First doses of protein-based Nuvaxovid are expected to be used in new year after European Medicines Agency gives go-ahead
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| People receive a Covid jab at a church in Bad Wilsnack, in the state of Brandenburg, Germany |
The approval of a new protein-based Covid-19 vaccine by the European Medicines Agency (EMA) has led to hopes that it could play an important role in persuading millions of Germans who have refused jabs from existing vaccines to get protection against the disease this winter.
The EMA approved the two-dose Novavax vaccine on Monday afternoon. The German government’s vaccination advisory board is expected to follow suit and allow for its use soon, a move that would be welcomed by health experts who are bracing for a huge and imminent wave of infections caused by the new Omicron variant. The first doses of Novavax are expected to be administered in Germany in the new year.
The rollout of the vaccine – called Nuvaxovid – by the US-based drugmaker Novavax has been repeatedly hampered by a series of lengthy delays including production issues.
It is making its appearance in the battle against the virus about a year after the novel mRNA vaccines produced by Pfizer/BioNTech and Moderna, and the viral vector vaccines made by Oxford/AstraZeneca and Johnson & Johnson.
While those four simulate a virus in the body, Nuvaxovid uses a more traditional type of technology. It has been found to have an efficacy of over 90% in preventing symptomatic infection with the Alpha variant, and is currently undergoing further tests to check its ability to protect against the Omicron variant.
Reluctance in Germany and other German-speaking countries to take the novel mRNA vaccines is put down to mistrust in the new technology, with people mainly citing safety concerns about side effects or long-term health impacts, largely because of the apparent speed with which they were introduced.
In fact, the number of side effects suffered has been very low despite the billions who have already taken the vaccine worldwide, as the head of the Robert Koch Institute, the German government’s disease control agency, has repeatedly said.
The new Covid jabs made by Novavax and the French-Austrian manufacturer Valneva, whose VLA2001 is also based on the more conventional method, are typically characterised as a Totimpfstoff, or “dead vaccine”, even though experts say the term is not scientifically accurate.
In November, Karl Lauterbach, the then health spokesperson for the Social Democratic Party, who has since become the health minister, said that because of the popular use of the term “dead vaccine” among vaccine-hesitant Germans, the term would also generally be applied by health experts.
The Nuvaxovid vaccine is more accurately described as a protein vaccine, which in contrast to classical vaccines is genetically produced and contains minuscule particles from a version of the virus’s spike protein grown in moth cells in the laboratory that prompt the formation of antibodies in an individual. Valneva, which is still waiting for approval, is made up of Covid-19 virus that has been deactivated and cannot reproduce.
Both vaccines require the addition of a so-called proprietary adjuvant to boost the recipient’s immune response to them.
The EU has secured 100m doses of Novavax and 60m doses of Valneva, with 4m Novavax doses immediately destined for Germany.
Across Europe, but in particular in Germany, experts are hoping that both vaccines will have the effect of persuading those who have so far turned down the offer of a vaccine to change their minds, at a time when raising immunity levels by vaccination is one of the key weapons against halting the virus’s spread. So far, just over 70% of Germans are fully vaccinated. Unless this figure climbs to between 80 to 90%, the nation’s immunity will not be high enough to dampen the virus.
In a survey by the German pollster Forsa this autumn, 56% of participants said their vaccine willingness would rise if vaccines based on so-called “classical methods”, such as Novavax and Valneva, were approved. Only 5% said they would be lured to have a vaccination by monetary reward or the threat of being excluded from activities as a result of their unvaccinated status.
About 14 million German adults are yet to have the first two doses of a Covid vaccine. However, in a survey of unvaccinated people, 40% said they were merely hesitant and could indeed be persuaded if “dead vaccines” were available to them.
Nevertheless, experts have warned against expecting a significant rise in those willing to receive Novavax or Valneva jabs.
Dr Thomas Aßmann, a GP and vaccinator in Lindlar, about 30km (19 miles) east of Cologne, said: “I am a bit sceptical. If we take into account that the new mRNA vaccines they are fearful of have now been successfully administered around 7 to 8 billion times, I am concerned that those who say they’re holding out for the ‘classic’ vaccines will now look at the figures and say Novavax can’t be trusted yet,” he told the broadcaster NTV. “We must just hope that the new vaccine is good and stable and have a long efficacy, particularly against Omicron.”
Even Lauterbach, whose first two weeks in office have been dominated by his attempts to accelerate a vaccine drive, particularly booster shots, ahead of the expected emergence of Omicron as the main variant in Germany from around the end of the year, is sceptical.
“We should desist from assuming that Novavax will be a gamechanger,” he told the Bild newspaper in an hour-long interview broadcast live on Sunday night. He said based on studies and the fact that the mRNA vaccines had been administered between 7bn and 8bn times worldwide, they were “a whole lot safer”.
Confronted in the interview by a woman whose gynaecologist had urged her she should not get vaccinated because of a risk of thrombosis, Lauterbach shot back: “I would advise her to get a second opinion.”
Lauterbach has said he backs a proposal that is expected to be put before the Bundestag in January to bring in a nationwide vaccine mandate. He acknowledged the importance of enabling those who wanted a traditional vaccine to be able to access it ahead of the introduction of any such measure.
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