Russia became the first country to officially register a coronavirus vaccine and declared it ready for human use. Putin claims one of his daughters has already been inoculated. Putin claims all the testing was done but has no scientific evidence; no Phase 3 trial to prove the vaccine works and has no human consequences.
The Dow Jones soared upwards by 350 points after President Vladimir Putin said that his country had developed the world’s first coronavirus vaccine. Putin emphasized that the vaccine underwent the necessary tests and has proven efficient, offering a lasting immunity from the coronavirus despite the fact it was never tested in a Phase 3 trial.
The world’s medical scientists and physicians, including those in Russia, have warned that the rush to start using the vaccine before Phase 3 trials, which generally last for months and involve thousands of people, could backfire.
Still, Putin is telling the world the vaccine has undergone proper testing and is safe…
“I would like to repeat that it has passed all the necessary tests,” he said. “The most important thing is to ensure the full safety of using the vaccine and its efficiency.”
The Russian leader added that one of his two adult daughters had received two shots of the vaccine…
“She has taken part in the experiment.”
The daughter he is referring to has contracted the coronavirus and had a temperature of 38 degrees Celsius (100.4 Fahrenheit) on the day of the first vaccine injection. Then it dropped to just over 37 degrees (98.6 Fahrenheit) on the following day. After the second shot, she again had a slight increase in temperature, but then it was all over.
“She’s feeling well and has a high number of antibodies,” Putin added. He didn’t specify which of his two daughters — Maria or Katerina — received the vaccine.
If you’re thinking, how does a vaccine work for someone who already has a potentially deadly disease? You’re asking a good question.
Her apparent recovery may have nothing to do with the vaccine and should not be considered as anything but antidotal without a phase 3 trial. Yet, Russian authorities are rushing inoculate medical workers, teachers, and other risk groups first.
Deputy Prime Minister Tatyana Golikova said that the vaccination of doctors could start as early as this month. This assurance came as Russia’s Health Ministry said in Tuesday’s statement that the vaccine is expected to provide immunity from the coronavirus for up to two years.
One of the nonsensical issues with the vaccine is Putin’s emphasizing that this vaccination will be voluntary. For the vaccine to work if proven effective is making sure that at least 70% of the Russian population is inoculated. Otherwise, any vaccine that’s not taken by that percentage of the population is likely to become over time not effective.
Russian officials are claiming large scale production of the vaccine will start in September, and mass vaccination may begin as early as October. If the vaccine is real, Putin will have to require every Russian and resident of the country to take the vaccine.
When the pandemic struck Russia, Putin ordered state officials to shorten the time of clinical trials for potential coronavirus vaccines. However, there just hasn’t been enough time for a phase 3 trial.
Putin may be caught up in wishful thinking, but there is a political angle to Russia to claim an effective vaccine before its proven effective in a phase 3 study. Being able to claim to be the first country in the world to develop a vaccine was a matter of national prestige as Putin continues to assert the image of Russia as a global power. Russian state television stations and other media sources in Russia have praised scientists working on it and presented the work the envy of other nations.
According to Russian Professor Alexander Gintsburg, head of the Gamaleya Institute, the vaccine developed, raised eyebrows in May when he said that he and other researchers tried the vaccine on themselves.
Human studies started June 17 among 76 volunteers. Half were injected with a vaccine in liquid form, and the other half with a vaccine that came as soluble powder. Half of the first group were recruited from the military, which raised concerns that service members may have been pressured to participate.
While Wall Street is exuberant over the Russian claim of developing a coronavirus vaccine, experts around the world are scoffing at Russian authorities’ assurances that the vaccine drug produced the desired immune response and caused no significant side effects. Pointing out that such claims need to be backed by published scientific data. A comprehensive Phase 3 trial is required protocol by the World Health Organization (WHO) on all vaccine candidates before being rolled out.
UNDERSTANDING PHASE 3 PROTOCOL OF THE FDA:
- Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.
- The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.
- To do this, investigators use a process called randomization. This involves randomly choosing some participants to receive the new medication and others to receive an existing medication.
- Phase III trials are usually double-blind, which means that neither the participant nor the investigator knows which medication the participant is taking. This helps to eliminate bias when interpreting results.
- The FDA usually requires a phase III clinical trial before approving a new medication. Due to the larger number of participants and longer duration or phase III, rare and long-term side effects are more likely to show up during this phase.
- If investigators demonstrate that the medication is at least as safe and effective as others already on the market, the FDA will usually approve the medication.
Every expert on record outside Russia has warned that vaccines that are not adequately tested can cause harm in many ways:
· From a negative impact on health to creating a false sense of security
· Undermining trust in vaccinations
· Could cause the virus to mutate into something even more dangerous