Duterte as first volunteer for Russian vaccine
FROM A DISTANCE - Carmen N. Pedrosa (The Philippine Star) - August 16, 2020 - 12:00am

Once again President Duterte shows what it is to be a leader. He announced he would be the first volunteer for the vaccine to be donated by Russia to the Philippines. It is not an easy decision because it means taking the risk and show Filipinos that is what we need to show that the Philippines is one with the world in tackling the pandemic COVID-19.

Vladimir Putin, president of Russia, has faith in the vaccine because one of his daughters has already been inoculated with it.

The vaccine has been approved safe and effective that Russia plans to start mass vaccinations in October.

What do we know about the vaccine?

The vaccine has been dubbed “Sputnik V,” in reference to the first artificial satellite, Sputnik 1, which was launched by the USSR in 1957 – a sign that the Russian government plans to trumpet it as a matter of national pride. It has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow.

Russia expects regulatory approval for a potential COVID-19 vaccine this month and is ready to provide it to the Philippines, or team up with a local firm to mass-produce it.

The Philippines’ number of cases is among the highest in Asia, rising to 136,638 on Monday after a record daily jump of 6,958 cases.

“I will tell President Putin that I have huge trust in your studies in combating COVID and I believe that the vaccine that you have produced is really good for humanity,” Duterte said.

To allay public fears, Duterte offered to be a guinea pig when the vaccine arrives and said: “I can be the first they can experiment on.”

The Philippines stands ready to work with Russia on vaccine trials, supply and production.

This month, he restored a strict lockdown in and around the capital Manila for an initial two weeks, heeding the plea of medical frontline workers for a “timeout” amid a surge in infections during a period when restrictions were eased.

If the situation becomes a “runaway contagion,” Duterte will mobilize the military to enforce the lockdown.

According to Kirill Dmitriev, head of Russia’s Direct Investment Fund which bankrolled the effort, a vaccine developed by the Gamaleya Research Institute in Moscow may be approved in days, before scientists complete what’s called a phase three study.

That final-stage study, usually involving tens of thousands of people, is the only way to prove if an experimental vaccine is safe and really works.

Dr. Anthony Fauci, the top US infectious disease specialist, questioned the fast-track approach last week.

“I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think is problematic at best,” he said.

The vaccine would be administered in two shots, 21 days apart. Both shots contain modified adenoviruses, which would ordinarily cause a common cold. Both have been given the gene for the spike protein from the coronavirus SARS-CoV-2. This protein allows the virus to enter human cells. In theory, this should prime the immune system for an encounter with the actual coronavirus.

This is a fairly standard approach to a vaccine, and other groups are pursuing similar methods.

From Sarah Gilbert on how her team is making the Oxford coronavirus vaccine: She discusses the tests it has been through:

“New vaccines must normally pass three tests before they can be used widely. A phase I trial involves a small number of volunteers, and is intended to determine a safe dose.

“Phase II requires more people, because it tests whether the vaccine triggers an immune response, and also looks more carefully for side effects.

“Then a large phase III trial is used to find out whether the vaccine actually protects against infection. This isn’t just a formality: a vaccine might trigger an immune response in phase II, but this may not be enough to confer real immunity in phase III.”

The Russian researchers have preregistered phase I and phase II trials and, according to one website for the vaccine, these trials were completed in early August. It claims that there were no adverse effects, and that the vaccine triggered the desired immune response.

But no detailed results have been released. It also claims that a phase III trial will commence today in a number of countries including Brazil, Mexico, Saudi Arabia and the UAE.

In other words, the vaccine hasn’t been through the full gamut of tests. Without the data from phase I and II, we don’t know how safe it is. And without phase III, we don’t know if it works. “We actually have no idea if it is safe and effective at all,” writes epidemiologist Gideon Meyerowitz-Katz in The Guardian.

“Most obviously, the vaccine may cause dangerous side effects.

Adenovirus-based vaccines have been widely used, so the risk is arguably low, but without seeing trial data, there is no way to be sure.

“The vaccine also may not provide protection against the coronavirus. If people take it and believe themselves to be immune when they aren’t, the virus could spread more widely and cause many more deaths.”

There is also a socio-political risk. Many countries already have problems controlling existing diseases through vaccination, because people are reluctant to vaccinate themselves or their children. This is due to the anti-vaccination movement’s false claims that existing vaccines are dangerous. Releasing an untested vaccine could exacerbate the problem.

“This is a reckless and foolish decision,” Francois Balloux at University College London said in a statement. “Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”

Is a working vaccine on the way?

According to the World Health Organization, six vaccines are currently in phase III trials, but none has yet completed them.

More than 100 vaccines are in development and many have showed positive results, raising hopes that one will be ready to be rolled out within the next 12 months.

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