Update (1145ET): The WHO has decided to review the COVID-19 vaccine candidate officially approved by Russian regulators on Tuesday, saying it would require "a rigorous safety data review".
“We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine,” said Tarik Jasarevic, the United Nations health agency’s spokesman. He made the statement while answering questions during a digital press briefing on Tuesday.
"Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data."
Russia’s Sputnik V vaccine was developed by Moscow's Gamaleya research institute with help from the Russian defense ministry. It was tested at Moscow's state medical university.
A total of 165 candidate vaccines are being tested around the world, according to a WHO tally. 139 of these are still in pre-clinical evaluation, while 26 have progressed to various phases of human testing. The 6 market leaders have already reached Phase 3.
The Gamaleya Institute candidate being produced in Russia (it's far from the only vaccine project underway in the country) is among the 26 being tested on humans in the country. However, it's still listed as 'Phase 1' for testing.
Kirill Dmitriev, the head of the Russian Direct Investment Fund, the project's main financial backer, confirmed Tuesday that Phase 3 trials are ready to begin on Wednesday, while mass production likely won't begin until September or October. More than 20 countries have already ordered doses, he added. Jasarevic added that the process being undertaken by the WHO to review the Russian vaccine would be the same undertaken for any other vaccine project.
“Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory,” Jasarevic explained.
"WHO has in place a process of pre-qualification for vaccines but also for medicines. Manufacturers ask to have the WHO pre-qualification because it is a sort of stamp of quality."
"To get this, there is a review and assessment of all required safety and efficacy data that are gathered through the clinical trials. WHO will do this for any candidate vaccine."
But even if things don't work out with the Russian candidate, Jasarevic said, there are many other vaccine candidates in Phase 3, and beyond.
"We are encouraged by the speed by which several candidate vaccines have been developing and as we have been always saying, we hope some of these vaccines will prove to be safe and efficient," said Jasarevic. "Accelerating progress does not mean compromising on safety," he said.
However, Dr. Ali Nouri, a molecular biologist and President of the Federation of American Scientists, slammed Russia's decision as "reckless" and insisted that Russia's vaccine is "well behind" the biggest western and Chinese competitors.
1) Russia’s approval of an early vaccine candidate is reckless as it places domestic- and geo-politics ahead of science and medicine. According to the @WHO vaccine tracker, the Gamaleya candidate hasn't even cleared Phase II, let alone Phase III...🧵https://t.co/Rn2yNJZmvc— Dr. Ali Nouri (@AliNouriPhD) August 11, 2020
2) That means the candidate vaccine is well behind Moderna, Sinovac, Oxford, and 5 others that are all in phase III. According to the clinical trials tracker, it's been tested for production of antibodies in a small number of healthy, under 60 age group...https://t.co/emOsYKyKCE— Dr. Ali Nouri (@AliNouriPhD) August 11, 2020
3) That's not a large-scale field trial where 1000s are vaccinated and compared to placebo for protection against the virus. Phase III is critical to show safety and efficacy especially in the over 60 age group that is the most vulnerable to SARS-C0V-2...https://t.co/C1RYvLzJrl— Dr. Ali Nouri (@AliNouriPhD) August 11, 2020
4) In 20th century we worked w/Soviet Union & @WHO to wipe out Smallpox after it killed hundreds of millions. Today, in the midst of a pandemic that requires global cooperation, our leaders are pursuing narrow, nationalistic agendas. We need #ScienceDiplomacy more than ever. pic.twitter.com/ropcB5LcrD— Dr. Ali Nouri (@AliNouriPhD) August 11, 2020
They also urged global cooperation. Though with President Trump slinging mud at China, the WHO and Russia in turn, any hope for "international cooperation" has been put to rest long ago.
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Former FDA Director Scott Gottlieb, who has been kicking himself for leaving the Trump Administration to spend more time "with family" late last year - only to miss out on what could have been a career-making turn as the nation's corona-savior - and trying to compensate by appearing on "Squawk Box" and myriad other cable-TV shows as a certified "expert", has some doubts about Russia's new COVID vaccine.
And that's hardly surprising. Since, to be fair, Gottlieb has expressed doubts for certain data dumps from Moderna and others which he has dubbed premature. Though it's also worth noting that he's on the board of Pfizer, a big-pharma giant that is working on its own COVID vaccine, having benefited from billions in promised and substantiated funding from the US government.
During Tuesday's appearance on CNBC's "Squawk Box", Gottlieb weighed in on the COVID issue du jour: the newly registered Russian vaccine, which President Putin has touted as a 'first in the world' accomplishment.
