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Russian Vaccine not passed phase 3 efficacy trials


Koon Yew Yin 12 Aug 2020 

The Covid 19 pandemic has been affecting everyone and all the listed companies with the exception of glove and other medical products to prevent the virus. As soon as I realised this situation a few months ago, I sold all my other holdings to buy glove stocks. 

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Most of the commentators on the i3investor Top Glove, Supermax, Comfort or glove stocks forum are expressing their fear that the Russian vaccine will be the saviour of the Covid 19 pandemic. As a result, there will be no more demand for gloves and investors should sell their holdings as soon as possible. 

They are misleading investors. What is the truth? Investors must know the truth. 

The Vaccine Testing Process

The World Health Organization has not received enough information on the Russian COVID-19 vaccine to evaluate it, the assistant director of its regional branch, the Pan American Health Organization, Jarbas Barbosa has said..

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The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drug makers in Russia, released an open letter urging the Russian Health Ministry to postpone approval of the vaccine until Phase 3 trials had been successfully completed.

“It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” reads the letter from ACTO, published last Monday.

According to The New York Times Coronavirus Vaccine Tracker, there are currently 8 vaccines in large-scale Phase 3 efficacy tests. Typically, Phase 3 trials are large enough to reveal any evidence of rare, potentially life-threatening side effects. The FDA has said a COVID-19 vaccine will need to protect at least 50 percent of vaccinated persons to receive agency approval in the United States. 

Researchers around the world are developing more than 165 vaccines against the coronavirus, and 30 vaccines are in human trials. Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective vaccine by next year.

PRECLINICAL TESTING: Scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.

PHASE 1 SAFETY TRIALS: Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.

PHASE 2 EXPANDED TRIALS: Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.

PHASE 3 EFFICACY TRIALS: Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus. In June, the F.D.A. said that a coronavirus vaccine would have to protect at least 50% of vaccinated people to be considered effective. In addition, Phase 3 trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.

APPROVED: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval. Once a vaccine is licensed, researchers continue to monitor people who receive it to make sure it’s safe and effective.

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