Russia has reportedly completed the clinical trial phase of its potential novel coronavirus vaccine developed by Moscow-based Gamaleya Institute and is preparing to start a mass vaccination campaign in October.
Global Update as on 23 August 2020
India’s Serum Institute clarifies that media reports on COVID-19 vaccine availability within 73 days is misleading
Serum Institute of India (SII) has issued a statement saying that news reports claiming that the country’s first coronavirus vaccine ‘Covishield’ – developed by the Oxford University- AstraZeneca will be commercialized in 73 days is misleading.
We would like to clarify that the current media claim on COVISHIELD’s availability in 73 days is misleading.
Phase-3 trials are still underway. We will officially confirm it’s availability.
Read clarification statement here – https://t.co/FvgClzcnHr#SII #COVID19 #LatestNews pic.twitter.com/mQWrqgbzO4
— SerumInstituteIndia (@SerumInstIndia) August 23, 2020
The world’s largest vaccine manufacturer said that phase-3 trials for the vaccine are still underway, and they will officially confirm it’s availability.
Indian media reported that a senior official of Serum Institute of India was quoted as saying that the government has given the company a ‘special manufacturing priority license’ and fast-tracked the trial protocol processes to get the trials completed in 58 days. The company has entered into an exclusive agreement with AstraZeneca to sell the vaccine in India and 92 other countries.
Russia prepares to produce 6 Million Doses of Sputnik V per month
Russian state-controlled domestic news agency, RIA Novosti has quoted Russian Industry Minister Denis Manturov as saying that Russia is planning to produce between 1.5 million and 2 million Sputnik V, Russian registered COVID-19 vaccine doses per month by the year-end. He said that the country will gradually ramp up its production to 6 million doses a month.
Earlier, Russian Direct Investment Fund (RDIF) CEO Kirill Dmitriev made an announcement that they are also looking for a partnership with India for producing COVID-19 vaccine Sputnik V.
COVID-19 vaccine is unlikely to be ready before the winter of 2021, England’s Chief Medical Officer
Recently, Professor Chris Whitty, Chief Medical Officer of England expressed that he would be “delighted” if a vaccine came early. But he added, “I’d be quite surprised if we had a highly effective vaccine ready for mass use in a large percentage of the population before the end of winter, certainly before this side of Christmas.”
He concluded saying, “I think it is unlikely we will have a vaccine that is highly effective and ready to deploy at scale this winter meaning 2020/21.”
China has been giving the non-certified vaccine to high-risk patients since July
Chinese National Health Commission official, Zheng Zhongwei cited speaking to the national television about the country having approved guidelines for emergency use of potential coronavirus vaccines since June 24.
China had been offering candidate coronavirus vaccines to employees at state-owned firms traveling overseas.
US President Donald Trump accuses his country’s Food and Drug Administration (FDA) of slow down the human trials of coronavirus vaccines
In a tweet yesterday, American President slammed US FDA for trying to slow down the human trials of coronavirus vaccines.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
There currently are three vaccine candidates on phase 3 trials in the United States.
Earlier update on 14 August 2020
Russia’s Health Minister Mikhail Murashko has reportedly said that “Data on preclinical and clinical studies will be published in the coming days, possibly by Monday,”
Country’s leading health expert Vladimir Bondarev, the head of the Russian Health Ministry’s Scientific Centre for Expert Evaluation of Medicinal Products has reportedly said that “in Russia, it is customary to certify [vaccines for] children from birth to 18 years old; adults from 18 to 60 years old; and older people — over 60 years old. Clinical studies have now been carried out on a group of volunteers aged from 18 to 60 years old. Thus, this vaccine is now indicated for use in people from 18 to 60 years old.”
However, Alexander Gintsburg, the director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology which developed the vaccine, said that he was vaccinated and he felt good, the news agency reported. He is in his late 60s.
The Gamaleya developed vaccine will be mass-produced by Russian business conglomerate Sistema has said it expects by the end of the year. Meanwhile, Kirill Dmitriev, head of Russia’s sovereign wealth fund, said Russia had already received foreign requests for 1 billion doses.
Earlier update on 02 August 2020
Reports from Russian media suggest that ‘paperwork’ for the vaccine’s registration with the country’s respective administrative body is underway and once cleared, doctors and teachers would be the first to receive the dosages.
The reports did not specify whether all the three stages of clinical trials were over, or only stage-II was completed. Earlier, a news report by Russia’s Tass news agency in July had stated that this potential vaccine candidate had entered phase 2 of clinical trials on July 13 which usually takes few months to be completed.
There are also references in Russian news reports that phase 3 trials would be carried out alongside the deployment of the vaccine for public use. Russia’s first potential vaccine would be approved by regulators this month.
But, experts all across the globe are concerned at Russia’s fast-track approach. Few of them hinted at the likely chance of the vaccine getting approved without phase 3 trials being carried out.
“I do hope that the Chinese and the Russians are actually testing the vaccines before they are administering the vaccine to anyone. Because claims of having a vaccine ready to distribute before you do testing is problematic at the very least,” US infectious disease expert Anthony Fauci said.
Dr. Fauci has said that the US should have a “safe and effective” vaccine by the end of this year.
“I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines,” he told US lawmakers.
China has also approved its potential coronavirus vaccine for limited use after the completion of phase-II trials. This is being administered only to military personnel for the time being. At least seven Chinese candidates are currently being tested on human beings.