Gottlieb has his doubts:
"I wouldn't take it, certainly not outside a clinical trial right now, it appears it has only been tested in several hundreds patients at most," Gottlieb complained. He also warned that the "adenoviral vector" used by the Russian scientists is similar to the strategy being pursued by CanSino. And Gottlieb alleged the data out of the CanSino trial has been 'suboptimal'.
But it's not just the lack of clinical data that bothers Gottlieb: the adenoviral vector used by the Russian vaccine is also being used by CanSino, a Chinese pharma giant working on its own vaccine. Gottlieb says the data released from CanSino so far "hasn't been great"...and since Russia hasn't released much in the way of any data, Gottlieb says it's fair to question the results touted by the Russian government.
Gottlieb, however, did concede that it's "not a trivial vaccine," noting the complexity of the adenoviral vector. Still, "it's not at all clear how efficacious the Russian adenovirus vaccine is going to be".
Then again, Putin says he tested the Russian vaccine on his own daughter. And she only got a mild fever!
At this point, everybody speculating about the Russian vaccine will be doing so prematurely, as the scientific community awaits more details from the Russians.
At any rate, the latest 'news analysis' from Bloomberg warns readers of its website that most Americans won't be able to receive a vaccine until well into next year.
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One month after Russia's Gamelei Institute finished the first experimental vaccine trials on clinical subjects at Moscow's state medical college, Russia has set an international precedent by becoming the first country to register a COVID-19 vaccine with international medical authorities.
Russia declared the vaccine "ready for use" and extraordinarily "safe" despite "international skepticism," the Associated Press reported. Putin made the announcement during a "government meeting", where he also revealed that one of his own daughters had participated in the experimental trials.
"I would like to repeat that it has passed all the necessary tests," he said. "The most important thing is to ensure full safety of using the vaccine and its efficiency."
The trials established that a single course of the Russian vaccine is enough to establish immunity to COVID-19, while side-effects were minimal, with slight fevers appearing in Putin's daughter, and other subjecst.
“As far as I know, a vaccine against the coronavirus infection has been registered this morning (in Russia) for the first time in the world,” the President told members of the government. “I thank everyone who worked on the vaccine - it’s a very important moment for the whole world."
Of course, it's worth noting that Russia-linked hackers were accused of spying on and possibly stealing vaccine-related "medical secrets" gleaned form research conducted in the UK.
Putin insisted that vaccination in Russia should only be carried out on a voluntary basis.
"I know that it works rather effectively, forms a stable immunity, and, I repeat, it passed all the necessary inspections," the President added.
While the west raised alarms about potential safety issues caused by Russian "recklessness", Vadim Tarasov, a top scientist at Moscow’s Sechenov University, where the trials took place, said Russia the country had a "head start" as it has spent the last 2 decades dedicating significant resources to the virus. The technology behind the Russian vaccine is based upon adenovirus, otherwise known as the common cold, he added. Created artificially, the vaccine proteins replicate those of COVID-19 and trigger "an immune response similar to that caused by the coronavirus itself," Tarasov revealed.
Nikolay Briko, the Russian Health Ministry’s chief non-resident epidemiologist, echoed these sentiments."This vaccine wasn’t developed from scratch, the Gamelei Research Center had a serious, significant research base on vaccines," he was quoted as saying. "The technology of developing such a vaccine was perfected. So perhaps, the process was sped up due to the fact that the vaccine was not created from scratch. It is important that all stages (of vaccine research) are followed and that international requirements are adhered to."
To try and reassure the Russian public, Putin declared his daughter, who participated in the "experiment" suffered only a mild fever that quickly went away.
"One of my daughters got the vaccine. In this sense, she took part in the experiment. After the first vaccination, she had a temperature of 38, the next day - 37 and that was all."
The news that Putin administered the vaccine to his own daughter - one of two adult daughters known as Putin's children, although precisely which daughter received the vaccine wasn't revealed - elicited some snickers on Twitter.
Nothing says ‘we have a great vaccine’ than also saying ‘No, you can’t see our scientific data on the vaccine testing’— Darth Putin (@DarthPutinKGB) August 11, 2020
Did Putin's daughter know she was getting the vaccine?— Ivan the K™ (@IvanTheK) August 11, 2020
But believe it or not (clearly, the reporters at the AP are still skeptical), news of the world's first registered vaccine sent futures higher in premarket trading.
Of course, Russia's playing fast and loose with the "rules" allowed the experimental vaccine to be tested on Russian "elites" as early as April.
The first doses of the vaccine will be reserved for health-care workers and other vulnerable parties, Putin said. Russia says it hopes the vaccine will be available for mass innoculation early next year.