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In August, Russia became the first country in the world to approve a Covid-19 vaccine. However, as clinical trials were not completed at the same time that the country did not release data from the studies, Western experts cautioned against using the vaccine. The rapid development raised questions about whether Russia valued prestige before science and safety in the fight against COVID-19.
The first evaluation of the vaccine was published on Friday in The Lancet. According to two studies, the 76 participants in phase 1 and 2 of the clinical trials developed antibodies within three weeks. During the 42 days of the studies, the participants did not experience serious side effects, according to the researchers.
Vaccinforskaren Matti Sällberg notes that the vaccine works in a similar way to, among others, Astra Zenecas, both based on adenoviruses, which cause colds in humans. The virus is genetically modified to protect against covid-19.
– Now we know that there are no strange things with this vaccine. That was exactly what we asked for. We wanted data and now we have it.
The immune response generated by the vaccine is similar to the results of other vaccine studies, he says. The side effects of vaccines are mild and classic: fever and headache.
Whether the country has already agreed to approve the vaccine is another matter, says Matti Sällberg. Much remains to be done before Sputnik-V can be said to actually work. The researchers behind the report also believe that studies are needed that span a longer period of time and involve more participants, both in different age groups and with underlying diseases.
According to Matti Sällberg it’s in part about vaccinating more people to detect even unusual side effects.
– With 76 people, you can find side effects that appear worldwide, or at least ten percent. But if you want to find the most unusual, you should vaccinate between 1,000 and 10,000.
– But the most important thing of all is to vaccinate in groups that are at risk of contagion and do controlled phase 3 studies where half receive the vaccine and half do not. Then you can find out if the vaccine really protects against infection. Before that, you have no idea, says Matti Sällberg.
It rejects the approval of the Russian vaccine since August.
– It wasn’t a real approval. Russia will continue to conduct major phase 3 studies before vaccinating the general public. It was more of a political movement.
Last week, the country began phase 3 of the clinical trials, which include more than 40,000 participants, according to Reuters.
In early September, Astra Zeneca announced that the company’s vaccine is entering the third and final phase of clinical trials.
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