The debate about AstraZeneca, mutations and vaccine efficacy is causing concern: do we have to start from square one in vaccine development? Fortunately not.
We should remember that never before in history have there been such efforts to find a viable drug for an emergent disease so quickly, said Hans-Georg Eichler, Executive Director of the EMA in an interview with Ö1. And most importantly, "It was successful, it was fast."
Even though it may not feel like it, we have come a long way. This pandemic will go down in history without question.
But we will certainly also look back on a time when a huge medical advancement was achieved in a very short time — with mRNA, a whole new vaccine concept is being developed.
It should be noted that "We now know much, much more about this virus, how it develops, what makes it tick, and we can now produce an adequate vaccine much more quickly than we could six to nine months ago," said Eichler.
In other words, we are far from starting from square one.
Never before in history have there been such efforts to find a viable drug for an emergent disease so quickly.
BioNtech founders Özlem Türeci and Uğur Şahin were also optimistic in an interview with Der Spiegel, saying that if the virus mutates too much, it is possible to adapt the vaccine in purely technological terms. "We could simply replace the genetic information for the current viral antigen with the new mutated one. This is all very fast and would take maybe six weeks."
But so far, that has not been necessary. A peer reviewed study recently published in the journal nature medicine confirms that the Biontech/Pfizer vaccine is effective against British and South African variants of the coronavirus.
South Africa, however, is suspending the use of the vaccine from the British-Swedish company AstraZeneca, while scientists are still deliberating on the best use of the drug. The pharmaceutical company had previously conceded that the vaccine offers only limited protection against mild infections caused by variant B.1.351. Nevertheless, the vaccine is still thought to prevent more severe cases.
That said, the reduced effectiveness of vaccines are reason enough to adapt vaccines that are capable of protecting against new emerging variants — or even a combination of different mutations — in a timely manner.
Two altered forms of the British coronavirus variant B.1.1.7 have been discovered in the United Kingdom. A government team of experts has now classified one of them as a "variant of concern."
The continuous change of the virus makes clinical data and constant monitoring imperative.
That's why Oxford University is already working on a new generation of booster vaccines. "This is the same problem that all vaccine developers face," said Sarah Gilbert, a lead researcher in the development of the AstraZeneca vaccine. GSK and CureVac also said in a press releasethat they are already working on a next-generation mRNA vaccine.
The WHO had 240 vaccine projects listed as of February 2, 2021.
Infectologist and vaccine researcher, Marylyn Addo of Hamburg's Eppendorf University Hospital, also stressed to Der Spiegel that we have "good tools to counter potentially problematic changes in the virus." SARS-CoV-2 actually changes relatively slowly compared to other viruses, she said.
The fact that the modification of vaccinations truly works becomes clear when we look at the example of seasonal influenza: the flu virus is itself highly adaptive, which is why the vaccine is modified every year and, accordingly, annual vaccination is also necessary. And annual flu vaccinations have long been commonplace.
If SARS-CoV-2 behaves similarly, periodic adaptation of vaccines to ever-emerging viral variants would be the result.
Marylyn Addo says, "We currently have a chance to keep up with the virus. But to do that, it's also important to slow down the rate of infection."
But keeping pace with the coronavirus involves not only vaccine development, but also the very approval of the vaccine in question. Özlem Türeci and Uğur Şahin also note this. This is where it comes down to the regulatory authorities, they said. "Do they accept that we have proven the effectiveness and safety of our vaccine in general and that we can then use it against further virus mutations?" asked Türeci. If not, another study with tens of thousands of subjects would have to be done. However, discussions are said to be underway.
Moreover, the regulatory authorities have plenty of experience with such adaptations — as demonstrated by the seasonal flu vaccine, which is produced every year to combat new strains.
It is possible to keep up with new coronavirus strains, but the rate of infection must first be slowed.
Nevertheless, Karl Lauterbach, the health expert of Germany's Social Democratic Party in the Bundestag and himself an epidemiologist, also warned of the dynamics of mutations: "The issue will be a priority for us in the future. At the beginning of March, the British mutation will have increased to around 30% of our cases. The problem is: the British strain also partly carries the evasive variant from South Africa, and that is the most dangerous — a combination mutation, so to speak," he said in an interview with the Münchener Merkur newspaper. On Twitter, Lauterbach insists on creating infrastructure to speed up the detection of new strains of the virus, the development of new vaccines, vaccine production and vaccination.
The European Medicines Agency's (EMA) Hans-Georg Eichler is well aware of the urgency of the situation. "We at the EMA are considering with international regulatory authorities how we can get such new vaccines approved as quickly as possible. The details are not yet known, but we will certainly not go back to square one, which is where we were eight, nine months ago."