Russian Vaccines are not Necessarily Safe?

Recently, Russian President Putin revealed in a meeting with government members that Russia has registered the world's first new coronavirus pneumonia vaccine. 

The controversy has been raging and raging.

The relevant Russian staff are very 'confident' and said that it is estimated that the vaccine will be mass-produced from the end of August to September, and Russia is expected to start mass vaccination work in October this year.

Less than a day after the news came out, it immediately caused an uproar in the scientific community. Scientists from many countries have already stood up to question this.

'Science' and 'Nature' websites respectively published articles pointing out the problems with the vaccine. The core theme of the two review articles is : Russia's vaccine has not yet completed large-scale trials to test its safety and effectiveness. At this time, launching the vaccine to the public will put all people who inject the vaccine at risk.

What On Earth is this Kind of Happenings?

Here we must first clarify what processes a 'regular' vaccine needs to go through before it is officially released for vaccination on a large scale.

Under normal circumstances, vaccines generally go through virus isolation, laboratory vaccine construction, cell testing, animal testing, phase III clinical research, then large-scale production, and finally approved by the drug regulatory authority before they can be marketed.

However, the second phase of the Sputnik-V trial started on June 17 and there were only 76 people. The Gamallea Institute, the vaccine research and development unit, even directly admitted that the experiment has not been evaluated yet and will release the data when it is done. This 'premature birth' vaccine has just completed the second phase of clinical trials and has 'rushed away', and researchers have not yet released any experimental data.

Francois Balloux, a geneticist at University College London, issued a statement in the Science Media Centre in the United Kingdom, stating that the release of the vaccine in this way is a 'very arbitrary and reckless decision, and it is unethical to vaccinate a vaccine that has not been tested on a large scale'. Not only may it have a negative impact on health, it will also weaken the confidence of others in the vaccine.

Peter Hotez, a vaccine scientist at Baylor College of Medicine in Houston, USA, also supports this idea, because once Russia's vaccine goes wrong, the entire global vaccine research and development unit will be hit, which will prevent the development of high-quality new coronary pneumonia vaccines in disguise.

The 'Sputnik-V' vaccine consists of two different versions of adenovirus vaccines, requiring two injections in total. The adenovirus vector of the first dose of vaccine is AD26, and a vaccine developed by Johnson & Johnson Pharmaceuticals currently uses this virus vector. The second dose is similar to the 'enhancer' effect, the adenovirus vector is AD5, and the two viral vectors can express the spike protein of the new coronavirus.

Some scientists expressed concern about the AD5 adenovirus used in the vaccine, because as early as 2007, a team that developed an HIV vaccine also used the AD5 adenovirus vector to express the surface protein of HIV. In the verification experiment, they found this vaccine can even increase the risk of HIV infection.

Although Putin emphasized that her daughter's body temperature rose briefly after vaccination, she still felt good and had high levels of antibodies in her body. 'After the first injection, her body temperature was 38 degrees Celsius, the next day it was 37.5 degrees Celsius, nothing more. After the second injection, her temperature rose slightly and then returned to normal.' But this is just one of those 'data point'.

The World Health Organization (WHO) stated that it welcomes all progress in the development of a vaccine against COVID-19 coronavirus infection. However, vaccine research should be carried out in accordance with established procedures at each stage of development to ensure the safety and effectiveness of the drugs produced.

The World Health Organization said that it hopes to review data related to the safety of Russia's new coronavirus vaccine.

Can the Russian vaccine be only 'semi-finished product'?