It’s Not One Drug For One Bug Any More.

Photo: Martin Sanchez.
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By the most recent estimates, the world has 140 potential COVID-19 vaccines under consideration, but only 28 of those have so far made it to human trials, and only 5 have made it to the key Phase III trials.

What is a phase III trial anyway?

When new drugs are tested there are several phases of trials.

Phase I trials aim to find the best dose of a new drug with the fewest side effects.

Phase II trials further assess safety as well as if a drug actually works.

Phase III trials compare a new drug to the best existing drug on lots of people.

Since there is no drug yet for COVID-19, most likely half the patients will be given the vaccine, and half will be given a nonactive substance. None of the patients will not know if they are getting a real vaccine or not.

So whose vaccines are in Phase III testing? According to discount drug plan GoodRx, they are:

  1. Moderna and the National Institute of Allergy and Infectious Diseases. They published results from phase I that showed an immune response in all participants. Phase III is underway.
  2. University of Oxford (England)/ AstraZeneca/ Serum Institute of India. They gave the vaccine to more than 1,000 healthy adult volunteers in phase 1 and reported that it produced antibodies and T-cells that lasted at least 2 months. They’ve outlined plans for phases II and III.
  3. Sinovac, a vaccine from China. They are approved for phase III but have not begun enrollment. They reported that in phase II trials, the vaccine triggered an immune response and caused no serious side effects.
  4. Beijing Institute of Biological Products and Sinopharm (also from China). Phase I participants showed a strong immune response and no severe side effects. They are recruiting for Phase III in the United Arab Emirates.
  5. Wuhan Institute of Biological Products and Sinopharm. They are also recruiting for Phase III in the United Arab Emirates.

So it is just a 5-horse race at this point?

Not so fast!

The Russians are enthusiastically claiming that they have the lead with yet another vaccine and may be ready to roll it out for doctors and teachers as early as October 1st.

The Russian vaccine was developed by the Gamaleya Institute in Moscow. It uses two strains of adenovirus that typically cause mild colds in humans.

The Gamaleya Institute tested its vaccine on soldiers, raising ethical questions about consent, though the defense ministry said all of the soldiers had volunteered. The institute’s director, Aleksandr Gintsberg, went on television in May to say he even tried the vaccine on himself before announcing the completion of trials in monkeys.

Patients will receive a second booster shot three weeks after the first. This enables the body to produce sufficient antibodies to fight off the virus.

Russian developers say they will conduct Phase III testing as it registers the vaccine for approval in early August.

The head of Russia’s sovereign wealth fund that is financing the vaccine research, Kiril Dmitriyev, called it “a Sputnik moment,” in reference to the successful launch by the Soviet Union in 1957 of the world’s first satellite.

“Americans were so surprised when they heard Sputnik’s beeping,” Dmitriyev told CNN. “It’s the same with this vaccine. Russia will have got there first.”

Russia, Mr Dmitriev said, which has more than 827,000 Covid-19 cases, is against politicizing the race to reach a vaccine and is ready to share its findings with scientists around the world.

But Russia also has a second vaccine under development at the Vector Virology Institute in Siberia. Government clinical trials register shows that the institute is assessing a different type of  vaccine based on a cellular platform that was originally used to make a successful Ebola vaccine.

In testimony before the U.S. Congress on July 31, Anthony Fauci, the United States’ top infectious-diseases official, expressed concern about reported COVID-19 vaccines being developed in Russia and China.

“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone,” Fauci said. “We are most likely 12 to 18 months away from a vaccine.”

Volunteering for vaccine trials.

 If you live in the US and would like to take part in a vaccine trial, you can sign up here. You will answer a few questions about your age, health, and who you live with, and then if there is a trial in your area, and you fall into a group needed for testing, then you may be called..

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