Russian president Putin hails new Sputnik moment as Russia is first to approve a COVID-19 vaccine, reports Reuters.
WHO in discussion with Russia
According to a WHO spokesman, The World Health Organization (WHO) is discussing with Russian health authorities regarding the process for possible WHO prequalification for its newly approved COVID-19 vaccine.
“We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data.”
First country to grant approval
President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine.
He added the approval after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess and likened to its success in the Cold War-era space race.
Vaccine Sputnik V
Though the vaccine awaits it’s final trial, it will be named “Sputnik V”, in homage to the world’s first satellite launched by the Soviet Union.
Concerns and feedbacks
Experts concern
Moscow’s decision to grant approval before then has raised concerns among some experts.
For more information read our article World’s First COVID19 Vaccine Gets Approval
Scientists fear Moscow may be putting national prestige before safety as only about 10% of clinical trials are successful.
Completely safe
Putin and other officials have said it is completely safe. The president said one of his daughters had taken it as a volunteer and felt good afterwards.
President’s confidence
Putin in a government meeting said:
“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the necessary checks.”
Mass roll out planned
Production
The Russian business conglomerate Sistema expressed it’s expectations to put the vaccine, developed by Moscow’s Gamaleya Institute, into mass production by the end of the year.
Vaccine administration
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. Mass roll-out in Russia is expected to start in October.
Two doses of S-antigen
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.
S-antigen enters human cells and produces 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.
Revival of economy
Authorities hope it will allow the Russian economy, which has been battered by fallout from the virus, to return to full capacity.
Dosage trial, request and production
Kirill Dmitriev, head of Russia’s sovereign wealth fund, said :
- Russia had already received foreign requests for 1 billion doses.
- The vaccine is expected to be produced in Brazil.
Clinical trials
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.
Phase III trial
The approval by the health ministry came before the Phase III trial.
Such trials require a certain number of participants to catch the virus to observe the vaccine’s effect, for it to receive regulatory approval.
ACTO urged to postpone approval
Association of Clinical Trials Organizations (ACTO) a trade body representing the world’s top drugmakers in Russia, urged the ministry to postpone approval until that final trial had been successfully completed. It said there were high risks associated with registering a drug before that happened.
How is it risky?
ACTO said that during the third phase,
- the main evidence of a vaccine’s efficacy, and
- information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases are collected.
Experts comments
University Hospital in Tuebingen, Germany
Peter Kremsner from the University Hospital in Tuebingen, Germany, currently testing CureVac’s COVID-19 vaccine in clinical trials said, “Normally you need a large number of people to be tested before you approve a vaccine.”
Dr. Anthony Fauci
Top U.S. infectious disease official Dr. Anthony Fauci said he had not heard any evidence that the vaccine was ready for widespread use.
“I hope that the Russians have actually definitively proven that the vaccine is safe and effective. I seriously doubt that they’ve done that.”
U.S. Health Secretary
U.S. Health Secretary 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.
“The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective.”
Azar later told reporters in Taiwan he was confident the United States would soon develop its own vaccine.
COVID-19 vaccines under development
More than 100 possible COVID-19 vaccines are being developed around the world.
According to WHO data, at least four are in final Phase III human trials.
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Source: Reuters
