Sputnik V Moment As Russia Emerge First Country to Approve COVID-19 Vaccine

Sputnik V Moment As Russia Emerge First Country to Approve COVID-19 Vaccine

Sputnik V was endorsed by President Vladimir Putin as a vaccine against COVID-19 disease after its final clinical trials.

Putin said on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing.

Moscow’s decision to grant approval before then has raised concerns among some experts. Only about 10% of clinical trials are successful and some scientists fear Moscow may be putting national reputation before safety.

The Russian president said one of his daughters had taken it as a volunteer and felt good afterwards– Putin and other officials have said it is completely safe.

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

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Sputnik V- sinzuuliveblog
Russian President Putin Government Meeting

Sputnik V was developed by Moscow’s Gamaleya Institute, and will be mass produced by the end of the year–t he Russian business conglomerate Sistema revealed there expectation.

Mass spread-out in Russia is expected to start in October — The government officials have said it will be administered to medical personnel, and then to teachers, on a voluntary basis at the end of this month or in early September.

MORE ABOUT Sputnik V | Credit Reuters

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.

Head of Russia’s sovereign wealth fund, Kirill Dmitriev said Russia had already received foreign requests for 1 billion doses.

He said the vaccine was also expected to be produced in Brazil.

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Dmitriev said clinical trials were expected to start soon in the United Arab Emirates and the Philippines.

Rodrigo Duterte, Philippine President has said he is willing to participate personally.


Sputnik V- sinzuuliveblog

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.

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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,”The Letter Said

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

Peter Kremsner from the University Hospital in Tuebingen, Germany said — “Normally you need a large number of people to be tested before you approve a vaccine,”.

“In that respect, I think it’s reckless to do that (approve it) if lots of people haven’t already been tested.”

Dr. Anthony Fauci said

he had not heard any evidence that the vaccine was ready for widespread use- he is a top U.S. infectious disease official.

“I hope that the Russians have actually definitively proven that the vaccine is safe and effective.

Fauci added — I seriously doubt that they’ve done that.

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U.S. Health Secretary Azar said on ABC News’ “Good Morning America” programme– “The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective,”

Alex Azar, asked about Russia’s announcement, said safety was paramount and late-stage trials were key.

He said the United States was on track for an effective vaccine by the end of the year, with six candidates under development.

According to WHO data

More than 100 possible COVID-19 vaccines are being developed around the world. At least four are in final Phase III human trials.


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