Sputnik-1 began the Space Race in 1957, taking the world by surprise at the amazing feat of Soviet science. This was followed soon by Yuri Gagarin, as the first man to travel in Space and Valentina Tereshkova as the first woman in Space. Jolted by the successes scored by their Cold War rival, the United States poured resources into the race and scored its own spectacular first by landing Neil Armstrong and Buzz Aldrin on the moon in 1969. The decline and breakup of the Soviet Union later made the world oblivious to the enduring strengths of the Russian scientific establishment.
That was till a few days ago, when Russian health minister Mikhail Murashko announced that Russia had produced a vaccine that was given regulatory approval after less than two months of human trials. The vaccine was produced by the Gamaleya Institute, linked to the Russian defence ministry and financed by the Russian Direct Investment Fund. The vaccine was being administered to volunteers in Russia, the United Arab Emirates, Saudi Arabia, Brazil and Mexico. The prospect of obtaining and administering that vaccine has been reportedly welcomed in the Philippines and several other countries that are eager to try it out. This announcement staggered the global scientific community.
However, it has also been met by scepticism and downright denunciation by several scientists in the Western world. Some scientists in Russia, too, have expressed concerns, and the World Health Organisation has urged caution. The doubts about Russias claim arose because the WHO said they had only been notified of a Phase 1 trial, while the completion of a Phase 3 trial was considered essential for evaluating evidence of efficacy and safety. Classically, the Phase 1 trial is performed on a few human volunteers to see the initial response. Phase 2 sees more volunteers and more tests, with the determination of the dosage required to elicit a good immunological response. Phase 3 involves a large randomised controlled trial with several thousand healthy volunteers given the vaccine and other matched individuals given a placebo. The vaccine is ready for release only when it successfully clears Phase 3. As use in the general public increases, post-marketing surveillance is also conducted (Phase 4), to assess the failure rates and adverse effects which may not have been detected or were difficult to estimate in the Phase3 trial.
Why are such elaborate procedures needed to study potential vaccines before their release? Three critical elements which need to be determined, for a new vaccine to be judged as fit for general use, are efficacy, safety and duration of protection. Efficacy in protecting against the pathogenic microbe and a fairly long duration of protection are expectations that the vaccine must fulfil. Safety is a prime consideration, especially because the vaccine is being administered to healthy persons. Do no harm is the first principle.
Why will a vaccine be ineffective? First, the antigen may be inappropriate or too weak as a stimulus to produce a strong immune response. Second, antibodies may be produced, but they may not be neutralising antibodies which get rid of the virus. Third, a phenomenon called the Original Antigenic Sin may come into play. In this, the antigen which is employed in the vaccine may stimulate a strong immune response to itself. However, being a modified antigen or only a part of the virus, it may not create the imagery of the actual virus for the immune system to store and react to. The body will only recognise the vaccine antigen as the stimulus to react to, but not the virus itself! Like failing to recognise the real criminal because of a badly-done police sketch.
https://www.financialexpress.com/opinion/covid-vaccine-race-unfazed-claims-on-un-phased-trials/2054519/
About SocialNewsXYZ
An Indo-American News website. It covers Gossips, Politics, Movies, Technolgy, and Sports News and Photo Galleries and Live Coverage of Events via Youtube. The website is established in 2015 and is owned by AGK FIRE INC.
Sputnik-1 began the Space Race in 1957, taking the world by surprise at the amazing feat of Soviet science. This was followed soon by Yuri Gagarin, as the first man to travel in Space and Valentina Tereshkova as the first woman in Space. Jolted by the successes scored by their Cold War rival, the United States poured resources into the race and scored its own spectacular first by landing Neil Armstrong and Buzz Aldrin on the moon in 1969. The decline and breakup of the Soviet Union later made the world oblivious to the enduring strengths of the Russian scientific establishment. That was till a few days ago, when Russian health minister Mikhail Murashko announced that Russia had produced a vaccine that was given regulatory approval after less than two months of human trials. The vaccine was produced by the Gamaleya Institute, linked to the Russian defence ministry and financed by the Russian Direct Investment Fund. The vaccine was being administered to volunteers in Russia, the United Arab Emirates, Saudi Arabia, Brazil and Mexico. The prospect of obtaining and administering that vaccine has been reportedly welcomed in the Philippines and several other countries that are eager to try it out. This announcement staggered the global scientific community. However, it has also been met by scepticism and downright denunciation by several scientists in the Western world. Some scientists in Russia, too, have expressed concerns, and the World Health Organisation has urged caution. The doubts about Russias claim arose because the WHO said they had only been notified of a Phase 1 trial, while the completion of a Phase 3 trial was considered essential for evaluating evidence of efficacy and safety. Classically, the Phase 1 trial is performed on a few human volunteers to see the initial response. Phase 2 sees more volunteers and more tests, with the determination of the dosage required to elicit a good immunological response. Phase 3 involves a large randomised controlled trial with several thousand healthy volunteers given the vaccine and other matched individuals given a placebo. The vaccine is ready for release only when it successfully clears Phase 3. As use in the general public increases, post-marketing surveillance is also conducted (Phase 4), to assess the failure rates and adverse effects which may not have been detected or were difficult to estimate in the Phase3 trial. Why are such elaborate procedures needed to study potential vaccines before their release? Three critical elements which need to be determined, for a new vaccine to be judged as fit for general use, are efficacy, safety and duration of protection. Efficacy in protecting against the pathogenic microbe and a fairly long duration of protection are expectations that the vaccine must fulfil. Safety is a prime consideration, especially because the vaccine is being administered to healthy persons. Do no harm is the first principle. Why will a vaccine be ineffective? First, the antigen may be inappropriate or too weak as a stimulus to produce a strong immune response. Second, antibodies may be produced, but they may not be neutralising antibodies which get rid of the virus. Third, a phenomenon called the Original Antigenic Sin may come into play. In this, the antigen which is employed in the vaccine may stimulate a strong immune response to itself. However, being a modified antigen or only a part of the virus, it may not create the imagery of the actual virus for the immune system to store and react to. The body will only recognise the vaccine antigen as the stimulus to react to, but not the virus itself! Like failing to recognise the real criminal because of a badly-done police sketch. https://www.financialexpress.com/opinion/covid-vaccine-race-unfazed-claims-on-un-phased-trials/2054519/