Russian Roulette: The first new crown vaccine is on the market.

Russia today announced the approval of the world's first new crown vaccine.
, a Moscow-called Gamaleya research institute, used two different viral vectors that express the new coronary S protein to inject in two doses.
Ad26 vector used in the Johnson and Johnson vaccine and the second Ad5 used in the Chinese vaccine.
the vaccine, which is said to have been used by President Vladimir Putin's daughter, is ready to be put on the market gradually and preferred by teachers and health care workers.
the vaccine produced better immunogenicity in a 38-person first-stage clinic, but other common side effects of similar vaccines were found, such as fever, headache, injection point reactions, and so on.
now more than 200 new coronary vaccines have entered the clinic, and several have entered phase III.
if all goes well, there could be a safe and effective vaccine on the market in October, an unprecedented rate that the CEO of veteran vaccine maker Merca East has publicly questioned.
, of course, can be increased if you are willing to take more risks, and that's exactly what Russia is using today.
addition to easing the global pandemic of the new crown, the vaccine competition has added some non-academic elements.
, like the U.S.-Soviet space race that year, represents the efficiency and creativity of a nation's government.
although the Apollo program also had astronauts who died in training, the Soviet Union was more at risk at the time, with at least 126 people killed in the Negerin disaster alone.
these high-risk explorations can have serious consequences if they are based on subjective will and ignore scientific guidance.
risk factor for the new crown vaccine is lower than that of space flight, and the current infection mortality rate is estimated to be between 0.5 and 1 per cent, with little impact on young patients.
with the current preventive measures, the normal phase III clinical needs more than 30,000 volunteers a few months to see the effect.
So there are suspicions online that Russia has collected unrealed data to support the vaccine's efficacy, and an obvious shortcut is to infect volunteers with the new coronavirus, which can significantly shorten the trial time and reduce the number of patients needed.
that while such trials can be used in some viral infections, there are huge ethical problems with the new crown because it does not have a reliable and efficient drug.
, and even if the effects can be confirmed in a small number of patients in a short period of time, rare toxic side effects need to be defined in large sample populations, especially in high-risk groups.
Phase III clinical in the long process of new drug development is the last step, but the most critical step, hundreds of miles and half 90 more accurately explained the difficulty of phase III clinical.
so if you can skip phase iii clinical new drug discovery speed and success rate will be greatly improved, but at the cost of introducing uncertainty.
Although some serious diseases, such as advanced oncology drugs, can be marketed as early clinical alternatives, the mortality rate from infections of less than 1% of new crown infections determines that the disease is much less severe and that vaccine safety requirements are high.
russia was the first to market the vaccine, not because the data were better, but because the assessment of risk returns was different from that of other countries.
FDA system is now the gold standard for international approval of new drugs, but the FDA also after years of stumbling to establish the current risk/benefit evaluation system.
100 years ago, counterfeit drugs were also prevalent in the United States, and the FDA did not require evidence of efficacy until 1962, and differences in efficacy requirements with standard therapies began to become popular this century.
the chain-dropping thing like Exondys51 is an extreme example.
The third phase of the vaccine is still being clinically conducted in several countries, but if approved now, it could affect patient recruitment, making the vaccine safer and more effective, and of course early large-scale use is primarily a risk of toxic side effects.
new coronary infections are asymptomatic, with less than 1% mortality and lower rates for patients under 50.
and many people may already be naturally immune and may not be infected at all, the average risk to society as a whole is not as high as first thought at the beginning of the outbreak.
if a vaccine produces even a very low level of severe side effects in a low-risk population, it won't pay off.
this is not a concern, and almost all new crown vaccines now produce more obvious side effects at effective doses.
A lot of people now don't trust vaccine products that have proven to be more risky than risks, and if this semi-finished product does have a serious side effect, it will further marginalize the vaccine as an important prevention tool.
Russia's decision today is a serious miscalculation of the risks and benefits of the product, essentially a Russian roulette gamble.
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