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Today, BioNTech / Pfizer announced the results of an interim analysis of its new BNT162b2 coronavirus infection mRNA vaccine, phase III clinical trial. This three-phase clinical recruitment of 43,538 volunteers, using two injections of the vaccine and the placebo, was originally planned for the first interim analysis when a total of 32 people in the two groups were infected, but was later expanded to 62. The final analysis must wait. 164 people were infected. Today’s analysis is based on data from 94 infected patients 7 days after the second injection (28 days after the first injection). The results show that BNT162b2 has a protective capacity of more than 90% and no serious side effects were found. Pfizer and BioNTech are preparing to submit an Emergency Marketing Application (EUA) for this vaccine. Affected by this news, BNTX and Pfizer rose 13% and almost 8%, respectively, and the Dow Jones index rose almost 3%.
Drug source analysis
Today’s result exceeds the expectations of most experts. Although no detailed data has been announced and efficacy may be overstated at this time, hardly anyone doubts that this product will have some efficacy. Even after accumulating more data, efficiency can fluctuate, but is unlikely to fluctuate significantly. Due to the severity of this virus, it is estimated that the vaccine has a protective capacity of 50-60% and can be marketed if the safety is not too great, because a vaccine with general efficacy and some common preventive measures can effectively control the chain of infection. The end point of this trial is the number of people who are positive for the new coronavirus with symptoms, so the prevention of asymptomatic infection and the reduction of the risk of severe disease are unknown. An important indicator is the durability of protection, and this test cannot be answered. Furthermore, the efficacy of this vaccine has not been announced for different populations and the safety of the entire trial at the end of the trial has not yet been observed.
But unless unexpected toxicity is discovered in the future, these problems are unlikely to alter the overall situation today. Even if this vaccine is ineffective for some people and cannot reduce the risk of asymptomatic infections and serious illness, the ability to reduce symptomatic infections by 90% has made the primary goal of herd immunity very easy and safe. Even if the durability is limited and the need to fight twice a year like the flu, it won’t be too burdensome. The main task of this vaccine is to restore normal social life, not to reduce the risk of new crowns to zero. According to information announced today, BNT162b2 has this potential. Of course, this product must be stored at a low temperature, because the high demand for production capacity can become a speed-limiting step. There are also a large number of anti-vaccine groups in some countries that may refuse to use it, which will delay the establishment of herd immunity. But this is definitely the most critical battle against the new crown.
The sequence of the new corona virus was announced in January this year. Just 10 months later, a safe and effective vaccine was developed to showcase the power of current biotechnology. Of course, the speed, intensity and breadth of the new vaccine drug and new drug development in this counterattack against the new corona are unprecedented. This product is the first time that mRNA technology has produced positive data in phase III clinical trials. An entirely new technology has become famous in an emergency, which in itself is no great miracle. This vaccine is relatively simple and relies mainly on protein S antibodies because the mRNA vaccine only expresses this protein, but it is somewhat unexpected to produce such a curative effect, especially considering that the curative effect of high-dose antibody drugs in patients with early infection is not outstanding. The success of mRNA vaccines makes other vaccines more promising, because other types of vaccines also produce protein S antibodies but can also induce more complex immune responses, such as T cell-mediated immunity. Previous concerns about mediated toxicity by antibodies and the insufficient protection of the antibodies alone have disappeared with the opening of the Schrödinger cat box.
If BNT162b2 can really put an end to the new corona epidemic, it will become a legend in the history of pharmaceuticals, just like the American amateur ice hockey team defeated the Soviet professional team in the 80th Olympics. A new technology with a blank résumé, a German Lone Ranger who has the courage to explore (BNTX was Europe’s largest privately held biotech company for a long time), and a powerful pharmaceutical giant that has always lacked speed, when the the world needs it the most. He completed an impossible task with the greatest efficiency. The next time politicians crusade against the pharmaceutical industry, they must first think about ending the disaster of the century as the new crown, and ultimately the pharmaceutical industry will depend on it. I hope that the final analysis has no accidental side effects and that people’s lives return to normal. (Bioon.com)
