INTERNATIONAL

Vaccine forms strong immunity, says Putin

Vladimir Putin

Vladimir Putin  

Russian President Vladimir Putin said on Tuesday the ‘Sputnik V’ vaccine for COVID-19 which has got regulatory approval is safe and effective.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the necessary checks,” Mr. Putin told a government meeting.

The vaccine is administered in two doses and consists of two serotypes of a human adenovirus, each carrying an S-antigen of the new coronavirus, which enter human cells and produce an immune response.

The platform used for the vaccine was developed by Russian scientists over two decades and had formed the basis for several vaccines in the past, including those against Ebola.

Authorities hope it will allow the Russian economy, which has been battered by fallout from the virus, to return to full capacity.

Kirill Dmitriev, head of Russia's sovereign wealth fund, said Russia had already received foreign requests for 1 billion doses. He said the vaccine also expected to be produced in Brazil.

Mr. Dmitriev said clinical trials were expected to start soon in the United Arab Emirates and the Philippines. Philippine President Rodrigo Duterte has said he is willing to participate personally.

The approval by the Health Ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.

Such trials, which require a certain proportion of participants to catch the virus to observe the vaccine's effect, are normally considered essential precursors for a vaccine to receive regulatory approval.

The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world's top drugmakers in Russia, this week urged the Ministry to postpone approval until that final trial had been successfully completed.

In a letter to the Ministry, it said there were high risks associated with registering a drug before that happened.

“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,” it said.

Some international experts have also questioned the speed at which Russia approved its vaccine.

“Normally you need a large number of people to be tested before you approve a vaccine,” said Peter Kremsner from the University Hospital in Tuebingen, Germany, currently testing CureVac's COVID-19 vaccine in clinical trials.

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