs And Investor Relations at Novavax, is convinced that the company will be able to produce more than two billion vaccine doses by 2022. In addition, the company promised that the vaccine is currently being adapted to the new Omikron variant.
With the new Omikron variant, the global corona situation is getting worse. The current developments on the mutation in the ticker. (tt with dpa / AFP)
Transparency notice: We have revised the article in some places.
